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Prone positioning curbs need for intubation in nonintubated COVID-19 patients
as indicated by data from a new meta-analysis of more than 2,000 individuals.
The use of prone positioning for nonintubated patients (so-called “awake prone positioning”) has been common since the early days of the COVID-19 pandemic. Prone positioning is more comfortable for patients, and it entails no additional cost. Also, awake prone positioning is less labor intensive than prone positioning for intubated patients, said Jie Li, PhD, in a presentation at the Critical Care Congress sponsored by the Society of Critical Care Medicine.
However, data on the specific benefits of prone positioning are lacking and contradictory, said Dr. Li, a respiratory care specialist at Rush University, Chicago.
Dr. Li and colleagues from a multinational research group found that outcomes were improved for patients who were treated with awake prone positioning – notably, fewer treatment failures at day 28 – but a pair of subsequent studies by other researchers showed contradictory outcomes.
For more definitive evidence, Dr. Li and colleagues conducted a systematic review and meta-analysis of 11 randomized, controlled trials and one unpublished study of awake prone positioning for patients with COVID-19. The studies were published between Jan. 1, 2020, and July 1, 2022, and included a total of 2,886 adult patients.
The primary outcome was the reported cumulative risk of intubation among nonintubated COVID-19 patients. Secondary outcomes included mortality, the need for escalating respiratory support, length of hospital length of stay, ICU admission, and adverse events.
Overall, awake prone positioning significantly reduced the intubation risk among nonintubated patients compared to standard care (risk ratio, 0.85).
A further subgroup analysis showed a significant reduction in risk for intubation among patients supported by high-flow nasal cannula or noninvasive ventilation (RR, 0.83).
However, no additional reduction in intubation risk occurred among patients who received conventional oxygen therapy (RR, 1.02).
Mortality rates were similar for patients who underwent awake prone positioning and those who underwent supine positioning (RR, 0.96), as was the need for additional respiratory support (RR, 1.03). The length of hospital stay, ICU admission, and adverse events were similar between the patients who underwent prone positioning and those who underwent supine positioning.
The findings were limited by several factors. There was a potential for confounding by disease severity, which may have increased the use of respiratory support devices, Li said in her presentation.
“Another factor we should not ignore is the daily duration of prone positioning,” said Dr. Li. More research is needed to identify which factors play the greatest roles in treatment success.
The current study was important in that it evaluated the current evidence of awake prone positioning, “particularly to identify the patients who benefit most from this treatment, in order to guide clinical practice,” Dr. Li said in an interview.
“Since early in the pandemic, awake prone positioning has been broadly utilized to treat patients with COVID-19,” she said. “In 2021, we published a multinational randomized controlled trial with over 1,100 patients enrolled and reported lower treatment failure. However, no significant differences of treatment failure were reported in several subsequent multicenter randomized, controlled trials published after our study.”
Dr. Li said she was not surprised by the findings, which reflect those of her team’s previously published meta-analysis. “The increased number of patients helps confirm our previous finding, even with the inclusion of several recently published randomized controlled trials,” she said.
For clinicians, “the current evidence supports the use of awake prone positioning for patients with COVID-19, particularly those who require advanced respiratory support from high-flow nasal cannula or noninvasive ventilation,” Dr. Li said.
The study received no outside funding. Dr. Li has relationships with AARC, Heyer, Aeorgen, the Rice Foundation, and Fisher & Paykel Healthcare.
A version of this article first appeared on Medscape.com.
as indicated by data from a new meta-analysis of more than 2,000 individuals.
The use of prone positioning for nonintubated patients (so-called “awake prone positioning”) has been common since the early days of the COVID-19 pandemic. Prone positioning is more comfortable for patients, and it entails no additional cost. Also, awake prone positioning is less labor intensive than prone positioning for intubated patients, said Jie Li, PhD, in a presentation at the Critical Care Congress sponsored by the Society of Critical Care Medicine.
However, data on the specific benefits of prone positioning are lacking and contradictory, said Dr. Li, a respiratory care specialist at Rush University, Chicago.
Dr. Li and colleagues from a multinational research group found that outcomes were improved for patients who were treated with awake prone positioning – notably, fewer treatment failures at day 28 – but a pair of subsequent studies by other researchers showed contradictory outcomes.
For more definitive evidence, Dr. Li and colleagues conducted a systematic review and meta-analysis of 11 randomized, controlled trials and one unpublished study of awake prone positioning for patients with COVID-19. The studies were published between Jan. 1, 2020, and July 1, 2022, and included a total of 2,886 adult patients.
The primary outcome was the reported cumulative risk of intubation among nonintubated COVID-19 patients. Secondary outcomes included mortality, the need for escalating respiratory support, length of hospital length of stay, ICU admission, and adverse events.
Overall, awake prone positioning significantly reduced the intubation risk among nonintubated patients compared to standard care (risk ratio, 0.85).
A further subgroup analysis showed a significant reduction in risk for intubation among patients supported by high-flow nasal cannula or noninvasive ventilation (RR, 0.83).
However, no additional reduction in intubation risk occurred among patients who received conventional oxygen therapy (RR, 1.02).
Mortality rates were similar for patients who underwent awake prone positioning and those who underwent supine positioning (RR, 0.96), as was the need for additional respiratory support (RR, 1.03). The length of hospital stay, ICU admission, and adverse events were similar between the patients who underwent prone positioning and those who underwent supine positioning.
The findings were limited by several factors. There was a potential for confounding by disease severity, which may have increased the use of respiratory support devices, Li said in her presentation.
“Another factor we should not ignore is the daily duration of prone positioning,” said Dr. Li. More research is needed to identify which factors play the greatest roles in treatment success.
The current study was important in that it evaluated the current evidence of awake prone positioning, “particularly to identify the patients who benefit most from this treatment, in order to guide clinical practice,” Dr. Li said in an interview.
“Since early in the pandemic, awake prone positioning has been broadly utilized to treat patients with COVID-19,” she said. “In 2021, we published a multinational randomized controlled trial with over 1,100 patients enrolled and reported lower treatment failure. However, no significant differences of treatment failure were reported in several subsequent multicenter randomized, controlled trials published after our study.”
Dr. Li said she was not surprised by the findings, which reflect those of her team’s previously published meta-analysis. “The increased number of patients helps confirm our previous finding, even with the inclusion of several recently published randomized controlled trials,” she said.
For clinicians, “the current evidence supports the use of awake prone positioning for patients with COVID-19, particularly those who require advanced respiratory support from high-flow nasal cannula or noninvasive ventilation,” Dr. Li said.
The study received no outside funding. Dr. Li has relationships with AARC, Heyer, Aeorgen, the Rice Foundation, and Fisher & Paykel Healthcare.
A version of this article first appeared on Medscape.com.
as indicated by data from a new meta-analysis of more than 2,000 individuals.
The use of prone positioning for nonintubated patients (so-called “awake prone positioning”) has been common since the early days of the COVID-19 pandemic. Prone positioning is more comfortable for patients, and it entails no additional cost. Also, awake prone positioning is less labor intensive than prone positioning for intubated patients, said Jie Li, PhD, in a presentation at the Critical Care Congress sponsored by the Society of Critical Care Medicine.
However, data on the specific benefits of prone positioning are lacking and contradictory, said Dr. Li, a respiratory care specialist at Rush University, Chicago.
Dr. Li and colleagues from a multinational research group found that outcomes were improved for patients who were treated with awake prone positioning – notably, fewer treatment failures at day 28 – but a pair of subsequent studies by other researchers showed contradictory outcomes.
For more definitive evidence, Dr. Li and colleagues conducted a systematic review and meta-analysis of 11 randomized, controlled trials and one unpublished study of awake prone positioning for patients with COVID-19. The studies were published between Jan. 1, 2020, and July 1, 2022, and included a total of 2,886 adult patients.
The primary outcome was the reported cumulative risk of intubation among nonintubated COVID-19 patients. Secondary outcomes included mortality, the need for escalating respiratory support, length of hospital length of stay, ICU admission, and adverse events.
Overall, awake prone positioning significantly reduced the intubation risk among nonintubated patients compared to standard care (risk ratio, 0.85).
A further subgroup analysis showed a significant reduction in risk for intubation among patients supported by high-flow nasal cannula or noninvasive ventilation (RR, 0.83).
However, no additional reduction in intubation risk occurred among patients who received conventional oxygen therapy (RR, 1.02).
Mortality rates were similar for patients who underwent awake prone positioning and those who underwent supine positioning (RR, 0.96), as was the need for additional respiratory support (RR, 1.03). The length of hospital stay, ICU admission, and adverse events were similar between the patients who underwent prone positioning and those who underwent supine positioning.
The findings were limited by several factors. There was a potential for confounding by disease severity, which may have increased the use of respiratory support devices, Li said in her presentation.
“Another factor we should not ignore is the daily duration of prone positioning,” said Dr. Li. More research is needed to identify which factors play the greatest roles in treatment success.
The current study was important in that it evaluated the current evidence of awake prone positioning, “particularly to identify the patients who benefit most from this treatment, in order to guide clinical practice,” Dr. Li said in an interview.
“Since early in the pandemic, awake prone positioning has been broadly utilized to treat patients with COVID-19,” she said. “In 2021, we published a multinational randomized controlled trial with over 1,100 patients enrolled and reported lower treatment failure. However, no significant differences of treatment failure were reported in several subsequent multicenter randomized, controlled trials published after our study.”
Dr. Li said she was not surprised by the findings, which reflect those of her team’s previously published meta-analysis. “The increased number of patients helps confirm our previous finding, even with the inclusion of several recently published randomized controlled trials,” she said.
For clinicians, “the current evidence supports the use of awake prone positioning for patients with COVID-19, particularly those who require advanced respiratory support from high-flow nasal cannula or noninvasive ventilation,” Dr. Li said.
The study received no outside funding. Dr. Li has relationships with AARC, Heyer, Aeorgen, the Rice Foundation, and Fisher & Paykel Healthcare.
A version of this article first appeared on Medscape.com.
FROM SCCM 2023
COVID vs. flu: Which is deadlier?
a new study shows.
People who were hospitalized with Omicron COVID-19 infections were 54% more likely to die, compared with people who were hospitalized with the flu, Swiss researchers found.
The results of the study continue to debunk an earlier belief from the start of the pandemic that the flu was the more dangerous of the two respiratory viruses. The researchers noted that the deadliness of COVID-19, compared with flu, persisted “despite virus evolution and improved management strategies.”
The study was published in JAMA Network Open and included 5,212 patients in Switzerland hospitalized with COVID-19 or the flu. All the COVID patients were infected with the Omicron variant and hospitalized between Jan. 15, 2022, and March 15, 2022. Flu data included cases from January 2018 to March 15, 2022.
Overall, 7% of COVID-19 patients died, compared with 4.4% of flu patients. Researchers noted that the death rate for hospitalized COVID patients had declined since their previous study, which was conducted during the first COVID wave in the first half of 2020. At that time, the death rate of hospitalized COVID patients was 12.8%.
Since then, 98% of the Swiss population has been vaccinated. “Vaccination still plays a significant role regarding the main outcome,” the authors concluded, since a secondary analysis in this most recent study showed that unvaccinated COVID patients were twice as likely to die, compared with flu patients.
“Our results demonstrate that COVID-19 still cannot simply be compared with influenza,” they wrote.
While the death rate among COVID patients was significantly higher, there was no difference in the rate that COVID or flu patients were admitted to the ICU, which was around 8%.
A limitation of the study was that all the COVID cases did not have laboratory testing to confirm the Omicron variant. However, the study authors noted that Omicron accounted for at least 95% of cases during the time the patients were hospitalized. The authors were confident that their results were not biased by the potential for other variants being included in the data.
Four coauthors reported receiving grants and personal fees from various sources.
A version of this article first appeared on WebMD.com.
a new study shows.
People who were hospitalized with Omicron COVID-19 infections were 54% more likely to die, compared with people who were hospitalized with the flu, Swiss researchers found.
The results of the study continue to debunk an earlier belief from the start of the pandemic that the flu was the more dangerous of the two respiratory viruses. The researchers noted that the deadliness of COVID-19, compared with flu, persisted “despite virus evolution and improved management strategies.”
The study was published in JAMA Network Open and included 5,212 patients in Switzerland hospitalized with COVID-19 or the flu. All the COVID patients were infected with the Omicron variant and hospitalized between Jan. 15, 2022, and March 15, 2022. Flu data included cases from January 2018 to March 15, 2022.
Overall, 7% of COVID-19 patients died, compared with 4.4% of flu patients. Researchers noted that the death rate for hospitalized COVID patients had declined since their previous study, which was conducted during the first COVID wave in the first half of 2020. At that time, the death rate of hospitalized COVID patients was 12.8%.
Since then, 98% of the Swiss population has been vaccinated. “Vaccination still plays a significant role regarding the main outcome,” the authors concluded, since a secondary analysis in this most recent study showed that unvaccinated COVID patients were twice as likely to die, compared with flu patients.
“Our results demonstrate that COVID-19 still cannot simply be compared with influenza,” they wrote.
While the death rate among COVID patients was significantly higher, there was no difference in the rate that COVID or flu patients were admitted to the ICU, which was around 8%.
A limitation of the study was that all the COVID cases did not have laboratory testing to confirm the Omicron variant. However, the study authors noted that Omicron accounted for at least 95% of cases during the time the patients were hospitalized. The authors were confident that their results were not biased by the potential for other variants being included in the data.
Four coauthors reported receiving grants and personal fees from various sources.
A version of this article first appeared on WebMD.com.
a new study shows.
People who were hospitalized with Omicron COVID-19 infections were 54% more likely to die, compared with people who were hospitalized with the flu, Swiss researchers found.
The results of the study continue to debunk an earlier belief from the start of the pandemic that the flu was the more dangerous of the two respiratory viruses. The researchers noted that the deadliness of COVID-19, compared with flu, persisted “despite virus evolution and improved management strategies.”
The study was published in JAMA Network Open and included 5,212 patients in Switzerland hospitalized with COVID-19 or the flu. All the COVID patients were infected with the Omicron variant and hospitalized between Jan. 15, 2022, and March 15, 2022. Flu data included cases from January 2018 to March 15, 2022.
Overall, 7% of COVID-19 patients died, compared with 4.4% of flu patients. Researchers noted that the death rate for hospitalized COVID patients had declined since their previous study, which was conducted during the first COVID wave in the first half of 2020. At that time, the death rate of hospitalized COVID patients was 12.8%.
Since then, 98% of the Swiss population has been vaccinated. “Vaccination still plays a significant role regarding the main outcome,” the authors concluded, since a secondary analysis in this most recent study showed that unvaccinated COVID patients were twice as likely to die, compared with flu patients.
“Our results demonstrate that COVID-19 still cannot simply be compared with influenza,” they wrote.
While the death rate among COVID patients was significantly higher, there was no difference in the rate that COVID or flu patients were admitted to the ICU, which was around 8%.
A limitation of the study was that all the COVID cases did not have laboratory testing to confirm the Omicron variant. However, the study authors noted that Omicron accounted for at least 95% of cases during the time the patients were hospitalized. The authors were confident that their results were not biased by the potential for other variants being included in the data.
Four coauthors reported receiving grants and personal fees from various sources.
A version of this article first appeared on WebMD.com.
FROM JAMA NETWORK OPEN
Eight-week TB treatment strategy shows potential
A strategy for the
“We found that if we use the strategy of a bedaquiline-linezolid five-drug regimen for 8 weeks and then followed patients for 96 weeks, [the regimen] was noninferior, clinically, to the standard regimen in terms of the number of people alive, free of TB disease, and not on treatment,” said lead author Nicholas Paton, MD, of the National University of Singapore, in a press conference held during the Conference on Retroviruses & Opportunistic Infections.
“The total time on treatment was reduced by half – instead of 160 days, it was 85 days for the total duration.”
Commenting on the study, which was published concurrently in the New England Journal of Medicine, Richard E. Chaisson, MD, noted that, although more needs to be understood, the high number of responses is nevertheless encouraging.
“Clinicians will not feel comfortable with the short regimens at this point, but it is remarkable that so many patients did well with shorter treatments,” Dr. Chaisson, who is a professor of medicine, epidemiology, and international health and director of the Johns Hopkins University Center for Tuberculosis Research, Baltimore, said in an interview.
Importantly, the study should help push forward “future studies [that] will stratify patients according to their likelihood of responding to shorter treatments,” he said.
The current global standard for TB treatment, practiced for 4 decades, has been a 6-month rifampin-based regimen. Although the regimen performs well, curing more than 95% of cases in clinical trials, in real-world practice, the prolonged duration can be problematic, with issues of nonadherence and loss of patients to follow-up.
Previous research has shown that shorter regimens have potential, with some studies showing as many as 85% of patients cured with 3- and 4-month regimens, and some promising 2-month regimens showing efficacy specifically for those with smear-negative TB.
These efforts suggest that “the current 6-month regimen may lead to overtreatment in the majority of persons in order to prevent relapse in a minority of persons,” the authors asserted.
TRUNCATE-TB
To investigate a suitable shorter-term alternative, the authors conducted the phase 2-3, prospective, open-label TRUNCATE-TB trial, in which 674 patients with rifampin-susceptible pulmonary TB were enrolled at 18 sites in Asia and Africa.
The patients were randomly assigned to receive either the standard treatment regimen (rifampin and isoniazid for 24 weeks with pyrazinamide and ethambutol for the first 8 weeks; n = 181), or one of four novel five-drug regimens to be administered over 8 weeks, along with extended treatment for persistent clinical disease of up to 12 weeks, if needed, and a plan for retreatment in the case of relapse (n = 493).
Two of the regimens were dropped because of logistic criteria; the two remaining shorter-course groups included in the study involved either high-dose rifampin plus linezolid or bedaquiline plus linezolid, each combined with isoniazid, pyrazinamide, and ethambutol.
Of the patients, 62% were male, and four withdrew or were lost to follow-up by the end of the study at a final follow-up at week 96.
Among patients assigned to the 8-week regimens, 80% stopped at exactly 8 weeks, while 9% wound up having extended treatment to 10 weeks and 3% were extended to 12 weeks.
For the primary endpoint, a composite of death, ongoing treatment, or active disease at week 96, the rate was lowest in the standard 24-week therapy group, occurring in 7 of 181 patients (3.9%), compared with 21 of 184 patients (11.4%) in the rifampin plus linezolid group (adjusted difference, 7.4 percentage points, which did not meet noninferiority criterion), and 11 of 189 (5.8%) in the group in the bedaquiline plus linezolid group (adjusted difference, 0.8 percentage points, meeting noninferiority criterion).
The mean total duration of treatment through week 96 in the standard treatment group was 180 days versus 106 days in the rifampin–linezolid group, and 85 days in the bedaquiline-linezolid group.
The results were consistent across multiple subgroups defined according to baseline characteristics, including some that could be linked to severe disease and a high risk for relapse.
In terms of safety, there were no significant differences between the groups in terms of grade 3 or 4 adverse events.
Of note, only two patients (1.1%) in the bedaquiline plus linezolid group acquired a resistance, which Dr. Paton said was “encouraging,” because of concerns about resistance to that drug.
‘Unfavorable’ composite also evaluated
In an updated analysis of the study that Dr. Paton presented at the meeting, the authors looked at a revised “unfavorable” primary outcome – a composite including treatment failure, relapse, death, or nonattendance at week 96 without evidence of prior disease clearance.
The rate remained lowest in the standard 24-week therapy group (3.9%) versus 25% in the rifampin plus linezolid group, and 13.8% in the bedaquiline plus linezolid group.
Though the lower rate with the standard treatment was expected, Dr. Paton said the results nevertheless hold promise, at least for some patients, for successful treatment with the 8-week bedaquiline plus linezolid strategy.
“What the trial has told us is that even with that 13.8% relapse rate, we can manage patients within this strategy and people can do fine at the end, because with some simple clinical biomarkers, we can pick the people who may have a high chance of achieving a cure.”
Dr. Chaisson expressed concern over the higher unfavorable rates, but said the results help pave the way for refining a workable-shorter term strategy.
“TRUNCATE-TB did find that most patients could be successfully treated in 2 months with the novel regimen of bedaquiline plus linezolid, but the failure rate was still unacceptably high,” he said.
“This regimen will not be widely adapted at this point, but additional analyses may identify subsets of patients who will do well with shorter regimens, and future studies will stratify patients according to their likelihood of responding to shorter treatments.”
The authors of an accompanying editorial further commented that the benefits of a shorter treatment strategy could very well outweigh possible shortcomings.
“Treatment algorithms such as that used in the TRUNCATE-TB trial are fundamental to tuberculosis control,” wrote Véronique Dartois, PhD, Center for Discovery and Innovation, Nutley, N.J., and Eric J. Rubin, MD, PhD, the editor-in-chief of NEJM. “Although implementing them could be a challenge, any added burden might be offset by reduced costs, better adherence, and increased patient satisfaction. Thus, for tuberculosis, a strategy might be more than just a regimen.”
The good news, as summed up by CROI vice-chair Landon Myer, MD, PhD, in the press conference, is that “we’re moving closer and closer to the holy grail of a short, efficacious regimen for TB treatment. We’re getting there slowly, but we’re getting there.”
The study received grant funding from the Singapore National Medical Research Council; a grant from the Department of Health and Social Care; the Foreign, Commonwealth, and Development Office; the Medical Research Council; and Wellcome Trust; as well as a grant from the UK Research and Innovation Medical Research Council. Dr. Dartois reported no relevant financial relationships. Dr. Chaisson had no disclosures to report.
A version of this article originally appeared on Medscape.com.
A strategy for the
“We found that if we use the strategy of a bedaquiline-linezolid five-drug regimen for 8 weeks and then followed patients for 96 weeks, [the regimen] was noninferior, clinically, to the standard regimen in terms of the number of people alive, free of TB disease, and not on treatment,” said lead author Nicholas Paton, MD, of the National University of Singapore, in a press conference held during the Conference on Retroviruses & Opportunistic Infections.
“The total time on treatment was reduced by half – instead of 160 days, it was 85 days for the total duration.”
Commenting on the study, which was published concurrently in the New England Journal of Medicine, Richard E. Chaisson, MD, noted that, although more needs to be understood, the high number of responses is nevertheless encouraging.
“Clinicians will not feel comfortable with the short regimens at this point, but it is remarkable that so many patients did well with shorter treatments,” Dr. Chaisson, who is a professor of medicine, epidemiology, and international health and director of the Johns Hopkins University Center for Tuberculosis Research, Baltimore, said in an interview.
Importantly, the study should help push forward “future studies [that] will stratify patients according to their likelihood of responding to shorter treatments,” he said.
The current global standard for TB treatment, practiced for 4 decades, has been a 6-month rifampin-based regimen. Although the regimen performs well, curing more than 95% of cases in clinical trials, in real-world practice, the prolonged duration can be problematic, with issues of nonadherence and loss of patients to follow-up.
Previous research has shown that shorter regimens have potential, with some studies showing as many as 85% of patients cured with 3- and 4-month regimens, and some promising 2-month regimens showing efficacy specifically for those with smear-negative TB.
These efforts suggest that “the current 6-month regimen may lead to overtreatment in the majority of persons in order to prevent relapse in a minority of persons,” the authors asserted.
TRUNCATE-TB
To investigate a suitable shorter-term alternative, the authors conducted the phase 2-3, prospective, open-label TRUNCATE-TB trial, in which 674 patients with rifampin-susceptible pulmonary TB were enrolled at 18 sites in Asia and Africa.
The patients were randomly assigned to receive either the standard treatment regimen (rifampin and isoniazid for 24 weeks with pyrazinamide and ethambutol for the first 8 weeks; n = 181), or one of four novel five-drug regimens to be administered over 8 weeks, along with extended treatment for persistent clinical disease of up to 12 weeks, if needed, and a plan for retreatment in the case of relapse (n = 493).
Two of the regimens were dropped because of logistic criteria; the two remaining shorter-course groups included in the study involved either high-dose rifampin plus linezolid or bedaquiline plus linezolid, each combined with isoniazid, pyrazinamide, and ethambutol.
Of the patients, 62% were male, and four withdrew or were lost to follow-up by the end of the study at a final follow-up at week 96.
Among patients assigned to the 8-week regimens, 80% stopped at exactly 8 weeks, while 9% wound up having extended treatment to 10 weeks and 3% were extended to 12 weeks.
For the primary endpoint, a composite of death, ongoing treatment, or active disease at week 96, the rate was lowest in the standard 24-week therapy group, occurring in 7 of 181 patients (3.9%), compared with 21 of 184 patients (11.4%) in the rifampin plus linezolid group (adjusted difference, 7.4 percentage points, which did not meet noninferiority criterion), and 11 of 189 (5.8%) in the group in the bedaquiline plus linezolid group (adjusted difference, 0.8 percentage points, meeting noninferiority criterion).
The mean total duration of treatment through week 96 in the standard treatment group was 180 days versus 106 days in the rifampin–linezolid group, and 85 days in the bedaquiline-linezolid group.
The results were consistent across multiple subgroups defined according to baseline characteristics, including some that could be linked to severe disease and a high risk for relapse.
In terms of safety, there were no significant differences between the groups in terms of grade 3 or 4 adverse events.
Of note, only two patients (1.1%) in the bedaquiline plus linezolid group acquired a resistance, which Dr. Paton said was “encouraging,” because of concerns about resistance to that drug.
‘Unfavorable’ composite also evaluated
In an updated analysis of the study that Dr. Paton presented at the meeting, the authors looked at a revised “unfavorable” primary outcome – a composite including treatment failure, relapse, death, or nonattendance at week 96 without evidence of prior disease clearance.
The rate remained lowest in the standard 24-week therapy group (3.9%) versus 25% in the rifampin plus linezolid group, and 13.8% in the bedaquiline plus linezolid group.
Though the lower rate with the standard treatment was expected, Dr. Paton said the results nevertheless hold promise, at least for some patients, for successful treatment with the 8-week bedaquiline plus linezolid strategy.
“What the trial has told us is that even with that 13.8% relapse rate, we can manage patients within this strategy and people can do fine at the end, because with some simple clinical biomarkers, we can pick the people who may have a high chance of achieving a cure.”
Dr. Chaisson expressed concern over the higher unfavorable rates, but said the results help pave the way for refining a workable-shorter term strategy.
“TRUNCATE-TB did find that most patients could be successfully treated in 2 months with the novel regimen of bedaquiline plus linezolid, but the failure rate was still unacceptably high,” he said.
“This regimen will not be widely adapted at this point, but additional analyses may identify subsets of patients who will do well with shorter regimens, and future studies will stratify patients according to their likelihood of responding to shorter treatments.”
The authors of an accompanying editorial further commented that the benefits of a shorter treatment strategy could very well outweigh possible shortcomings.
“Treatment algorithms such as that used in the TRUNCATE-TB trial are fundamental to tuberculosis control,” wrote Véronique Dartois, PhD, Center for Discovery and Innovation, Nutley, N.J., and Eric J. Rubin, MD, PhD, the editor-in-chief of NEJM. “Although implementing them could be a challenge, any added burden might be offset by reduced costs, better adherence, and increased patient satisfaction. Thus, for tuberculosis, a strategy might be more than just a regimen.”
The good news, as summed up by CROI vice-chair Landon Myer, MD, PhD, in the press conference, is that “we’re moving closer and closer to the holy grail of a short, efficacious regimen for TB treatment. We’re getting there slowly, but we’re getting there.”
The study received grant funding from the Singapore National Medical Research Council; a grant from the Department of Health and Social Care; the Foreign, Commonwealth, and Development Office; the Medical Research Council; and Wellcome Trust; as well as a grant from the UK Research and Innovation Medical Research Council. Dr. Dartois reported no relevant financial relationships. Dr. Chaisson had no disclosures to report.
A version of this article originally appeared on Medscape.com.
A strategy for the
“We found that if we use the strategy of a bedaquiline-linezolid five-drug regimen for 8 weeks and then followed patients for 96 weeks, [the regimen] was noninferior, clinically, to the standard regimen in terms of the number of people alive, free of TB disease, and not on treatment,” said lead author Nicholas Paton, MD, of the National University of Singapore, in a press conference held during the Conference on Retroviruses & Opportunistic Infections.
“The total time on treatment was reduced by half – instead of 160 days, it was 85 days for the total duration.”
Commenting on the study, which was published concurrently in the New England Journal of Medicine, Richard E. Chaisson, MD, noted that, although more needs to be understood, the high number of responses is nevertheless encouraging.
“Clinicians will not feel comfortable with the short regimens at this point, but it is remarkable that so many patients did well with shorter treatments,” Dr. Chaisson, who is a professor of medicine, epidemiology, and international health and director of the Johns Hopkins University Center for Tuberculosis Research, Baltimore, said in an interview.
Importantly, the study should help push forward “future studies [that] will stratify patients according to their likelihood of responding to shorter treatments,” he said.
The current global standard for TB treatment, practiced for 4 decades, has been a 6-month rifampin-based regimen. Although the regimen performs well, curing more than 95% of cases in clinical trials, in real-world practice, the prolonged duration can be problematic, with issues of nonadherence and loss of patients to follow-up.
Previous research has shown that shorter regimens have potential, with some studies showing as many as 85% of patients cured with 3- and 4-month regimens, and some promising 2-month regimens showing efficacy specifically for those with smear-negative TB.
These efforts suggest that “the current 6-month regimen may lead to overtreatment in the majority of persons in order to prevent relapse in a minority of persons,” the authors asserted.
TRUNCATE-TB
To investigate a suitable shorter-term alternative, the authors conducted the phase 2-3, prospective, open-label TRUNCATE-TB trial, in which 674 patients with rifampin-susceptible pulmonary TB were enrolled at 18 sites in Asia and Africa.
The patients were randomly assigned to receive either the standard treatment regimen (rifampin and isoniazid for 24 weeks with pyrazinamide and ethambutol for the first 8 weeks; n = 181), or one of four novel five-drug regimens to be administered over 8 weeks, along with extended treatment for persistent clinical disease of up to 12 weeks, if needed, and a plan for retreatment in the case of relapse (n = 493).
Two of the regimens were dropped because of logistic criteria; the two remaining shorter-course groups included in the study involved either high-dose rifampin plus linezolid or bedaquiline plus linezolid, each combined with isoniazid, pyrazinamide, and ethambutol.
Of the patients, 62% were male, and four withdrew or were lost to follow-up by the end of the study at a final follow-up at week 96.
Among patients assigned to the 8-week regimens, 80% stopped at exactly 8 weeks, while 9% wound up having extended treatment to 10 weeks and 3% were extended to 12 weeks.
For the primary endpoint, a composite of death, ongoing treatment, or active disease at week 96, the rate was lowest in the standard 24-week therapy group, occurring in 7 of 181 patients (3.9%), compared with 21 of 184 patients (11.4%) in the rifampin plus linezolid group (adjusted difference, 7.4 percentage points, which did not meet noninferiority criterion), and 11 of 189 (5.8%) in the group in the bedaquiline plus linezolid group (adjusted difference, 0.8 percentage points, meeting noninferiority criterion).
The mean total duration of treatment through week 96 in the standard treatment group was 180 days versus 106 days in the rifampin–linezolid group, and 85 days in the bedaquiline-linezolid group.
The results were consistent across multiple subgroups defined according to baseline characteristics, including some that could be linked to severe disease and a high risk for relapse.
In terms of safety, there were no significant differences between the groups in terms of grade 3 or 4 adverse events.
Of note, only two patients (1.1%) in the bedaquiline plus linezolid group acquired a resistance, which Dr. Paton said was “encouraging,” because of concerns about resistance to that drug.
‘Unfavorable’ composite also evaluated
In an updated analysis of the study that Dr. Paton presented at the meeting, the authors looked at a revised “unfavorable” primary outcome – a composite including treatment failure, relapse, death, or nonattendance at week 96 without evidence of prior disease clearance.
The rate remained lowest in the standard 24-week therapy group (3.9%) versus 25% in the rifampin plus linezolid group, and 13.8% in the bedaquiline plus linezolid group.
Though the lower rate with the standard treatment was expected, Dr. Paton said the results nevertheless hold promise, at least for some patients, for successful treatment with the 8-week bedaquiline plus linezolid strategy.
“What the trial has told us is that even with that 13.8% relapse rate, we can manage patients within this strategy and people can do fine at the end, because with some simple clinical biomarkers, we can pick the people who may have a high chance of achieving a cure.”
Dr. Chaisson expressed concern over the higher unfavorable rates, but said the results help pave the way for refining a workable-shorter term strategy.
“TRUNCATE-TB did find that most patients could be successfully treated in 2 months with the novel regimen of bedaquiline plus linezolid, but the failure rate was still unacceptably high,” he said.
“This regimen will not be widely adapted at this point, but additional analyses may identify subsets of patients who will do well with shorter regimens, and future studies will stratify patients according to their likelihood of responding to shorter treatments.”
The authors of an accompanying editorial further commented that the benefits of a shorter treatment strategy could very well outweigh possible shortcomings.
“Treatment algorithms such as that used in the TRUNCATE-TB trial are fundamental to tuberculosis control,” wrote Véronique Dartois, PhD, Center for Discovery and Innovation, Nutley, N.J., and Eric J. Rubin, MD, PhD, the editor-in-chief of NEJM. “Although implementing them could be a challenge, any added burden might be offset by reduced costs, better adherence, and increased patient satisfaction. Thus, for tuberculosis, a strategy might be more than just a regimen.”
The good news, as summed up by CROI vice-chair Landon Myer, MD, PhD, in the press conference, is that “we’re moving closer and closer to the holy grail of a short, efficacious regimen for TB treatment. We’re getting there slowly, but we’re getting there.”
The study received grant funding from the Singapore National Medical Research Council; a grant from the Department of Health and Social Care; the Foreign, Commonwealth, and Development Office; the Medical Research Council; and Wellcome Trust; as well as a grant from the UK Research and Innovation Medical Research Council. Dr. Dartois reported no relevant financial relationships. Dr. Chaisson had no disclosures to report.
A version of this article originally appeared on Medscape.com.
FROM CROI 2023
COVID infection provides immunity equal to vaccination: Study
People who’ve been infected with COVID reduced their chances of hospitalization and death by 88% over 10 months compared to somebody who hasn’t been infected, according to the study, published in The Lancet.
The natural immunity provided by infection was “at least as high, if not higher” than the immunity provided by two doses of Moderna or Pfizer mRNA vaccines against the ancestral, Alpha, Delta, and Omicron BA.1 variants, the researchers reported.
But protection against the BA.1 subvariant of Omicron was not as high – 36% at 10 months after infection, wrote the research team from the Institute for Health Metrics and Evaluation at the University of Washington.
They examined 65 studies from 19 countries through Sept. 31, 2022. They did not study data about infection from Omicron XBB and its sub-lineages. People who had immunity from both infection and vaccination, known as hybrid immunity, were not studied.
The findings don’t mean people should skip the vaccines and get COVID on purpose, one of the researchers told NBC News.
“The problem of saying ‘I’m gonna get infected to get immunity’ is you might be one of those people that end up in the hospital or die,” said Christopher Murray, MD, DPhil, director of the IHME. “Why would you take the risk when you can get immunity through vaccination quite safely?”
The findings could help people figure out the most effective time to get vaccinated or boosted and guide officials in setting policies on workplace vaccine mandates and rules for high-occupancy indoor settings, the researchers concluded.
This was the largest meta-analysis of immunity following infection to date, NBC News reports.
A version of this article originally appeared on WebMD.com.
People who’ve been infected with COVID reduced their chances of hospitalization and death by 88% over 10 months compared to somebody who hasn’t been infected, according to the study, published in The Lancet.
The natural immunity provided by infection was “at least as high, if not higher” than the immunity provided by two doses of Moderna or Pfizer mRNA vaccines against the ancestral, Alpha, Delta, and Omicron BA.1 variants, the researchers reported.
But protection against the BA.1 subvariant of Omicron was not as high – 36% at 10 months after infection, wrote the research team from the Institute for Health Metrics and Evaluation at the University of Washington.
They examined 65 studies from 19 countries through Sept. 31, 2022. They did not study data about infection from Omicron XBB and its sub-lineages. People who had immunity from both infection and vaccination, known as hybrid immunity, were not studied.
The findings don’t mean people should skip the vaccines and get COVID on purpose, one of the researchers told NBC News.
“The problem of saying ‘I’m gonna get infected to get immunity’ is you might be one of those people that end up in the hospital or die,” said Christopher Murray, MD, DPhil, director of the IHME. “Why would you take the risk when you can get immunity through vaccination quite safely?”
The findings could help people figure out the most effective time to get vaccinated or boosted and guide officials in setting policies on workplace vaccine mandates and rules for high-occupancy indoor settings, the researchers concluded.
This was the largest meta-analysis of immunity following infection to date, NBC News reports.
A version of this article originally appeared on WebMD.com.
People who’ve been infected with COVID reduced their chances of hospitalization and death by 88% over 10 months compared to somebody who hasn’t been infected, according to the study, published in The Lancet.
The natural immunity provided by infection was “at least as high, if not higher” than the immunity provided by two doses of Moderna or Pfizer mRNA vaccines against the ancestral, Alpha, Delta, and Omicron BA.1 variants, the researchers reported.
But protection against the BA.1 subvariant of Omicron was not as high – 36% at 10 months after infection, wrote the research team from the Institute for Health Metrics and Evaluation at the University of Washington.
They examined 65 studies from 19 countries through Sept. 31, 2022. They did not study data about infection from Omicron XBB and its sub-lineages. People who had immunity from both infection and vaccination, known as hybrid immunity, were not studied.
The findings don’t mean people should skip the vaccines and get COVID on purpose, one of the researchers told NBC News.
“The problem of saying ‘I’m gonna get infected to get immunity’ is you might be one of those people that end up in the hospital or die,” said Christopher Murray, MD, DPhil, director of the IHME. “Why would you take the risk when you can get immunity through vaccination quite safely?”
The findings could help people figure out the most effective time to get vaccinated or boosted and guide officials in setting policies on workplace vaccine mandates and rules for high-occupancy indoor settings, the researchers concluded.
This was the largest meta-analysis of immunity following infection to date, NBC News reports.
A version of this article originally appeared on WebMD.com.
FROM THE LANCET
Untreated COVID often involves relapse, clarifying antiviral rebound discussion
These findings offer a natural history of COVID-19 that will inform discussions and research concerning antiviral therapy, lead author Jonathan Z. Li, MD, associate professor of infectious disease at Brigham and Women’s Hospital and Harvard Medical School, both in Boston, and colleagues reported in Annals of Internal Medicine.
“There are increasing reports that high-risk patients are avoiding nirmatrelvir-ritonavir due to concerns about post-Paxlovid rebound, but there remains a gap in our knowledge of the frequency of symptom and viral relapse during untreated natural infection,” Dr. Li said in a written comment.
To address this gap, Dr. Li and colleagues analyzed data from 563 participants from the placebo group of the Adaptive Platform Treatment Trial for Outpatients with COVID-19 (ACTIV-2/A5401).
From days 0-28, patients recorded severity of 13 symptoms, with scores ranging from absent to severe (absent = 0, mild = 1, moderate = 2, severe = 3). RNA testing was performed on samples from nasal swabs on days 0–14, 21, and 28.
“The symptom rebound definition was determined by consensus of the study team, which comprises more than 10 infectious disease, pulmonary, and critical care physicians, as likely representing a clinically meaningful change in symptoms,” Dr. Li said.
Symptom scores needed to increase by at least 4 points to reach the threshold. For instance, a patient would qualify for relapse if they had worsening of four symptoms from mild to moderate, emergence of two new moderate symptoms, or emergence of one new moderate and two new mild symptoms.
The threshold for viral relapse was defined by an increase of at least 0.5 log10 RNA copies/mL from one nasal swab to the next, while high-level viral relapse was defined by an increase of at least 5.0 log10 RNA copies/mL. The former threshold was chosen based on previous analysis of viral rebound after nirmatrelvir treatment in the EPIC-HR phase 3 trial, whereas the high-level relapse point was based on Dr. Li and colleagues’ previous work linking this cutoff with the presence of infectious virus.
Their present analysis revealed that 26% of patients had symptom relapse at a median of 11 days after first symptom onset. Viral relapse occurred in 31% of patients, while high-level viral relapse occurred in 13% of participants. In about 9 out 10 cases, these relapses were detected at only one time point, suggesting they were transient. Of note, symptom relapse and high-level viral relapse occurred simultaneously in only 3% of patients.
This lack of correlation was “surprising” and “highlights that recovery from any infection is not always a linear process,” Dr. Li said.
This finding also suggests that untreated patients with recurring symptoms probably pose a low risk of contagion, according to David Wohl, MD, coauthor of the paper and professor of medicine in the division of infectious diseases at the University of North Carolina at Chapel Hill.
Paxlovid may not be to blame for COVID-19 rebound
“These results provide important context for the reports of Paxlovid rebound and show that baseline rates of symptom and viral relapse should be accounted for when studying the risk of rebound after antiviral therapy,” Dr. Li said.
Dr. Wohl suggested that these data can also play a role in conversations with patients who experience rebound after taking antiviral therapy.
“Many who have a return of their symptoms after taking Paxlovid blame the drug, and that may be justified, but this study suggests it happens in untreated people too,” Dr. Wohl said in a written comment.
Longer antiviral therapy deserves investigation
This is a “very important study” because it offers a baseline for comparing the natural history of COVID-19 with clinical course after antiviral therapy, said Timothy Henrich, MD, associate professor in the division of experimental medicine at University of California, San Francisco.
“Unlike this natural history, where it’s kind of sputtering up and down as it goes down, [after antiviral therapy,] it goes away for several days, and then it comes back up; and when it comes up, people have symptoms again,” Dr. Henrich said in an interview.
This suggests that each type of rebound is a unique phenomenon and, from a clinical perspective, that antiviral therapy may need to be extended.
“We treat for too short a period of time,” Dr. Henrich said. “We’re able to suppress [SARS-CoV-2] to the point where we’re not detecting it in the nasal pharynx, but it’s clearly still there. And it’s clearly still in a place that can replicate without the drug.”
That said, treating for longer may not be a sure-fire solution, especially if antiviral therapy is started early in the clinical course, as this could delay SARS-CoV-2-specific immune responses that are necessary for resolution, Dr. Henrich added,
“We need further study of longer-term therapies,” he said.
An array of research questions need to be addressed, according to Aditya Shah, MBBS, an infectious disease specialist at Mayo Clinic, Rochester, Minn. In a written comment, he probed the significance of rebound in various clinical scenarios.
“What [type of] rebound matters and what doesn’t?” Dr. Shah asked. “Does symptom rebound matter? How many untreated and treated ‘symptom rebounders’ need additional treatment or health care? If rebound does not really matter, but if Paxlovid helps in certain unvaccinated and high-risk patients, then does rebound matter? Future research should also focus on Paxlovid utility in vaccinated but high-risk patients. Is it as beneficial in them as it is in unvaccinated high-risk patients?”
While potentially regimen-altering questions like these remain unanswered, Dr. Henrich advised providers to keep patients focused on what we do know about the benefits of antiviral therapy given the current 5-day course, which is that it reduces the risk of severe disease and hospitalization.
The investigators disclosed relationships with Merck, Gilead, ViiV, and others. Dr. Henrich disclosed grant support from Merck and a consulting role with Roche. Dr. Shah disclosed no conflicts of interest.
These findings offer a natural history of COVID-19 that will inform discussions and research concerning antiviral therapy, lead author Jonathan Z. Li, MD, associate professor of infectious disease at Brigham and Women’s Hospital and Harvard Medical School, both in Boston, and colleagues reported in Annals of Internal Medicine.
“There are increasing reports that high-risk patients are avoiding nirmatrelvir-ritonavir due to concerns about post-Paxlovid rebound, but there remains a gap in our knowledge of the frequency of symptom and viral relapse during untreated natural infection,” Dr. Li said in a written comment.
To address this gap, Dr. Li and colleagues analyzed data from 563 participants from the placebo group of the Adaptive Platform Treatment Trial for Outpatients with COVID-19 (ACTIV-2/A5401).
From days 0-28, patients recorded severity of 13 symptoms, with scores ranging from absent to severe (absent = 0, mild = 1, moderate = 2, severe = 3). RNA testing was performed on samples from nasal swabs on days 0–14, 21, and 28.
“The symptom rebound definition was determined by consensus of the study team, which comprises more than 10 infectious disease, pulmonary, and critical care physicians, as likely representing a clinically meaningful change in symptoms,” Dr. Li said.
Symptom scores needed to increase by at least 4 points to reach the threshold. For instance, a patient would qualify for relapse if they had worsening of four symptoms from mild to moderate, emergence of two new moderate symptoms, or emergence of one new moderate and two new mild symptoms.
The threshold for viral relapse was defined by an increase of at least 0.5 log10 RNA copies/mL from one nasal swab to the next, while high-level viral relapse was defined by an increase of at least 5.0 log10 RNA copies/mL. The former threshold was chosen based on previous analysis of viral rebound after nirmatrelvir treatment in the EPIC-HR phase 3 trial, whereas the high-level relapse point was based on Dr. Li and colleagues’ previous work linking this cutoff with the presence of infectious virus.
Their present analysis revealed that 26% of patients had symptom relapse at a median of 11 days after first symptom onset. Viral relapse occurred in 31% of patients, while high-level viral relapse occurred in 13% of participants. In about 9 out 10 cases, these relapses were detected at only one time point, suggesting they were transient. Of note, symptom relapse and high-level viral relapse occurred simultaneously in only 3% of patients.
This lack of correlation was “surprising” and “highlights that recovery from any infection is not always a linear process,” Dr. Li said.
This finding also suggests that untreated patients with recurring symptoms probably pose a low risk of contagion, according to David Wohl, MD, coauthor of the paper and professor of medicine in the division of infectious diseases at the University of North Carolina at Chapel Hill.
Paxlovid may not be to blame for COVID-19 rebound
“These results provide important context for the reports of Paxlovid rebound and show that baseline rates of symptom and viral relapse should be accounted for when studying the risk of rebound after antiviral therapy,” Dr. Li said.
Dr. Wohl suggested that these data can also play a role in conversations with patients who experience rebound after taking antiviral therapy.
“Many who have a return of their symptoms after taking Paxlovid blame the drug, and that may be justified, but this study suggests it happens in untreated people too,” Dr. Wohl said in a written comment.
Longer antiviral therapy deserves investigation
This is a “very important study” because it offers a baseline for comparing the natural history of COVID-19 with clinical course after antiviral therapy, said Timothy Henrich, MD, associate professor in the division of experimental medicine at University of California, San Francisco.
“Unlike this natural history, where it’s kind of sputtering up and down as it goes down, [after antiviral therapy,] it goes away for several days, and then it comes back up; and when it comes up, people have symptoms again,” Dr. Henrich said in an interview.
This suggests that each type of rebound is a unique phenomenon and, from a clinical perspective, that antiviral therapy may need to be extended.
“We treat for too short a period of time,” Dr. Henrich said. “We’re able to suppress [SARS-CoV-2] to the point where we’re not detecting it in the nasal pharynx, but it’s clearly still there. And it’s clearly still in a place that can replicate without the drug.”
That said, treating for longer may not be a sure-fire solution, especially if antiviral therapy is started early in the clinical course, as this could delay SARS-CoV-2-specific immune responses that are necessary for resolution, Dr. Henrich added,
“We need further study of longer-term therapies,” he said.
An array of research questions need to be addressed, according to Aditya Shah, MBBS, an infectious disease specialist at Mayo Clinic, Rochester, Minn. In a written comment, he probed the significance of rebound in various clinical scenarios.
“What [type of] rebound matters and what doesn’t?” Dr. Shah asked. “Does symptom rebound matter? How many untreated and treated ‘symptom rebounders’ need additional treatment or health care? If rebound does not really matter, but if Paxlovid helps in certain unvaccinated and high-risk patients, then does rebound matter? Future research should also focus on Paxlovid utility in vaccinated but high-risk patients. Is it as beneficial in them as it is in unvaccinated high-risk patients?”
While potentially regimen-altering questions like these remain unanswered, Dr. Henrich advised providers to keep patients focused on what we do know about the benefits of antiviral therapy given the current 5-day course, which is that it reduces the risk of severe disease and hospitalization.
The investigators disclosed relationships with Merck, Gilead, ViiV, and others. Dr. Henrich disclosed grant support from Merck and a consulting role with Roche. Dr. Shah disclosed no conflicts of interest.
These findings offer a natural history of COVID-19 that will inform discussions and research concerning antiviral therapy, lead author Jonathan Z. Li, MD, associate professor of infectious disease at Brigham and Women’s Hospital and Harvard Medical School, both in Boston, and colleagues reported in Annals of Internal Medicine.
“There are increasing reports that high-risk patients are avoiding nirmatrelvir-ritonavir due to concerns about post-Paxlovid rebound, but there remains a gap in our knowledge of the frequency of symptom and viral relapse during untreated natural infection,” Dr. Li said in a written comment.
To address this gap, Dr. Li and colleagues analyzed data from 563 participants from the placebo group of the Adaptive Platform Treatment Trial for Outpatients with COVID-19 (ACTIV-2/A5401).
From days 0-28, patients recorded severity of 13 symptoms, with scores ranging from absent to severe (absent = 0, mild = 1, moderate = 2, severe = 3). RNA testing was performed on samples from nasal swabs on days 0–14, 21, and 28.
“The symptom rebound definition was determined by consensus of the study team, which comprises more than 10 infectious disease, pulmonary, and critical care physicians, as likely representing a clinically meaningful change in symptoms,” Dr. Li said.
Symptom scores needed to increase by at least 4 points to reach the threshold. For instance, a patient would qualify for relapse if they had worsening of four symptoms from mild to moderate, emergence of two new moderate symptoms, or emergence of one new moderate and two new mild symptoms.
The threshold for viral relapse was defined by an increase of at least 0.5 log10 RNA copies/mL from one nasal swab to the next, while high-level viral relapse was defined by an increase of at least 5.0 log10 RNA copies/mL. The former threshold was chosen based on previous analysis of viral rebound after nirmatrelvir treatment in the EPIC-HR phase 3 trial, whereas the high-level relapse point was based on Dr. Li and colleagues’ previous work linking this cutoff with the presence of infectious virus.
Their present analysis revealed that 26% of patients had symptom relapse at a median of 11 days after first symptom onset. Viral relapse occurred in 31% of patients, while high-level viral relapse occurred in 13% of participants. In about 9 out 10 cases, these relapses were detected at only one time point, suggesting they were transient. Of note, symptom relapse and high-level viral relapse occurred simultaneously in only 3% of patients.
This lack of correlation was “surprising” and “highlights that recovery from any infection is not always a linear process,” Dr. Li said.
This finding also suggests that untreated patients with recurring symptoms probably pose a low risk of contagion, according to David Wohl, MD, coauthor of the paper and professor of medicine in the division of infectious diseases at the University of North Carolina at Chapel Hill.
Paxlovid may not be to blame for COVID-19 rebound
“These results provide important context for the reports of Paxlovid rebound and show that baseline rates of symptom and viral relapse should be accounted for when studying the risk of rebound after antiviral therapy,” Dr. Li said.
Dr. Wohl suggested that these data can also play a role in conversations with patients who experience rebound after taking antiviral therapy.
“Many who have a return of their symptoms after taking Paxlovid blame the drug, and that may be justified, but this study suggests it happens in untreated people too,” Dr. Wohl said in a written comment.
Longer antiviral therapy deserves investigation
This is a “very important study” because it offers a baseline for comparing the natural history of COVID-19 with clinical course after antiviral therapy, said Timothy Henrich, MD, associate professor in the division of experimental medicine at University of California, San Francisco.
“Unlike this natural history, where it’s kind of sputtering up and down as it goes down, [after antiviral therapy,] it goes away for several days, and then it comes back up; and when it comes up, people have symptoms again,” Dr. Henrich said in an interview.
This suggests that each type of rebound is a unique phenomenon and, from a clinical perspective, that antiviral therapy may need to be extended.
“We treat for too short a period of time,” Dr. Henrich said. “We’re able to suppress [SARS-CoV-2] to the point where we’re not detecting it in the nasal pharynx, but it’s clearly still there. And it’s clearly still in a place that can replicate without the drug.”
That said, treating for longer may not be a sure-fire solution, especially if antiviral therapy is started early in the clinical course, as this could delay SARS-CoV-2-specific immune responses that are necessary for resolution, Dr. Henrich added,
“We need further study of longer-term therapies,” he said.
An array of research questions need to be addressed, according to Aditya Shah, MBBS, an infectious disease specialist at Mayo Clinic, Rochester, Minn. In a written comment, he probed the significance of rebound in various clinical scenarios.
“What [type of] rebound matters and what doesn’t?” Dr. Shah asked. “Does symptom rebound matter? How many untreated and treated ‘symptom rebounders’ need additional treatment or health care? If rebound does not really matter, but if Paxlovid helps in certain unvaccinated and high-risk patients, then does rebound matter? Future research should also focus on Paxlovid utility in vaccinated but high-risk patients. Is it as beneficial in them as it is in unvaccinated high-risk patients?”
While potentially regimen-altering questions like these remain unanswered, Dr. Henrich advised providers to keep patients focused on what we do know about the benefits of antiviral therapy given the current 5-day course, which is that it reduces the risk of severe disease and hospitalization.
The investigators disclosed relationships with Merck, Gilead, ViiV, and others. Dr. Henrich disclosed grant support from Merck and a consulting role with Roche. Dr. Shah disclosed no conflicts of interest.
FROM ANNALS OF INTERNAL MEDICINE
What’s new in brain health?
This transcript has been edited for clarity.
Dear colleagues, I am Christoph Diener from the medical faculty of the University of Duisburg-Essen in Germany.
Treatment of tension-type headache
I would like to start with headache. You are all aware that we have several new studies regarding the prevention of migraine, but very few studies involving nondrug treatments for tension-type headache.
A working group in Göttingen, Germany, conducted a study in people with frequent episodic and chronic tension-type headache. The first of the four randomized groups received traditional Chinese acupuncture for 3 months. The second group received physical therapy and exercise for 1 hour per week for 12 weeks. The third group received a combination of acupuncture and exercise. The last was a control group that received only standard care.
The outcome parameters of tension-type headache were evaluated after 6 months and again after 12 months. Previously, these same researchers published that the intensity but not the frequency of tension-type headache was reduced by active therapy.
In Cephalalgia, they published the outcome for the endpoints of depression, anxiety, and quality of life. Acupuncture, exercise, and the combination of the two improved depression, anxiety, and quality of life. This shows that nonmedical treatment is effective in people with frequent episodic and chronic tension-type headache.
Headache after COVID-19
The next study was published in Headache and discusses headache after COVID-19. In this review of published studies, more than 50% of people with COVID-19 develop headache. It is more frequent in young patients and people with preexisting primary headaches, such as migraine and tension-type headache. Prognosis is usually good, but some patients develop new, daily persistent headache, which is a major problem because treatment is unclear. We desperately need studies investigating how to treat this new, daily persistent headache after COVID-19.
SSRIs during COVID-19 infection
The next study also focuses on COVID-19. We have conflicting results from several studies suggesting that selective serotonin reuptake inhibitors might be effective in people with mild COVID-19 infection. This hypothesis was tested in a study in Brazil and was published in JAMA, The study included 1,288 outpatients with mild COVID-19 who either received 50 mg of fluvoxamine twice daily for 10 days or placebo. There was no benefit of the treatment for any outcome.
Preventing dementia with antihypertensive treatment
The next study was published in the European Heart Journal and addresses the question of whether effective antihypertensive treatment in elderly persons can prevent dementia. This is a meta-analysis of five placebo-controlled trials with more than 28,000 patients. The meta-analysis clearly shows that treating hypertension in elderly patients does prevent dementia. The benefit is higher if the blood pressure is lowered by a larger amount which also stays true for elderly patients. There is no negative impact of lowering blood pressure in this population.
Antiplatelet therapy
The next study was published in Stroke and reexamines whether resumption of antiplatelet therapy should be early or late in people who had an intracerebral hemorrhage while on antiplatelet therapy. In the Taiwanese Health Registry, this was studied in 1,584 patients. The researchers divided participants into groups based on whether antiplatelet therapy was resumed within 30 days or after 30 days. In 1 year, the rate of recurrent intracerebral hemorrhage was 3.2%. There was no difference whether antiplatelet therapy was resumed early or late.
Regular exercise in Parkinson’s disease
The final study is a review of nonmedical therapy. This meta-analysis of 19 randomized trials looked at the benefit of regular exercise in patients with Parkinson’s disease and depression. The analysis clearly showed that rigorous and moderate exercise improved depression in patients with Parkinson’s disease. This is very important because exercise improves not only the symptoms of Parkinson’s disease but also comorbid depression while presenting no serious adverse events or side effects.
Dr. Diener is a professor in the department of neurology at Stroke Center–Headache Center, University Duisburg-Essen, Germany. He disclosed ties with Abbott, Addex Pharma, Alder, Allergan, Almirall, Amgen, Autonomic Technology, AstraZeneca, Bayer Vital, Berlin Chemie, Bristol-Myers Squibb, Boehringer Ingelheim, Chordate, CoAxia, Corimmun, Covidien, Coherex, CoLucid, Daiichi Sankyo, D-Pharm, Electrocore, Fresenius, GlaxoSmithKline, Grunenthal, Janssen-Cilag, Labrys Biologics Lilly, La Roche, Lundbeck, 3M Medica, MSD, Medtronic, Menarini, MindFrame, Minster, Neuroscore, Neurobiological Technologies, Novartis, Novo Nordisk, Johnson & Johnson, Knoll, Paion, Parke-Davis, Pierre Fabre, Pfizer Inc, Schaper and Brummer, Sanofi-Aventis, Schering-Plough, Servier, Solvay, St. Jude, Talecris, Thrombogenics, WebMD Global, Weber and Weber, Wyeth, and Yamanouchi. Dr. Diener has served as editor of Aktuelle Neurologie, Arzneimitteltherapie, Kopfschmerz News, Stroke News, and the Treatment Guidelines of the German Neurological Society; as co-editor of Cephalalgia; and on the editorial board of The Lancet Neurology, Stroke, European Neurology, and Cerebrovascular Disorders. The department of neurology in Essen is supported by the German Research Council, the German Ministry of Education and Research, European Union, National Institutes of Health, Bertelsmann Foundation, and Heinz Nixdorf Foundation. Dr. Diener has no ownership interest and does not own stocks in any pharmaceutical company. A version of this article originally appeared on Medscape.com.
This transcript has been edited for clarity.
Dear colleagues, I am Christoph Diener from the medical faculty of the University of Duisburg-Essen in Germany.
Treatment of tension-type headache
I would like to start with headache. You are all aware that we have several new studies regarding the prevention of migraine, but very few studies involving nondrug treatments for tension-type headache.
A working group in Göttingen, Germany, conducted a study in people with frequent episodic and chronic tension-type headache. The first of the four randomized groups received traditional Chinese acupuncture for 3 months. The second group received physical therapy and exercise for 1 hour per week for 12 weeks. The third group received a combination of acupuncture and exercise. The last was a control group that received only standard care.
The outcome parameters of tension-type headache were evaluated after 6 months and again after 12 months. Previously, these same researchers published that the intensity but not the frequency of tension-type headache was reduced by active therapy.
In Cephalalgia, they published the outcome for the endpoints of depression, anxiety, and quality of life. Acupuncture, exercise, and the combination of the two improved depression, anxiety, and quality of life. This shows that nonmedical treatment is effective in people with frequent episodic and chronic tension-type headache.
Headache after COVID-19
The next study was published in Headache and discusses headache after COVID-19. In this review of published studies, more than 50% of people with COVID-19 develop headache. It is more frequent in young patients and people with preexisting primary headaches, such as migraine and tension-type headache. Prognosis is usually good, but some patients develop new, daily persistent headache, which is a major problem because treatment is unclear. We desperately need studies investigating how to treat this new, daily persistent headache after COVID-19.
SSRIs during COVID-19 infection
The next study also focuses on COVID-19. We have conflicting results from several studies suggesting that selective serotonin reuptake inhibitors might be effective in people with mild COVID-19 infection. This hypothesis was tested in a study in Brazil and was published in JAMA, The study included 1,288 outpatients with mild COVID-19 who either received 50 mg of fluvoxamine twice daily for 10 days or placebo. There was no benefit of the treatment for any outcome.
Preventing dementia with antihypertensive treatment
The next study was published in the European Heart Journal and addresses the question of whether effective antihypertensive treatment in elderly persons can prevent dementia. This is a meta-analysis of five placebo-controlled trials with more than 28,000 patients. The meta-analysis clearly shows that treating hypertension in elderly patients does prevent dementia. The benefit is higher if the blood pressure is lowered by a larger amount which also stays true for elderly patients. There is no negative impact of lowering blood pressure in this population.
Antiplatelet therapy
The next study was published in Stroke and reexamines whether resumption of antiplatelet therapy should be early or late in people who had an intracerebral hemorrhage while on antiplatelet therapy. In the Taiwanese Health Registry, this was studied in 1,584 patients. The researchers divided participants into groups based on whether antiplatelet therapy was resumed within 30 days or after 30 days. In 1 year, the rate of recurrent intracerebral hemorrhage was 3.2%. There was no difference whether antiplatelet therapy was resumed early or late.
Regular exercise in Parkinson’s disease
The final study is a review of nonmedical therapy. This meta-analysis of 19 randomized trials looked at the benefit of regular exercise in patients with Parkinson’s disease and depression. The analysis clearly showed that rigorous and moderate exercise improved depression in patients with Parkinson’s disease. This is very important because exercise improves not only the symptoms of Parkinson’s disease but also comorbid depression while presenting no serious adverse events or side effects.
Dr. Diener is a professor in the department of neurology at Stroke Center–Headache Center, University Duisburg-Essen, Germany. He disclosed ties with Abbott, Addex Pharma, Alder, Allergan, Almirall, Amgen, Autonomic Technology, AstraZeneca, Bayer Vital, Berlin Chemie, Bristol-Myers Squibb, Boehringer Ingelheim, Chordate, CoAxia, Corimmun, Covidien, Coherex, CoLucid, Daiichi Sankyo, D-Pharm, Electrocore, Fresenius, GlaxoSmithKline, Grunenthal, Janssen-Cilag, Labrys Biologics Lilly, La Roche, Lundbeck, 3M Medica, MSD, Medtronic, Menarini, MindFrame, Minster, Neuroscore, Neurobiological Technologies, Novartis, Novo Nordisk, Johnson & Johnson, Knoll, Paion, Parke-Davis, Pierre Fabre, Pfizer Inc, Schaper and Brummer, Sanofi-Aventis, Schering-Plough, Servier, Solvay, St. Jude, Talecris, Thrombogenics, WebMD Global, Weber and Weber, Wyeth, and Yamanouchi. Dr. Diener has served as editor of Aktuelle Neurologie, Arzneimitteltherapie, Kopfschmerz News, Stroke News, and the Treatment Guidelines of the German Neurological Society; as co-editor of Cephalalgia; and on the editorial board of The Lancet Neurology, Stroke, European Neurology, and Cerebrovascular Disorders. The department of neurology in Essen is supported by the German Research Council, the German Ministry of Education and Research, European Union, National Institutes of Health, Bertelsmann Foundation, and Heinz Nixdorf Foundation. Dr. Diener has no ownership interest and does not own stocks in any pharmaceutical company. A version of this article originally appeared on Medscape.com.
This transcript has been edited for clarity.
Dear colleagues, I am Christoph Diener from the medical faculty of the University of Duisburg-Essen in Germany.
Treatment of tension-type headache
I would like to start with headache. You are all aware that we have several new studies regarding the prevention of migraine, but very few studies involving nondrug treatments for tension-type headache.
A working group in Göttingen, Germany, conducted a study in people with frequent episodic and chronic tension-type headache. The first of the four randomized groups received traditional Chinese acupuncture for 3 months. The second group received physical therapy and exercise for 1 hour per week for 12 weeks. The third group received a combination of acupuncture and exercise. The last was a control group that received only standard care.
The outcome parameters of tension-type headache were evaluated after 6 months and again after 12 months. Previously, these same researchers published that the intensity but not the frequency of tension-type headache was reduced by active therapy.
In Cephalalgia, they published the outcome for the endpoints of depression, anxiety, and quality of life. Acupuncture, exercise, and the combination of the two improved depression, anxiety, and quality of life. This shows that nonmedical treatment is effective in people with frequent episodic and chronic tension-type headache.
Headache after COVID-19
The next study was published in Headache and discusses headache after COVID-19. In this review of published studies, more than 50% of people with COVID-19 develop headache. It is more frequent in young patients and people with preexisting primary headaches, such as migraine and tension-type headache. Prognosis is usually good, but some patients develop new, daily persistent headache, which is a major problem because treatment is unclear. We desperately need studies investigating how to treat this new, daily persistent headache after COVID-19.
SSRIs during COVID-19 infection
The next study also focuses on COVID-19. We have conflicting results from several studies suggesting that selective serotonin reuptake inhibitors might be effective in people with mild COVID-19 infection. This hypothesis was tested in a study in Brazil and was published in JAMA, The study included 1,288 outpatients with mild COVID-19 who either received 50 mg of fluvoxamine twice daily for 10 days or placebo. There was no benefit of the treatment for any outcome.
Preventing dementia with antihypertensive treatment
The next study was published in the European Heart Journal and addresses the question of whether effective antihypertensive treatment in elderly persons can prevent dementia. This is a meta-analysis of five placebo-controlled trials with more than 28,000 patients. The meta-analysis clearly shows that treating hypertension in elderly patients does prevent dementia. The benefit is higher if the blood pressure is lowered by a larger amount which also stays true for elderly patients. There is no negative impact of lowering blood pressure in this population.
Antiplatelet therapy
The next study was published in Stroke and reexamines whether resumption of antiplatelet therapy should be early or late in people who had an intracerebral hemorrhage while on antiplatelet therapy. In the Taiwanese Health Registry, this was studied in 1,584 patients. The researchers divided participants into groups based on whether antiplatelet therapy was resumed within 30 days or after 30 days. In 1 year, the rate of recurrent intracerebral hemorrhage was 3.2%. There was no difference whether antiplatelet therapy was resumed early or late.
Regular exercise in Parkinson’s disease
The final study is a review of nonmedical therapy. This meta-analysis of 19 randomized trials looked at the benefit of regular exercise in patients with Parkinson’s disease and depression. The analysis clearly showed that rigorous and moderate exercise improved depression in patients with Parkinson’s disease. This is very important because exercise improves not only the symptoms of Parkinson’s disease but also comorbid depression while presenting no serious adverse events or side effects.
Dr. Diener is a professor in the department of neurology at Stroke Center–Headache Center, University Duisburg-Essen, Germany. He disclosed ties with Abbott, Addex Pharma, Alder, Allergan, Almirall, Amgen, Autonomic Technology, AstraZeneca, Bayer Vital, Berlin Chemie, Bristol-Myers Squibb, Boehringer Ingelheim, Chordate, CoAxia, Corimmun, Covidien, Coherex, CoLucid, Daiichi Sankyo, D-Pharm, Electrocore, Fresenius, GlaxoSmithKline, Grunenthal, Janssen-Cilag, Labrys Biologics Lilly, La Roche, Lundbeck, 3M Medica, MSD, Medtronic, Menarini, MindFrame, Minster, Neuroscore, Neurobiological Technologies, Novartis, Novo Nordisk, Johnson & Johnson, Knoll, Paion, Parke-Davis, Pierre Fabre, Pfizer Inc, Schaper and Brummer, Sanofi-Aventis, Schering-Plough, Servier, Solvay, St. Jude, Talecris, Thrombogenics, WebMD Global, Weber and Weber, Wyeth, and Yamanouchi. Dr. Diener has served as editor of Aktuelle Neurologie, Arzneimitteltherapie, Kopfschmerz News, Stroke News, and the Treatment Guidelines of the German Neurological Society; as co-editor of Cephalalgia; and on the editorial board of The Lancet Neurology, Stroke, European Neurology, and Cerebrovascular Disorders. The department of neurology in Essen is supported by the German Research Council, the German Ministry of Education and Research, European Union, National Institutes of Health, Bertelsmann Foundation, and Heinz Nixdorf Foundation. Dr. Diener has no ownership interest and does not own stocks in any pharmaceutical company. A version of this article originally appeared on Medscape.com.
COVID-19 shot appears to reduce diabetes risk, even after Omicron
new data suggest.
The findings, from more than 20,000 patients in the Cedars-Sinai Health System in Los Angeles, suggest that “continued efforts to prevent COVID-19 infection may be beneficial to patient health until we develop better understanding of the effects of potential long-term effects of COVID-19,” lead author Alan C. Kwan, MD, of the department of cardiology at Cedars Sinai’s Smidt Heart Institute, said in an interview.
Several studies conducted early in the pandemic suggested increased risks for both new-onset diabetes and cardiometabolic diseases following COVID-19 infection, possibly because of persistent inflammation contributing to insulin resistance.
However, it hasn’t been clear if those risks have persisted with the more recent predominance of the less-virulent Omicron variant or whether the COVID-19 vaccine influences the risk. This new study suggests that both are the case.
“Our results verify that the risk of developing type 2 diabetes after a COVID-19 infection was not just an early observation but, in fact, a real risk that has, unfortunately, persisted through the Omicron era,” Dr. Kwan noted.
“While the level of evidence by our study and others may not reach the degree needed to affect formal guidelines at this time, we believe it is reasonable to have increased clinical suspicion for diabetes after COVID-19 infection and a lower threshold for testing,” he added.
Moreover, “we believe that our study and others suggest the potential role of COVID-19 to affect cardiovascular risk, and so both prevention of COVID-19 infection, through reasonable personal practices and vaccination, and an increased attention to cardiovascular health after COVID-19 infection is warranted.”
The findings were published online in JAMA Network Open.
Dr. Kwan and colleagues analyzed data for a total of 23,709 patients treated (inpatient and outpatient) for at least one COVID-19 infection between March 2020 and June 2022.
Rates of new-onset diabetes (using ICD-10 codes, primarily type 2 diabetes), hypertension, and hyperlipidemia were all elevated in the 90 days following COVID-19 infection compared with the 90 days prior. The same was true of two diagnoses unrelated to COVID-19, urinary tract infection and gastroesophageal reflux, used as benchmarks of health care engagement.
The highest odds for post versus preinfection were for diabetes (odds ratio, 2.35; P < .001), followed by hypertension (OR, 1.54; P < .001), the benchmark diagnoses (OR, 1.42; P < .001), and hyperlipidemia (OR, 1.22; P = .03).
Following adjustments, the risk versus the benchmark conditions for new-onset diabetes before versus after COVID-19 was significantly elevated (OR, 1.58; P < .001), while the risks for hypertension and hyperlipidemia versus benchmark diagnoses were not (OR, 1.06; P = .52 and 0.91, P = .43, respectively).
The diabetes risk after versus before COVID-19 infection was higher among those who had not been vaccinated (OR, 1.78; P < .001), compared with those who had received the vaccine (OR, 1.07; P = .80).
However, there was no significant interaction between vaccination and diabetes diagnosis (P = .08). “For this reason, we believe our data are suggestive of a protective effect in the population who received vaccination prior to infection, but [this is] not definitive,” Dr. Kwan said.
There were no apparent interactions by age, sex, or pre-existing cardiovascular risk factors, including hypertension or hyperlipidemia. Age, sex, and timing of index infection regarding the Omicron variant were not associated with an increased risk of a new cardiometabolic diagnosis before or after COVID-19 infection in any of the models.
Dr. Kwan said in an interview: “We have continued to be surprised by the evolving understanding of the SARS-CoV-2 virus and the effects on human health. In the beginning of the pandemic it was framed as a purely respiratory virus, which we now know to be a severely limited description of all of its potential effects on the human body. We believe that our research and others raise a concern for increased cardiometabolic risk after COVID infection.”
He added that, “while knowledge is incomplete on this topic, we believe that clinical providers may wish to have a higher degree of suspicion for both diabetes and risk of future cardiac events in patients after COVID infection, and that continued efforts to prevent COVID infection may be beneficial to patient health until we develop better understanding of the potential long-term effects of COVID.”
This study was funded by the Erika J. Glazer Family Foundation, the Doris Duke Charitable Foundation, and grants from the National Institutes of Health. Dr. Kwan reported receiving grants from the Doris Duke Charitable Foundation during the conduct of the study.
A version of this article originally appeared on Medscape.com.
new data suggest.
The findings, from more than 20,000 patients in the Cedars-Sinai Health System in Los Angeles, suggest that “continued efforts to prevent COVID-19 infection may be beneficial to patient health until we develop better understanding of the effects of potential long-term effects of COVID-19,” lead author Alan C. Kwan, MD, of the department of cardiology at Cedars Sinai’s Smidt Heart Institute, said in an interview.
Several studies conducted early in the pandemic suggested increased risks for both new-onset diabetes and cardiometabolic diseases following COVID-19 infection, possibly because of persistent inflammation contributing to insulin resistance.
However, it hasn’t been clear if those risks have persisted with the more recent predominance of the less-virulent Omicron variant or whether the COVID-19 vaccine influences the risk. This new study suggests that both are the case.
“Our results verify that the risk of developing type 2 diabetes after a COVID-19 infection was not just an early observation but, in fact, a real risk that has, unfortunately, persisted through the Omicron era,” Dr. Kwan noted.
“While the level of evidence by our study and others may not reach the degree needed to affect formal guidelines at this time, we believe it is reasonable to have increased clinical suspicion for diabetes after COVID-19 infection and a lower threshold for testing,” he added.
Moreover, “we believe that our study and others suggest the potential role of COVID-19 to affect cardiovascular risk, and so both prevention of COVID-19 infection, through reasonable personal practices and vaccination, and an increased attention to cardiovascular health after COVID-19 infection is warranted.”
The findings were published online in JAMA Network Open.
Dr. Kwan and colleagues analyzed data for a total of 23,709 patients treated (inpatient and outpatient) for at least one COVID-19 infection between March 2020 and June 2022.
Rates of new-onset diabetes (using ICD-10 codes, primarily type 2 diabetes), hypertension, and hyperlipidemia were all elevated in the 90 days following COVID-19 infection compared with the 90 days prior. The same was true of two diagnoses unrelated to COVID-19, urinary tract infection and gastroesophageal reflux, used as benchmarks of health care engagement.
The highest odds for post versus preinfection were for diabetes (odds ratio, 2.35; P < .001), followed by hypertension (OR, 1.54; P < .001), the benchmark diagnoses (OR, 1.42; P < .001), and hyperlipidemia (OR, 1.22; P = .03).
Following adjustments, the risk versus the benchmark conditions for new-onset diabetes before versus after COVID-19 was significantly elevated (OR, 1.58; P < .001), while the risks for hypertension and hyperlipidemia versus benchmark diagnoses were not (OR, 1.06; P = .52 and 0.91, P = .43, respectively).
The diabetes risk after versus before COVID-19 infection was higher among those who had not been vaccinated (OR, 1.78; P < .001), compared with those who had received the vaccine (OR, 1.07; P = .80).
However, there was no significant interaction between vaccination and diabetes diagnosis (P = .08). “For this reason, we believe our data are suggestive of a protective effect in the population who received vaccination prior to infection, but [this is] not definitive,” Dr. Kwan said.
There were no apparent interactions by age, sex, or pre-existing cardiovascular risk factors, including hypertension or hyperlipidemia. Age, sex, and timing of index infection regarding the Omicron variant were not associated with an increased risk of a new cardiometabolic diagnosis before or after COVID-19 infection in any of the models.
Dr. Kwan said in an interview: “We have continued to be surprised by the evolving understanding of the SARS-CoV-2 virus and the effects on human health. In the beginning of the pandemic it was framed as a purely respiratory virus, which we now know to be a severely limited description of all of its potential effects on the human body. We believe that our research and others raise a concern for increased cardiometabolic risk after COVID infection.”
He added that, “while knowledge is incomplete on this topic, we believe that clinical providers may wish to have a higher degree of suspicion for both diabetes and risk of future cardiac events in patients after COVID infection, and that continued efforts to prevent COVID infection may be beneficial to patient health until we develop better understanding of the potential long-term effects of COVID.”
This study was funded by the Erika J. Glazer Family Foundation, the Doris Duke Charitable Foundation, and grants from the National Institutes of Health. Dr. Kwan reported receiving grants from the Doris Duke Charitable Foundation during the conduct of the study.
A version of this article originally appeared on Medscape.com.
new data suggest.
The findings, from more than 20,000 patients in the Cedars-Sinai Health System in Los Angeles, suggest that “continued efforts to prevent COVID-19 infection may be beneficial to patient health until we develop better understanding of the effects of potential long-term effects of COVID-19,” lead author Alan C. Kwan, MD, of the department of cardiology at Cedars Sinai’s Smidt Heart Institute, said in an interview.
Several studies conducted early in the pandemic suggested increased risks for both new-onset diabetes and cardiometabolic diseases following COVID-19 infection, possibly because of persistent inflammation contributing to insulin resistance.
However, it hasn’t been clear if those risks have persisted with the more recent predominance of the less-virulent Omicron variant or whether the COVID-19 vaccine influences the risk. This new study suggests that both are the case.
“Our results verify that the risk of developing type 2 diabetes after a COVID-19 infection was not just an early observation but, in fact, a real risk that has, unfortunately, persisted through the Omicron era,” Dr. Kwan noted.
“While the level of evidence by our study and others may not reach the degree needed to affect formal guidelines at this time, we believe it is reasonable to have increased clinical suspicion for diabetes after COVID-19 infection and a lower threshold for testing,” he added.
Moreover, “we believe that our study and others suggest the potential role of COVID-19 to affect cardiovascular risk, and so both prevention of COVID-19 infection, through reasonable personal practices and vaccination, and an increased attention to cardiovascular health after COVID-19 infection is warranted.”
The findings were published online in JAMA Network Open.
Dr. Kwan and colleagues analyzed data for a total of 23,709 patients treated (inpatient and outpatient) for at least one COVID-19 infection between March 2020 and June 2022.
Rates of new-onset diabetes (using ICD-10 codes, primarily type 2 diabetes), hypertension, and hyperlipidemia were all elevated in the 90 days following COVID-19 infection compared with the 90 days prior. The same was true of two diagnoses unrelated to COVID-19, urinary tract infection and gastroesophageal reflux, used as benchmarks of health care engagement.
The highest odds for post versus preinfection were for diabetes (odds ratio, 2.35; P < .001), followed by hypertension (OR, 1.54; P < .001), the benchmark diagnoses (OR, 1.42; P < .001), and hyperlipidemia (OR, 1.22; P = .03).
Following adjustments, the risk versus the benchmark conditions for new-onset diabetes before versus after COVID-19 was significantly elevated (OR, 1.58; P < .001), while the risks for hypertension and hyperlipidemia versus benchmark diagnoses were not (OR, 1.06; P = .52 and 0.91, P = .43, respectively).
The diabetes risk after versus before COVID-19 infection was higher among those who had not been vaccinated (OR, 1.78; P < .001), compared with those who had received the vaccine (OR, 1.07; P = .80).
However, there was no significant interaction between vaccination and diabetes diagnosis (P = .08). “For this reason, we believe our data are suggestive of a protective effect in the population who received vaccination prior to infection, but [this is] not definitive,” Dr. Kwan said.
There were no apparent interactions by age, sex, or pre-existing cardiovascular risk factors, including hypertension or hyperlipidemia. Age, sex, and timing of index infection regarding the Omicron variant were not associated with an increased risk of a new cardiometabolic diagnosis before or after COVID-19 infection in any of the models.
Dr. Kwan said in an interview: “We have continued to be surprised by the evolving understanding of the SARS-CoV-2 virus and the effects on human health. In the beginning of the pandemic it was framed as a purely respiratory virus, which we now know to be a severely limited description of all of its potential effects on the human body. We believe that our research and others raise a concern for increased cardiometabolic risk after COVID infection.”
He added that, “while knowledge is incomplete on this topic, we believe that clinical providers may wish to have a higher degree of suspicion for both diabetes and risk of future cardiac events in patients after COVID infection, and that continued efforts to prevent COVID infection may be beneficial to patient health until we develop better understanding of the potential long-term effects of COVID.”
This study was funded by the Erika J. Glazer Family Foundation, the Doris Duke Charitable Foundation, and grants from the National Institutes of Health. Dr. Kwan reported receiving grants from the Doris Duke Charitable Foundation during the conduct of the study.
A version of this article originally appeared on Medscape.com.
FROM JAMA NETWORK OPEN
New challenge for docs: End of COVID federal public health emergency
The Biden administration intends to end by May 11 certain COVID-19 emergency measures used to aid in the response to the pandemic, while many others will remain in place.
A separate declaration covers the Food and Drug Administration’s emergency use authorizations (EUAs) for COVID medicines and tests. That would not be affected by the May 11 deadline, the FDA said. In addition, Congress and state lawmakers have extended some COVID response measures.
The result is a patchwork of emergency COVID-19 measures with different end dates.
The American Medical Association and the American Academy of Family Physicians (AAFP) are assessing how best to advise their members about the end of the public health emergency.
Several waivers regarding copays and coverage and policies regarding controlled substances will expire, Claire Ernst, director of government affairs at the Medical Group Management Association, told this news organization.
The impact of the unwinding “will vary based on some factors, such as what state the practice resides in,” Ms. Ernst said. “Fortunately, Congress provided some predictability for practices by extending many of the telehealth waivers through the end of 2024.”
The AAFP told this news organization that it has joined several other groups in calling for the release of proposed Drug Enforcement Administration (DEA) regulations meant to permanently allow prescriptions of buprenorphine treatment for opioid use disorder via telehealth. The AAFP and other groups want to review these proposals and, if needed, urge the DEA to modify or finalize before there are any disruptions in access to medications for opioid use disorder.
Patients’ questions
Clinicians can expect to field patients’ questions about their insurance coverage and what they need to pay, said Nancy Foster, vice president for quality and patient safety policy at the American Hospital Association (AHA).
“Your doctor’s office, that clinic you typically get care at, that is the face of medicine to you,” Ms. Foster told this news organization. “Many doctors and their staff will be asked, ‘What’s happening with Medicaid?’ ‘What about my Medicare coverage?’ ‘Can I still access care in the same way that I did before?’ ”
Physicians will need to be ready to answers those question, or point patients to where they can get answers, Ms. Foster said.
For example, Medicaid will no longer cover postpartum care for some enrollees after giving birth, said Taylor Platt, health policy manager for the American College of Obstetricians and Gynecologists.
The federal response to the pandemic created “a de facto postpartum coverage extension for Medicaid enrollees,” which will be lost in some states, Ms. Platt told this news organization. However, 28 states and the District of Columbia have taken separate measures to extend postpartum coverage to 1 year.
“This coverage has been critical for postpartum individuals to address health needs like substance use and mental health treatment and chronic conditions,” Ms. Platt said.
States significantly changed Medicaid policy to expand access to care during the pandemic.
All 50 states and the District of Columbia, for example, expanded coverage or access to telehealth services in Medicaid during the pandemic, according to a Jan. 31 report from the Kaiser Family Foundation (KFF). These expansions expire under various deadlines, although most states have made or are planning to make some Medicaid telehealth flexibilities permanent, KFF said.
The KFF report notes that all states and the District of Columbia temporarily waived some aspects of state licensure requirements, so that clinicians with equivalent licenses in other states could practice via telehealth.
In some states, these waivers are still active and are tied to the end of the federal emergency declaration. In others, they expired, with some states allowing for long-term or permanent interstate telemedicine, KFF said. (The Federation of State Medical Boards has a detailed summary of these modifications.)
The end of free COVID vaccines, testing for some patients
The AAFP has also raised concerns about continued access to COVID-19 vaccines, particularly for uninsured adults. Ashish Jha, MD, MPH, the White House COVID-19 Response Coordinator, said in a tweet that this transition, however, wouldn’t happen until a few months after the public health emergency ends.
After those few months, there will be a transition from U.S. government–distributed vaccines and treatments to ones purchased through the regular health care system, the “way we do for every other vaccine and treatment,” Dr. Jha added.
But that raises the same kind of difficult questions that permeate U.S. health care, with a potential to keep COVID active, said Patricia Jackson, RN, president of the Association for Professionals in Infection Control and Epidemiology (APIC).
People who don’t have insurance may lose access to COVID testing and vaccines.
“Will that lead to increases in transmission? Who knows,” Ms. Jackson told this news organization. “We will have to see. There are some health equity issues that potentially arise.”
Future FDA actions
Biden’s May 11 deadline applies to emergency provisions made under a Section 319 declaration, which allow the Department of Health and Human Services to respond to crises.
But a separate flexibility, known as a Section 564 declaration, covers the FDA’s EUAs, which can remain in effect even as the other declarations end.
The best-known EUAs for the pandemic were used to bring COVID vaccines and treatments to market. Many of these have since been converted to normal approvals as companies presented more evidence to support the initial emergency approvals. In other cases, EUAs have been withdrawn owing to disappointing research results, changing virus strains, and evolving medical treatments.
The FDA also used many EUAs to cover new uses of ventilators and other hospital equipment and expand these supplies in response to the pandemic, said Mark Howell, AHA’s director of policy and patient safety.
The FDA should examine the EUAs issued during the pandemic to see what greater flexibilities might be used to deal with future serious shortages of critical supplies. International incidents such as the war in Ukraine show how fragile the supply chain can be. The FDA should consider its recent experience with EUAs to address this, Mr. Howell said.
“What do we do coming out of the pandemic? And how do we think about being more proactive in this space to ensure that our supply doesn’t bottleneck, that we continue to make sure that providers have access to supply that’s not only safe and effective, but that they can use?” Mr. Howell told this news organization.
Such planning might also help prepare the country for the next pandemic, which is a near certainty, APIC’s Ms. Jackson said. The nation needs a nimbler response to the next major outbreak of an infectious disease, she said.
“There is going to be a next time,” Ms. Jackson said. “We are going to have another pandemic.”
A version of this article first appeared on Medscape.com.
The Biden administration intends to end by May 11 certain COVID-19 emergency measures used to aid in the response to the pandemic, while many others will remain in place.
A separate declaration covers the Food and Drug Administration’s emergency use authorizations (EUAs) for COVID medicines and tests. That would not be affected by the May 11 deadline, the FDA said. In addition, Congress and state lawmakers have extended some COVID response measures.
The result is a patchwork of emergency COVID-19 measures with different end dates.
The American Medical Association and the American Academy of Family Physicians (AAFP) are assessing how best to advise their members about the end of the public health emergency.
Several waivers regarding copays and coverage and policies regarding controlled substances will expire, Claire Ernst, director of government affairs at the Medical Group Management Association, told this news organization.
The impact of the unwinding “will vary based on some factors, such as what state the practice resides in,” Ms. Ernst said. “Fortunately, Congress provided some predictability for practices by extending many of the telehealth waivers through the end of 2024.”
The AAFP told this news organization that it has joined several other groups in calling for the release of proposed Drug Enforcement Administration (DEA) regulations meant to permanently allow prescriptions of buprenorphine treatment for opioid use disorder via telehealth. The AAFP and other groups want to review these proposals and, if needed, urge the DEA to modify or finalize before there are any disruptions in access to medications for opioid use disorder.
Patients’ questions
Clinicians can expect to field patients’ questions about their insurance coverage and what they need to pay, said Nancy Foster, vice president for quality and patient safety policy at the American Hospital Association (AHA).
“Your doctor’s office, that clinic you typically get care at, that is the face of medicine to you,” Ms. Foster told this news organization. “Many doctors and their staff will be asked, ‘What’s happening with Medicaid?’ ‘What about my Medicare coverage?’ ‘Can I still access care in the same way that I did before?’ ”
Physicians will need to be ready to answers those question, or point patients to where they can get answers, Ms. Foster said.
For example, Medicaid will no longer cover postpartum care for some enrollees after giving birth, said Taylor Platt, health policy manager for the American College of Obstetricians and Gynecologists.
The federal response to the pandemic created “a de facto postpartum coverage extension for Medicaid enrollees,” which will be lost in some states, Ms. Platt told this news organization. However, 28 states and the District of Columbia have taken separate measures to extend postpartum coverage to 1 year.
“This coverage has been critical for postpartum individuals to address health needs like substance use and mental health treatment and chronic conditions,” Ms. Platt said.
States significantly changed Medicaid policy to expand access to care during the pandemic.
All 50 states and the District of Columbia, for example, expanded coverage or access to telehealth services in Medicaid during the pandemic, according to a Jan. 31 report from the Kaiser Family Foundation (KFF). These expansions expire under various deadlines, although most states have made or are planning to make some Medicaid telehealth flexibilities permanent, KFF said.
The KFF report notes that all states and the District of Columbia temporarily waived some aspects of state licensure requirements, so that clinicians with equivalent licenses in other states could practice via telehealth.
In some states, these waivers are still active and are tied to the end of the federal emergency declaration. In others, they expired, with some states allowing for long-term or permanent interstate telemedicine, KFF said. (The Federation of State Medical Boards has a detailed summary of these modifications.)
The end of free COVID vaccines, testing for some patients
The AAFP has also raised concerns about continued access to COVID-19 vaccines, particularly for uninsured adults. Ashish Jha, MD, MPH, the White House COVID-19 Response Coordinator, said in a tweet that this transition, however, wouldn’t happen until a few months after the public health emergency ends.
After those few months, there will be a transition from U.S. government–distributed vaccines and treatments to ones purchased through the regular health care system, the “way we do for every other vaccine and treatment,” Dr. Jha added.
But that raises the same kind of difficult questions that permeate U.S. health care, with a potential to keep COVID active, said Patricia Jackson, RN, president of the Association for Professionals in Infection Control and Epidemiology (APIC).
People who don’t have insurance may lose access to COVID testing and vaccines.
“Will that lead to increases in transmission? Who knows,” Ms. Jackson told this news organization. “We will have to see. There are some health equity issues that potentially arise.”
Future FDA actions
Biden’s May 11 deadline applies to emergency provisions made under a Section 319 declaration, which allow the Department of Health and Human Services to respond to crises.
But a separate flexibility, known as a Section 564 declaration, covers the FDA’s EUAs, which can remain in effect even as the other declarations end.
The best-known EUAs for the pandemic were used to bring COVID vaccines and treatments to market. Many of these have since been converted to normal approvals as companies presented more evidence to support the initial emergency approvals. In other cases, EUAs have been withdrawn owing to disappointing research results, changing virus strains, and evolving medical treatments.
The FDA also used many EUAs to cover new uses of ventilators and other hospital equipment and expand these supplies in response to the pandemic, said Mark Howell, AHA’s director of policy and patient safety.
The FDA should examine the EUAs issued during the pandemic to see what greater flexibilities might be used to deal with future serious shortages of critical supplies. International incidents such as the war in Ukraine show how fragile the supply chain can be. The FDA should consider its recent experience with EUAs to address this, Mr. Howell said.
“What do we do coming out of the pandemic? And how do we think about being more proactive in this space to ensure that our supply doesn’t bottleneck, that we continue to make sure that providers have access to supply that’s not only safe and effective, but that they can use?” Mr. Howell told this news organization.
Such planning might also help prepare the country for the next pandemic, which is a near certainty, APIC’s Ms. Jackson said. The nation needs a nimbler response to the next major outbreak of an infectious disease, she said.
“There is going to be a next time,” Ms. Jackson said. “We are going to have another pandemic.”
A version of this article first appeared on Medscape.com.
The Biden administration intends to end by May 11 certain COVID-19 emergency measures used to aid in the response to the pandemic, while many others will remain in place.
A separate declaration covers the Food and Drug Administration’s emergency use authorizations (EUAs) for COVID medicines and tests. That would not be affected by the May 11 deadline, the FDA said. In addition, Congress and state lawmakers have extended some COVID response measures.
The result is a patchwork of emergency COVID-19 measures with different end dates.
The American Medical Association and the American Academy of Family Physicians (AAFP) are assessing how best to advise their members about the end of the public health emergency.
Several waivers regarding copays and coverage and policies regarding controlled substances will expire, Claire Ernst, director of government affairs at the Medical Group Management Association, told this news organization.
The impact of the unwinding “will vary based on some factors, such as what state the practice resides in,” Ms. Ernst said. “Fortunately, Congress provided some predictability for practices by extending many of the telehealth waivers through the end of 2024.”
The AAFP told this news organization that it has joined several other groups in calling for the release of proposed Drug Enforcement Administration (DEA) regulations meant to permanently allow prescriptions of buprenorphine treatment for opioid use disorder via telehealth. The AAFP and other groups want to review these proposals and, if needed, urge the DEA to modify or finalize before there are any disruptions in access to medications for opioid use disorder.
Patients’ questions
Clinicians can expect to field patients’ questions about their insurance coverage and what they need to pay, said Nancy Foster, vice president for quality and patient safety policy at the American Hospital Association (AHA).
“Your doctor’s office, that clinic you typically get care at, that is the face of medicine to you,” Ms. Foster told this news organization. “Many doctors and their staff will be asked, ‘What’s happening with Medicaid?’ ‘What about my Medicare coverage?’ ‘Can I still access care in the same way that I did before?’ ”
Physicians will need to be ready to answers those question, or point patients to where they can get answers, Ms. Foster said.
For example, Medicaid will no longer cover postpartum care for some enrollees after giving birth, said Taylor Platt, health policy manager for the American College of Obstetricians and Gynecologists.
The federal response to the pandemic created “a de facto postpartum coverage extension for Medicaid enrollees,” which will be lost in some states, Ms. Platt told this news organization. However, 28 states and the District of Columbia have taken separate measures to extend postpartum coverage to 1 year.
“This coverage has been critical for postpartum individuals to address health needs like substance use and mental health treatment and chronic conditions,” Ms. Platt said.
States significantly changed Medicaid policy to expand access to care during the pandemic.
All 50 states and the District of Columbia, for example, expanded coverage or access to telehealth services in Medicaid during the pandemic, according to a Jan. 31 report from the Kaiser Family Foundation (KFF). These expansions expire under various deadlines, although most states have made or are planning to make some Medicaid telehealth flexibilities permanent, KFF said.
The KFF report notes that all states and the District of Columbia temporarily waived some aspects of state licensure requirements, so that clinicians with equivalent licenses in other states could practice via telehealth.
In some states, these waivers are still active and are tied to the end of the federal emergency declaration. In others, they expired, with some states allowing for long-term or permanent interstate telemedicine, KFF said. (The Federation of State Medical Boards has a detailed summary of these modifications.)
The end of free COVID vaccines, testing for some patients
The AAFP has also raised concerns about continued access to COVID-19 vaccines, particularly for uninsured adults. Ashish Jha, MD, MPH, the White House COVID-19 Response Coordinator, said in a tweet that this transition, however, wouldn’t happen until a few months after the public health emergency ends.
After those few months, there will be a transition from U.S. government–distributed vaccines and treatments to ones purchased through the regular health care system, the “way we do for every other vaccine and treatment,” Dr. Jha added.
But that raises the same kind of difficult questions that permeate U.S. health care, with a potential to keep COVID active, said Patricia Jackson, RN, president of the Association for Professionals in Infection Control and Epidemiology (APIC).
People who don’t have insurance may lose access to COVID testing and vaccines.
“Will that lead to increases in transmission? Who knows,” Ms. Jackson told this news organization. “We will have to see. There are some health equity issues that potentially arise.”
Future FDA actions
Biden’s May 11 deadline applies to emergency provisions made under a Section 319 declaration, which allow the Department of Health and Human Services to respond to crises.
But a separate flexibility, known as a Section 564 declaration, covers the FDA’s EUAs, which can remain in effect even as the other declarations end.
The best-known EUAs for the pandemic were used to bring COVID vaccines and treatments to market. Many of these have since been converted to normal approvals as companies presented more evidence to support the initial emergency approvals. In other cases, EUAs have been withdrawn owing to disappointing research results, changing virus strains, and evolving medical treatments.
The FDA also used many EUAs to cover new uses of ventilators and other hospital equipment and expand these supplies in response to the pandemic, said Mark Howell, AHA’s director of policy and patient safety.
The FDA should examine the EUAs issued during the pandemic to see what greater flexibilities might be used to deal with future serious shortages of critical supplies. International incidents such as the war in Ukraine show how fragile the supply chain can be. The FDA should consider its recent experience with EUAs to address this, Mr. Howell said.
“What do we do coming out of the pandemic? And how do we think about being more proactive in this space to ensure that our supply doesn’t bottleneck, that we continue to make sure that providers have access to supply that’s not only safe and effective, but that they can use?” Mr. Howell told this news organization.
Such planning might also help prepare the country for the next pandemic, which is a near certainty, APIC’s Ms. Jackson said. The nation needs a nimbler response to the next major outbreak of an infectious disease, she said.
“There is going to be a next time,” Ms. Jackson said. “We are going to have another pandemic.”
A version of this article first appeared on Medscape.com.
Must-read acute care medicine articles from 2022
When 2022 began, we started seeing some light at the end of the COVID-19 tunnel. Vaccines were widely available, and even with new variants of the virus still occasionally emerging, the rates of severe morbidity and mortality appeared to be decreasing.
Expectedly, journals appeared to start moving more toward mainstream topics and publications rather than what seemed like a major focus on COVID-19 publications. The resulting literature was fantastic.
Several of those topics were discussed in a prior Emergency Medicine Viewpoint from this news organization, and many more of the research advances of 2022 will be discussed in the near future. However, in this Viewpoint, I would like to present my annual review of my three “must-read” articles of the past year.
As in past years, I am choosing reviews of the literature rather than original research articles (which, all too often, become outdated or debunked within a few years). I choose these articles in the hopes that readers will not simply settle for my brief reviews of the key points but instead will feel compelled to download and read the entire articles. These publications address common conditions and quandaries we face in the daily practice of emergency medicine and are practice-changing.
Myocardial dysfunction after cardiac arrest: Tips and pitfalls
The management of post–cardiac arrest patients remains a hot topic in the resuscitation literature as we continue to understand that the immediate post-arrest period is critical to patient outcome.
Ortuno and colleagues reviewed the current literature on post-arrest care and wrote an outstanding summary of how to optimally care for these patients. More specifically, they focused on post-arrest patients who demonstrate continued shock, or “post–cardiac arrest myocardial dysfunction” (PCAMD).
They propose three mechanisms for the pathogenesis of PCAMD: ischemia reperfusion phenomenon, systemic inflammatory response, and increased catecholamine release
I will skip through the details of the pathophysiology that they describe in the article, but I certainly do recommend that everyone review their descriptions.
Management of these patients begins with a good hemodynamic assessment, which includes clinical markers of perfusion (blood pressure, capillary refill), ECG, and point-of-care ultrasound (POCUS). If the initial assessment reveals an obvious cause of the cardiac arrest (e.g., massive pulmonary embolism, myocardial infarction, pericardial tamponade), then the underlying cause should be treated expeditiously.
In the absence of an obvious treatable cause of the shock, the fluid status and cardiac function should be addressed with POCUS. If the patient is hypovolemic, intravenous fluids should be administered. If the fluid status is adequate, POCUS should be used to estimate the patient’s ventricular function. If the ventricle appears to be hyperdynamic with good contractility, shock should be treated with norepinephrine. On the other hand, if the ventricle is hypodynamic, dobutamine should be substituted for norepinephrine or, more often, added to norepinephrine.
The above represents a simplified summary of the critical points, but the authors do delve into further detail and also discuss some other options for therapies, including steroids, coronary revascularization, extracorporeal membrane oxygenation, and so on. The review is very thoughtful, thorough, and definitely worth a full read.
Top myths of diagnosis and management of infectious diseases in hospital medicine
Most, if not all of us in medicine, have heard the saying that 50% of what we learn in medical school (or residency) will turn out to be wrong. I certainly believe in this concept and consequently, like many of you, I enjoy reading about myths and misconceptions that we have been taught. With that in mind, I have to say that I love this article because it seems to have been written specifically to address what I was taught!
This author group, consisting mostly of clinical PharmDs who are experts in antibiotic use, provide us with an evidence-based discussion of myths and pitfalls in how antibiotics are often used in current clinical practice. The authors review their top 10 myths involving the use of antibiotics in treating infections in the hospital setting. A few of these relate more to the inpatient setting, but here are my favorite emergency department (ED)–related myths that they address:
- “Antibiotics do no harm.” The authors address the risk-benefit of antibiotics based on assumed vs. confirmed infections, including a brief discussion of adverse drug effects.
- “Antibiotic durations of 7, 14, or 21 days are typically necessary.” The authors address appropriate duration of antibiotic use and the fact that unnecessarily long durations of use can lead to resistance. They also provide reassurance that some infections can be treated with quite short durations of antibiotics.
- “If one drug is good, two (or more!) is better.” The use of multiple antibiotics, often with overlapping bacterial coverage, is rampant in medicine and further increases the risk for adverse drug effects and resistance.
- “Oral antibiotics are not as good as intravenous antibiotics for hospitalized patients.” This is definitely a myth that I learned. I recall being taught by many senior physicians that anyone sick enough for admission should be treated with intravenous antibiotics. As it turns out, absorption and effectiveness of most oral antibiotics is just as good as intravenous antibiotics, and the oral formulations are often safer.
- “A history of a penicillin allergy means the patient can never receive a beta-lactam antibiotic.” This is a myth that was debunked quite a few years ago, but it seems that many clinicians still need a reminder.
The authors included five more myths that are worth the read. This is an article that needs to be disseminated among all hospital clinicians.
Guidelines for low-risk, recurrent abdominal pain in the emergency department
The Society for Academic Emergency Medicine (SAEM) recently initiated a program focused on creating evidence-based approaches to challenging chief complaints and presentations in the emergency department (ED). In 2021, they published an approach to managing patients with recurrent, low-risk chest pain in the ED. This past year, they published their second guideline, focused on the management of patients with low-risk, recurrent abdominal pain in the ED.
Recurrent low-risk abdominal pain is a common and vexing presentation to EDs around the world, and there is little prior published guidance. Do all of these patients need repeat imaging? How do we manage their pain? Are there nonabdominal conditions that should be considered?
Broder and colleagues did a fantastic review of the current literature and, on behalf of SAEM, have provided a rational approach to optimal management of these patients. The four major questions they addressed, with brief summaries of their recommendations, are:
- Should adult ED patients with low-risk, recurrent and previously undifferentiated abdominal pain receive a repeat CT abdomen-pelvis (CTAP) after a negative CTAP within the past 12 months? This is a typical question that we all ponder when managing these patients. Unfortunately, the writing group found insufficient evidence to definitively identify populations in whom CTAP was recommended vs could be safely withheld. It is a bit disappointing that there is no definite answer to the question. On the other hand, it is reassuring to know that the world’s best evidence essentially says that it is perfectly appropriate to use your own good clinical judgment.
- Should adult ED patients with low-risk, recurrent, and previously undifferentiated abdominal pain with a negative CTAP receive additional imaging with abdominal ultrasound? In this case, the writing group found enough evidence, though low-level, to suggest against routine ultrasound in the absence of concern specifically for pelvic or hepatobiliary pathology. Like most tests, ultrasound is best used when there are specific concerns rather than being used in an undifferentiated fashion.
- Should adult ED patients with low-risk, recurrent, and previously undifferentiated abdominal pain receive screening for depression/anxiety? The writing group found enough evidence, though low-level again, to suggest that screening for depression and/or anxiety be performed during the ED evaluation. This could lead to successful therapy for the abdominal pain.
- Should adult ED patients with low-risk, recurrent, and previously undifferentiated abdominal pain receive nonopioid and/or nonpharmacologic analgesics? The writing group found little evidence to suggest for or against these analgesics, but they made a consensus recommendation suggesting an opioid-minimizing strategy for pain control.
Although the final recommendations of the writing group were not definitive or based on the strongest level of evidence, I find it helpful to have this guidance, nevertheless, on behalf of a major national organization. I also find it helpful to know that even with the best evidence available, optimal patient care will often boil down to physician experience and gestalt. I should also add that the overall article is chock-full of pearls and helpful information that will further inform the readers’ decisions, and so the full version is definitely worth the read.
In summary
There you have it – my three favorite practice-changing articles of 2022. Although I have tried to provide key points here, the full discussions of those key points in the published articles will provide a great deal more education than I can offer in this brief write-up, and so I strongly encourage everyone to read the full versions. Please be sure to include in the comments section your own pick for favorite or must-read articles from the past year.
Amal Mattu, MD, is a professor, vice chair of education, and codirector of the emergency cardiology fellowship in the department of emergency medicine at the University of Maryland, Baltimore. She reported no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
When 2022 began, we started seeing some light at the end of the COVID-19 tunnel. Vaccines were widely available, and even with new variants of the virus still occasionally emerging, the rates of severe morbidity and mortality appeared to be decreasing.
Expectedly, journals appeared to start moving more toward mainstream topics and publications rather than what seemed like a major focus on COVID-19 publications. The resulting literature was fantastic.
Several of those topics were discussed in a prior Emergency Medicine Viewpoint from this news organization, and many more of the research advances of 2022 will be discussed in the near future. However, in this Viewpoint, I would like to present my annual review of my three “must-read” articles of the past year.
As in past years, I am choosing reviews of the literature rather than original research articles (which, all too often, become outdated or debunked within a few years). I choose these articles in the hopes that readers will not simply settle for my brief reviews of the key points but instead will feel compelled to download and read the entire articles. These publications address common conditions and quandaries we face in the daily practice of emergency medicine and are practice-changing.
Myocardial dysfunction after cardiac arrest: Tips and pitfalls
The management of post–cardiac arrest patients remains a hot topic in the resuscitation literature as we continue to understand that the immediate post-arrest period is critical to patient outcome.
Ortuno and colleagues reviewed the current literature on post-arrest care and wrote an outstanding summary of how to optimally care for these patients. More specifically, they focused on post-arrest patients who demonstrate continued shock, or “post–cardiac arrest myocardial dysfunction” (PCAMD).
They propose three mechanisms for the pathogenesis of PCAMD: ischemia reperfusion phenomenon, systemic inflammatory response, and increased catecholamine release
I will skip through the details of the pathophysiology that they describe in the article, but I certainly do recommend that everyone review their descriptions.
Management of these patients begins with a good hemodynamic assessment, which includes clinical markers of perfusion (blood pressure, capillary refill), ECG, and point-of-care ultrasound (POCUS). If the initial assessment reveals an obvious cause of the cardiac arrest (e.g., massive pulmonary embolism, myocardial infarction, pericardial tamponade), then the underlying cause should be treated expeditiously.
In the absence of an obvious treatable cause of the shock, the fluid status and cardiac function should be addressed with POCUS. If the patient is hypovolemic, intravenous fluids should be administered. If the fluid status is adequate, POCUS should be used to estimate the patient’s ventricular function. If the ventricle appears to be hyperdynamic with good contractility, shock should be treated with norepinephrine. On the other hand, if the ventricle is hypodynamic, dobutamine should be substituted for norepinephrine or, more often, added to norepinephrine.
The above represents a simplified summary of the critical points, but the authors do delve into further detail and also discuss some other options for therapies, including steroids, coronary revascularization, extracorporeal membrane oxygenation, and so on. The review is very thoughtful, thorough, and definitely worth a full read.
Top myths of diagnosis and management of infectious diseases in hospital medicine
Most, if not all of us in medicine, have heard the saying that 50% of what we learn in medical school (or residency) will turn out to be wrong. I certainly believe in this concept and consequently, like many of you, I enjoy reading about myths and misconceptions that we have been taught. With that in mind, I have to say that I love this article because it seems to have been written specifically to address what I was taught!
This author group, consisting mostly of clinical PharmDs who are experts in antibiotic use, provide us with an evidence-based discussion of myths and pitfalls in how antibiotics are often used in current clinical practice. The authors review their top 10 myths involving the use of antibiotics in treating infections in the hospital setting. A few of these relate more to the inpatient setting, but here are my favorite emergency department (ED)–related myths that they address:
- “Antibiotics do no harm.” The authors address the risk-benefit of antibiotics based on assumed vs. confirmed infections, including a brief discussion of adverse drug effects.
- “Antibiotic durations of 7, 14, or 21 days are typically necessary.” The authors address appropriate duration of antibiotic use and the fact that unnecessarily long durations of use can lead to resistance. They also provide reassurance that some infections can be treated with quite short durations of antibiotics.
- “If one drug is good, two (or more!) is better.” The use of multiple antibiotics, often with overlapping bacterial coverage, is rampant in medicine and further increases the risk for adverse drug effects and resistance.
- “Oral antibiotics are not as good as intravenous antibiotics for hospitalized patients.” This is definitely a myth that I learned. I recall being taught by many senior physicians that anyone sick enough for admission should be treated with intravenous antibiotics. As it turns out, absorption and effectiveness of most oral antibiotics is just as good as intravenous antibiotics, and the oral formulations are often safer.
- “A history of a penicillin allergy means the patient can never receive a beta-lactam antibiotic.” This is a myth that was debunked quite a few years ago, but it seems that many clinicians still need a reminder.
The authors included five more myths that are worth the read. This is an article that needs to be disseminated among all hospital clinicians.
Guidelines for low-risk, recurrent abdominal pain in the emergency department
The Society for Academic Emergency Medicine (SAEM) recently initiated a program focused on creating evidence-based approaches to challenging chief complaints and presentations in the emergency department (ED). In 2021, they published an approach to managing patients with recurrent, low-risk chest pain in the ED. This past year, they published their second guideline, focused on the management of patients with low-risk, recurrent abdominal pain in the ED.
Recurrent low-risk abdominal pain is a common and vexing presentation to EDs around the world, and there is little prior published guidance. Do all of these patients need repeat imaging? How do we manage their pain? Are there nonabdominal conditions that should be considered?
Broder and colleagues did a fantastic review of the current literature and, on behalf of SAEM, have provided a rational approach to optimal management of these patients. The four major questions they addressed, with brief summaries of their recommendations, are:
- Should adult ED patients with low-risk, recurrent and previously undifferentiated abdominal pain receive a repeat CT abdomen-pelvis (CTAP) after a negative CTAP within the past 12 months? This is a typical question that we all ponder when managing these patients. Unfortunately, the writing group found insufficient evidence to definitively identify populations in whom CTAP was recommended vs could be safely withheld. It is a bit disappointing that there is no definite answer to the question. On the other hand, it is reassuring to know that the world’s best evidence essentially says that it is perfectly appropriate to use your own good clinical judgment.
- Should adult ED patients with low-risk, recurrent, and previously undifferentiated abdominal pain with a negative CTAP receive additional imaging with abdominal ultrasound? In this case, the writing group found enough evidence, though low-level, to suggest against routine ultrasound in the absence of concern specifically for pelvic or hepatobiliary pathology. Like most tests, ultrasound is best used when there are specific concerns rather than being used in an undifferentiated fashion.
- Should adult ED patients with low-risk, recurrent, and previously undifferentiated abdominal pain receive screening for depression/anxiety? The writing group found enough evidence, though low-level again, to suggest that screening for depression and/or anxiety be performed during the ED evaluation. This could lead to successful therapy for the abdominal pain.
- Should adult ED patients with low-risk, recurrent, and previously undifferentiated abdominal pain receive nonopioid and/or nonpharmacologic analgesics? The writing group found little evidence to suggest for or against these analgesics, but they made a consensus recommendation suggesting an opioid-minimizing strategy for pain control.
Although the final recommendations of the writing group were not definitive or based on the strongest level of evidence, I find it helpful to have this guidance, nevertheless, on behalf of a major national organization. I also find it helpful to know that even with the best evidence available, optimal patient care will often boil down to physician experience and gestalt. I should also add that the overall article is chock-full of pearls and helpful information that will further inform the readers’ decisions, and so the full version is definitely worth the read.
In summary
There you have it – my three favorite practice-changing articles of 2022. Although I have tried to provide key points here, the full discussions of those key points in the published articles will provide a great deal more education than I can offer in this brief write-up, and so I strongly encourage everyone to read the full versions. Please be sure to include in the comments section your own pick for favorite or must-read articles from the past year.
Amal Mattu, MD, is a professor, vice chair of education, and codirector of the emergency cardiology fellowship in the department of emergency medicine at the University of Maryland, Baltimore. She reported no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
When 2022 began, we started seeing some light at the end of the COVID-19 tunnel. Vaccines were widely available, and even with new variants of the virus still occasionally emerging, the rates of severe morbidity and mortality appeared to be decreasing.
Expectedly, journals appeared to start moving more toward mainstream topics and publications rather than what seemed like a major focus on COVID-19 publications. The resulting literature was fantastic.
Several of those topics were discussed in a prior Emergency Medicine Viewpoint from this news organization, and many more of the research advances of 2022 will be discussed in the near future. However, in this Viewpoint, I would like to present my annual review of my three “must-read” articles of the past year.
As in past years, I am choosing reviews of the literature rather than original research articles (which, all too often, become outdated or debunked within a few years). I choose these articles in the hopes that readers will not simply settle for my brief reviews of the key points but instead will feel compelled to download and read the entire articles. These publications address common conditions and quandaries we face in the daily practice of emergency medicine and are practice-changing.
Myocardial dysfunction after cardiac arrest: Tips and pitfalls
The management of post–cardiac arrest patients remains a hot topic in the resuscitation literature as we continue to understand that the immediate post-arrest period is critical to patient outcome.
Ortuno and colleagues reviewed the current literature on post-arrest care and wrote an outstanding summary of how to optimally care for these patients. More specifically, they focused on post-arrest patients who demonstrate continued shock, or “post–cardiac arrest myocardial dysfunction” (PCAMD).
They propose three mechanisms for the pathogenesis of PCAMD: ischemia reperfusion phenomenon, systemic inflammatory response, and increased catecholamine release
I will skip through the details of the pathophysiology that they describe in the article, but I certainly do recommend that everyone review their descriptions.
Management of these patients begins with a good hemodynamic assessment, which includes clinical markers of perfusion (blood pressure, capillary refill), ECG, and point-of-care ultrasound (POCUS). If the initial assessment reveals an obvious cause of the cardiac arrest (e.g., massive pulmonary embolism, myocardial infarction, pericardial tamponade), then the underlying cause should be treated expeditiously.
In the absence of an obvious treatable cause of the shock, the fluid status and cardiac function should be addressed with POCUS. If the patient is hypovolemic, intravenous fluids should be administered. If the fluid status is adequate, POCUS should be used to estimate the patient’s ventricular function. If the ventricle appears to be hyperdynamic with good contractility, shock should be treated with norepinephrine. On the other hand, if the ventricle is hypodynamic, dobutamine should be substituted for norepinephrine or, more often, added to norepinephrine.
The above represents a simplified summary of the critical points, but the authors do delve into further detail and also discuss some other options for therapies, including steroids, coronary revascularization, extracorporeal membrane oxygenation, and so on. The review is very thoughtful, thorough, and definitely worth a full read.
Top myths of diagnosis and management of infectious diseases in hospital medicine
Most, if not all of us in medicine, have heard the saying that 50% of what we learn in medical school (or residency) will turn out to be wrong. I certainly believe in this concept and consequently, like many of you, I enjoy reading about myths and misconceptions that we have been taught. With that in mind, I have to say that I love this article because it seems to have been written specifically to address what I was taught!
This author group, consisting mostly of clinical PharmDs who are experts in antibiotic use, provide us with an evidence-based discussion of myths and pitfalls in how antibiotics are often used in current clinical practice. The authors review their top 10 myths involving the use of antibiotics in treating infections in the hospital setting. A few of these relate more to the inpatient setting, but here are my favorite emergency department (ED)–related myths that they address:
- “Antibiotics do no harm.” The authors address the risk-benefit of antibiotics based on assumed vs. confirmed infections, including a brief discussion of adverse drug effects.
- “Antibiotic durations of 7, 14, or 21 days are typically necessary.” The authors address appropriate duration of antibiotic use and the fact that unnecessarily long durations of use can lead to resistance. They also provide reassurance that some infections can be treated with quite short durations of antibiotics.
- “If one drug is good, two (or more!) is better.” The use of multiple antibiotics, often with overlapping bacterial coverage, is rampant in medicine and further increases the risk for adverse drug effects and resistance.
- “Oral antibiotics are not as good as intravenous antibiotics for hospitalized patients.” This is definitely a myth that I learned. I recall being taught by many senior physicians that anyone sick enough for admission should be treated with intravenous antibiotics. As it turns out, absorption and effectiveness of most oral antibiotics is just as good as intravenous antibiotics, and the oral formulations are often safer.
- “A history of a penicillin allergy means the patient can never receive a beta-lactam antibiotic.” This is a myth that was debunked quite a few years ago, but it seems that many clinicians still need a reminder.
The authors included five more myths that are worth the read. This is an article that needs to be disseminated among all hospital clinicians.
Guidelines for low-risk, recurrent abdominal pain in the emergency department
The Society for Academic Emergency Medicine (SAEM) recently initiated a program focused on creating evidence-based approaches to challenging chief complaints and presentations in the emergency department (ED). In 2021, they published an approach to managing patients with recurrent, low-risk chest pain in the ED. This past year, they published their second guideline, focused on the management of patients with low-risk, recurrent abdominal pain in the ED.
Recurrent low-risk abdominal pain is a common and vexing presentation to EDs around the world, and there is little prior published guidance. Do all of these patients need repeat imaging? How do we manage their pain? Are there nonabdominal conditions that should be considered?
Broder and colleagues did a fantastic review of the current literature and, on behalf of SAEM, have provided a rational approach to optimal management of these patients. The four major questions they addressed, with brief summaries of their recommendations, are:
- Should adult ED patients with low-risk, recurrent and previously undifferentiated abdominal pain receive a repeat CT abdomen-pelvis (CTAP) after a negative CTAP within the past 12 months? This is a typical question that we all ponder when managing these patients. Unfortunately, the writing group found insufficient evidence to definitively identify populations in whom CTAP was recommended vs could be safely withheld. It is a bit disappointing that there is no definite answer to the question. On the other hand, it is reassuring to know that the world’s best evidence essentially says that it is perfectly appropriate to use your own good clinical judgment.
- Should adult ED patients with low-risk, recurrent, and previously undifferentiated abdominal pain with a negative CTAP receive additional imaging with abdominal ultrasound? In this case, the writing group found enough evidence, though low-level, to suggest against routine ultrasound in the absence of concern specifically for pelvic or hepatobiliary pathology. Like most tests, ultrasound is best used when there are specific concerns rather than being used in an undifferentiated fashion.
- Should adult ED patients with low-risk, recurrent, and previously undifferentiated abdominal pain receive screening for depression/anxiety? The writing group found enough evidence, though low-level again, to suggest that screening for depression and/or anxiety be performed during the ED evaluation. This could lead to successful therapy for the abdominal pain.
- Should adult ED patients with low-risk, recurrent, and previously undifferentiated abdominal pain receive nonopioid and/or nonpharmacologic analgesics? The writing group found little evidence to suggest for or against these analgesics, but they made a consensus recommendation suggesting an opioid-minimizing strategy for pain control.
Although the final recommendations of the writing group were not definitive or based on the strongest level of evidence, I find it helpful to have this guidance, nevertheless, on behalf of a major national organization. I also find it helpful to know that even with the best evidence available, optimal patient care will often boil down to physician experience and gestalt. I should also add that the overall article is chock-full of pearls and helpful information that will further inform the readers’ decisions, and so the full version is definitely worth the read.
In summary
There you have it – my three favorite practice-changing articles of 2022. Although I have tried to provide key points here, the full discussions of those key points in the published articles will provide a great deal more education than I can offer in this brief write-up, and so I strongly encourage everyone to read the full versions. Please be sure to include in the comments section your own pick for favorite or must-read articles from the past year.
Amal Mattu, MD, is a professor, vice chair of education, and codirector of the emergency cardiology fellowship in the department of emergency medicine at the University of Maryland, Baltimore. She reported no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
The five biggest changes in the 2023 adult vaccine schedules
This transcript has been edited for clarity.
Hello. I’m Dr Sandra Fryhofer. Welcome to Medicine Matters.
It’s a new year, which means a new ACIP adult immunization schedule – a valuable resource collating ACIP’s most up-to-date vaccination recommendations.
Here are this year’s five most important changes:
- COVID vaccines now front and center
- New emphasis on polio vaccination
- Inclusion of some nonvaccine products (such as monoclonal antibody products)
- Pharmacists group has approved the schedule for the first time
- New shared clinical decision-making option for pneumococcal vaccines
The schedule’s organization remains the same. It still has four sections:
- Table 1: vaccinations by age
- Table 2: vaccinations by medical condition and other indications
- The Notes section (alphabetically ordered by vaccine type)
- Appendix listing of vaccine-specific contraindications and precautions
But what’s unique this year is that some of the abbreviations have historical implications. The first change is no big surprise in light of what we’ve gone through in the past few years. COVID vaccines are listed first on the cover page by brand name for those authorized and by company name for those still under US emergency use authorization. They’re also listed first on the graphics and in the notes.
COVID and mRNA and protein-based vaccines have now been assigned official abbreviations based on vaccine platform and valency.
- 1vCOV-mRNA: Comirnaty/Pfizer-BioNTech and Spikevax Moderna COVID-19 vaccines
- 2vCOV-mRNA: Pfizer-BioNTech and Moderna bivalent COVID-19 vaccines
- 1vCOV-aPS: Novavax COVID-19 vaccine
Also remarkable is the absence of COVID viral vector vaccines on the list. However, the viral vector COVID vaccine (which has been available but is not preferred) does have a CDC website link in the Notes section.
A sad but necessary inclusion was triggered by recent polio cases in New York. Polio was believed to be eradicated, and we thought adults no longer needed to be vaccinated against polio. In the new schedule, the polio vaccine is listed on the cover page but is not included in the tables. Current polio vaccination recommendations are now in the Notes section.
Also of historical significance and something that may set a precedent is the inclusion of nonvaccine products. The value of COVID preexposure prophylaxis with products including monoclonal antibodies (such as Evusheld) for people who are moderately or severely immunocompromised is mentioned in the Notes section.
For the first time ever, the schedule has been approved by the American Pharmacists Association, which validates pharmacists as established partners in vaccine administration.
Color-code key
One aspect of the schedule that has not changed is the color-code key:
- Yellow: Recommended if the patient meets the age requirement
- Purple: Indicated for those with additional risk factors or another indication
- Blue: Recommended based on shared clinical decision-making
- Orange: Precaution
- Red: Contraindicated or not recommended; the vaccine should not be administered. Overlays on the red more precisely clarify whether a vaccine is really contraindicated or just not recommended. An asterisk on red means vaccinate after pregnancy if indicated.
- Gray: No recommendation or not applicable
Vaccinations by age
Table 1 lists recommended vaccinations by age. There is one major change. COVID vaccines are on the first row of the graphic, with the need for both a primary series and boosters emphasized on the overlay. The notes have hyperlinks to the most up-to-date COVID vaccination recommendations.
Pneumococcal vaccination. Pneumococcal vaccination is routinely recommended starting at age 65. Current recommendations for those not previously vaccinated have not changed since last year. But on Table 1, the bottom half of the row for those 65 or older is now blue (and that’s new). This new color blue means shared clinical decision-making and applies to people who were previously considered fully vaccinated with the now extinct combination of PCV13 and PPSV23. These patients now have the option of getting a dose of PCV20 five years after completing their PCV13-PPSV23 combo series. This option is blue because the decision is up to you and your patient.
Check the notes for more pneumococcal vaccination details. For example, for those partially vaccinated using lower valency vaccines, there’s an option of substituting PCV20 for PPSV23 to broaden and increase durability of protection.
The pneumococcal vaccination recommendation options are complicated. A new pneumococcal vaccination app can help.
Hepatitis B. For adults under age 60, the color code for the hepatitis B vaccine is yellow, meaning it’s indicated for all. For older patients, the color code is purple. If a patient who is age 60 or older wants the hepatitis B vaccine, they can have it even in the absence of additional risk indications.
Vaccinations by medical condition or other indications
Other than a few minor word changes on the overlay, the only thing that’s new is the COVID vaccine row.
This table is helpful for matching vaccine recommendations with specific medical conditions, including pregnancy, immunocompromise, HIV (with specifics according to CD4 count), asplenia, complement deficiencies, heart disease, lung disease, alcoholism, chronic liver disease, diabetes, health care personnel, and men who have sex with men.
Use this table to dot the i’s and cross the t’s when it comes to vaccination recommendations. For example, take a look at the pregnancy column. Live virus vaccines, including LAIV, MMR, and varicella, are contraindicated and color-coded red. MMR and varicella also have an asterisk, meaning vaccinate after pregnancy if indicated. HPV vaccines are not live virus vaccines, but the overlay says they are not recommended during pregnancy. The asterisk indicates that you can vaccinate after pregnancy.
Vaccine notes
The notes are in alphabetical order, and their organization (routine, special situations, and shared clinical decision-making when indicated) has not changed. They are concise and succinct, but sometimes they’re not enough. That’s why vaccine-specific links to more complete recommendations are so convenient.
Notes for hepatitis B contain nuances on specific dosing for vaccinating patients on dialysis, as well as a reminder that newer hepatitis C vaccines such as Heplisav and PreHevbrio are not recommended during pregnancy due to lack of safety data.
For influenza, everyone 6 months or older still needs yearly flu vaccination with an age- and health-appropriate flu vaccine. But for those aged 65 or older, the notes specify the three vaccine versions now preferred: high-dose, recombinant, or adjuvanted versions. However, if these aren’t available, it’s better to get any flu vaccine than to go without.
Under meningococcal vaccines, the notes for MenACWY and MenB are combined. For MenB, trade names Bexsero and Trumenba are specified because the products are not interchangeable. Booster intervals for those still at risk are different for each vaccine type: every 5 years for MenACWY boosters, and every 2-3 years for boosts of MenB.
The recent polio cases in New York have put polio vaccination in the spotlight. ACIP has now reinstated its Polio Vaccine Work Group. The new schedule lists polio vaccines on the cover page. Current recommendations have been added to the notes section. Routine vaccination for adults is not necessary, at least for now. However, those at increased risk for exposure to polio fall in the special-situation category. For those at increased risk who have completed a polio vaccine series, a single lifetime IPV booster can be given. For those at increased risk who have not completed their polio vaccine series, now would be the time to finish the series.
Appendix
The final step in using the new schedule is checking the appendix and its list of vaccine-specific contraindications and precautions.
I hope this review of the new ACIP adult immunization schedule has been helpful. For Medicine Matters, I’m Dr. Sandra Fryhofer.
Dr. Fryhofer is clinical associate professor of medicine, Emory University, Atlanta. She reported numerous conflicts of interest.
A version of this article first appeared on Medscape.com.
This transcript has been edited for clarity.
Hello. I’m Dr Sandra Fryhofer. Welcome to Medicine Matters.
It’s a new year, which means a new ACIP adult immunization schedule – a valuable resource collating ACIP’s most up-to-date vaccination recommendations.
Here are this year’s five most important changes:
- COVID vaccines now front and center
- New emphasis on polio vaccination
- Inclusion of some nonvaccine products (such as monoclonal antibody products)
- Pharmacists group has approved the schedule for the first time
- New shared clinical decision-making option for pneumococcal vaccines
The schedule’s organization remains the same. It still has four sections:
- Table 1: vaccinations by age
- Table 2: vaccinations by medical condition and other indications
- The Notes section (alphabetically ordered by vaccine type)
- Appendix listing of vaccine-specific contraindications and precautions
But what’s unique this year is that some of the abbreviations have historical implications. The first change is no big surprise in light of what we’ve gone through in the past few years. COVID vaccines are listed first on the cover page by brand name for those authorized and by company name for those still under US emergency use authorization. They’re also listed first on the graphics and in the notes.
COVID and mRNA and protein-based vaccines have now been assigned official abbreviations based on vaccine platform and valency.
- 1vCOV-mRNA: Comirnaty/Pfizer-BioNTech and Spikevax Moderna COVID-19 vaccines
- 2vCOV-mRNA: Pfizer-BioNTech and Moderna bivalent COVID-19 vaccines
- 1vCOV-aPS: Novavax COVID-19 vaccine
Also remarkable is the absence of COVID viral vector vaccines on the list. However, the viral vector COVID vaccine (which has been available but is not preferred) does have a CDC website link in the Notes section.
A sad but necessary inclusion was triggered by recent polio cases in New York. Polio was believed to be eradicated, and we thought adults no longer needed to be vaccinated against polio. In the new schedule, the polio vaccine is listed on the cover page but is not included in the tables. Current polio vaccination recommendations are now in the Notes section.
Also of historical significance and something that may set a precedent is the inclusion of nonvaccine products. The value of COVID preexposure prophylaxis with products including monoclonal antibodies (such as Evusheld) for people who are moderately or severely immunocompromised is mentioned in the Notes section.
For the first time ever, the schedule has been approved by the American Pharmacists Association, which validates pharmacists as established partners in vaccine administration.
Color-code key
One aspect of the schedule that has not changed is the color-code key:
- Yellow: Recommended if the patient meets the age requirement
- Purple: Indicated for those with additional risk factors or another indication
- Blue: Recommended based on shared clinical decision-making
- Orange: Precaution
- Red: Contraindicated or not recommended; the vaccine should not be administered. Overlays on the red more precisely clarify whether a vaccine is really contraindicated or just not recommended. An asterisk on red means vaccinate after pregnancy if indicated.
- Gray: No recommendation or not applicable
Vaccinations by age
Table 1 lists recommended vaccinations by age. There is one major change. COVID vaccines are on the first row of the graphic, with the need for both a primary series and boosters emphasized on the overlay. The notes have hyperlinks to the most up-to-date COVID vaccination recommendations.
Pneumococcal vaccination. Pneumococcal vaccination is routinely recommended starting at age 65. Current recommendations for those not previously vaccinated have not changed since last year. But on Table 1, the bottom half of the row for those 65 or older is now blue (and that’s new). This new color blue means shared clinical decision-making and applies to people who were previously considered fully vaccinated with the now extinct combination of PCV13 and PPSV23. These patients now have the option of getting a dose of PCV20 five years after completing their PCV13-PPSV23 combo series. This option is blue because the decision is up to you and your patient.
Check the notes for more pneumococcal vaccination details. For example, for those partially vaccinated using lower valency vaccines, there’s an option of substituting PCV20 for PPSV23 to broaden and increase durability of protection.
The pneumococcal vaccination recommendation options are complicated. A new pneumococcal vaccination app can help.
Hepatitis B. For adults under age 60, the color code for the hepatitis B vaccine is yellow, meaning it’s indicated for all. For older patients, the color code is purple. If a patient who is age 60 or older wants the hepatitis B vaccine, they can have it even in the absence of additional risk indications.
Vaccinations by medical condition or other indications
Other than a few minor word changes on the overlay, the only thing that’s new is the COVID vaccine row.
This table is helpful for matching vaccine recommendations with specific medical conditions, including pregnancy, immunocompromise, HIV (with specifics according to CD4 count), asplenia, complement deficiencies, heart disease, lung disease, alcoholism, chronic liver disease, diabetes, health care personnel, and men who have sex with men.
Use this table to dot the i’s and cross the t’s when it comes to vaccination recommendations. For example, take a look at the pregnancy column. Live virus vaccines, including LAIV, MMR, and varicella, are contraindicated and color-coded red. MMR and varicella also have an asterisk, meaning vaccinate after pregnancy if indicated. HPV vaccines are not live virus vaccines, but the overlay says they are not recommended during pregnancy. The asterisk indicates that you can vaccinate after pregnancy.
Vaccine notes
The notes are in alphabetical order, and their organization (routine, special situations, and shared clinical decision-making when indicated) has not changed. They are concise and succinct, but sometimes they’re not enough. That’s why vaccine-specific links to more complete recommendations are so convenient.
Notes for hepatitis B contain nuances on specific dosing for vaccinating patients on dialysis, as well as a reminder that newer hepatitis C vaccines such as Heplisav and PreHevbrio are not recommended during pregnancy due to lack of safety data.
For influenza, everyone 6 months or older still needs yearly flu vaccination with an age- and health-appropriate flu vaccine. But for those aged 65 or older, the notes specify the three vaccine versions now preferred: high-dose, recombinant, or adjuvanted versions. However, if these aren’t available, it’s better to get any flu vaccine than to go without.
Under meningococcal vaccines, the notes for MenACWY and MenB are combined. For MenB, trade names Bexsero and Trumenba are specified because the products are not interchangeable. Booster intervals for those still at risk are different for each vaccine type: every 5 years for MenACWY boosters, and every 2-3 years for boosts of MenB.
The recent polio cases in New York have put polio vaccination in the spotlight. ACIP has now reinstated its Polio Vaccine Work Group. The new schedule lists polio vaccines on the cover page. Current recommendations have been added to the notes section. Routine vaccination for adults is not necessary, at least for now. However, those at increased risk for exposure to polio fall in the special-situation category. For those at increased risk who have completed a polio vaccine series, a single lifetime IPV booster can be given. For those at increased risk who have not completed their polio vaccine series, now would be the time to finish the series.
Appendix
The final step in using the new schedule is checking the appendix and its list of vaccine-specific contraindications and precautions.
I hope this review of the new ACIP adult immunization schedule has been helpful. For Medicine Matters, I’m Dr. Sandra Fryhofer.
Dr. Fryhofer is clinical associate professor of medicine, Emory University, Atlanta. She reported numerous conflicts of interest.
A version of this article first appeared on Medscape.com.
This transcript has been edited for clarity.
Hello. I’m Dr Sandra Fryhofer. Welcome to Medicine Matters.
It’s a new year, which means a new ACIP adult immunization schedule – a valuable resource collating ACIP’s most up-to-date vaccination recommendations.
Here are this year’s five most important changes:
- COVID vaccines now front and center
- New emphasis on polio vaccination
- Inclusion of some nonvaccine products (such as monoclonal antibody products)
- Pharmacists group has approved the schedule for the first time
- New shared clinical decision-making option for pneumococcal vaccines
The schedule’s organization remains the same. It still has four sections:
- Table 1: vaccinations by age
- Table 2: vaccinations by medical condition and other indications
- The Notes section (alphabetically ordered by vaccine type)
- Appendix listing of vaccine-specific contraindications and precautions
But what’s unique this year is that some of the abbreviations have historical implications. The first change is no big surprise in light of what we’ve gone through in the past few years. COVID vaccines are listed first on the cover page by brand name for those authorized and by company name for those still under US emergency use authorization. They’re also listed first on the graphics and in the notes.
COVID and mRNA and protein-based vaccines have now been assigned official abbreviations based on vaccine platform and valency.
- 1vCOV-mRNA: Comirnaty/Pfizer-BioNTech and Spikevax Moderna COVID-19 vaccines
- 2vCOV-mRNA: Pfizer-BioNTech and Moderna bivalent COVID-19 vaccines
- 1vCOV-aPS: Novavax COVID-19 vaccine
Also remarkable is the absence of COVID viral vector vaccines on the list. However, the viral vector COVID vaccine (which has been available but is not preferred) does have a CDC website link in the Notes section.
A sad but necessary inclusion was triggered by recent polio cases in New York. Polio was believed to be eradicated, and we thought adults no longer needed to be vaccinated against polio. In the new schedule, the polio vaccine is listed on the cover page but is not included in the tables. Current polio vaccination recommendations are now in the Notes section.
Also of historical significance and something that may set a precedent is the inclusion of nonvaccine products. The value of COVID preexposure prophylaxis with products including monoclonal antibodies (such as Evusheld) for people who are moderately or severely immunocompromised is mentioned in the Notes section.
For the first time ever, the schedule has been approved by the American Pharmacists Association, which validates pharmacists as established partners in vaccine administration.
Color-code key
One aspect of the schedule that has not changed is the color-code key:
- Yellow: Recommended if the patient meets the age requirement
- Purple: Indicated for those with additional risk factors or another indication
- Blue: Recommended based on shared clinical decision-making
- Orange: Precaution
- Red: Contraindicated or not recommended; the vaccine should not be administered. Overlays on the red more precisely clarify whether a vaccine is really contraindicated or just not recommended. An asterisk on red means vaccinate after pregnancy if indicated.
- Gray: No recommendation or not applicable
Vaccinations by age
Table 1 lists recommended vaccinations by age. There is one major change. COVID vaccines are on the first row of the graphic, with the need for both a primary series and boosters emphasized on the overlay. The notes have hyperlinks to the most up-to-date COVID vaccination recommendations.
Pneumococcal vaccination. Pneumococcal vaccination is routinely recommended starting at age 65. Current recommendations for those not previously vaccinated have not changed since last year. But on Table 1, the bottom half of the row for those 65 or older is now blue (and that’s new). This new color blue means shared clinical decision-making and applies to people who were previously considered fully vaccinated with the now extinct combination of PCV13 and PPSV23. These patients now have the option of getting a dose of PCV20 five years after completing their PCV13-PPSV23 combo series. This option is blue because the decision is up to you and your patient.
Check the notes for more pneumococcal vaccination details. For example, for those partially vaccinated using lower valency vaccines, there’s an option of substituting PCV20 for PPSV23 to broaden and increase durability of protection.
The pneumococcal vaccination recommendation options are complicated. A new pneumococcal vaccination app can help.
Hepatitis B. For adults under age 60, the color code for the hepatitis B vaccine is yellow, meaning it’s indicated for all. For older patients, the color code is purple. If a patient who is age 60 or older wants the hepatitis B vaccine, they can have it even in the absence of additional risk indications.
Vaccinations by medical condition or other indications
Other than a few minor word changes on the overlay, the only thing that’s new is the COVID vaccine row.
This table is helpful for matching vaccine recommendations with specific medical conditions, including pregnancy, immunocompromise, HIV (with specifics according to CD4 count), asplenia, complement deficiencies, heart disease, lung disease, alcoholism, chronic liver disease, diabetes, health care personnel, and men who have sex with men.
Use this table to dot the i’s and cross the t’s when it comes to vaccination recommendations. For example, take a look at the pregnancy column. Live virus vaccines, including LAIV, MMR, and varicella, are contraindicated and color-coded red. MMR and varicella also have an asterisk, meaning vaccinate after pregnancy if indicated. HPV vaccines are not live virus vaccines, but the overlay says they are not recommended during pregnancy. The asterisk indicates that you can vaccinate after pregnancy.
Vaccine notes
The notes are in alphabetical order, and their organization (routine, special situations, and shared clinical decision-making when indicated) has not changed. They are concise and succinct, but sometimes they’re not enough. That’s why vaccine-specific links to more complete recommendations are so convenient.
Notes for hepatitis B contain nuances on specific dosing for vaccinating patients on dialysis, as well as a reminder that newer hepatitis C vaccines such as Heplisav and PreHevbrio are not recommended during pregnancy due to lack of safety data.
For influenza, everyone 6 months or older still needs yearly flu vaccination with an age- and health-appropriate flu vaccine. But for those aged 65 or older, the notes specify the three vaccine versions now preferred: high-dose, recombinant, or adjuvanted versions. However, if these aren’t available, it’s better to get any flu vaccine than to go without.
Under meningococcal vaccines, the notes for MenACWY and MenB are combined. For MenB, trade names Bexsero and Trumenba are specified because the products are not interchangeable. Booster intervals for those still at risk are different for each vaccine type: every 5 years for MenACWY boosters, and every 2-3 years for boosts of MenB.
The recent polio cases in New York have put polio vaccination in the spotlight. ACIP has now reinstated its Polio Vaccine Work Group. The new schedule lists polio vaccines on the cover page. Current recommendations have been added to the notes section. Routine vaccination for adults is not necessary, at least for now. However, those at increased risk for exposure to polio fall in the special-situation category. For those at increased risk who have completed a polio vaccine series, a single lifetime IPV booster can be given. For those at increased risk who have not completed their polio vaccine series, now would be the time to finish the series.
Appendix
The final step in using the new schedule is checking the appendix and its list of vaccine-specific contraindications and precautions.
I hope this review of the new ACIP adult immunization schedule has been helpful. For Medicine Matters, I’m Dr. Sandra Fryhofer.
Dr. Fryhofer is clinical associate professor of medicine, Emory University, Atlanta. She reported numerous conflicts of interest.
A version of this article first appeared on Medscape.com.