Infectious Disease Practitioner

Black women living with HIV are a high-risk population for peripartum depressive symptoms, based on data from 143 women.

Women with high-risk pregnancies because of chronic conditions are at increased risk for developing postpartum depression, and HIV may be one such risk. However, risk factors for women living with HIV, particularly Black women, have not been well studied, wrote Emmanuela Nneamaka Ojukwu of the University of Miami School of Nursing, and colleagues.

Data suggest that as many as half of cases of postpartum depression (PPD) begin before delivery, the researchers noted. “Therefore, for this study, the symptoms of both PND (prenatal depression) and PPD have been classified in what we have termed peripartum depressive symptoms (PDS),” and defined as depressive symptoms during pregnancy and within 1 year postpartum, they said.

In a study published in the Archives of Psychiatric Nursing, the researchers conducted a secondary analysis of 143 Black women living with HIV seen at specialty prenatal and women’s health clinics in Miami.

Overall, 81 women (57%) reported either perinatal or postpartum depressive symptoms, or both. “Some of the symptoms prevalent among women in our study included restlessness, depressed mood, apathy, guilt, hopelessness, and social isolation,” the researchers said.
 

Social factors show significant impact

In a multivariate analysis, low income, intimate partner violence, and childcare burden were significant predictors of PDS (P less than .05). Women who reported intimate partner violence or abuse were 6.5 times more likely to experience PDS than were women who did not report abuse, and women with a childcare burden involving two children were 4.6 times more likely to experience PDS than were women with no childcare burden or only one child needing child care.

The average age of the women studied was 29 years, and 59% were above the federal poverty level. Nearly two-thirds (62%) were Black and 38% were Haitian; 63% were unemployed, 62% had a high school diploma or less, and 59% received care through Medicaid.

The researchers assessed four categories of health: HIV-related, gynecologic, obstetric, and psychosocial. The average viral load among the patients was 22,359 copies/mL at baseline, and they averaged 2.5 medical comorbidities. The most common comorbid conditions were other sexually transmitted infections and blood disorders, followed by cardiovascular and metabolic conditions.
 

Quantitative studies needed

Larger quantitative studies of Black pregnant women living with HIV are needed to analyze social factors at multiple levels, the researchers said. “To address depression among Black women living with HIV, local and federal governments should enact measures that increase the family income and diminish the prevalence of [intimate partner violence] among these women,” they said.

The study findings were limited by several factors including retrospective design and use of self-reports, as well as the small sample size and lack of generalizability to women living with HIV of other races or from other regions, the researchers noted. However, the results reflect data from previous studies and support the value of early screening and referral to improve well being for Black women living with HIV, as well as the importance of comprehensive medical care, they said.

“Women should be counseled that postpartum physical and psychological changes (and the stresses and demands of caring for a new baby) may make [antiretroviral] adherence more difficult and that additional support may be needed during this period,” the researchers wrote.

The study received no outside funding. The researchers had no financial conflicts to disclose.

SOURCE: Ojukwu EN et al. Arch Psychiatr Nurs. 2020 May 22. doi: 10.1016/j.apnu.2020.05.004.

Black women living with HIV are a high-risk population for peripartum depressive symptoms, based on data from 143 women.

Women with high-risk pregnancies because of chronic conditions are at increased risk for developing postpartum depression, and HIV may be one such risk. However, risk factors for women living with HIV, particularly Black women, have not been well studied, wrote Emmanuela Nneamaka Ojukwu of the University of Miami School of Nursing, and colleagues.

Data suggest that as many as half of cases of postpartum depression (PPD) begin before delivery, the researchers noted. “Therefore, for this study, the symptoms of both PND (prenatal depression) and PPD have been classified in what we have termed peripartum depressive symptoms (PDS),” and defined as depressive symptoms during pregnancy and within 1 year postpartum, they said.

In a study published in the Archives of Psychiatric Nursing, the researchers conducted a secondary analysis of 143 Black women living with HIV seen at specialty prenatal and women’s health clinics in Miami.

Overall, 81 women (57%) reported either perinatal or postpartum depressive symptoms, or both. “Some of the symptoms prevalent among women in our study included restlessness, depressed mood, apathy, guilt, hopelessness, and social isolation,” the researchers said.
 

Social factors show significant impact

In a multivariate analysis, low income, intimate partner violence, and childcare burden were significant predictors of PDS (P less than .05). Women who reported intimate partner violence or abuse were 6.5 times more likely to experience PDS than were women who did not report abuse, and women with a childcare burden involving two children were 4.6 times more likely to experience PDS than were women with no childcare burden or only one child needing child care.

The average age of the women studied was 29 years, and 59% were above the federal poverty level. Nearly two-thirds (62%) were Black and 38% were Haitian; 63% were unemployed, 62% had a high school diploma or less, and 59% received care through Medicaid.

The researchers assessed four categories of health: HIV-related, gynecologic, obstetric, and psychosocial. The average viral load among the patients was 22,359 copies/mL at baseline, and they averaged 2.5 medical comorbidities. The most common comorbid conditions were other sexually transmitted infections and blood disorders, followed by cardiovascular and metabolic conditions.
 

Quantitative studies needed

Larger quantitative studies of Black pregnant women living with HIV are needed to analyze social factors at multiple levels, the researchers said. “To address depression among Black women living with HIV, local and federal governments should enact measures that increase the family income and diminish the prevalence of [intimate partner violence] among these women,” they said.

The study findings were limited by several factors including retrospective design and use of self-reports, as well as the small sample size and lack of generalizability to women living with HIV of other races or from other regions, the researchers noted. However, the results reflect data from previous studies and support the value of early screening and referral to improve well being for Black women living with HIV, as well as the importance of comprehensive medical care, they said.

“Women should be counseled that postpartum physical and psychological changes (and the stresses and demands of caring for a new baby) may make [antiretroviral] adherence more difficult and that additional support may be needed during this period,” the researchers wrote.

The study received no outside funding. The researchers had no financial conflicts to disclose.

SOURCE: Ojukwu EN et al. Arch Psychiatr Nurs. 2020 May 22. doi: 10.1016/j.apnu.2020.05.004.

Black women living with HIV are a high-risk population for peripartum depressive symptoms, based on data from 143 women.

Women with high-risk pregnancies because of chronic conditions are at increased risk for developing postpartum depression, and HIV may be one such risk. However, risk factors for women living with HIV, particularly Black women, have not been well studied, wrote Emmanuela Nneamaka Ojukwu of the University of Miami School of Nursing, and colleagues.

Data suggest that as many as half of cases of postpartum depression (PPD) begin before delivery, the researchers noted. “Therefore, for this study, the symptoms of both PND (prenatal depression) and PPD have been classified in what we have termed peripartum depressive symptoms (PDS),” and defined as depressive symptoms during pregnancy and within 1 year postpartum, they said.

In a study published in the Archives of Psychiatric Nursing, the researchers conducted a secondary analysis of 143 Black women living with HIV seen at specialty prenatal and women’s health clinics in Miami.

Overall, 81 women (57%) reported either perinatal or postpartum depressive symptoms, or both. “Some of the symptoms prevalent among women in our study included restlessness, depressed mood, apathy, guilt, hopelessness, and social isolation,” the researchers said.
 

Social factors show significant impact

In a multivariate analysis, low income, intimate partner violence, and childcare burden were significant predictors of PDS (P less than .05). Women who reported intimate partner violence or abuse were 6.5 times more likely to experience PDS than were women who did not report abuse, and women with a childcare burden involving two children were 4.6 times more likely to experience PDS than were women with no childcare burden or only one child needing child care.

The average age of the women studied was 29 years, and 59% were above the federal poverty level. Nearly two-thirds (62%) were Black and 38% were Haitian; 63% were unemployed, 62% had a high school diploma or less, and 59% received care through Medicaid.

The researchers assessed four categories of health: HIV-related, gynecologic, obstetric, and psychosocial. The average viral load among the patients was 22,359 copies/mL at baseline, and they averaged 2.5 medical comorbidities. The most common comorbid conditions were other sexually transmitted infections and blood disorders, followed by cardiovascular and metabolic conditions.
 

Quantitative studies needed

Larger quantitative studies of Black pregnant women living with HIV are needed to analyze social factors at multiple levels, the researchers said. “To address depression among Black women living with HIV, local and federal governments should enact measures that increase the family income and diminish the prevalence of [intimate partner violence] among these women,” they said.

The study findings were limited by several factors including retrospective design and use of self-reports, as well as the small sample size and lack of generalizability to women living with HIV of other races or from other regions, the researchers noted. However, the results reflect data from previous studies and support the value of early screening and referral to improve well being for Black women living with HIV, as well as the importance of comprehensive medical care, they said.

“Women should be counseled that postpartum physical and psychological changes (and the stresses and demands of caring for a new baby) may make [antiretroviral] adherence more difficult and that additional support may be needed during this period,” the researchers wrote.

The study received no outside funding. The researchers had no financial conflicts to disclose.

SOURCE: Ojukwu EN et al. Arch Psychiatr Nurs. 2020 May 22. doi: 10.1016/j.apnu.2020.05.004.

As the COVID-19 pandemic continues to chug along, some communities feel it slowing to a pace at which they might feel comfortable about a return to, if not quite “business as usual,” at least “business as sort of normal-ish.” They are ready to accept a level of disease that signals they have reached a steady state. However, in other communities, the virus has picked up speed and is threatening to overwhelm the medical infrastructure. If you are in one of those fortunate and skillfully managed states in which folks are beginning to talk seriously, but with little evidence, that it is time to return to normal, it is probably far too early. Are there any metrics that could be applied to make the decision to ease restrictions more rational?

Courtesy Dr. William G. Wilkoff

Eons ago in pandemic terms, the World Health Organization in Thailand published a list of criteria to aid in determining when a community could consider lifting the limits that seemed to have been effective in halting transmission of the virus (“Transitioning to and maintaining a steady state of low-level or no transmission,” WHO, Thailand, 2020 Apr 18). While much more has been learned about the behavior of the virus since the spring of 2020, the criteria from the WHO in Thailand are worth considering.

Here is my summary of their criteria for returning to normalcy. First, virus transmission is controlled to the point that only sporadic cases and small clusters exist, and that all of these are traceable in origin. Second, health care and public health systems are in place with sufficient capacities to manage a shift from detection to treatment should the case load increase dramatically; this capacity should include detection, testing, isolation, and quarantine. Third, outbreaks in high-risk populations such as nursing homes have been minimized. Fourth, workplace prevention strategies are in place and have been demonstrated to be effective. Fifth, risk of imported cases is at manageable levels. Finally, communities are engaged.

It is hard to argue with the rationale behind each of these criteria. However, the United States is not Thailand, and just thinking about how this country would go about meeting those criteria provides a window into some of the reasons why we have done so poorly and will continue to be challenged in dealing with the pandemic.

First, notice that the criteria make no mention of a vaccine. One gets the sense that from the top down our country is banking too heavily on the effectiveness and widespread delivery of a vaccine. Even if and when a vaccine is developed and delivered, all of these criteria still must be met and kept in mind for a future pandemic.

Second, the criteria call for an effective health care system, but it is abundantly clear that the United States does not have a cohesive health care system and probably won’t for the foreseeable future. The best we can hope for is individual states cobbling together their own systems, which may in turn serve as examples for those states who haven’t had the foresight. We have had a public health system of sorts, but its credibility and effectiveness has been neutered to the point that again we must rely on each state’s ability to see through the haze and create it’s own systems for detection, testing, tracking, isolating, and quarantining – often with little help in materiel support from the federal government. The sliver of good news is that, after a bit of a stumbling start, detecting and limiting the importation of cases from abroad is being addressed.

We continue to hear and see evidence that there are segments of the population who are not engaged in the activities that we have learned are necessary to stabilize the pandemic. My sense is that those people represent a very small minority. But, it is probably large enough to make the route to a steady state on a national level long and painful. This unfortunately is to be expected in a country that was built on a framework of personal freedoms. The best you can hope for in achieving a steady state is to live in one of the states that seems to be achieving the fine balance between personal freedoms and the common good.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

As the COVID-19 pandemic continues to chug along, some communities feel it slowing to a pace at which they might feel comfortable about a return to, if not quite “business as usual,” at least “business as sort of normal-ish.” They are ready to accept a level of disease that signals they have reached a steady state. However, in other communities, the virus has picked up speed and is threatening to overwhelm the medical infrastructure. If you are in one of those fortunate and skillfully managed states in which folks are beginning to talk seriously, but with little evidence, that it is time to return to normal, it is probably far too early. Are there any metrics that could be applied to make the decision to ease restrictions more rational?

Courtesy Dr. William G. Wilkoff

Eons ago in pandemic terms, the World Health Organization in Thailand published a list of criteria to aid in determining when a community could consider lifting the limits that seemed to have been effective in halting transmission of the virus (“Transitioning to and maintaining a steady state of low-level or no transmission,” WHO, Thailand, 2020 Apr 18). While much more has been learned about the behavior of the virus since the spring of 2020, the criteria from the WHO in Thailand are worth considering.

Here is my summary of their criteria for returning to normalcy. First, virus transmission is controlled to the point that only sporadic cases and small clusters exist, and that all of these are traceable in origin. Second, health care and public health systems are in place with sufficient capacities to manage a shift from detection to treatment should the case load increase dramatically; this capacity should include detection, testing, isolation, and quarantine. Third, outbreaks in high-risk populations such as nursing homes have been minimized. Fourth, workplace prevention strategies are in place and have been demonstrated to be effective. Fifth, risk of imported cases is at manageable levels. Finally, communities are engaged.

It is hard to argue with the rationale behind each of these criteria. However, the United States is not Thailand, and just thinking about how this country would go about meeting those criteria provides a window into some of the reasons why we have done so poorly and will continue to be challenged in dealing with the pandemic.

First, notice that the criteria make no mention of a vaccine. One gets the sense that from the top down our country is banking too heavily on the effectiveness and widespread delivery of a vaccine. Even if and when a vaccine is developed and delivered, all of these criteria still must be met and kept in mind for a future pandemic.

Second, the criteria call for an effective health care system, but it is abundantly clear that the United States does not have a cohesive health care system and probably won’t for the foreseeable future. The best we can hope for is individual states cobbling together their own systems, which may in turn serve as examples for those states who haven’t had the foresight. We have had a public health system of sorts, but its credibility and effectiveness has been neutered to the point that again we must rely on each state’s ability to see through the haze and create it’s own systems for detection, testing, tracking, isolating, and quarantining – often with little help in materiel support from the federal government. The sliver of good news is that, after a bit of a stumbling start, detecting and limiting the importation of cases from abroad is being addressed.

We continue to hear and see evidence that there are segments of the population who are not engaged in the activities that we have learned are necessary to stabilize the pandemic. My sense is that those people represent a very small minority. But, it is probably large enough to make the route to a steady state on a national level long and painful. This unfortunately is to be expected in a country that was built on a framework of personal freedoms. The best you can hope for in achieving a steady state is to live in one of the states that seems to be achieving the fine balance between personal freedoms and the common good.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

As the COVID-19 pandemic continues to chug along, some communities feel it slowing to a pace at which they might feel comfortable about a return to, if not quite “business as usual,” at least “business as sort of normal-ish.” They are ready to accept a level of disease that signals they have reached a steady state. However, in other communities, the virus has picked up speed and is threatening to overwhelm the medical infrastructure. If you are in one of those fortunate and skillfully managed states in which folks are beginning to talk seriously, but with little evidence, that it is time to return to normal, it is probably far too early. Are there any metrics that could be applied to make the decision to ease restrictions more rational?

Courtesy Dr. William G. Wilkoff

Eons ago in pandemic terms, the World Health Organization in Thailand published a list of criteria to aid in determining when a community could consider lifting the limits that seemed to have been effective in halting transmission of the virus (“Transitioning to and maintaining a steady state of low-level or no transmission,” WHO, Thailand, 2020 Apr 18). While much more has been learned about the behavior of the virus since the spring of 2020, the criteria from the WHO in Thailand are worth considering.

Here is my summary of their criteria for returning to normalcy. First, virus transmission is controlled to the point that only sporadic cases and small clusters exist, and that all of these are traceable in origin. Second, health care and public health systems are in place with sufficient capacities to manage a shift from detection to treatment should the case load increase dramatically; this capacity should include detection, testing, isolation, and quarantine. Third, outbreaks in high-risk populations such as nursing homes have been minimized. Fourth, workplace prevention strategies are in place and have been demonstrated to be effective. Fifth, risk of imported cases is at manageable levels. Finally, communities are engaged.

It is hard to argue with the rationale behind each of these criteria. However, the United States is not Thailand, and just thinking about how this country would go about meeting those criteria provides a window into some of the reasons why we have done so poorly and will continue to be challenged in dealing with the pandemic.

First, notice that the criteria make no mention of a vaccine. One gets the sense that from the top down our country is banking too heavily on the effectiveness and widespread delivery of a vaccine. Even if and when a vaccine is developed and delivered, all of these criteria still must be met and kept in mind for a future pandemic.

Second, the criteria call for an effective health care system, but it is abundantly clear that the United States does not have a cohesive health care system and probably won’t for the foreseeable future. The best we can hope for is individual states cobbling together their own systems, which may in turn serve as examples for those states who haven’t had the foresight. We have had a public health system of sorts, but its credibility and effectiveness has been neutered to the point that again we must rely on each state’s ability to see through the haze and create it’s own systems for detection, testing, tracking, isolating, and quarantining – often with little help in materiel support from the federal government. The sliver of good news is that, after a bit of a stumbling start, detecting and limiting the importation of cases from abroad is being addressed.

We continue to hear and see evidence that there are segments of the population who are not engaged in the activities that we have learned are necessary to stabilize the pandemic. My sense is that those people represent a very small minority. But, it is probably large enough to make the route to a steady state on a national level long and painful. This unfortunately is to be expected in a country that was built on a framework of personal freedoms. The best you can hope for in achieving a steady state is to live in one of the states that seems to be achieving the fine balance between personal freedoms and the common good.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

Diarrhea affected one in every five patients with inflammatory bowel disease (IBD) and COVID-19, compared with only 7%-10% of all patients with COVID-19 in prior studies, researchers reported in Clinical Gastroenterology and Hepatology.

In a systematic review and meta-analysis of 23 studies incorporating data from 449 patients with IBD and COVID-19, their most common symptoms were fever (affecting 48.3% of patients), cough (46.5%), and diarrhea (20.5%), and diarrhea was approximately twice as prevalent as dyspnea, nausea, abdominal pain, and fatigue, wrote Ferdinando D’Amico of Humanitas University in Milan and his associates. “[S]ymptoms experienced by IBD patients with COVID-19 are similar to those occurring in the general population, except for a higher percentage of diarrhea,” they wrote. This increased prevalence might result from IBD itself or from inflammatory effects of viral gut tropism, they noted. “Currently, the diagnostic–therapeutic approach does not differ between IBD and non-IBD patients, but further studies are needed to evaluate whether fecal research of viral RNA and treatment with IBD drugs may play a role in the management of COVID-19 patients.”

To characterize the clinical presentation and course of patients with IBD and COVID-19, the researchers searched PubMed, Embase, Web of Science, and MedRxiv through July 29, 2020, for keywords related to COVID-19, Crohn’s disease, ulcerative colitis, and IBD. They identified 23 studies presenting clinical data from adults or children with a confirmed IBD diagnosis and least one case of COVID-19. Among 243,760 patients with IBD, 1,028 patients had COVID-19 infection, including 509 patients with Crohn’s disease, 428 patients with ulcerative colitis, 49 patients with indeterminate colitis, and 42 patients for whom the IBD subtype was not recorded.

In all, 0.4% of patients with IBD had COVID-19. Nearly all had been diagnosed by polymerase chain reaction of nasopharyngeal swabs, and approximately 40% also had received chest CT scans. Most were male (56.5%), and 43.5% were older than 65 years. Patients were receiving a wide range of IBD therapies, most commonly anti–tumor necrosis factor (TNF) agents, mesalamine, thiopurine (alone or in combination with biologics), vedolizumab, ustekinumab, steroids, methotrexate, and tofacitinib. Results from six studies indicated that patients with IBD were significantly more likely to be diagnosed with COVID-19 if they were older than 66 years (odds ratio, 21.3) or had other comorbidities (OR, 1.24). The most commonly used drugs for managing COVID-19 were hydroxychloroquine, lopinavir/ritonavir, steroids, antibiotics, chloroquine, tofacitinib, and infliximab.

A total of 30.6% of patients with IBD and COVID-19 were hospitalized, 11.4% stayed in the ICU, 3.7% required mechanical ventilation, and 3.8% died from COVID-19. Significant risk factors for death from COVID-19 included older age, active IBD, and a Charlson Comorbidity Index score above 1. Similarly, risk factors for severe COVID-19 included older age, having two or more comorbidities, receiving systemic steroids, and receiving mesalamine/sulfasalazine. In one study, a recent (3-month) history of corticosteroid treatment was associated with a 60% increase in the risk for severe COVID-19. Other immune-mediated therapies did not show this association. Patients with ulcerative colitis were significantly more likely to be seen in the ED or hospitalized, compared with patients with other forms of IBD (adjusted OR, 12.7).

No funding sources were disclosed. Dr. D’Amico reported having no conflicts of interest. Two coinvestigators disclosed ties to AbbVie, MSD, Schering-Plough, UCB Pharma, and several other pharmaceutical companies.

SOURCE: D’Amico F et al. Clin Gastroenterol Hepatol. 2020 Aug 7. doi: 10.1016/j.cgh.2020.08.003.
 

Diarrhea affected one in every five patients with inflammatory bowel disease (IBD) and COVID-19, compared with only 7%-10% of all patients with COVID-19 in prior studies, researchers reported in Clinical Gastroenterology and Hepatology.

In a systematic review and meta-analysis of 23 studies incorporating data from 449 patients with IBD and COVID-19, their most common symptoms were fever (affecting 48.3% of patients), cough (46.5%), and diarrhea (20.5%), and diarrhea was approximately twice as prevalent as dyspnea, nausea, abdominal pain, and fatigue, wrote Ferdinando D’Amico of Humanitas University in Milan and his associates. “[S]ymptoms experienced by IBD patients with COVID-19 are similar to those occurring in the general population, except for a higher percentage of diarrhea,” they wrote. This increased prevalence might result from IBD itself or from inflammatory effects of viral gut tropism, they noted. “Currently, the diagnostic–therapeutic approach does not differ between IBD and non-IBD patients, but further studies are needed to evaluate whether fecal research of viral RNA and treatment with IBD drugs may play a role in the management of COVID-19 patients.”

To characterize the clinical presentation and course of patients with IBD and COVID-19, the researchers searched PubMed, Embase, Web of Science, and MedRxiv through July 29, 2020, for keywords related to COVID-19, Crohn’s disease, ulcerative colitis, and IBD. They identified 23 studies presenting clinical data from adults or children with a confirmed IBD diagnosis and least one case of COVID-19. Among 243,760 patients with IBD, 1,028 patients had COVID-19 infection, including 509 patients with Crohn’s disease, 428 patients with ulcerative colitis, 49 patients with indeterminate colitis, and 42 patients for whom the IBD subtype was not recorded.

In all, 0.4% of patients with IBD had COVID-19. Nearly all had been diagnosed by polymerase chain reaction of nasopharyngeal swabs, and approximately 40% also had received chest CT scans. Most were male (56.5%), and 43.5% were older than 65 years. Patients were receiving a wide range of IBD therapies, most commonly anti–tumor necrosis factor (TNF) agents, mesalamine, thiopurine (alone or in combination with biologics), vedolizumab, ustekinumab, steroids, methotrexate, and tofacitinib. Results from six studies indicated that patients with IBD were significantly more likely to be diagnosed with COVID-19 if they were older than 66 years (odds ratio, 21.3) or had other comorbidities (OR, 1.24). The most commonly used drugs for managing COVID-19 were hydroxychloroquine, lopinavir/ritonavir, steroids, antibiotics, chloroquine, tofacitinib, and infliximab.

A total of 30.6% of patients with IBD and COVID-19 were hospitalized, 11.4% stayed in the ICU, 3.7% required mechanical ventilation, and 3.8% died from COVID-19. Significant risk factors for death from COVID-19 included older age, active IBD, and a Charlson Comorbidity Index score above 1. Similarly, risk factors for severe COVID-19 included older age, having two or more comorbidities, receiving systemic steroids, and receiving mesalamine/sulfasalazine. In one study, a recent (3-month) history of corticosteroid treatment was associated with a 60% increase in the risk for severe COVID-19. Other immune-mediated therapies did not show this association. Patients with ulcerative colitis were significantly more likely to be seen in the ED or hospitalized, compared with patients with other forms of IBD (adjusted OR, 12.7).

No funding sources were disclosed. Dr. D’Amico reported having no conflicts of interest. Two coinvestigators disclosed ties to AbbVie, MSD, Schering-Plough, UCB Pharma, and several other pharmaceutical companies.

SOURCE: D’Amico F et al. Clin Gastroenterol Hepatol. 2020 Aug 7. doi: 10.1016/j.cgh.2020.08.003.
 

Diarrhea affected one in every five patients with inflammatory bowel disease (IBD) and COVID-19, compared with only 7%-10% of all patients with COVID-19 in prior studies, researchers reported in Clinical Gastroenterology and Hepatology.

In a systematic review and meta-analysis of 23 studies incorporating data from 449 patients with IBD and COVID-19, their most common symptoms were fever (affecting 48.3% of patients), cough (46.5%), and diarrhea (20.5%), and diarrhea was approximately twice as prevalent as dyspnea, nausea, abdominal pain, and fatigue, wrote Ferdinando D’Amico of Humanitas University in Milan and his associates. “[S]ymptoms experienced by IBD patients with COVID-19 are similar to those occurring in the general population, except for a higher percentage of diarrhea,” they wrote. This increased prevalence might result from IBD itself or from inflammatory effects of viral gut tropism, they noted. “Currently, the diagnostic–therapeutic approach does not differ between IBD and non-IBD patients, but further studies are needed to evaluate whether fecal research of viral RNA and treatment with IBD drugs may play a role in the management of COVID-19 patients.”

To characterize the clinical presentation and course of patients with IBD and COVID-19, the researchers searched PubMed, Embase, Web of Science, and MedRxiv through July 29, 2020, for keywords related to COVID-19, Crohn’s disease, ulcerative colitis, and IBD. They identified 23 studies presenting clinical data from adults or children with a confirmed IBD diagnosis and least one case of COVID-19. Among 243,760 patients with IBD, 1,028 patients had COVID-19 infection, including 509 patients with Crohn’s disease, 428 patients with ulcerative colitis, 49 patients with indeterminate colitis, and 42 patients for whom the IBD subtype was not recorded.

In all, 0.4% of patients with IBD had COVID-19. Nearly all had been diagnosed by polymerase chain reaction of nasopharyngeal swabs, and approximately 40% also had received chest CT scans. Most were male (56.5%), and 43.5% were older than 65 years. Patients were receiving a wide range of IBD therapies, most commonly anti–tumor necrosis factor (TNF) agents, mesalamine, thiopurine (alone or in combination with biologics), vedolizumab, ustekinumab, steroids, methotrexate, and tofacitinib. Results from six studies indicated that patients with IBD were significantly more likely to be diagnosed with COVID-19 if they were older than 66 years (odds ratio, 21.3) or had other comorbidities (OR, 1.24). The most commonly used drugs for managing COVID-19 were hydroxychloroquine, lopinavir/ritonavir, steroids, antibiotics, chloroquine, tofacitinib, and infliximab.

A total of 30.6% of patients with IBD and COVID-19 were hospitalized, 11.4% stayed in the ICU, 3.7% required mechanical ventilation, and 3.8% died from COVID-19. Significant risk factors for death from COVID-19 included older age, active IBD, and a Charlson Comorbidity Index score above 1. Similarly, risk factors for severe COVID-19 included older age, having two or more comorbidities, receiving systemic steroids, and receiving mesalamine/sulfasalazine. In one study, a recent (3-month) history of corticosteroid treatment was associated with a 60% increase in the risk for severe COVID-19. Other immune-mediated therapies did not show this association. Patients with ulcerative colitis were significantly more likely to be seen in the ED or hospitalized, compared with patients with other forms of IBD (adjusted OR, 12.7).

No funding sources were disclosed. Dr. D’Amico reported having no conflicts of interest. Two coinvestigators disclosed ties to AbbVie, MSD, Schering-Plough, UCB Pharma, and several other pharmaceutical companies.

SOURCE: D’Amico F et al. Clin Gastroenterol Hepatol. 2020 Aug 7. doi: 10.1016/j.cgh.2020.08.003.
 

Women with HIV and men with HIV who have sex with women (MSW) have substantially different experiences with treatment than men with HIV who have sex with men (MSM), according to findings presented at the HIV Glasgow 2020 Virtual Meeting. MSM had better overall health outcomes than the other two groups, the study found, suggesting that MSW and women have unmet needs that require providers’ attention.

Chinyere Okoli of ViiV Healthcare Global Medical Affairs in Brentford, England, and her associates administered a Web-based survey about HIV-related perceptions and behaviors to 2,389 adults with HIV in 25 countries. The respondents included 1,018 MSM, 479 MSW, and 696 women.

In high-income countries, MSM respondents had been diagnosed a median 9 years earlier, MSW respondents a median 4 years earlier, and women respondents a median 5 years earlier. In middle-income countries, diagnosis was a median 3 years ago for MSM respondents and a median 6 years for MSW and women respondents.

Rates of suboptimal adherence to antiretroviral therapy (ART) were lowest (15.5%) among MSM, compared with MSW (38.8%) and women (28%). Similarly, viral nonsuppression had occurred in only 10.9% of MSM, whereas it had occurred in 43.2% of MSW and 37.1% of women. A little more than one-third (36.5%) of MSM had suboptimal overall health, whereas 47.2% of MSW and 46.2% of women had suboptimal overall health (P < .05).

A similar percentage of MSM (38%) and women (38.2%) reported polypharmacy; both percentages were significantly lower than for MSW (45.1%; P = .020). Yet MSW were less likely than the other two groups to have comorbidities unrelated to HIV: 46.1%, compared with 64.6% of MSM and 56.7% of women (P < .001).

Although a higher proportion (63%) of MSW than MSM (44%) or women (55%) were receiving a multitablet ART regimen, MSW were least likely to consider the impact of side effects when they began ART and were most likely to experience side effects. Only 45% of MSW prioritized minimizing side effects when they began receiving ART, and more than half (52%) were experiencing side effects with their current regimen.

By contrast, a majority of MSM (60%) prioritized minimizing side effects at ART initiation, and only 35% currently had side effects. Women fell in the middle with 48% considering side effects when starting ART and 49% reporting current side effects.

The proportion of respondents who said ART side effects were affecting their lives was not significantly different: 69% of MSM, 73% of MSW, and 74% of women. However, 56% of MSW reported skipping at least one dose in the past month because of side effects, which was more than twice the percentage of MSM (24%; P < .001). One-third of women (33%) reported skipping at least one dose.

MSW were also least comfortable talking to their health care provider about ART side effects: 55% reported discomfort, compared with 34% of MSM and 43% of women. A high majority of MSW (87.9%) said they experienced barriers to talking to their providers about relevant health concerns. The proportion who reported barriers was lower for MSM (59%) and women (72.7%; P < .001).

The substantial differences between MSM and MSW, which were even greater than those between MSW and women, suggest this population has the greatest amount of unmet needs, the researchers concluded. “Acknowledging these differences when planning/administering care can help narrow disparities,” they wrote.
 

A version of this article originally appeared on Medscape.com.

Women with HIV and men with HIV who have sex with women (MSW) have substantially different experiences with treatment than men with HIV who have sex with men (MSM), according to findings presented at the HIV Glasgow 2020 Virtual Meeting. MSM had better overall health outcomes than the other two groups, the study found, suggesting that MSW and women have unmet needs that require providers’ attention.

Chinyere Okoli of ViiV Healthcare Global Medical Affairs in Brentford, England, and her associates administered a Web-based survey about HIV-related perceptions and behaviors to 2,389 adults with HIV in 25 countries. The respondents included 1,018 MSM, 479 MSW, and 696 women.

In high-income countries, MSM respondents had been diagnosed a median 9 years earlier, MSW respondents a median 4 years earlier, and women respondents a median 5 years earlier. In middle-income countries, diagnosis was a median 3 years ago for MSM respondents and a median 6 years for MSW and women respondents.

Rates of suboptimal adherence to antiretroviral therapy (ART) were lowest (15.5%) among MSM, compared with MSW (38.8%) and women (28%). Similarly, viral nonsuppression had occurred in only 10.9% of MSM, whereas it had occurred in 43.2% of MSW and 37.1% of women. A little more than one-third (36.5%) of MSM had suboptimal overall health, whereas 47.2% of MSW and 46.2% of women had suboptimal overall health (P < .05).

A similar percentage of MSM (38%) and women (38.2%) reported polypharmacy; both percentages were significantly lower than for MSW (45.1%; P = .020). Yet MSW were less likely than the other two groups to have comorbidities unrelated to HIV: 46.1%, compared with 64.6% of MSM and 56.7% of women (P < .001).

Although a higher proportion (63%) of MSW than MSM (44%) or women (55%) were receiving a multitablet ART regimen, MSW were least likely to consider the impact of side effects when they began ART and were most likely to experience side effects. Only 45% of MSW prioritized minimizing side effects when they began receiving ART, and more than half (52%) were experiencing side effects with their current regimen.

By contrast, a majority of MSM (60%) prioritized minimizing side effects at ART initiation, and only 35% currently had side effects. Women fell in the middle with 48% considering side effects when starting ART and 49% reporting current side effects.

The proportion of respondents who said ART side effects were affecting their lives was not significantly different: 69% of MSM, 73% of MSW, and 74% of women. However, 56% of MSW reported skipping at least one dose in the past month because of side effects, which was more than twice the percentage of MSM (24%; P < .001). One-third of women (33%) reported skipping at least one dose.

MSW were also least comfortable talking to their health care provider about ART side effects: 55% reported discomfort, compared with 34% of MSM and 43% of women. A high majority of MSW (87.9%) said they experienced barriers to talking to their providers about relevant health concerns. The proportion who reported barriers was lower for MSM (59%) and women (72.7%; P < .001).

The substantial differences between MSM and MSW, which were even greater than those between MSW and women, suggest this population has the greatest amount of unmet needs, the researchers concluded. “Acknowledging these differences when planning/administering care can help narrow disparities,” they wrote.
 

A version of this article originally appeared on Medscape.com.

Women with HIV and men with HIV who have sex with women (MSW) have substantially different experiences with treatment than men with HIV who have sex with men (MSM), according to findings presented at the HIV Glasgow 2020 Virtual Meeting. MSM had better overall health outcomes than the other two groups, the study found, suggesting that MSW and women have unmet needs that require providers’ attention.

Chinyere Okoli of ViiV Healthcare Global Medical Affairs in Brentford, England, and her associates administered a Web-based survey about HIV-related perceptions and behaviors to 2,389 adults with HIV in 25 countries. The respondents included 1,018 MSM, 479 MSW, and 696 women.

In high-income countries, MSM respondents had been diagnosed a median 9 years earlier, MSW respondents a median 4 years earlier, and women respondents a median 5 years earlier. In middle-income countries, diagnosis was a median 3 years ago for MSM respondents and a median 6 years for MSW and women respondents.

Rates of suboptimal adherence to antiretroviral therapy (ART) were lowest (15.5%) among MSM, compared with MSW (38.8%) and women (28%). Similarly, viral nonsuppression had occurred in only 10.9% of MSM, whereas it had occurred in 43.2% of MSW and 37.1% of women. A little more than one-third (36.5%) of MSM had suboptimal overall health, whereas 47.2% of MSW and 46.2% of women had suboptimal overall health (P < .05).

A similar percentage of MSM (38%) and women (38.2%) reported polypharmacy; both percentages were significantly lower than for MSW (45.1%; P = .020). Yet MSW were less likely than the other two groups to have comorbidities unrelated to HIV: 46.1%, compared with 64.6% of MSM and 56.7% of women (P < .001).

Although a higher proportion (63%) of MSW than MSM (44%) or women (55%) were receiving a multitablet ART regimen, MSW were least likely to consider the impact of side effects when they began ART and were most likely to experience side effects. Only 45% of MSW prioritized minimizing side effects when they began receiving ART, and more than half (52%) were experiencing side effects with their current regimen.

By contrast, a majority of MSM (60%) prioritized minimizing side effects at ART initiation, and only 35% currently had side effects. Women fell in the middle with 48% considering side effects when starting ART and 49% reporting current side effects.

The proportion of respondents who said ART side effects were affecting their lives was not significantly different: 69% of MSM, 73% of MSW, and 74% of women. However, 56% of MSW reported skipping at least one dose in the past month because of side effects, which was more than twice the percentage of MSM (24%; P < .001). One-third of women (33%) reported skipping at least one dose.

MSW were also least comfortable talking to their health care provider about ART side effects: 55% reported discomfort, compared with 34% of MSM and 43% of women. A high majority of MSW (87.9%) said they experienced barriers to talking to their providers about relevant health concerns. The proportion who reported barriers was lower for MSM (59%) and women (72.7%; P < .001).

The substantial differences between MSM and MSW, which were even greater than those between MSW and women, suggest this population has the greatest amount of unmet needs, the researchers concluded. “Acknowledging these differences when planning/administering care can help narrow disparities,” they wrote.
 

A version of this article originally appeared on Medscape.com.

Blood group O was associated with a decreased risk for contracting SARS-CoV-2 infection, according to the results of large retrospective analysis of the Danish population.

Researchers Mike Bogetofte Barnkob, MD, of the Department of Clinical Immunology, Odense (Denmark) University Hospital, and colleagues performed a retrospective cohort analysis of all Danish individuals with a known ABO blood group who were tested for SARS-CoV-2 between Feb. 27, 2020, and July 30, 2020.

Of the 841,327 people tested, ABO and RhD blood groups could be identified for 473,654 individuals. ABO and RhD data from 2,204,742 (38% of the entire Danish population) were used as a reference, according to the online report in Blood Advances.

The primary outcome was status of ABO and RhD blood groups and test results for SARS-CoV-2. The secondary outcomes followed were hospitalization and death from COVID-19.
 

Reduced prevalence

The study found that ABO blood groups varied significantly between patients and the reference group, with only 38.41% (95% confidence interval, 37.30%-39.50%) of the patients belonging to blood group O, compared with 41.70% (95% CI, 41.60%-41.80%) in the controls, corresponding to a relative risk of 0.87 (95% CI, 0.83-0.91) for acquiring COVID-19.

There was a slight, but statistically significant, difference in blood group distribution between the SARS-CoV-22 individuals and the reference population (P < .001), according to the authors.

Among the SARS-CoV-2 individuals, fewer group O individuals were found (P < .001); while more A, B, and AB individuals were seen (P < .001, P = .011, and P = .091, respectively). There was no significant difference seen among A, B, and AB blood groups (P = .30). The RR for contracting SARS-CoV-2 were 1.09 (95% CI, 1.04-1.14) for A group individuals; 1.06 (95% CI, 0.99-1.14) for B group; and 1.15 (95% CI, 1.03-1.27) for AB group, respectively.

There was no difference found in the RhD group between positive test cases and the reference population (P = .15). In addition, there was no statistical difference (all P > .40) between ABO blood groups and clinical severity of COVID-19 for nonhospitalized patients versus hospitalized patients or for deceased patients versus living patients, the researchers added.
 

Possible causes

The authors speculated on two possible causes of the lower prevalence of SARS-CoV-2 infection in the blood group O population. The first is that anti-A and anti-B antibodies may have an effect on neutralizing SARS-CoV viruses and that anti-A and anti-B are present on mucosal surfaces in some individuals lacking the corresponding ABO blood group. The second is that the association between ABO blood groups and levels of von Willebrand factor, which is higher in non-O individuals and is tied to an increased likelihood of arterial and venous thrombosis, could have an indirect or unknown impact on susceptibility to infection, according to the authors.

“Given the known increased risk of thrombosis in non-O individuals and the evolving central role for thrombosis in the pathogenesis of COVID-19, it is important to explore this aspect more closely in larger patient cohorts (e.g., by examining ABO blood type and viral load, the severity of symptoms, and the long-term effects following COVID-19),” the researchers concluded.

One author reported receiving fees from Bristol Myers Squibb, Novartis, and Roche. The remaining authors reported they had no competing financial interests.

[email protected]

SOURCE: Barnkob MB et al. Blood Adv. 2020 Oct 14. doi: 10.1182/bloodadvances.2020002657.

Blood group O was associated with a decreased risk for contracting SARS-CoV-2 infection, according to the results of large retrospective analysis of the Danish population.

Researchers Mike Bogetofte Barnkob, MD, of the Department of Clinical Immunology, Odense (Denmark) University Hospital, and colleagues performed a retrospective cohort analysis of all Danish individuals with a known ABO blood group who were tested for SARS-CoV-2 between Feb. 27, 2020, and July 30, 2020.

Of the 841,327 people tested, ABO and RhD blood groups could be identified for 473,654 individuals. ABO and RhD data from 2,204,742 (38% of the entire Danish population) were used as a reference, according to the online report in Blood Advances.

The primary outcome was status of ABO and RhD blood groups and test results for SARS-CoV-2. The secondary outcomes followed were hospitalization and death from COVID-19.
 

Reduced prevalence

The study found that ABO blood groups varied significantly between patients and the reference group, with only 38.41% (95% confidence interval, 37.30%-39.50%) of the patients belonging to blood group O, compared with 41.70% (95% CI, 41.60%-41.80%) in the controls, corresponding to a relative risk of 0.87 (95% CI, 0.83-0.91) for acquiring COVID-19.

There was a slight, but statistically significant, difference in blood group distribution between the SARS-CoV-22 individuals and the reference population (P < .001), according to the authors.

Among the SARS-CoV-2 individuals, fewer group O individuals were found (P < .001); while more A, B, and AB individuals were seen (P < .001, P = .011, and P = .091, respectively). There was no significant difference seen among A, B, and AB blood groups (P = .30). The RR for contracting SARS-CoV-2 were 1.09 (95% CI, 1.04-1.14) for A group individuals; 1.06 (95% CI, 0.99-1.14) for B group; and 1.15 (95% CI, 1.03-1.27) for AB group, respectively.

There was no difference found in the RhD group between positive test cases and the reference population (P = .15). In addition, there was no statistical difference (all P > .40) between ABO blood groups and clinical severity of COVID-19 for nonhospitalized patients versus hospitalized patients or for deceased patients versus living patients, the researchers added.
 

Possible causes

The authors speculated on two possible causes of the lower prevalence of SARS-CoV-2 infection in the blood group O population. The first is that anti-A and anti-B antibodies may have an effect on neutralizing SARS-CoV viruses and that anti-A and anti-B are present on mucosal surfaces in some individuals lacking the corresponding ABO blood group. The second is that the association between ABO blood groups and levels of von Willebrand factor, which is higher in non-O individuals and is tied to an increased likelihood of arterial and venous thrombosis, could have an indirect or unknown impact on susceptibility to infection, according to the authors.

“Given the known increased risk of thrombosis in non-O individuals and the evolving central role for thrombosis in the pathogenesis of COVID-19, it is important to explore this aspect more closely in larger patient cohorts (e.g., by examining ABO blood type and viral load, the severity of symptoms, and the long-term effects following COVID-19),” the researchers concluded.

One author reported receiving fees from Bristol Myers Squibb, Novartis, and Roche. The remaining authors reported they had no competing financial interests.

[email protected]

SOURCE: Barnkob MB et al. Blood Adv. 2020 Oct 14. doi: 10.1182/bloodadvances.2020002657.

Blood group O was associated with a decreased risk for contracting SARS-CoV-2 infection, according to the results of large retrospective analysis of the Danish population.

Researchers Mike Bogetofte Barnkob, MD, of the Department of Clinical Immunology, Odense (Denmark) University Hospital, and colleagues performed a retrospective cohort analysis of all Danish individuals with a known ABO blood group who were tested for SARS-CoV-2 between Feb. 27, 2020, and July 30, 2020.

Of the 841,327 people tested, ABO and RhD blood groups could be identified for 473,654 individuals. ABO and RhD data from 2,204,742 (38% of the entire Danish population) were used as a reference, according to the online report in Blood Advances.

The primary outcome was status of ABO and RhD blood groups and test results for SARS-CoV-2. The secondary outcomes followed were hospitalization and death from COVID-19.
 

Reduced prevalence

The study found that ABO blood groups varied significantly between patients and the reference group, with only 38.41% (95% confidence interval, 37.30%-39.50%) of the patients belonging to blood group O, compared with 41.70% (95% CI, 41.60%-41.80%) in the controls, corresponding to a relative risk of 0.87 (95% CI, 0.83-0.91) for acquiring COVID-19.

There was a slight, but statistically significant, difference in blood group distribution between the SARS-CoV-22 individuals and the reference population (P < .001), according to the authors.

Among the SARS-CoV-2 individuals, fewer group O individuals were found (P < .001); while more A, B, and AB individuals were seen (P < .001, P = .011, and P = .091, respectively). There was no significant difference seen among A, B, and AB blood groups (P = .30). The RR for contracting SARS-CoV-2 were 1.09 (95% CI, 1.04-1.14) for A group individuals; 1.06 (95% CI, 0.99-1.14) for B group; and 1.15 (95% CI, 1.03-1.27) for AB group, respectively.

There was no difference found in the RhD group between positive test cases and the reference population (P = .15). In addition, there was no statistical difference (all P > .40) between ABO blood groups and clinical severity of COVID-19 for nonhospitalized patients versus hospitalized patients or for deceased patients versus living patients, the researchers added.
 

Possible causes

The authors speculated on two possible causes of the lower prevalence of SARS-CoV-2 infection in the blood group O population. The first is that anti-A and anti-B antibodies may have an effect on neutralizing SARS-CoV viruses and that anti-A and anti-B are present on mucosal surfaces in some individuals lacking the corresponding ABO blood group. The second is that the association between ABO blood groups and levels of von Willebrand factor, which is higher in non-O individuals and is tied to an increased likelihood of arterial and venous thrombosis, could have an indirect or unknown impact on susceptibility to infection, according to the authors.

“Given the known increased risk of thrombosis in non-O individuals and the evolving central role for thrombosis in the pathogenesis of COVID-19, it is important to explore this aspect more closely in larger patient cohorts (e.g., by examining ABO blood type and viral load, the severity of symptoms, and the long-term effects following COVID-19),” the researchers concluded.

One author reported receiving fees from Bristol Myers Squibb, Novartis, and Roche. The remaining authors reported they had no competing financial interests.

[email protected]

SOURCE: Barnkob MB et al. Blood Adv. 2020 Oct 14. doi: 10.1182/bloodadvances.2020002657.

Treatment-naive HIV patients had similar rates of treatment failure and virologic failure on standard triple therapy and a variety of dual therapy regimens, based on a meta-analysis including data from more than 5,000 patients.

Although triple therapy remains the standard of care, the availability of more potent drugs has revived interest in dual and mono therapies, wrote Pisaturo Mariantonietta, MD, of the University of Campania Luigi Vanvitelli, Naples, Italy, and colleagues.

In a study published in Clinical Microbiology and Infection, the researchers identified 14 articles including 5,205 treatment-naive HIV adults. The studies were published between 2008 and 2020; 13 were randomized, controlled trials.

The dual therapies used in the studies included atazanavir/r plus maraviroc; lopinavir/r plus lamivudine; raltegravir plus darunavir/r; lopinavir/r plus tenofovir, raltegravir, efavirenz, or maraviroc; atazanavir/r plus raltegravir and darunavir/r plus maraviroc; and dolutegravir plus lamivudine.

Overall, no significant differences occurred in the primary endpoint of treatment failure across 10 studies between dual therapy and triple therapy patients based on data at 48 weeks (relative risk 1.20). “The rate of treatment failure did not differ among the two groups when stratifying the patients according to the drug used in the dual regimen,” the researchers said.

Low viral load’s link to treatment failure

Among 2,398 patients with a low HIV viral load (less than 100,000 copies/mL), dual therapy patients were significantly more likely to experience treatment failure than were triple therapy patients (RR, 1.47, P = .007). No differences were noted between dual and triple therapy failure among patients with high HIV viral loads at baseline. Patterns were similar at 96 weeks, but only three studies included 96-week data, the researchers said.

The rate of discontinuation because of adverse events was not significantly different between the groups at 48 weeks.

The study findings were limited by several factors, including the use of different regimens in the dual strategies, some of which are no longer in use, as well as there being insufficient data to fully compare outcomes at 96 weeks, and lack of information on cerebrospinal fluid viral load, the researchers noted.

However, the results suggest that dual therapy might be considered for HIV-naive patients with a low viral load, they said.

“Further RCTs that will evaluate the efficacy of antiretroviral regimens in use today among difficult-to-treat populations, such as patients with high viral load, including both intention-to-treat and per-protocol analysis, are needed to address this topic,” they concluded.

Consider range of patient factors when choosing therapies

Conducting the study at this time was important because of the expanding options for treating HIV patients, Donna E. Sweet, MD, an HIV specialist and professor of medicine at the University of Kansas, Wichita, said in an interview.

“We now have two single tablet formulations that are dual rather than triple therapy, and as treaters we are all trying to know when to use them,” she explained.

Dr. Sweet said she was not surprised by the study findings, given that well-conducted, randomized, controlled trials allowed the combination therapies to be approved.

Some of the key challenges to identifying the optimal treatment for HIV patients include factoring in the use of concomitant medications that could lead to drug-drug interactions, noted Dr. Sweet, who serves an editorial advisory board member of Internal Medicine News.

The take-home message for clinicians, in her opinion, is that “less drugs may mean less toxicity, but we don’t want to sacrifice efficacy,” she said. “There may be patients who are better suited than others for two vs. three drugs,” Dr. Sweet emphasized.

The next steps for research on the value of dual vs. triple therapy should include longer term efficacy studies, especially in those with lower CD4 counts and higher viral loads, said Dr. Sweet. In addition to factors such as CD4 counts and viral load, the food requirements of certain ART regimens could affect adherence and therefore a clinician decision to use two drugs rather than three, she noted.

Dr. Sweet disclosed past relationships with ViiV, Gilead, Merck, and Janssen on their speakers bureaus, and current advisory roles with Gilead and ViiV.

The study received no outside funding. Lead author Dr. Mariantonietta and several coauthors disclosed relationships with companies including ViiV Healthcare, AbbVie, Janssen-Cilag and Gilead Science, and Merck Sharp & Dohme, but no conflicts in connection with this study.

SOURCE: Mariantonietta P et al. Clin Microbiol Infect. 2020 Oct 5. doi: 10.1016/j.cmi.2020.09.048.

Treatment-naive HIV patients had similar rates of treatment failure and virologic failure on standard triple therapy and a variety of dual therapy regimens, based on a meta-analysis including data from more than 5,000 patients.

Although triple therapy remains the standard of care, the availability of more potent drugs has revived interest in dual and mono therapies, wrote Pisaturo Mariantonietta, MD, of the University of Campania Luigi Vanvitelli, Naples, Italy, and colleagues.

In a study published in Clinical Microbiology and Infection, the researchers identified 14 articles including 5,205 treatment-naive HIV adults. The studies were published between 2008 and 2020; 13 were randomized, controlled trials.

The dual therapies used in the studies included atazanavir/r plus maraviroc; lopinavir/r plus lamivudine; raltegravir plus darunavir/r; lopinavir/r plus tenofovir, raltegravir, efavirenz, or maraviroc; atazanavir/r plus raltegravir and darunavir/r plus maraviroc; and dolutegravir plus lamivudine.

Overall, no significant differences occurred in the primary endpoint of treatment failure across 10 studies between dual therapy and triple therapy patients based on data at 48 weeks (relative risk 1.20). “The rate of treatment failure did not differ among the two groups when stratifying the patients according to the drug used in the dual regimen,” the researchers said.

Low viral load’s link to treatment failure

Among 2,398 patients with a low HIV viral load (less than 100,000 copies/mL), dual therapy patients were significantly more likely to experience treatment failure than were triple therapy patients (RR, 1.47, P = .007). No differences were noted between dual and triple therapy failure among patients with high HIV viral loads at baseline. Patterns were similar at 96 weeks, but only three studies included 96-week data, the researchers said.

The rate of discontinuation because of adverse events was not significantly different between the groups at 48 weeks.

The study findings were limited by several factors, including the use of different regimens in the dual strategies, some of which are no longer in use, as well as there being insufficient data to fully compare outcomes at 96 weeks, and lack of information on cerebrospinal fluid viral load, the researchers noted.

However, the results suggest that dual therapy might be considered for HIV-naive patients with a low viral load, they said.

“Further RCTs that will evaluate the efficacy of antiretroviral regimens in use today among difficult-to-treat populations, such as patients with high viral load, including both intention-to-treat and per-protocol analysis, are needed to address this topic,” they concluded.

Consider range of patient factors when choosing therapies

Conducting the study at this time was important because of the expanding options for treating HIV patients, Donna E. Sweet, MD, an HIV specialist and professor of medicine at the University of Kansas, Wichita, said in an interview.

“We now have two single tablet formulations that are dual rather than triple therapy, and as treaters we are all trying to know when to use them,” she explained.

Dr. Sweet said she was not surprised by the study findings, given that well-conducted, randomized, controlled trials allowed the combination therapies to be approved.

Some of the key challenges to identifying the optimal treatment for HIV patients include factoring in the use of concomitant medications that could lead to drug-drug interactions, noted Dr. Sweet, who serves an editorial advisory board member of Internal Medicine News.

The take-home message for clinicians, in her opinion, is that “less drugs may mean less toxicity, but we don’t want to sacrifice efficacy,” she said. “There may be patients who are better suited than others for two vs. three drugs,” Dr. Sweet emphasized.

The next steps for research on the value of dual vs. triple therapy should include longer term efficacy studies, especially in those with lower CD4 counts and higher viral loads, said Dr. Sweet. In addition to factors such as CD4 counts and viral load, the food requirements of certain ART regimens could affect adherence and therefore a clinician decision to use two drugs rather than three, she noted.

Dr. Sweet disclosed past relationships with ViiV, Gilead, Merck, and Janssen on their speakers bureaus, and current advisory roles with Gilead and ViiV.

The study received no outside funding. Lead author Dr. Mariantonietta and several coauthors disclosed relationships with companies including ViiV Healthcare, AbbVie, Janssen-Cilag and Gilead Science, and Merck Sharp & Dohme, but no conflicts in connection with this study.

SOURCE: Mariantonietta P et al. Clin Microbiol Infect. 2020 Oct 5. doi: 10.1016/j.cmi.2020.09.048.

Treatment-naive HIV patients had similar rates of treatment failure and virologic failure on standard triple therapy and a variety of dual therapy regimens, based on a meta-analysis including data from more than 5,000 patients.

Although triple therapy remains the standard of care, the availability of more potent drugs has revived interest in dual and mono therapies, wrote Pisaturo Mariantonietta, MD, of the University of Campania Luigi Vanvitelli, Naples, Italy, and colleagues.

In a study published in Clinical Microbiology and Infection, the researchers identified 14 articles including 5,205 treatment-naive HIV adults. The studies were published between 2008 and 2020; 13 were randomized, controlled trials.

The dual therapies used in the studies included atazanavir/r plus maraviroc; lopinavir/r plus lamivudine; raltegravir plus darunavir/r; lopinavir/r plus tenofovir, raltegravir, efavirenz, or maraviroc; atazanavir/r plus raltegravir and darunavir/r plus maraviroc; and dolutegravir plus lamivudine.

Overall, no significant differences occurred in the primary endpoint of treatment failure across 10 studies between dual therapy and triple therapy patients based on data at 48 weeks (relative risk 1.20). “The rate of treatment failure did not differ among the two groups when stratifying the patients according to the drug used in the dual regimen,” the researchers said.

Low viral load’s link to treatment failure

Among 2,398 patients with a low HIV viral load (less than 100,000 copies/mL), dual therapy patients were significantly more likely to experience treatment failure than were triple therapy patients (RR, 1.47, P = .007). No differences were noted between dual and triple therapy failure among patients with high HIV viral loads at baseline. Patterns were similar at 96 weeks, but only three studies included 96-week data, the researchers said.

The rate of discontinuation because of adverse events was not significantly different between the groups at 48 weeks.

The study findings were limited by several factors, including the use of different regimens in the dual strategies, some of which are no longer in use, as well as there being insufficient data to fully compare outcomes at 96 weeks, and lack of information on cerebrospinal fluid viral load, the researchers noted.

However, the results suggest that dual therapy might be considered for HIV-naive patients with a low viral load, they said.

“Further RCTs that will evaluate the efficacy of antiretroviral regimens in use today among difficult-to-treat populations, such as patients with high viral load, including both intention-to-treat and per-protocol analysis, are needed to address this topic,” they concluded.

Consider range of patient factors when choosing therapies

Conducting the study at this time was important because of the expanding options for treating HIV patients, Donna E. Sweet, MD, an HIV specialist and professor of medicine at the University of Kansas, Wichita, said in an interview.

“We now have two single tablet formulations that are dual rather than triple therapy, and as treaters we are all trying to know when to use them,” she explained.

Dr. Sweet said she was not surprised by the study findings, given that well-conducted, randomized, controlled trials allowed the combination therapies to be approved.

Some of the key challenges to identifying the optimal treatment for HIV patients include factoring in the use of concomitant medications that could lead to drug-drug interactions, noted Dr. Sweet, who serves an editorial advisory board member of Internal Medicine News.

The take-home message for clinicians, in her opinion, is that “less drugs may mean less toxicity, but we don’t want to sacrifice efficacy,” she said. “There may be patients who are better suited than others for two vs. three drugs,” Dr. Sweet emphasized.

The next steps for research on the value of dual vs. triple therapy should include longer term efficacy studies, especially in those with lower CD4 counts and higher viral loads, said Dr. Sweet. In addition to factors such as CD4 counts and viral load, the food requirements of certain ART regimens could affect adherence and therefore a clinician decision to use two drugs rather than three, she noted.

Dr. Sweet disclosed past relationships with ViiV, Gilead, Merck, and Janssen on their speakers bureaus, and current advisory roles with Gilead and ViiV.

The study received no outside funding. Lead author Dr. Mariantonietta and several coauthors disclosed relationships with companies including ViiV Healthcare, AbbVie, Janssen-Cilag and Gilead Science, and Merck Sharp & Dohme, but no conflicts in connection with this study.

SOURCE: Mariantonietta P et al. Clin Microbiol Infect. 2020 Oct 5. doi: 10.1016/j.cmi.2020.09.048.

People with HIV who are hospitalized for COVID-19 have a significantly heightened risk of 28-day mortality compared with people without HIV.

A comparison of outcomes of people with HIV to people without HIV who were hospitalized in the United Kingdom with COVID-19 from Jan. 17 to June 4 showed that HIV-positive status was associated with a 63% increased risk of day 28 mortality.

This was especially true for HIV+ patients younger than 70 years of age, said Anna Maria Geretti, MD, PhD, professor of virology and infectious diseases, University of Liverpool, England.

The results are from an analysis of data from the ISARIC World Health Organization (WHO) Clinical Characterisation Protocol (UK) study, and were presented at the HIV Glasgow annual meeting, held virtually this year because of the pandemic.

“We investigated whether HIV status could be important in COVID-19 outcomes because there was anxiety on the part of our patients, and we wanted to gather some evidence-based information in order to help guide them,” Dr. Geretti said in an interview.

“ISARIC is an international protocol and the UK is one of the nations participating. We applied for access to its very large database, which connects data from all patients who are hospitalized with either known or suspected COVID-19. We wanted to see specifically how the presentation and outcomes of patients with HIV compared with the rest of the population without HIV. It afforded us an ideal opportunity to start to answer this question, and this is our first analysis in what will be an ongoing process. Importantly, we showed that there is a need to really look more carefully at the population with HIV,” she said.

Out of a total of 47,539 patients in the database, 115 (0.24%) had confirmed HIV-positive status, and 103 of those 115, or 89.6%, had a record of being on antiretroviral therapy.

On admission, the patients with HIV were younger, with a median age of 55 compared with 74 for patients without HIV (P < .001). They also had a higher prevalence of obesity, moderate to severe liver disease, higher lymphocyte counts and C-reactive protein, as well as more systemic symptoms.

There were no differences in respiratory rate, need for oxygen, or prevalence of chest infiltrates.

The cumulative incidence of mortality at day 28 was 25.2% in HIV-positive patients compared with 32.1% in HIV-negative patients (P = .12).

But when the researchers looked more closely, they noticed that the mortality rate was actually higher in younger HIV+ patients compared with HIV-negative patients.

Stratified by age, 28-day mortality was significantly higher in HIV+ patients aged <50 years (P =.004); and those aged 50 to 59 years (P = .05).

“So below the age of 70, the risk of mortality was double in people with HIV. The people with HIV who died often had diabetes with complications and also more frequent obesity, but this was not the only explanation,” Dr. Geretti said. “There is something to do with the HIV status per se.”

Next steps will be to expand the data set and repeat the analysis with an additional 100 patients “at least” she said.

The researchers also hope to zero in on what about being HIV+ is increasing the mortality risk from COVID-19.

“Right now we need greater numbers and we hope that the research community will be stimulated to take a closer look at this information, and merge other data so that we can strengthen confidence in the data and tease out what factors are causing this increased risk for mortality,” Dr. Geretti said.

She also emphasized that all patients admitted to hospital with COVID-19 should be asked about their HIV status.

“It is important that the HIV status be recorded if we want to increase our ability to understand how HIV impacts survival,” she stressed. “In our experience we found that most of the hospital records were not doing that. Since HIV+ patients seem to be at increased risk, HIV status should be factored into the clinical management. Ask patients if they are HIV+, and if it is not known, then do a test. That would be good practice.”

Dr. Geretti reported no relevant financial relationships. The work was supported by grants from the National Institute of Health Research, the Medical Research Council, the Wellcome Trust, the Department for International Development, and the Bill and Melinda Gates Foundation.
 

A version of this article originally appeared on Medscape.com.

People with HIV who are hospitalized for COVID-19 have a significantly heightened risk of 28-day mortality compared with people without HIV.

A comparison of outcomes of people with HIV to people without HIV who were hospitalized in the United Kingdom with COVID-19 from Jan. 17 to June 4 showed that HIV-positive status was associated with a 63% increased risk of day 28 mortality.

This was especially true for HIV+ patients younger than 70 years of age, said Anna Maria Geretti, MD, PhD, professor of virology and infectious diseases, University of Liverpool, England.

The results are from an analysis of data from the ISARIC World Health Organization (WHO) Clinical Characterisation Protocol (UK) study, and were presented at the HIV Glasgow annual meeting, held virtually this year because of the pandemic.

“We investigated whether HIV status could be important in COVID-19 outcomes because there was anxiety on the part of our patients, and we wanted to gather some evidence-based information in order to help guide them,” Dr. Geretti said in an interview.

“ISARIC is an international protocol and the UK is one of the nations participating. We applied for access to its very large database, which connects data from all patients who are hospitalized with either known or suspected COVID-19. We wanted to see specifically how the presentation and outcomes of patients with HIV compared with the rest of the population without HIV. It afforded us an ideal opportunity to start to answer this question, and this is our first analysis in what will be an ongoing process. Importantly, we showed that there is a need to really look more carefully at the population with HIV,” she said.

Out of a total of 47,539 patients in the database, 115 (0.24%) had confirmed HIV-positive status, and 103 of those 115, or 89.6%, had a record of being on antiretroviral therapy.

On admission, the patients with HIV were younger, with a median age of 55 compared with 74 for patients without HIV (P < .001). They also had a higher prevalence of obesity, moderate to severe liver disease, higher lymphocyte counts and C-reactive protein, as well as more systemic symptoms.

There were no differences in respiratory rate, need for oxygen, or prevalence of chest infiltrates.

The cumulative incidence of mortality at day 28 was 25.2% in HIV-positive patients compared with 32.1% in HIV-negative patients (P = .12).

But when the researchers looked more closely, they noticed that the mortality rate was actually higher in younger HIV+ patients compared with HIV-negative patients.

Stratified by age, 28-day mortality was significantly higher in HIV+ patients aged <50 years (P =.004); and those aged 50 to 59 years (P = .05).

“So below the age of 70, the risk of mortality was double in people with HIV. The people with HIV who died often had diabetes with complications and also more frequent obesity, but this was not the only explanation,” Dr. Geretti said. “There is something to do with the HIV status per se.”

Next steps will be to expand the data set and repeat the analysis with an additional 100 patients “at least” she said.

The researchers also hope to zero in on what about being HIV+ is increasing the mortality risk from COVID-19.

“Right now we need greater numbers and we hope that the research community will be stimulated to take a closer look at this information, and merge other data so that we can strengthen confidence in the data and tease out what factors are causing this increased risk for mortality,” Dr. Geretti said.

She also emphasized that all patients admitted to hospital with COVID-19 should be asked about their HIV status.

“It is important that the HIV status be recorded if we want to increase our ability to understand how HIV impacts survival,” she stressed. “In our experience we found that most of the hospital records were not doing that. Since HIV+ patients seem to be at increased risk, HIV status should be factored into the clinical management. Ask patients if they are HIV+, and if it is not known, then do a test. That would be good practice.”

Dr. Geretti reported no relevant financial relationships. The work was supported by grants from the National Institute of Health Research, the Medical Research Council, the Wellcome Trust, the Department for International Development, and the Bill and Melinda Gates Foundation.
 

A version of this article originally appeared on Medscape.com.

People with HIV who are hospitalized for COVID-19 have a significantly heightened risk of 28-day mortality compared with people without HIV.

A comparison of outcomes of people with HIV to people without HIV who were hospitalized in the United Kingdom with COVID-19 from Jan. 17 to June 4 showed that HIV-positive status was associated with a 63% increased risk of day 28 mortality.

This was especially true for HIV+ patients younger than 70 years of age, said Anna Maria Geretti, MD, PhD, professor of virology and infectious diseases, University of Liverpool, England.

The results are from an analysis of data from the ISARIC World Health Organization (WHO) Clinical Characterisation Protocol (UK) study, and were presented at the HIV Glasgow annual meeting, held virtually this year because of the pandemic.

“We investigated whether HIV status could be important in COVID-19 outcomes because there was anxiety on the part of our patients, and we wanted to gather some evidence-based information in order to help guide them,” Dr. Geretti said in an interview.

“ISARIC is an international protocol and the UK is one of the nations participating. We applied for access to its very large database, which connects data from all patients who are hospitalized with either known or suspected COVID-19. We wanted to see specifically how the presentation and outcomes of patients with HIV compared with the rest of the population without HIV. It afforded us an ideal opportunity to start to answer this question, and this is our first analysis in what will be an ongoing process. Importantly, we showed that there is a need to really look more carefully at the population with HIV,” she said.

Out of a total of 47,539 patients in the database, 115 (0.24%) had confirmed HIV-positive status, and 103 of those 115, or 89.6%, had a record of being on antiretroviral therapy.

On admission, the patients with HIV were younger, with a median age of 55 compared with 74 for patients without HIV (P < .001). They also had a higher prevalence of obesity, moderate to severe liver disease, higher lymphocyte counts and C-reactive protein, as well as more systemic symptoms.

There were no differences in respiratory rate, need for oxygen, or prevalence of chest infiltrates.

The cumulative incidence of mortality at day 28 was 25.2% in HIV-positive patients compared with 32.1% in HIV-negative patients (P = .12).

But when the researchers looked more closely, they noticed that the mortality rate was actually higher in younger HIV+ patients compared with HIV-negative patients.

Stratified by age, 28-day mortality was significantly higher in HIV+ patients aged <50 years (P =.004); and those aged 50 to 59 years (P = .05).

“So below the age of 70, the risk of mortality was double in people with HIV. The people with HIV who died often had diabetes with complications and also more frequent obesity, but this was not the only explanation,” Dr. Geretti said. “There is something to do with the HIV status per se.”

Next steps will be to expand the data set and repeat the analysis with an additional 100 patients “at least” she said.

The researchers also hope to zero in on what about being HIV+ is increasing the mortality risk from COVID-19.

“Right now we need greater numbers and we hope that the research community will be stimulated to take a closer look at this information, and merge other data so that we can strengthen confidence in the data and tease out what factors are causing this increased risk for mortality,” Dr. Geretti said.

She also emphasized that all patients admitted to hospital with COVID-19 should be asked about their HIV status.

“It is important that the HIV status be recorded if we want to increase our ability to understand how HIV impacts survival,” she stressed. “In our experience we found that most of the hospital records were not doing that. Since HIV+ patients seem to be at increased risk, HIV status should be factored into the clinical management. Ask patients if they are HIV+, and if it is not known, then do a test. That would be good practice.”

Dr. Geretti reported no relevant financial relationships. The work was supported by grants from the National Institute of Health Research, the Medical Research Council, the Wellcome Trust, the Department for International Development, and the Bill and Melinda Gates Foundation.
 

A version of this article originally appeared on Medscape.com.

Switching patients with HIV from a protease inhibitor–based antiretroviral therapy regimen to an integrase inhibitor–based regimen can be performed safely, with maintenance of high levels of virologic suppression and improvements in both bone mineral density and renal function biomarkers, data from a randomized trial indicate.

Among 212 women with successful HIV virologic suppression following 48 weeks of treatment with ritonavir-boosted atazanavir plus tenofovir disoproxil fumarate (ATV/r +TDF), among those who were switched to continued therapy with an integrase inhibitor–based regimen of elvitegravir/cobicistat/emtricitabine and tenofovir alafenamide (E/C/F/TAF), mean increases in lumbar spine bone mineral density (BMD) were greater and renal function was improved compared with patients who were maintained with ATV/r + TDF, reported Monica Thormann, MD, from Salvador B. Gautier Hospital in Santo Domingo, Dominican Republic, and colleagues at the HIV Glasgow drug therapy meeting, which was held online in 2020.

Although the E/C/F/TAF regimen was associated with a significantly greater increase in lipids, there was no significant change in the total cholesterol to high-density lipoprotein (HDL) cholesterol ratio.

The patients in the study had previously participated in a blinded randomized trial comparing the integrase inhibitor combination plus TDF with ATV/r + TDF in treatment-naive women.

In the current study, patients were randomly assigned in a 3:1 ratio to maintenance with either E/C/F/TAF (159 patients) or ATV/r + TDF (53 patients).

Forty-eight weeks after the switch, virologic suppression (to fewer than 50 copies/mL) was maintained among 94.3% of those on the integrase inhibitor–based regimen, compared with 86.8% of those on the protease inhibitor–based regimen. Virologic failure was seen in 1.9% of those on the integrase inhibitor–based regimen and in 3.8% of those on the protease inhibitor–based regimen.

In addition, virologic suppression below 20 c/mL at week 48 was more common among women maintained on E/C/F/TAF, at 84.9% vs 71.7% (P = .041). No treatment-emergent resistance was seen with either regimen.

As noted, there were higher mean percentage increases in BMD in the E/C/F/TAF group for both total hip and lumbar spine, but only the latter measure improved significantly in comparison with patients treated with ATV/r + TDF (2.82% vs 0%, P < .001).

Markers of renal tubule damage, including the beta-2 microglobulin to creatinine ratio and the rentinol-binding protein to creatinine ratio, were significantly improved with the integrase inhibitor regimen.

Increases in total cholesterol, LDL cholesterol, and HDL cholesterol were 27 vs 5 mg/dL, 16 vs 8 mg/dL, and 5 vs 0 mg/dL in each case comparing the integrase inhibitor–based regimen to the protease inhibitor–based regimen. All of those comparisons were statistically significant.

As noted, however, the total cholesterol to HDL cholesterol ratio was not significantly different between the treatment arms. The rate or initiation of lipid-modifying agents was 1.3% in the E/C/F/TAF group vs 0 in the ATV/r + TDF group, but this difference was not statistically significant.

“These data demonstrate that women who switch to an integrase inhibitor + TAF‐based regimen maintain high levels of virologic suppression with improvement in BMD and renal function biomarkers, as compared with those remaining on their ritonavir boosted atazanavir + TDF‐based regimen,” the authors wrote.
 

This article first appeared on Medscape.com.

Switching patients with HIV from a protease inhibitor–based antiretroviral therapy regimen to an integrase inhibitor–based regimen can be performed safely, with maintenance of high levels of virologic suppression and improvements in both bone mineral density and renal function biomarkers, data from a randomized trial indicate.

Among 212 women with successful HIV virologic suppression following 48 weeks of treatment with ritonavir-boosted atazanavir plus tenofovir disoproxil fumarate (ATV/r +TDF), among those who were switched to continued therapy with an integrase inhibitor–based regimen of elvitegravir/cobicistat/emtricitabine and tenofovir alafenamide (E/C/F/TAF), mean increases in lumbar spine bone mineral density (BMD) were greater and renal function was improved compared with patients who were maintained with ATV/r + TDF, reported Monica Thormann, MD, from Salvador B. Gautier Hospital in Santo Domingo, Dominican Republic, and colleagues at the HIV Glasgow drug therapy meeting, which was held online in 2020.

Although the E/C/F/TAF regimen was associated with a significantly greater increase in lipids, there was no significant change in the total cholesterol to high-density lipoprotein (HDL) cholesterol ratio.

The patients in the study had previously participated in a blinded randomized trial comparing the integrase inhibitor combination plus TDF with ATV/r + TDF in treatment-naive women.

In the current study, patients were randomly assigned in a 3:1 ratio to maintenance with either E/C/F/TAF (159 patients) or ATV/r + TDF (53 patients).

Forty-eight weeks after the switch, virologic suppression (to fewer than 50 copies/mL) was maintained among 94.3% of those on the integrase inhibitor–based regimen, compared with 86.8% of those on the protease inhibitor–based regimen. Virologic failure was seen in 1.9% of those on the integrase inhibitor–based regimen and in 3.8% of those on the protease inhibitor–based regimen.

In addition, virologic suppression below 20 c/mL at week 48 was more common among women maintained on E/C/F/TAF, at 84.9% vs 71.7% (P = .041). No treatment-emergent resistance was seen with either regimen.

As noted, there were higher mean percentage increases in BMD in the E/C/F/TAF group for both total hip and lumbar spine, but only the latter measure improved significantly in comparison with patients treated with ATV/r + TDF (2.82% vs 0%, P < .001).

Markers of renal tubule damage, including the beta-2 microglobulin to creatinine ratio and the rentinol-binding protein to creatinine ratio, were significantly improved with the integrase inhibitor regimen.

Increases in total cholesterol, LDL cholesterol, and HDL cholesterol were 27 vs 5 mg/dL, 16 vs 8 mg/dL, and 5 vs 0 mg/dL in each case comparing the integrase inhibitor–based regimen to the protease inhibitor–based regimen. All of those comparisons were statistically significant.

As noted, however, the total cholesterol to HDL cholesterol ratio was not significantly different between the treatment arms. The rate or initiation of lipid-modifying agents was 1.3% in the E/C/F/TAF group vs 0 in the ATV/r + TDF group, but this difference was not statistically significant.

“These data demonstrate that women who switch to an integrase inhibitor + TAF‐based regimen maintain high levels of virologic suppression with improvement in BMD and renal function biomarkers, as compared with those remaining on their ritonavir boosted atazanavir + TDF‐based regimen,” the authors wrote.
 

This article first appeared on Medscape.com.

Switching patients with HIV from a protease inhibitor–based antiretroviral therapy regimen to an integrase inhibitor–based regimen can be performed safely, with maintenance of high levels of virologic suppression and improvements in both bone mineral density and renal function biomarkers, data from a randomized trial indicate.

Among 212 women with successful HIV virologic suppression following 48 weeks of treatment with ritonavir-boosted atazanavir plus tenofovir disoproxil fumarate (ATV/r +TDF), among those who were switched to continued therapy with an integrase inhibitor–based regimen of elvitegravir/cobicistat/emtricitabine and tenofovir alafenamide (E/C/F/TAF), mean increases in lumbar spine bone mineral density (BMD) were greater and renal function was improved compared with patients who were maintained with ATV/r + TDF, reported Monica Thormann, MD, from Salvador B. Gautier Hospital in Santo Domingo, Dominican Republic, and colleagues at the HIV Glasgow drug therapy meeting, which was held online in 2020.

Although the E/C/F/TAF regimen was associated with a significantly greater increase in lipids, there was no significant change in the total cholesterol to high-density lipoprotein (HDL) cholesterol ratio.

The patients in the study had previously participated in a blinded randomized trial comparing the integrase inhibitor combination plus TDF with ATV/r + TDF in treatment-naive women.

In the current study, patients were randomly assigned in a 3:1 ratio to maintenance with either E/C/F/TAF (159 patients) or ATV/r + TDF (53 patients).

Forty-eight weeks after the switch, virologic suppression (to fewer than 50 copies/mL) was maintained among 94.3% of those on the integrase inhibitor–based regimen, compared with 86.8% of those on the protease inhibitor–based regimen. Virologic failure was seen in 1.9% of those on the integrase inhibitor–based regimen and in 3.8% of those on the protease inhibitor–based regimen.

In addition, virologic suppression below 20 c/mL at week 48 was more common among women maintained on E/C/F/TAF, at 84.9% vs 71.7% (P = .041). No treatment-emergent resistance was seen with either regimen.

As noted, there were higher mean percentage increases in BMD in the E/C/F/TAF group for both total hip and lumbar spine, but only the latter measure improved significantly in comparison with patients treated with ATV/r + TDF (2.82% vs 0%, P < .001).

Markers of renal tubule damage, including the beta-2 microglobulin to creatinine ratio and the rentinol-binding protein to creatinine ratio, were significantly improved with the integrase inhibitor regimen.

Increases in total cholesterol, LDL cholesterol, and HDL cholesterol were 27 vs 5 mg/dL, 16 vs 8 mg/dL, and 5 vs 0 mg/dL in each case comparing the integrase inhibitor–based regimen to the protease inhibitor–based regimen. All of those comparisons were statistically significant.

As noted, however, the total cholesterol to HDL cholesterol ratio was not significantly different between the treatment arms. The rate or initiation of lipid-modifying agents was 1.3% in the E/C/F/TAF group vs 0 in the ATV/r + TDF group, but this difference was not statistically significant.

“These data demonstrate that women who switch to an integrase inhibitor + TAF‐based regimen maintain high levels of virologic suppression with improvement in BMD and renal function biomarkers, as compared with those remaining on their ritonavir boosted atazanavir + TDF‐based regimen,” the authors wrote.
 

This article first appeared on Medscape.com.

The combination of islatravir (ISL) and doravirine (DOR) maintains HIV-1 viral suppression for at least 96 weeks, according to new data.

ISL is a first-in-class nucleoside reverse transcriptase translocation inhibitor (NRTTI), Jean-Michel Molina, MD, PhD, of Saint‐Louis and Lariboisière Hospitals in Paris, explained at the annual HIV drug therapy meeting in Glasgow, Scotland. The randomized, double-blind, dose‐ranging trial compared ISL+DOR to a fixed‐dose combination of DOR, lamivudine, and tenofovir disoproxil fumarate (DOR/3TC/TDF) daily in 121 patients.

Patients in the ISL+DOR group initially received 0.25, 0.75, or 2.25 mg of ISL along with 100 mg of DOR and 200 mg of 3TC. Beginning at week 20, participants achieving HIV viral loads of 50 copies/mL or less discontinued 3TC but continued on their assigned dose of ISL+DOR for at least 24 weeks. At that point the investigators noted a greater number of discontinuations in the 2.25-mg group and settled on the 0.75-mg ISL dose. All patients in the ISL group were transitioned to that dose between weeks 60 and 72.

At week 96, 81.1% of the patients in the combined ISL group maintained viral loads <50 copies/mL, comparable to the 80.6% of those in the DOR/3TC/TDF group.

ISL+DOR appeared to be “well tolerated,” the investigators noted. They found drug-related adverse events in 7.8% of the patients in the ISL+DOR group compared with 22.6% of patients in the DOR/3TC/TDF group. In addition, among the 90 patients in the ISL+DOR group, no more than 5% of participants experienced any specific drug-related adverse event.

Source: HIV Glasgow 2020 Virtual Conference: Abstract O415. Oct. 5-8, 2020.

A version of this article originally appeared on Medscape.com.

The combination of islatravir (ISL) and doravirine (DOR) maintains HIV-1 viral suppression for at least 96 weeks, according to new data.

ISL is a first-in-class nucleoside reverse transcriptase translocation inhibitor (NRTTI), Jean-Michel Molina, MD, PhD, of Saint‐Louis and Lariboisière Hospitals in Paris, explained at the annual HIV drug therapy meeting in Glasgow, Scotland. The randomized, double-blind, dose‐ranging trial compared ISL+DOR to a fixed‐dose combination of DOR, lamivudine, and tenofovir disoproxil fumarate (DOR/3TC/TDF) daily in 121 patients.

Patients in the ISL+DOR group initially received 0.25, 0.75, or 2.25 mg of ISL along with 100 mg of DOR and 200 mg of 3TC. Beginning at week 20, participants achieving HIV viral loads of 50 copies/mL or less discontinued 3TC but continued on their assigned dose of ISL+DOR for at least 24 weeks. At that point the investigators noted a greater number of discontinuations in the 2.25-mg group and settled on the 0.75-mg ISL dose. All patients in the ISL group were transitioned to that dose between weeks 60 and 72.

At week 96, 81.1% of the patients in the combined ISL group maintained viral loads <50 copies/mL, comparable to the 80.6% of those in the DOR/3TC/TDF group.

ISL+DOR appeared to be “well tolerated,” the investigators noted. They found drug-related adverse events in 7.8% of the patients in the ISL+DOR group compared with 22.6% of patients in the DOR/3TC/TDF group. In addition, among the 90 patients in the ISL+DOR group, no more than 5% of participants experienced any specific drug-related adverse event.

Source: HIV Glasgow 2020 Virtual Conference: Abstract O415. Oct. 5-8, 2020.

A version of this article originally appeared on Medscape.com.

The combination of islatravir (ISL) and doravirine (DOR) maintains HIV-1 viral suppression for at least 96 weeks, according to new data.

ISL is a first-in-class nucleoside reverse transcriptase translocation inhibitor (NRTTI), Jean-Michel Molina, MD, PhD, of Saint‐Louis and Lariboisière Hospitals in Paris, explained at the annual HIV drug therapy meeting in Glasgow, Scotland. The randomized, double-blind, dose‐ranging trial compared ISL+DOR to a fixed‐dose combination of DOR, lamivudine, and tenofovir disoproxil fumarate (DOR/3TC/TDF) daily in 121 patients.

Patients in the ISL+DOR group initially received 0.25, 0.75, or 2.25 mg of ISL along with 100 mg of DOR and 200 mg of 3TC. Beginning at week 20, participants achieving HIV viral loads of 50 copies/mL or less discontinued 3TC but continued on their assigned dose of ISL+DOR for at least 24 weeks. At that point the investigators noted a greater number of discontinuations in the 2.25-mg group and settled on the 0.75-mg ISL dose. All patients in the ISL group were transitioned to that dose between weeks 60 and 72.

At week 96, 81.1% of the patients in the combined ISL group maintained viral loads <50 copies/mL, comparable to the 80.6% of those in the DOR/3TC/TDF group.

ISL+DOR appeared to be “well tolerated,” the investigators noted. They found drug-related adverse events in 7.8% of the patients in the ISL+DOR group compared with 22.6% of patients in the DOR/3TC/TDF group. In addition, among the 90 patients in the ISL+DOR group, no more than 5% of participants experienced any specific drug-related adverse event.

Source: HIV Glasgow 2020 Virtual Conference: Abstract O415. Oct. 5-8, 2020.

A version of this article originally appeared on Medscape.com.

In pediatric Crohn’s disease, a Clostridioides difficile infection detected within the first year after diagnosis is associated with a shorter time to first bowel resection surgery, according to a study that included both a retrospective and prospective analysis. The researchers also found evidence that changes in methionine biosynthesis and depletion of beneficial bacteria may contribute to risk of surgery.

C. difficile infection (CDI) disproportionately affects individuals with inflammatory bowel disease (IBD). Pediatric IBD patients have a 34% risk of recurrent CDI infection, compared with 7.5% in the general population. Previous research found that adults with ulcerative colitis and CDI are at more risk of colectomy, but the finding has not been replicated in children.

In a study published in Inflammatory Bowel Diseases, researchers led by Jennifer Hellmann and Lee Denson of the University of Cincinnati conducted a single-center retrospective analysis of 75 pediatric Crohn’s disease patients. They also conducted a prospective study of 70 pediatric Crohn’s disease patients, using shotgun metagenome sequencing to examine the relationship between microbiota composition and C. difficile carriage or surgery history.

Nineteen percent of patients tested positive for C. difficile. Use of antibiotics was associated with C. difficile (odds ratio, 7.9; P = .02). Of patients who underwent C. difficile testing in the first year, 23 went on to have surgery: 21% who were C. difficile negative required surgery, compared with 67% of those who were positive (hazard ratio, 4.4; P = .0003). The mean time to surgery was 527 days for C. difficile–positive patients and 1,268 days for those who were negative.

A multivariate regression analysis on 54 patients with complete data sets showed that the presence of C. difficile was associated with increased risk of surgery (OR, 16.2; P = .0006). When the analysis was run on all 73 patients, using null value for missing data, the results were similar (OR, 9.17; P = .008).

Shotgun sequencing found that 47 of 114 bacterial species that were associated with the presence of C. difficile were also associated with prior surgery for Crohn’s disease. Species included some that may play a role in mucosal homeostasis, such as Bifidobacterium breve and several Alistipes and Ruminococcus species. That suggests that a reduction in the numbers of these taxa may be associated with C. difficile presence and surgical risk.

The researchers also found that methionine synthesis pathways were depressed in C. difficile–positive and surgery patients. Methionine may bolster antioxidant capacity and improve villus morphology. IBD patients with dysbiosis and those experiencing Crohn’s disease exacerbations have been shown to have decreased methionine pathway activity, suggesting methionine biosynthesis changes have clinical relevance.

The study was funded by the National Institutes of Health.

SOURCE: Hellmann J et al. Inflamm Bowel Dis. 2020. doi: 10.1093/ibd/izz263.

In pediatric Crohn’s disease, a Clostridioides difficile infection detected within the first year after diagnosis is associated with a shorter time to first bowel resection surgery, according to a study that included both a retrospective and prospective analysis. The researchers also found evidence that changes in methionine biosynthesis and depletion of beneficial bacteria may contribute to risk of surgery.

C. difficile infection (CDI) disproportionately affects individuals with inflammatory bowel disease (IBD). Pediatric IBD patients have a 34% risk of recurrent CDI infection, compared with 7.5% in the general population. Previous research found that adults with ulcerative colitis and CDI are at more risk of colectomy, but the finding has not been replicated in children.

In a study published in Inflammatory Bowel Diseases, researchers led by Jennifer Hellmann and Lee Denson of the University of Cincinnati conducted a single-center retrospective analysis of 75 pediatric Crohn’s disease patients. They also conducted a prospective study of 70 pediatric Crohn’s disease patients, using shotgun metagenome sequencing to examine the relationship between microbiota composition and C. difficile carriage or surgery history.

Nineteen percent of patients tested positive for C. difficile. Use of antibiotics was associated with C. difficile (odds ratio, 7.9; P = .02). Of patients who underwent C. difficile testing in the first year, 23 went on to have surgery: 21% who were C. difficile negative required surgery, compared with 67% of those who were positive (hazard ratio, 4.4; P = .0003). The mean time to surgery was 527 days for C. difficile–positive patients and 1,268 days for those who were negative.

A multivariate regression analysis on 54 patients with complete data sets showed that the presence of C. difficile was associated with increased risk of surgery (OR, 16.2; P = .0006). When the analysis was run on all 73 patients, using null value for missing data, the results were similar (OR, 9.17; P = .008).

Shotgun sequencing found that 47 of 114 bacterial species that were associated with the presence of C. difficile were also associated with prior surgery for Crohn’s disease. Species included some that may play a role in mucosal homeostasis, such as Bifidobacterium breve and several Alistipes and Ruminococcus species. That suggests that a reduction in the numbers of these taxa may be associated with C. difficile presence and surgical risk.

The researchers also found that methionine synthesis pathways were depressed in C. difficile–positive and surgery patients. Methionine may bolster antioxidant capacity and improve villus morphology. IBD patients with dysbiosis and those experiencing Crohn’s disease exacerbations have been shown to have decreased methionine pathway activity, suggesting methionine biosynthesis changes have clinical relevance.

The study was funded by the National Institutes of Health.

SOURCE: Hellmann J et al. Inflamm Bowel Dis. 2020. doi: 10.1093/ibd/izz263.

In pediatric Crohn’s disease, a Clostridioides difficile infection detected within the first year after diagnosis is associated with a shorter time to first bowel resection surgery, according to a study that included both a retrospective and prospective analysis. The researchers also found evidence that changes in methionine biosynthesis and depletion of beneficial bacteria may contribute to risk of surgery.

C. difficile infection (CDI) disproportionately affects individuals with inflammatory bowel disease (IBD). Pediatric IBD patients have a 34% risk of recurrent CDI infection, compared with 7.5% in the general population. Previous research found that adults with ulcerative colitis and CDI are at more risk of colectomy, but the finding has not been replicated in children.

In a study published in Inflammatory Bowel Diseases, researchers led by Jennifer Hellmann and Lee Denson of the University of Cincinnati conducted a single-center retrospective analysis of 75 pediatric Crohn’s disease patients. They also conducted a prospective study of 70 pediatric Crohn’s disease patients, using shotgun metagenome sequencing to examine the relationship between microbiota composition and C. difficile carriage or surgery history.

Nineteen percent of patients tested positive for C. difficile. Use of antibiotics was associated with C. difficile (odds ratio, 7.9; P = .02). Of patients who underwent C. difficile testing in the first year, 23 went on to have surgery: 21% who were C. difficile negative required surgery, compared with 67% of those who were positive (hazard ratio, 4.4; P = .0003). The mean time to surgery was 527 days for C. difficile–positive patients and 1,268 days for those who were negative.

A multivariate regression analysis on 54 patients with complete data sets showed that the presence of C. difficile was associated with increased risk of surgery (OR, 16.2; P = .0006). When the analysis was run on all 73 patients, using null value for missing data, the results were similar (OR, 9.17; P = .008).

Shotgun sequencing found that 47 of 114 bacterial species that were associated with the presence of C. difficile were also associated with prior surgery for Crohn’s disease. Species included some that may play a role in mucosal homeostasis, such as Bifidobacterium breve and several Alistipes and Ruminococcus species. That suggests that a reduction in the numbers of these taxa may be associated with C. difficile presence and surgical risk.

The researchers also found that methionine synthesis pathways were depressed in C. difficile–positive and surgery patients. Methionine may bolster antioxidant capacity and improve villus morphology. IBD patients with dysbiosis and those experiencing Crohn’s disease exacerbations have been shown to have decreased methionine pathway activity, suggesting methionine biosynthesis changes have clinical relevance.

The study was funded by the National Institutes of Health.

SOURCE: Hellmann J et al. Inflamm Bowel Dis. 2020. doi: 10.1093/ibd/izz263.