American teenagers receive less formal sex education today than they did 25 years ago, with “troubling” racial inequities that leave youth of color and queer youth at greater risk than other teens for sexually transmitted diseases and unintended pregnancy, according to a new study.

“Many adolescents do not receive any instruction on essential topics or do not receive this instruction until after the first sex,” wrote Laura D. Lindberg, PhD, and Leslie M. Kantor, PhD, MPH, from the Guttmacher Institute, New York, and the department of urban-global public health at Rutgers University, Piscataway, N.J., respectively. “These gaps in sex education in the U.S. are uneven, and gender, racial, and other disparities are widespread,” they added, calling for “robust efforts ... to ensure equity and reduce health disparities.”

The study used cross-sectional data from the 2011-2015 and 2015-2019 National Surveys of Family Growth (NSFG) to examine content, timing, and location of formal sex education among 15- to 19-year-olds in the United States. The data came from samples of 2,047 females and 2,087 males in 2011-2015, and 1,894 females and 1,918 males in 2015-2019. The majority of respondents were aged 15-17 years and non-Hispanic White, with another quarter being Hispanic, and 14% Black.

The survey asked respondents whether, before they turned 18, they had ever received formal instruction at school, church, a community center, “or some other place” about how to say no to sex, methods of birth control, STDs, how to prevent HIV/AIDS, abstaining until marriage to have sex, where to get birth control, and how to use a condom.

Follow-up questions asked about what grade instruction was first received and whether it had occurred before first penile-vaginal intercourse. The 2015-2019 survey also asked about the location of instruction, but only concerning methods of birth control and abstinence until marriage.

The results showed that HIV and STD prevention was the most commonly reported area of instruction, received by more than 90% of both males and females. However, beyond this there were imbalances, with only about half (49%-55%) of respondents receiving instruction meeting the Surgeon General’s Healthy People 2030 composite sex education goal. Lack of instruction on birth control drove this result for 80% of respondents. Specifically, there was a strong slant emphasizing abstinence over birth control instruction. Over both survey periods and both genders, more respondents reported instruction on how to say no to sex (79%-84%) and abstaining until marriage (58%-73%), compared with where to obtain birth control (40%-53%) or how to use a condom (54%-60%). “Overall, about 20% of adolescents received instruction from multiple sources about waiting until marriage, but only 5%-8% received birth control information from multiple settings,” they reported.

There were racial/ethnic and sexual orientation differences in the scope and balance of instruction reported by teens. Less than half of Black (45%) and Hispanic (47%) males received instruction on the combined Healthy People topics, compared with 57% of White males. Black females were less likely (30%) than White females (45%) to receive information on where to get birth control before the first sex. Nonstraight males were less likely than straight males to receive instruction about STIs or HIV/AIDS (83% vs. 93%).

In addition, religious attendance emerged as a key factor in the receipt of sex education, “with more frequent religious attendance associated with a greater likelihood of instruction about delaying sex and less likelihood of instruction about contraception,” the authors noted.

Comparing their findings to previous NSFG surveys, the researchers commented that “the share of adolescents receiving instruction about birth control was higher in 1995 than in 2015-2019 for both the genders; in 1995, 87% of females and 81% of males reported sex education about birth control methods, compared with 64% and 63% in 2015-2019, respectively.” The findings “should spur policy makers at the national, state, and local levels to ensure the broader provision of sex education and that school districts serving young people of color are the focus of additional efforts and funding.”

Asked for comment, John Santelli, MD, MPH, professor of population and family health and pediatrics at Columbia University, New York, who was not involved with the study, said the findings fit into a series of studies by Lindberg going back to 1988 showing that receipt of formal sex education before age 18 has declined over time.

“We, the adults, in America can do better by our young people,” he said in an interview. “Adolescents need sex education that is science based, medically accurate, and developmentally appropriate. Many adolescents are not receiving education that the CDC and health professionals recommend including information about where to get birth control, condom skills, and even, how to say no to sex. The neglect of young Black and Hispanic men is very concerning. However, we are not doing a great job in educating most of our adolescents. Health care providers can be influential in speaking with parents about their children’s education about sex. We need to activate parents, health care providers, and members of the faith community to investigate what is happening about sex education in their own communities.”

Dr. Santelli noted that there are multiple ways to strengthen the provision of sex education in the United States. In a recent commentary, he and his coauthors highlighted the National Sex Education Standards (NSES), which, “developed in partnership between sex education organizations and health professionals, provide clear, consistent, and straightforward guidance on the essential content for students in grades K-12.” The NSES were also used in the development of the CDC’s recently released Health Education Curriculum Analysis Tool.

The commentary takes a strong stand against the recently released revised Medical Institute for Sexual Heath K-12 Standards for Optimal Sexual Development, which, compared with the NSES, are “seriously flawed from both scientific and human rights’ perspectives,” they wrote. “States and local communities aiming to improve adolescent sexual and reproductive health and looking for national standards on sex education should adopt the NSES.”

Dr. Lindberg and Dr. Kantor disclosed no conflicts of interest. Dr. Santelli teaches public health students about adolescent health and chairs the board of directors of the Sexuality Information and Education Council of the United States. He disclosed no financial conflicts.

American teenagers receive less formal sex education today than they did 25 years ago, with “troubling” racial inequities that leave youth of color and queer youth at greater risk than other teens for sexually transmitted diseases and unintended pregnancy, according to a new study.

“Many adolescents do not receive any instruction on essential topics or do not receive this instruction until after the first sex,” wrote Laura D. Lindberg, PhD, and Leslie M. Kantor, PhD, MPH, from the Guttmacher Institute, New York, and the department of urban-global public health at Rutgers University, Piscataway, N.J., respectively. “These gaps in sex education in the U.S. are uneven, and gender, racial, and other disparities are widespread,” they added, calling for “robust efforts ... to ensure equity and reduce health disparities.”

The study used cross-sectional data from the 2011-2015 and 2015-2019 National Surveys of Family Growth (NSFG) to examine content, timing, and location of formal sex education among 15- to 19-year-olds in the United States. The data came from samples of 2,047 females and 2,087 males in 2011-2015, and 1,894 females and 1,918 males in 2015-2019. The majority of respondents were aged 15-17 years and non-Hispanic White, with another quarter being Hispanic, and 14% Black.

The survey asked respondents whether, before they turned 18, they had ever received formal instruction at school, church, a community center, “or some other place” about how to say no to sex, methods of birth control, STDs, how to prevent HIV/AIDS, abstaining until marriage to have sex, where to get birth control, and how to use a condom.

Follow-up questions asked about what grade instruction was first received and whether it had occurred before first penile-vaginal intercourse. The 2015-2019 survey also asked about the location of instruction, but only concerning methods of birth control and abstinence until marriage.

The results showed that HIV and STD prevention was the most commonly reported area of instruction, received by more than 90% of both males and females. However, beyond this there were imbalances, with only about half (49%-55%) of respondents receiving instruction meeting the Surgeon General’s Healthy People 2030 composite sex education goal. Lack of instruction on birth control drove this result for 80% of respondents. Specifically, there was a strong slant emphasizing abstinence over birth control instruction. Over both survey periods and both genders, more respondents reported instruction on how to say no to sex (79%-84%) and abstaining until marriage (58%-73%), compared with where to obtain birth control (40%-53%) or how to use a condom (54%-60%). “Overall, about 20% of adolescents received instruction from multiple sources about waiting until marriage, but only 5%-8% received birth control information from multiple settings,” they reported.

There were racial/ethnic and sexual orientation differences in the scope and balance of instruction reported by teens. Less than half of Black (45%) and Hispanic (47%) males received instruction on the combined Healthy People topics, compared with 57% of White males. Black females were less likely (30%) than White females (45%) to receive information on where to get birth control before the first sex. Nonstraight males were less likely than straight males to receive instruction about STIs or HIV/AIDS (83% vs. 93%).

In addition, religious attendance emerged as a key factor in the receipt of sex education, “with more frequent religious attendance associated with a greater likelihood of instruction about delaying sex and less likelihood of instruction about contraception,” the authors noted.

Comparing their findings to previous NSFG surveys, the researchers commented that “the share of adolescents receiving instruction about birth control was higher in 1995 than in 2015-2019 for both the genders; in 1995, 87% of females and 81% of males reported sex education about birth control methods, compared with 64% and 63% in 2015-2019, respectively.” The findings “should spur policy makers at the national, state, and local levels to ensure the broader provision of sex education and that school districts serving young people of color are the focus of additional efforts and funding.”

Asked for comment, John Santelli, MD, MPH, professor of population and family health and pediatrics at Columbia University, New York, who was not involved with the study, said the findings fit into a series of studies by Lindberg going back to 1988 showing that receipt of formal sex education before age 18 has declined over time.

“We, the adults, in America can do better by our young people,” he said in an interview. “Adolescents need sex education that is science based, medically accurate, and developmentally appropriate. Many adolescents are not receiving education that the CDC and health professionals recommend including information about where to get birth control, condom skills, and even, how to say no to sex. The neglect of young Black and Hispanic men is very concerning. However, we are not doing a great job in educating most of our adolescents. Health care providers can be influential in speaking with parents about their children’s education about sex. We need to activate parents, health care providers, and members of the faith community to investigate what is happening about sex education in their own communities.”

Dr. Santelli noted that there are multiple ways to strengthen the provision of sex education in the United States. In a recent commentary, he and his coauthors highlighted the National Sex Education Standards (NSES), which, “developed in partnership between sex education organizations and health professionals, provide clear, consistent, and straightforward guidance on the essential content for students in grades K-12.” The NSES were also used in the development of the CDC’s recently released Health Education Curriculum Analysis Tool.

The commentary takes a strong stand against the recently released revised Medical Institute for Sexual Heath K-12 Standards for Optimal Sexual Development, which, compared with the NSES, are “seriously flawed from both scientific and human rights’ perspectives,” they wrote. “States and local communities aiming to improve adolescent sexual and reproductive health and looking for national standards on sex education should adopt the NSES.”

Dr. Lindberg and Dr. Kantor disclosed no conflicts of interest. Dr. Santelli teaches public health students about adolescent health and chairs the board of directors of the Sexuality Information and Education Council of the United States. He disclosed no financial conflicts.

American teenagers receive less formal sex education today than they did 25 years ago, with “troubling” racial inequities that leave youth of color and queer youth at greater risk than other teens for sexually transmitted diseases and unintended pregnancy, according to a new study.

“Many adolescents do not receive any instruction on essential topics or do not receive this instruction until after the first sex,” wrote Laura D. Lindberg, PhD, and Leslie M. Kantor, PhD, MPH, from the Guttmacher Institute, New York, and the department of urban-global public health at Rutgers University, Piscataway, N.J., respectively. “These gaps in sex education in the U.S. are uneven, and gender, racial, and other disparities are widespread,” they added, calling for “robust efforts ... to ensure equity and reduce health disparities.”

The study used cross-sectional data from the 2011-2015 and 2015-2019 National Surveys of Family Growth (NSFG) to examine content, timing, and location of formal sex education among 15- to 19-year-olds in the United States. The data came from samples of 2,047 females and 2,087 males in 2011-2015, and 1,894 females and 1,918 males in 2015-2019. The majority of respondents were aged 15-17 years and non-Hispanic White, with another quarter being Hispanic, and 14% Black.

The survey asked respondents whether, before they turned 18, they had ever received formal instruction at school, church, a community center, “or some other place” about how to say no to sex, methods of birth control, STDs, how to prevent HIV/AIDS, abstaining until marriage to have sex, where to get birth control, and how to use a condom.

Follow-up questions asked about what grade instruction was first received and whether it had occurred before first penile-vaginal intercourse. The 2015-2019 survey also asked about the location of instruction, but only concerning methods of birth control and abstinence until marriage.

The results showed that HIV and STD prevention was the most commonly reported area of instruction, received by more than 90% of both males and females. However, beyond this there were imbalances, with only about half (49%-55%) of respondents receiving instruction meeting the Surgeon General’s Healthy People 2030 composite sex education goal. Lack of instruction on birth control drove this result for 80% of respondents. Specifically, there was a strong slant emphasizing abstinence over birth control instruction. Over both survey periods and both genders, more respondents reported instruction on how to say no to sex (79%-84%) and abstaining until marriage (58%-73%), compared with where to obtain birth control (40%-53%) or how to use a condom (54%-60%). “Overall, about 20% of adolescents received instruction from multiple sources about waiting until marriage, but only 5%-8% received birth control information from multiple settings,” they reported.

There were racial/ethnic and sexual orientation differences in the scope and balance of instruction reported by teens. Less than half of Black (45%) and Hispanic (47%) males received instruction on the combined Healthy People topics, compared with 57% of White males. Black females were less likely (30%) than White females (45%) to receive information on where to get birth control before the first sex. Nonstraight males were less likely than straight males to receive instruction about STIs or HIV/AIDS (83% vs. 93%).

In addition, religious attendance emerged as a key factor in the receipt of sex education, “with more frequent religious attendance associated with a greater likelihood of instruction about delaying sex and less likelihood of instruction about contraception,” the authors noted.

Comparing their findings to previous NSFG surveys, the researchers commented that “the share of adolescents receiving instruction about birth control was higher in 1995 than in 2015-2019 for both the genders; in 1995, 87% of females and 81% of males reported sex education about birth control methods, compared with 64% and 63% in 2015-2019, respectively.” The findings “should spur policy makers at the national, state, and local levels to ensure the broader provision of sex education and that school districts serving young people of color are the focus of additional efforts and funding.”

Asked for comment, John Santelli, MD, MPH, professor of population and family health and pediatrics at Columbia University, New York, who was not involved with the study, said the findings fit into a series of studies by Lindberg going back to 1988 showing that receipt of formal sex education before age 18 has declined over time.

“We, the adults, in America can do better by our young people,” he said in an interview. “Adolescents need sex education that is science based, medically accurate, and developmentally appropriate. Many adolescents are not receiving education that the CDC and health professionals recommend including information about where to get birth control, condom skills, and even, how to say no to sex. The neglect of young Black and Hispanic men is very concerning. However, we are not doing a great job in educating most of our adolescents. Health care providers can be influential in speaking with parents about their children’s education about sex. We need to activate parents, health care providers, and members of the faith community to investigate what is happening about sex education in their own communities.”

Dr. Santelli noted that there are multiple ways to strengthen the provision of sex education in the United States. In a recent commentary, he and his coauthors highlighted the National Sex Education Standards (NSES), which, “developed in partnership between sex education organizations and health professionals, provide clear, consistent, and straightforward guidance on the essential content for students in grades K-12.” The NSES were also used in the development of the CDC’s recently released Health Education Curriculum Analysis Tool.

The commentary takes a strong stand against the recently released revised Medical Institute for Sexual Heath K-12 Standards for Optimal Sexual Development, which, compared with the NSES, are “seriously flawed from both scientific and human rights’ perspectives,” they wrote. “States and local communities aiming to improve adolescent sexual and reproductive health and looking for national standards on sex education should adopt the NSES.”

Dr. Lindberg and Dr. Kantor disclosed no conflicts of interest. Dr. Santelli teaches public health students about adolescent health and chairs the board of directors of the Sexuality Information and Education Council of the United States. He disclosed no financial conflicts.

Early lab studies show that a COVID-19 antibody treatment developed by GlaxoSmithKline and Vir Biotechnology could be effective against the Omicron variant.

The companies said Dec. 2 that they tested the drug, called sotrovimab, against individual mutations found in the Omicron variant, according to The Wall Street Journal. The preliminary findings haven’t yet been peer-reviewed, and the drug will need to be tested against the whole spike protein on the virus to confirm results.

GlaxoSmithKline and Vir have previously tested sotrovimab against mutations on other variants, the newspaper reported. When the Omicron variant was identified, the companies looked at earlier research to find the tests they had done against mutations that are also found in Omicron.

Sotrovimab targets a spot on the spike protein that is found in other coronaviruses and is thought to be less likely to mutate, according to the newspaper. Omicron has at least two mutations that overlap with the drug’s target site, but researchers at the companies don’t think the mutations will affect the treatment’s ability to bind to the spike protein.

GlaxoSmithKline expects to see results from testing the drug against the full mutated spike protein in the next 2 to 3 weeks, the Journal reported.

Sotrovimab has been authorized in about a dozen countries, including the United States, which paid about $1 billion for hundreds of thousands of doses.

Other companies have also been testing their antibody treatments against the Omicron variant.

Regeneron announced Nov. 30 that its drug could be less effective, and it said further analyses will determine how much less effective by using the actual Omicron genetic sequence, according to Reuters.

Outside scientists have also said the antibody drug from Eli Lilly & Co. isn’t as effective against Omicron. The company told Reuters that it is still testing the treatment against the variant.

Another experimental antibody therapy developed by Adagio Therapeutics appears to work well against the new variant, the Journal reported, but the treatment is in late-stage clinical trials and isn’t yet authorized.

Antiviral drugs could also help prevent hospitalization and may be less vulnerable to new variants because they target a different part of the virus, the newspaper reported. Merck and Pfizer have developed antiviral pills, which still require FDA approval.

In addition, Gilead believes its approved IV therapy, called remdesivir, will continue to be effective against the variant, Reuters reported.

The FDA said Nov. 30 that it is looking at the effect that authorized COVID-19 vaccines can have on Omicron and expects to have more information in coming weeks, Reuters reported.

A version of this article first appeared on WebMD.com.

Early lab studies show that a COVID-19 antibody treatment developed by GlaxoSmithKline and Vir Biotechnology could be effective against the Omicron variant.

The companies said Dec. 2 that they tested the drug, called sotrovimab, against individual mutations found in the Omicron variant, according to The Wall Street Journal. The preliminary findings haven’t yet been peer-reviewed, and the drug will need to be tested against the whole spike protein on the virus to confirm results.

GlaxoSmithKline and Vir have previously tested sotrovimab against mutations on other variants, the newspaper reported. When the Omicron variant was identified, the companies looked at earlier research to find the tests they had done against mutations that are also found in Omicron.

Sotrovimab targets a spot on the spike protein that is found in other coronaviruses and is thought to be less likely to mutate, according to the newspaper. Omicron has at least two mutations that overlap with the drug’s target site, but researchers at the companies don’t think the mutations will affect the treatment’s ability to bind to the spike protein.

GlaxoSmithKline expects to see results from testing the drug against the full mutated spike protein in the next 2 to 3 weeks, the Journal reported.

Sotrovimab has been authorized in about a dozen countries, including the United States, which paid about $1 billion for hundreds of thousands of doses.

Other companies have also been testing their antibody treatments against the Omicron variant.

Regeneron announced Nov. 30 that its drug could be less effective, and it said further analyses will determine how much less effective by using the actual Omicron genetic sequence, according to Reuters.

Outside scientists have also said the antibody drug from Eli Lilly & Co. isn’t as effective against Omicron. The company told Reuters that it is still testing the treatment against the variant.

Another experimental antibody therapy developed by Adagio Therapeutics appears to work well against the new variant, the Journal reported, but the treatment is in late-stage clinical trials and isn’t yet authorized.

Antiviral drugs could also help prevent hospitalization and may be less vulnerable to new variants because they target a different part of the virus, the newspaper reported. Merck and Pfizer have developed antiviral pills, which still require FDA approval.

In addition, Gilead believes its approved IV therapy, called remdesivir, will continue to be effective against the variant, Reuters reported.

The FDA said Nov. 30 that it is looking at the effect that authorized COVID-19 vaccines can have on Omicron and expects to have more information in coming weeks, Reuters reported.

A version of this article first appeared on WebMD.com.

Early lab studies show that a COVID-19 antibody treatment developed by GlaxoSmithKline and Vir Biotechnology could be effective against the Omicron variant.

The companies said Dec. 2 that they tested the drug, called sotrovimab, against individual mutations found in the Omicron variant, according to The Wall Street Journal. The preliminary findings haven’t yet been peer-reviewed, and the drug will need to be tested against the whole spike protein on the virus to confirm results.

GlaxoSmithKline and Vir have previously tested sotrovimab against mutations on other variants, the newspaper reported. When the Omicron variant was identified, the companies looked at earlier research to find the tests they had done against mutations that are also found in Omicron.

Sotrovimab targets a spot on the spike protein that is found in other coronaviruses and is thought to be less likely to mutate, according to the newspaper. Omicron has at least two mutations that overlap with the drug’s target site, but researchers at the companies don’t think the mutations will affect the treatment’s ability to bind to the spike protein.

GlaxoSmithKline expects to see results from testing the drug against the full mutated spike protein in the next 2 to 3 weeks, the Journal reported.

Sotrovimab has been authorized in about a dozen countries, including the United States, which paid about $1 billion for hundreds of thousands of doses.

Other companies have also been testing their antibody treatments against the Omicron variant.

Regeneron announced Nov. 30 that its drug could be less effective, and it said further analyses will determine how much less effective by using the actual Omicron genetic sequence, according to Reuters.

Outside scientists have also said the antibody drug from Eli Lilly & Co. isn’t as effective against Omicron. The company told Reuters that it is still testing the treatment against the variant.

Another experimental antibody therapy developed by Adagio Therapeutics appears to work well against the new variant, the Journal reported, but the treatment is in late-stage clinical trials and isn’t yet authorized.

Antiviral drugs could also help prevent hospitalization and may be less vulnerable to new variants because they target a different part of the virus, the newspaper reported. Merck and Pfizer have developed antiviral pills, which still require FDA approval.

In addition, Gilead believes its approved IV therapy, called remdesivir, will continue to be effective against the variant, Reuters reported.

The FDA said Nov. 30 that it is looking at the effect that authorized COVID-19 vaccines can have on Omicron and expects to have more information in coming weeks, Reuters reported.

A version of this article first appeared on WebMD.com.

Clinicians need to pay more attention to high levels of lipoprotein cholesterol (LDL-C) – a marker of cardiovascular disease (CVD) risk – in patients with type 2 diabetes, a new population-based study in Finland suggests.

In the study, recently published online in Scientific Reports , the authors showed that LDL-C control and statin prescriptions remain suboptimal in this patient population in clinical practice.

They identified four 5-year trajectories of LDL-C along with concurrent levels of statin treatment. The percentages of patients in each group were:

• Moderately stable LDL-C: 2.3 mmol/L (90 mg/dL): 86%  
• High stable LDL-C: 3.9 mmol/L (152 mg/dL): 7.7%
• Decreasing LDL-C: 3.8%
• Increasing LDL-C: 2.5% 

“The second-largest group consisted of predominantly untreated patients (7.7%) with alarmingly ‘high stable’ LDL-C levels around 3.9 mmol/L,” the researchers noted.

And among patients with “increasing” LDL-C cholesterol, statin treatment “declined drastically.”

Moreover, 42% of patients had no statins prescribed at the end of follow-up.

These findings show that “efforts to control LDL-C should be increased – especially in patients with continuously elevated levels – by initiating and intensifying statin treatment earlier and reinitiating the treatment after discontinuation, if possible,” lead author Laura Inglin, MPH, told this news organization.
 

Discuss risks vs. benefits of statins with patients

Patients may not understand the benefits versus potential side effects of statins, said Ms. Inglin, of the Institute of Public Health and Clinical Nutrition, University of Eastern Finland, Kuopio.

To improve management of cholesterol levels, she said, “clinician-patient discussions are crucial, addressing risk/benefits and treatment goals, and offering reputable sources” of information about statins.

When patients discontinue statin treatment, Ms. Inglin continued, “physicians should try to reinitiate another statin or to lower the dose if possible, following guidelines on how to do that,” as other research has reported that more than 70% of patients who stopped a statin because of side effects tolerated it when it was restarted.

The study also identified gender differences, she continued. Compared with men, women had significantly higher average LDL-C levels, but were less likely to be prescribed a statin or were prescribed a lower-dose statin, and they were more likely to discontinue statin therapy. 
 

Four LDL-C trajectories with statin treatment differences

Suboptimal lipid profiles, especially elevated LDL-C, are strongly associated with atherosclerotic CVD in individuals with type 2 diabetes, Ms. Inglin and colleagues write.

“To prevent or at least delay complications, regular follow-up visits and good control of A1c, LDL-C, blood pressure, and other CVD risk factors are vital in diabetes management,” they continued. “Guidelines have consistently identified statins as the principal lipid-lowering therapy, recommended particularly at moderate- to high-intensity.” 

The researchers aimed to identify LDL-C level trajectories and concomitant statin treatment in patients with type 2 diabetes.

They identified 8,592 patients – 4,622 men (54%) and 3,970 women (46%) – with type 2 diabetes seen by primary care physicians or specialists in North Karelia, Eastern Finland, during 2011-2017.

As with other international guidelines, the Finnish Current Care Guideline recommended assessing LDL-C levels every 1-3 years in patients with type 2 diabetes, with LDL-C treatment targets of < 2.5 mmol/L (< 100 mg/dL) for those at high CVD risk due to diabetes, and targets of < 1.8 mmol/L (< 70 mg/dL) or a 50% reduction from baseline in those at very high CVD risk due to additional risk factors.

At baseline, on average, men in the current study were aged 66 years and had had diabetes for 8 years; 60% were receiving a statin and 56% had an LDL-C < 2.5 mmol/L.

Women were, on average, age 69 years and had had diabetes for 8 years; 56% were receiving a statin and 51% had an LDL-C < 2.5 mmol/L.

The researchers identified the four distinct LDL-C trajectories, each with differences in statin treatment.

In the “moderate-stable” LDL-C group, 67% of men and 64% of women were receiving a statin, and the rates of high-intensity statin increased in both men and women.

In the “high-stable” LDL-C group, rates of statin use decreased from 42% to 27% among men and from 34% to 23% among women.

In the “decreasing” LDL-C group, the proportion of patients who received a statin increased; the percentage of patients who received a high-intensity statin also increased among men (6.2% to 29%) and women (7.7% to 14%).

In the “increasing” LDL-C group, the percentage of patients receiving a statin decreased from more than 64% to less than 43%.

“Physicians should increase efforts to achieve the LDL-C treatment targets – especially in the patient group with constantly elevated LDL-C levels – by paying attention to earlier initiation of statin treatment, intensification of treatments when necessary, and reinitiating if possible,” the researchers reiterated.

“The results of our study may support physicians to identify patients who need to be monitored more closely beyond a single time point measurement,” they concluded.

The study was partly funded by the Strategic Research Council of the Academy of Finland (project IMPRO), the Finnish Diabetes Association, and the Research Committee of the Kuopio University Hospital Catchment Area for the State Research Funding (project QCARE). The authors have reported no relevant financial relationships.

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

Clinicians need to pay more attention to high levels of lipoprotein cholesterol (LDL-C) – a marker of cardiovascular disease (CVD) risk – in patients with type 2 diabetes, a new population-based study in Finland suggests.

In the study, recently published online in Scientific Reports , the authors showed that LDL-C control and statin prescriptions remain suboptimal in this patient population in clinical practice.

They identified four 5-year trajectories of LDL-C along with concurrent levels of statin treatment. The percentages of patients in each group were:

• Moderately stable LDL-C: 2.3 mmol/L (90 mg/dL): 86%  
• High stable LDL-C: 3.9 mmol/L (152 mg/dL): 7.7%
• Decreasing LDL-C: 3.8%
• Increasing LDL-C: 2.5% 

“The second-largest group consisted of predominantly untreated patients (7.7%) with alarmingly ‘high stable’ LDL-C levels around 3.9 mmol/L,” the researchers noted.

And among patients with “increasing” LDL-C cholesterol, statin treatment “declined drastically.”

Moreover, 42% of patients had no statins prescribed at the end of follow-up.

These findings show that “efforts to control LDL-C should be increased – especially in patients with continuously elevated levels – by initiating and intensifying statin treatment earlier and reinitiating the treatment after discontinuation, if possible,” lead author Laura Inglin, MPH, told this news organization.
 

Discuss risks vs. benefits of statins with patients

Patients may not understand the benefits versus potential side effects of statins, said Ms. Inglin, of the Institute of Public Health and Clinical Nutrition, University of Eastern Finland, Kuopio.

To improve management of cholesterol levels, she said, “clinician-patient discussions are crucial, addressing risk/benefits and treatment goals, and offering reputable sources” of information about statins.

When patients discontinue statin treatment, Ms. Inglin continued, “physicians should try to reinitiate another statin or to lower the dose if possible, following guidelines on how to do that,” as other research has reported that more than 70% of patients who stopped a statin because of side effects tolerated it when it was restarted.

The study also identified gender differences, she continued. Compared with men, women had significantly higher average LDL-C levels, but were less likely to be prescribed a statin or were prescribed a lower-dose statin, and they were more likely to discontinue statin therapy. 
 

Four LDL-C trajectories with statin treatment differences

Suboptimal lipid profiles, especially elevated LDL-C, are strongly associated with atherosclerotic CVD in individuals with type 2 diabetes, Ms. Inglin and colleagues write.

“To prevent or at least delay complications, regular follow-up visits and good control of A1c, LDL-C, blood pressure, and other CVD risk factors are vital in diabetes management,” they continued. “Guidelines have consistently identified statins as the principal lipid-lowering therapy, recommended particularly at moderate- to high-intensity.” 

The researchers aimed to identify LDL-C level trajectories and concomitant statin treatment in patients with type 2 diabetes.

They identified 8,592 patients – 4,622 men (54%) and 3,970 women (46%) – with type 2 diabetes seen by primary care physicians or specialists in North Karelia, Eastern Finland, during 2011-2017.

As with other international guidelines, the Finnish Current Care Guideline recommended assessing LDL-C levels every 1-3 years in patients with type 2 diabetes, with LDL-C treatment targets of < 2.5 mmol/L (< 100 mg/dL) for those at high CVD risk due to diabetes, and targets of < 1.8 mmol/L (< 70 mg/dL) or a 50% reduction from baseline in those at very high CVD risk due to additional risk factors.

At baseline, on average, men in the current study were aged 66 years and had had diabetes for 8 years; 60% were receiving a statin and 56% had an LDL-C < 2.5 mmol/L.

Women were, on average, age 69 years and had had diabetes for 8 years; 56% were receiving a statin and 51% had an LDL-C < 2.5 mmol/L.

The researchers identified the four distinct LDL-C trajectories, each with differences in statin treatment.

In the “moderate-stable” LDL-C group, 67% of men and 64% of women were receiving a statin, and the rates of high-intensity statin increased in both men and women.

In the “high-stable” LDL-C group, rates of statin use decreased from 42% to 27% among men and from 34% to 23% among women.

In the “decreasing” LDL-C group, the proportion of patients who received a statin increased; the percentage of patients who received a high-intensity statin also increased among men (6.2% to 29%) and women (7.7% to 14%).

In the “increasing” LDL-C group, the percentage of patients receiving a statin decreased from more than 64% to less than 43%.

“Physicians should increase efforts to achieve the LDL-C treatment targets – especially in the patient group with constantly elevated LDL-C levels – by paying attention to earlier initiation of statin treatment, intensification of treatments when necessary, and reinitiating if possible,” the researchers reiterated.

“The results of our study may support physicians to identify patients who need to be monitored more closely beyond a single time point measurement,” they concluded.

The study was partly funded by the Strategic Research Council of the Academy of Finland (project IMPRO), the Finnish Diabetes Association, and the Research Committee of the Kuopio University Hospital Catchment Area for the State Research Funding (project QCARE). The authors have reported no relevant financial relationships.

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

Clinicians need to pay more attention to high levels of lipoprotein cholesterol (LDL-C) – a marker of cardiovascular disease (CVD) risk – in patients with type 2 diabetes, a new population-based study in Finland suggests.

In the study, recently published online in Scientific Reports , the authors showed that LDL-C control and statin prescriptions remain suboptimal in this patient population in clinical practice.

They identified four 5-year trajectories of LDL-C along with concurrent levels of statin treatment. The percentages of patients in each group were:

• Moderately stable LDL-C: 2.3 mmol/L (90 mg/dL): 86%  
• High stable LDL-C: 3.9 mmol/L (152 mg/dL): 7.7%
• Decreasing LDL-C: 3.8%
• Increasing LDL-C: 2.5% 

“The second-largest group consisted of predominantly untreated patients (7.7%) with alarmingly ‘high stable’ LDL-C levels around 3.9 mmol/L,” the researchers noted.

And among patients with “increasing” LDL-C cholesterol, statin treatment “declined drastically.”

Moreover, 42% of patients had no statins prescribed at the end of follow-up.

These findings show that “efforts to control LDL-C should be increased – especially in patients with continuously elevated levels – by initiating and intensifying statin treatment earlier and reinitiating the treatment after discontinuation, if possible,” lead author Laura Inglin, MPH, told this news organization.
 

Discuss risks vs. benefits of statins with patients

Patients may not understand the benefits versus potential side effects of statins, said Ms. Inglin, of the Institute of Public Health and Clinical Nutrition, University of Eastern Finland, Kuopio.

To improve management of cholesterol levels, she said, “clinician-patient discussions are crucial, addressing risk/benefits and treatment goals, and offering reputable sources” of information about statins.

When patients discontinue statin treatment, Ms. Inglin continued, “physicians should try to reinitiate another statin or to lower the dose if possible, following guidelines on how to do that,” as other research has reported that more than 70% of patients who stopped a statin because of side effects tolerated it when it was restarted.

The study also identified gender differences, she continued. Compared with men, women had significantly higher average LDL-C levels, but were less likely to be prescribed a statin or were prescribed a lower-dose statin, and they were more likely to discontinue statin therapy. 
 

Four LDL-C trajectories with statin treatment differences

Suboptimal lipid profiles, especially elevated LDL-C, are strongly associated with atherosclerotic CVD in individuals with type 2 diabetes, Ms. Inglin and colleagues write.

“To prevent or at least delay complications, regular follow-up visits and good control of A1c, LDL-C, blood pressure, and other CVD risk factors are vital in diabetes management,” they continued. “Guidelines have consistently identified statins as the principal lipid-lowering therapy, recommended particularly at moderate- to high-intensity.” 

The researchers aimed to identify LDL-C level trajectories and concomitant statin treatment in patients with type 2 diabetes.

They identified 8,592 patients – 4,622 men (54%) and 3,970 women (46%) – with type 2 diabetes seen by primary care physicians or specialists in North Karelia, Eastern Finland, during 2011-2017.

As with other international guidelines, the Finnish Current Care Guideline recommended assessing LDL-C levels every 1-3 years in patients with type 2 diabetes, with LDL-C treatment targets of < 2.5 mmol/L (< 100 mg/dL) for those at high CVD risk due to diabetes, and targets of < 1.8 mmol/L (< 70 mg/dL) or a 50% reduction from baseline in those at very high CVD risk due to additional risk factors.

At baseline, on average, men in the current study were aged 66 years and had had diabetes for 8 years; 60% were receiving a statin and 56% had an LDL-C < 2.5 mmol/L.

Women were, on average, age 69 years and had had diabetes for 8 years; 56% were receiving a statin and 51% had an LDL-C < 2.5 mmol/L.

The researchers identified the four distinct LDL-C trajectories, each with differences in statin treatment.

In the “moderate-stable” LDL-C group, 67% of men and 64% of women were receiving a statin, and the rates of high-intensity statin increased in both men and women.

In the “high-stable” LDL-C group, rates of statin use decreased from 42% to 27% among men and from 34% to 23% among women.

In the “decreasing” LDL-C group, the proportion of patients who received a statin increased; the percentage of patients who received a high-intensity statin also increased among men (6.2% to 29%) and women (7.7% to 14%).

In the “increasing” LDL-C group, the percentage of patients receiving a statin decreased from more than 64% to less than 43%.

“Physicians should increase efforts to achieve the LDL-C treatment targets – especially in the patient group with constantly elevated LDL-C levels – by paying attention to earlier initiation of statin treatment, intensification of treatments when necessary, and reinitiating if possible,” the researchers reiterated.

“The results of our study may support physicians to identify patients who need to be monitored more closely beyond a single time point measurement,” they concluded.

The study was partly funded by the Strategic Research Council of the Academy of Finland (project IMPRO), the Finnish Diabetes Association, and the Research Committee of the Kuopio University Hospital Catchment Area for the State Research Funding (project QCARE). The authors have reported no relevant financial relationships.

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

Adults with celiac disease (CD) do not appear to be at increased risk of having a more severe disease course or worse outcomes from COVID-19, according to a new study.

Patients with CD are a “population of interest” in terms of the clinical outcomes of COVID-19, Emad Mansoor, MD, Digestive Health Institute, University Hospitals of Cleveland, and colleagues said.

There is emerging evidence that chronic disorders may have an impact on COVID-19 outcomes. But until now, the consequences of COVID-19 in patients with CD have been unclear.

The study was published online Nov. 11, 2021, in Gut.

To investigate, Dr. Mansoor and colleagues used the TriNetX EHR database to identify 599 patients with CD and confirmed COVID-19 and 810,972 patients without CD but with confirmed COVID-19 from 51 health care organizations in the United States.

After propensity-score matching, the CD and non-CD cohorts were “relatively balanced”; there were 598 patients in each group.

Before propensity-score matching, COVID-19 patients with CD were significantly more likely to be hospitalized than peers without CD (18.2% vs. 11.3%; odds ratio, 1.74; 95% confidence interval, 1.41-2.14; P < .0001).

After matching, however, this association became insignificant (OR, 0.96; 95% CI, 0.71-1.11; P = .0906).

Before matching, patients with CD were also more apt to develop blood clots (5.3% vs. 2.1%; OR, 2.69; 95% CI, 1.88-3.83; P < .0001) but not after matching (OR, 0.938; 95% CI, 0.57-1.54; P = .800).

The same pattern was observed for the two other outcomes of interest: mortality and need for care in the ICU.

Overall, there were no significant differences among any of the measured outcomes between CD and non-CD patients with COVID-19 after propensity-score matching, Dr. Mansoor and colleagues reported.

“This is the largest study characterizing CD patients with COVID-19 to date to systematically investigate outcomes of CD patients with COVID-19,” Dr. Mansoor and colleagues wrote.

They also say that their findings are in line with a recent population-based study from Sweden, which found no significant increase in risk for hospitalization, severe COVID-19, or increase in death between CD and non-CD patients with COVID-19.

“Although reassuring, this study is all about outcomes in individuals with diagnosed CD and the potential impact of COVID-19 in patients with undiagnosed CD remains unknown,” the researchers wrote.

The study had no specific funding. The authors disclosed no relevant financial relationships.

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

Adults with celiac disease (CD) do not appear to be at increased risk of having a more severe disease course or worse outcomes from COVID-19, according to a new study.

Patients with CD are a “population of interest” in terms of the clinical outcomes of COVID-19, Emad Mansoor, MD, Digestive Health Institute, University Hospitals of Cleveland, and colleagues said.

There is emerging evidence that chronic disorders may have an impact on COVID-19 outcomes. But until now, the consequences of COVID-19 in patients with CD have been unclear.

The study was published online Nov. 11, 2021, in Gut.

To investigate, Dr. Mansoor and colleagues used the TriNetX EHR database to identify 599 patients with CD and confirmed COVID-19 and 810,972 patients without CD but with confirmed COVID-19 from 51 health care organizations in the United States.

After propensity-score matching, the CD and non-CD cohorts were “relatively balanced”; there were 598 patients in each group.

Before propensity-score matching, COVID-19 patients with CD were significantly more likely to be hospitalized than peers without CD (18.2% vs. 11.3%; odds ratio, 1.74; 95% confidence interval, 1.41-2.14; P < .0001).

After matching, however, this association became insignificant (OR, 0.96; 95% CI, 0.71-1.11; P = .0906).

Before matching, patients with CD were also more apt to develop blood clots (5.3% vs. 2.1%; OR, 2.69; 95% CI, 1.88-3.83; P < .0001) but not after matching (OR, 0.938; 95% CI, 0.57-1.54; P = .800).

The same pattern was observed for the two other outcomes of interest: mortality and need for care in the ICU.

Overall, there were no significant differences among any of the measured outcomes between CD and non-CD patients with COVID-19 after propensity-score matching, Dr. Mansoor and colleagues reported.

“This is the largest study characterizing CD patients with COVID-19 to date to systematically investigate outcomes of CD patients with COVID-19,” Dr. Mansoor and colleagues wrote.

They also say that their findings are in line with a recent population-based study from Sweden, which found no significant increase in risk for hospitalization, severe COVID-19, or increase in death between CD and non-CD patients with COVID-19.

“Although reassuring, this study is all about outcomes in individuals with diagnosed CD and the potential impact of COVID-19 in patients with undiagnosed CD remains unknown,” the researchers wrote.

The study had no specific funding. The authors disclosed no relevant financial relationships.

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

Adults with celiac disease (CD) do not appear to be at increased risk of having a more severe disease course or worse outcomes from COVID-19, according to a new study.

Patients with CD are a “population of interest” in terms of the clinical outcomes of COVID-19, Emad Mansoor, MD, Digestive Health Institute, University Hospitals of Cleveland, and colleagues said.

There is emerging evidence that chronic disorders may have an impact on COVID-19 outcomes. But until now, the consequences of COVID-19 in patients with CD have been unclear.

The study was published online Nov. 11, 2021, in Gut.

To investigate, Dr. Mansoor and colleagues used the TriNetX EHR database to identify 599 patients with CD and confirmed COVID-19 and 810,972 patients without CD but with confirmed COVID-19 from 51 health care organizations in the United States.

After propensity-score matching, the CD and non-CD cohorts were “relatively balanced”; there were 598 patients in each group.

Before propensity-score matching, COVID-19 patients with CD were significantly more likely to be hospitalized than peers without CD (18.2% vs. 11.3%; odds ratio, 1.74; 95% confidence interval, 1.41-2.14; P < .0001).

After matching, however, this association became insignificant (OR, 0.96; 95% CI, 0.71-1.11; P = .0906).

Before matching, patients with CD were also more apt to develop blood clots (5.3% vs. 2.1%; OR, 2.69; 95% CI, 1.88-3.83; P < .0001) but not after matching (OR, 0.938; 95% CI, 0.57-1.54; P = .800).

The same pattern was observed for the two other outcomes of interest: mortality and need for care in the ICU.

Overall, there were no significant differences among any of the measured outcomes between CD and non-CD patients with COVID-19 after propensity-score matching, Dr. Mansoor and colleagues reported.

“This is the largest study characterizing CD patients with COVID-19 to date to systematically investigate outcomes of CD patients with COVID-19,” Dr. Mansoor and colleagues wrote.

They also say that their findings are in line with a recent population-based study from Sweden, which found no significant increase in risk for hospitalization, severe COVID-19, or increase in death between CD and non-CD patients with COVID-19.

“Although reassuring, this study is all about outcomes in individuals with diagnosed CD and the potential impact of COVID-19 in patients with undiagnosed CD remains unknown,” the researchers wrote.

The study had no specific funding. The authors disclosed no relevant financial relationships.

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

The U.S. Food and Drug Administration (FDA) has approved daratumumab + hyaluronidase-fihj (Darzalex Faspro) and carfilzomib (Kyprolis) plus dexamethasone (Kd) for patients with relapsed or refractory multiple myeloma who have had one to three prior lines of therapy.

Using the newly approved combination in this setting is a time-saver for patients and clinics, observed an investigator.

“The approval of subcutaneous daratumumab in combination with Kd will help clinicians address unmet patient needs by reducing the administration time from hours to just minutes and reducing the frequency of infusion-related reactions, as compared to the intravenous daratumumab formulation in combination with Kd,” said Ajai Chari, MD, of Mount Sinai Cancer Clinical Trials Office in New York City in a Janssen press statement.

Efficacy data for the new approval come from a single-arm cohort of PLEIADES, a multicohort, open-label trial. The cohort included 66 patients with relapsed or refractory multiple myeloma who had received one or more prior lines of therapy. Patients received daratumumab + hyaluronidase-fihj subcutaneously in combination with carfilzomib and dexamethasone.

The main efficacy outcome measure was overall response rate, which was 84.8%. At a median follow-up of 9.2 months, the median duration of response had not been reached.

The response rate with the new combination, which features a subcutaneous injection, was akin to those with the older combination, which features the more time-consuming IV administration and was FDA approved, according to the company press release.

The most common adverse reactions (≥20%) occurring in patients treated with Darzalex Faspro, Kyprolis, and dexamethasone were upper respiratory tract infections, fatigue, insomnia, hypertension, diarrhea, cough, dyspnea, headache, pyrexia, nausea, and edema peripheral.

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

The U.S. Food and Drug Administration (FDA) has approved daratumumab + hyaluronidase-fihj (Darzalex Faspro) and carfilzomib (Kyprolis) plus dexamethasone (Kd) for patients with relapsed or refractory multiple myeloma who have had one to three prior lines of therapy.

Using the newly approved combination in this setting is a time-saver for patients and clinics, observed an investigator.

“The approval of subcutaneous daratumumab in combination with Kd will help clinicians address unmet patient needs by reducing the administration time from hours to just minutes and reducing the frequency of infusion-related reactions, as compared to the intravenous daratumumab formulation in combination with Kd,” said Ajai Chari, MD, of Mount Sinai Cancer Clinical Trials Office in New York City in a Janssen press statement.

Efficacy data for the new approval come from a single-arm cohort of PLEIADES, a multicohort, open-label trial. The cohort included 66 patients with relapsed or refractory multiple myeloma who had received one or more prior lines of therapy. Patients received daratumumab + hyaluronidase-fihj subcutaneously in combination with carfilzomib and dexamethasone.

The main efficacy outcome measure was overall response rate, which was 84.8%. At a median follow-up of 9.2 months, the median duration of response had not been reached.

The response rate with the new combination, which features a subcutaneous injection, was akin to those with the older combination, which features the more time-consuming IV administration and was FDA approved, according to the company press release.

The most common adverse reactions (≥20%) occurring in patients treated with Darzalex Faspro, Kyprolis, and dexamethasone were upper respiratory tract infections, fatigue, insomnia, hypertension, diarrhea, cough, dyspnea, headache, pyrexia, nausea, and edema peripheral.

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

The U.S. Food and Drug Administration (FDA) has approved daratumumab + hyaluronidase-fihj (Darzalex Faspro) and carfilzomib (Kyprolis) plus dexamethasone (Kd) for patients with relapsed or refractory multiple myeloma who have had one to three prior lines of therapy.

Using the newly approved combination in this setting is a time-saver for patients and clinics, observed an investigator.

“The approval of subcutaneous daratumumab in combination with Kd will help clinicians address unmet patient needs by reducing the administration time from hours to just minutes and reducing the frequency of infusion-related reactions, as compared to the intravenous daratumumab formulation in combination with Kd,” said Ajai Chari, MD, of Mount Sinai Cancer Clinical Trials Office in New York City in a Janssen press statement.

Efficacy data for the new approval come from a single-arm cohort of PLEIADES, a multicohort, open-label trial. The cohort included 66 patients with relapsed or refractory multiple myeloma who had received one or more prior lines of therapy. Patients received daratumumab + hyaluronidase-fihj subcutaneously in combination with carfilzomib and dexamethasone.

The main efficacy outcome measure was overall response rate, which was 84.8%. At a median follow-up of 9.2 months, the median duration of response had not been reached.

The response rate with the new combination, which features a subcutaneous injection, was akin to those with the older combination, which features the more time-consuming IV administration and was FDA approved, according to the company press release.

The most common adverse reactions (≥20%) occurring in patients treated with Darzalex Faspro, Kyprolis, and dexamethasone were upper respiratory tract infections, fatigue, insomnia, hypertension, diarrhea, cough, dyspnea, headache, pyrexia, nausea, and edema peripheral.

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

Not that long ago, a man in his mid-20s whom Morgan Farrington calls Kiddo showed up at her house with a fever, chills, and nausea. He was increasingly out of it. These were all signs of an abscess from missing a vein and using someone else’s syringe, said Farrington, founder of Goodworks, in Huntsville, Alabama.

But it wasn’t just an abscess. It was four blood clots and sepsis. He’d been craving his next fix of heroin so hard, and the relief that comes from the act of shooting up itself, that he’d dug a 3-day-old blood shot – a used syringe with someone else’s blood in it – out of the garbage and had used it.

“He was almost dead,” said Farrington. “Another day, maybe two, he would have been dead, for sure, for sure.”

Farrington gets it. She has her own history of injection drug use. She knows the compulsion to, in her words, “shoot up sugar water just to get a hit.” And that’s fine, she said. “I just wish that he would do so with his own safety in mind.”

So when he got out of the hospital a few weeks later, Farrington talked to him about not just clean syringes but also HIV pre-exposure prophylaxis (PrEP), the daily HIV prevention pills that have been found to be up to 84% protective against HIV in people who inject drugs. Both approaches – syringe services and PrEP – play a key role in the president’s new National HIV/AIDS Strategy. The strategy calls for expanding access to both services in traditional and nontraditional settings but doesn’t include mechanisms for that to happen.

Of the 1.2 million people in the U.S. who could benefit from PrEP, according to the Centers for Disease Control and Prevention, 23% are using it. But according to data published in 2020, just 0% and 5% of people who inject drugs who could benefit are using it. And most, like the guy Farrington continues to talk to, don’t even know it exists.
 

People who inject drugs are willing, clinicians may not be

Clinicians have a role to play, but right now, many clinicians act as gatekeepers, picking and choosing whom they’ll offer PrEP to. In 2014, just 1% of PrEP prescribers said they had prescribed the prevention pill to people who inject drugs. And recent data published in AIDS and Behavior showed that clinicians who expressed negative attitudes about people who injected drugs were less likely to offer to prescribe PrEP to a theoretical man who injected drugs asking for PrEP. There was a paradox in there, however: Clinicians were also more likely to think men who inject drugs were at high risk for acquiring HIV. But they also believed those men would be less likely to adhere, less safety conscious, and less responsible than gay and bisexual men. So, the investigators found that despite need, clinicians were more likely to prescribe to men at risk via sex than men at risk via injection drug use.

According to the CDC, to qualify for PrEP, the only requirements for people who inject drugs are testing negative for HIV and not sharing injection equipment – whether their injecting partners have confirmed HIV or whether their HIV status is unknown.

“As long as PrEP is a prescription, medication providers are really going to determine who accesses PrEP and who does not,” said study lead author Sarah Calabrese, PhD, assistant professor of psychiatry at George Washington University. “Even if you do anticipate that a patient might have adherence struggles. The solution is not withholding something that could be beneficial to them. The solution is supporting them to take that beneficial medication.”

And it appears that providers and regular people like Farrington have stepped into the access vacuum, with a decidedly harm-reduction approach: syringe services programs. While there’s no national data on how many people receive PrEP through needle exchange programs, those programs are the natural place to offer other health care services, said Hansel Tookes, MD, assistant professor of medicine at the University of Miami and founder of the Infectious Disease Elimination Act (IDEA) Syringe Exchange program and clinic. At the clinic, 80% of the people living with HIV have undetectable viral loads – a sign of good adherence to medication and general health. Previous research suggests that when people who inject drugs find out about PrEP, 57% are game for trying it. But early work suggests that people who inject drugs might need to access PrEP in a different way from other people who use PrEP.

Dr. Tookes is currently conducting a study looking at whether referring people who inject drugs out from needle exchanges to PrEP prescribers is as effective as offering it on site at the exchanges.

“My experience in the past 5 years of being faculty at the university and being a cofounder of a program like IDEA is that we really, if we’re going to be successful with engaging people who inject drugs in things like PrEP, we have to, like all things harm reduction, meet them where they’re at, both physically and mentally, and on their own terms,” said Dr. Tookes. “What better place than a syringe services program?”
 

Where people are: the exchanges

That’s where community health worker Farrington and others come in. More than 400 syringe access programs that exist in North America have PrEP programs, according to the North American Syringe Exchange Network (NASEN), and 86 of them report offering access to PrEP, either directly or through referrals. It’s an HIV prevention one-two punch: PrEP protects a person once they are exposed to HIV, and needle exchanges themselves reduce HIV transmission rates by reducing the odds that people will engage in behavior that exposes them to the virus in the first place.

So far, PrEP access for people who inject drugs looks different everywhere. At Las Vegas’ Huntridge Family Clinic, people can come to the lobby and pick up clean supplies from a syringe exchange vending machine, and while they’re there, talk to nurse practitioner Rob Phoenix, MSN, APRN, about HIV prevention.

In Cincinnati, where Adam Reilly, CDCA, runs a Ryan White–funded PrEP program out of the nonprofit Caracole, PrEP navigators go out with the syringe services vans run by the county health department and can connect them with providers willing to prescribe it. In Alabama, where needle exchanges are illegal, Farrington works as a community health worker through the North Alabama Area Health Education Center to go in to Huntsville’s legal tent cities to offer HIV and hepatitis C testing and tell them about PrEP. In Philadelphia, Drexel University, the city Department of Health, and Prevention Point Philadelphia co-offer PrEP through Prevention Point, which increased the number of people who inject drugs taking PrEP from just two to three a year to 584 times in 2021, according to Andres Freire, director of harm reduction health services at Prevention Point Philadelphia.

“Co-locating a PrEP clinic with our syringe-services program is the most effective means of delivering care to people who use drugs,” he said. “It is a friendly, nonstigmatizing place, as well as a place where individuals are already coming for services.”

At Dr. Tookes’ IDEA clinic and its PrEP study, people who inject drugs can not only get clean supplies, they can get a PrEP prescription on site and store their medications at the exchange so they don’t get stolen or used by others. And that idea didn’t come from him.

“It was one of my patients,” he said. “That person gave me an idea that impacted the health of hundreds of people in Miami.”

Indeed, Boston Health Care for the Homeless Program does the same. New data showed that what really worked for people who injected drugs in the group was not just medication storage on site but also PrEP prescriptions that lasted just a week at a time, or even same-day prescribing, as well as the program’s PrEP nurses showing up in person to their communities. That program managed to get PrEP referrals to 239 people, 152 of whom started taking PrEP. Six months later, 22 people were still using it.

But Dr. Tookes’s is a rare study on PrEP among people who inject drugs. The only data so far on the efficacy of PrEP for this group come from a 2013 study out of Thailand. Angela Bazzi, PhD, an associate professor of family medicine and public health at the University of California, San Diego, who studied the Boston program, said the dearth of research into effective ways of getting PrEP to people who inject drugs is fueling a negative feedback loop, where people who inject drugs and their providers largely don’t know about the HIV prevention pills, don’t see research on it, and therefore think it won’t work in people who inject drugs.

“There’s been a systematic exclusion of people who inject drugs from HIV prevention drug trials,” Dr. Bazzi told this news organization. Together with colleagues she wrote a viewpoint on the issue that was published in the International Journal of Drug Policy. “It really extends into effectiveness research, public health research, and clinical practice. We argued that the stigma surrounding addiction is the key driver of this.”

This is especially important, she said, because the U.S. Food and Drug Administration had been expected to make an approval decision on an injectable form of PrEP by Jan. 2021. That drug, cabotegravir, has been found to work for a month at a time. Injection drug users were excluded from the primary clinical trial of that drug, though a ViiV Healthcare spokesperson said the company is planning an after-market study in people who inject drugs some time in the future.
 

An incomplete solution

But syringe services aren’t enough, said Mr. Reilly. For one thing, public funding of PrEP programs can limit things like where navigators can send people. For instance, in Ohio, Mr. Reilly’s team can cover the costs of PrEP for people who inject drugs – but only with certain providers. State law prohibits them from contracting with Planned Parenthood.

Also, syringe services aren’t available everywhere. In Pennsylvania, where syringe services are legal only in the counties containing Philadelphia and Pittsburgh, the state’s two large cities, funding for basic syringe services precludes expanding services to offer PrEP.

“A lot of our focus has to stay with making sure our folks have access to the harm-reduction supplies they need, because the number of people we are seeing has grown exponentially during the pandemic,” said Katie Houston, a coordinator for Prevention Point Pittsburgh, which tries to address its clients’s PrEP needs by holding syringe-services distribution at a local clinic that provides PrEP. “Getting funding for our core supplies like syringes, crack pipes, and the works is extremely difficult because many grants/foundations don’t want to fund these supplies. And with the growing number of SSPs, the funding that has been available is being spread thin.”

And that means that traditional clinicians still have an important role to play, said Mr. Reilly.

“Syringe services programs are supposed to now provide treatment for hepatitis C and make sure people get on PrEP?” he said. “That seems like medical providers’s job.”

As for Farrington, operating as a solo health worker without the benefit of exchanges to help people like the young man who came to her house that night, she’ll keep going in to tent city and inviting sick people who inject drugs into her home to offer them what she can. She can’t legally offer syringe services. But she can keep checking in on people and offering them the help that’s available.

Recently, she saw that young man again. He was in a better place. He had found a place to live for the winter, so he wouldn’t have to stay in the hammock in someone’s yard when the temperatures dipped. And that was going a long way to stabilize everything else in his life. He’s still shooting up, she said, but having housing is making it easier for him to moderate his use. As for PrEP, he hasn’t started on that, either. But Farrington hasn’t given up hope.

“Not yet,” she said.

Dr. Tookes reports receiving research funding from Gilead Sciences. Dr. Calabrese reports receiving conference travel funding from Gilead Sciences. Farrington, Dr. Bazzi, Ms. Houston, Mr. Freire, and Mr. Reilly reported no relevant financial relationships.

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

Not that long ago, a man in his mid-20s whom Morgan Farrington calls Kiddo showed up at her house with a fever, chills, and nausea. He was increasingly out of it. These were all signs of an abscess from missing a vein and using someone else’s syringe, said Farrington, founder of Goodworks, in Huntsville, Alabama.

But it wasn’t just an abscess. It was four blood clots and sepsis. He’d been craving his next fix of heroin so hard, and the relief that comes from the act of shooting up itself, that he’d dug a 3-day-old blood shot – a used syringe with someone else’s blood in it – out of the garbage and had used it.

“He was almost dead,” said Farrington. “Another day, maybe two, he would have been dead, for sure, for sure.”

Farrington gets it. She has her own history of injection drug use. She knows the compulsion to, in her words, “shoot up sugar water just to get a hit.” And that’s fine, she said. “I just wish that he would do so with his own safety in mind.”

So when he got out of the hospital a few weeks later, Farrington talked to him about not just clean syringes but also HIV pre-exposure prophylaxis (PrEP), the daily HIV prevention pills that have been found to be up to 84% protective against HIV in people who inject drugs. Both approaches – syringe services and PrEP – play a key role in the president’s new National HIV/AIDS Strategy. The strategy calls for expanding access to both services in traditional and nontraditional settings but doesn’t include mechanisms for that to happen.

Of the 1.2 million people in the U.S. who could benefit from PrEP, according to the Centers for Disease Control and Prevention, 23% are using it. But according to data published in 2020, just 0% and 5% of people who inject drugs who could benefit are using it. And most, like the guy Farrington continues to talk to, don’t even know it exists.
 

People who inject drugs are willing, clinicians may not be

Clinicians have a role to play, but right now, many clinicians act as gatekeepers, picking and choosing whom they’ll offer PrEP to. In 2014, just 1% of PrEP prescribers said they had prescribed the prevention pill to people who inject drugs. And recent data published in AIDS and Behavior showed that clinicians who expressed negative attitudes about people who injected drugs were less likely to offer to prescribe PrEP to a theoretical man who injected drugs asking for PrEP. There was a paradox in there, however: Clinicians were also more likely to think men who inject drugs were at high risk for acquiring HIV. But they also believed those men would be less likely to adhere, less safety conscious, and less responsible than gay and bisexual men. So, the investigators found that despite need, clinicians were more likely to prescribe to men at risk via sex than men at risk via injection drug use.

According to the CDC, to qualify for PrEP, the only requirements for people who inject drugs are testing negative for HIV and not sharing injection equipment – whether their injecting partners have confirmed HIV or whether their HIV status is unknown.

“As long as PrEP is a prescription, medication providers are really going to determine who accesses PrEP and who does not,” said study lead author Sarah Calabrese, PhD, assistant professor of psychiatry at George Washington University. “Even if you do anticipate that a patient might have adherence struggles. The solution is not withholding something that could be beneficial to them. The solution is supporting them to take that beneficial medication.”

And it appears that providers and regular people like Farrington have stepped into the access vacuum, with a decidedly harm-reduction approach: syringe services programs. While there’s no national data on how many people receive PrEP through needle exchange programs, those programs are the natural place to offer other health care services, said Hansel Tookes, MD, assistant professor of medicine at the University of Miami and founder of the Infectious Disease Elimination Act (IDEA) Syringe Exchange program and clinic. At the clinic, 80% of the people living with HIV have undetectable viral loads – a sign of good adherence to medication and general health. Previous research suggests that when people who inject drugs find out about PrEP, 57% are game for trying it. But early work suggests that people who inject drugs might need to access PrEP in a different way from other people who use PrEP.

Dr. Tookes is currently conducting a study looking at whether referring people who inject drugs out from needle exchanges to PrEP prescribers is as effective as offering it on site at the exchanges.

“My experience in the past 5 years of being faculty at the university and being a cofounder of a program like IDEA is that we really, if we’re going to be successful with engaging people who inject drugs in things like PrEP, we have to, like all things harm reduction, meet them where they’re at, both physically and mentally, and on their own terms,” said Dr. Tookes. “What better place than a syringe services program?”
 

Where people are: the exchanges

That’s where community health worker Farrington and others come in. More than 400 syringe access programs that exist in North America have PrEP programs, according to the North American Syringe Exchange Network (NASEN), and 86 of them report offering access to PrEP, either directly or through referrals. It’s an HIV prevention one-two punch: PrEP protects a person once they are exposed to HIV, and needle exchanges themselves reduce HIV transmission rates by reducing the odds that people will engage in behavior that exposes them to the virus in the first place.

So far, PrEP access for people who inject drugs looks different everywhere. At Las Vegas’ Huntridge Family Clinic, people can come to the lobby and pick up clean supplies from a syringe exchange vending machine, and while they’re there, talk to nurse practitioner Rob Phoenix, MSN, APRN, about HIV prevention.

In Cincinnati, where Adam Reilly, CDCA, runs a Ryan White–funded PrEP program out of the nonprofit Caracole, PrEP navigators go out with the syringe services vans run by the county health department and can connect them with providers willing to prescribe it. In Alabama, where needle exchanges are illegal, Farrington works as a community health worker through the North Alabama Area Health Education Center to go in to Huntsville’s legal tent cities to offer HIV and hepatitis C testing and tell them about PrEP. In Philadelphia, Drexel University, the city Department of Health, and Prevention Point Philadelphia co-offer PrEP through Prevention Point, which increased the number of people who inject drugs taking PrEP from just two to three a year to 584 times in 2021, according to Andres Freire, director of harm reduction health services at Prevention Point Philadelphia.

“Co-locating a PrEP clinic with our syringe-services program is the most effective means of delivering care to people who use drugs,” he said. “It is a friendly, nonstigmatizing place, as well as a place where individuals are already coming for services.”

At Dr. Tookes’ IDEA clinic and its PrEP study, people who inject drugs can not only get clean supplies, they can get a PrEP prescription on site and store their medications at the exchange so they don’t get stolen or used by others. And that idea didn’t come from him.

“It was one of my patients,” he said. “That person gave me an idea that impacted the health of hundreds of people in Miami.”

Indeed, Boston Health Care for the Homeless Program does the same. New data showed that what really worked for people who injected drugs in the group was not just medication storage on site but also PrEP prescriptions that lasted just a week at a time, or even same-day prescribing, as well as the program’s PrEP nurses showing up in person to their communities. That program managed to get PrEP referrals to 239 people, 152 of whom started taking PrEP. Six months later, 22 people were still using it.

But Dr. Tookes’s is a rare study on PrEP among people who inject drugs. The only data so far on the efficacy of PrEP for this group come from a 2013 study out of Thailand. Angela Bazzi, PhD, an associate professor of family medicine and public health at the University of California, San Diego, who studied the Boston program, said the dearth of research into effective ways of getting PrEP to people who inject drugs is fueling a negative feedback loop, where people who inject drugs and their providers largely don’t know about the HIV prevention pills, don’t see research on it, and therefore think it won’t work in people who inject drugs.

“There’s been a systematic exclusion of people who inject drugs from HIV prevention drug trials,” Dr. Bazzi told this news organization. Together with colleagues she wrote a viewpoint on the issue that was published in the International Journal of Drug Policy. “It really extends into effectiveness research, public health research, and clinical practice. We argued that the stigma surrounding addiction is the key driver of this.”

This is especially important, she said, because the U.S. Food and Drug Administration had been expected to make an approval decision on an injectable form of PrEP by Jan. 2021. That drug, cabotegravir, has been found to work for a month at a time. Injection drug users were excluded from the primary clinical trial of that drug, though a ViiV Healthcare spokesperson said the company is planning an after-market study in people who inject drugs some time in the future.
 

An incomplete solution

But syringe services aren’t enough, said Mr. Reilly. For one thing, public funding of PrEP programs can limit things like where navigators can send people. For instance, in Ohio, Mr. Reilly’s team can cover the costs of PrEP for people who inject drugs – but only with certain providers. State law prohibits them from contracting with Planned Parenthood.

Also, syringe services aren’t available everywhere. In Pennsylvania, where syringe services are legal only in the counties containing Philadelphia and Pittsburgh, the state’s two large cities, funding for basic syringe services precludes expanding services to offer PrEP.

“A lot of our focus has to stay with making sure our folks have access to the harm-reduction supplies they need, because the number of people we are seeing has grown exponentially during the pandemic,” said Katie Houston, a coordinator for Prevention Point Pittsburgh, which tries to address its clients’s PrEP needs by holding syringe-services distribution at a local clinic that provides PrEP. “Getting funding for our core supplies like syringes, crack pipes, and the works is extremely difficult because many grants/foundations don’t want to fund these supplies. And with the growing number of SSPs, the funding that has been available is being spread thin.”

And that means that traditional clinicians still have an important role to play, said Mr. Reilly.

“Syringe services programs are supposed to now provide treatment for hepatitis C and make sure people get on PrEP?” he said. “That seems like medical providers’s job.”

As for Farrington, operating as a solo health worker without the benefit of exchanges to help people like the young man who came to her house that night, she’ll keep going in to tent city and inviting sick people who inject drugs into her home to offer them what she can. She can’t legally offer syringe services. But she can keep checking in on people and offering them the help that’s available.

Recently, she saw that young man again. He was in a better place. He had found a place to live for the winter, so he wouldn’t have to stay in the hammock in someone’s yard when the temperatures dipped. And that was going a long way to stabilize everything else in his life. He’s still shooting up, she said, but having housing is making it easier for him to moderate his use. As for PrEP, he hasn’t started on that, either. But Farrington hasn’t given up hope.

“Not yet,” she said.

Dr. Tookes reports receiving research funding from Gilead Sciences. Dr. Calabrese reports receiving conference travel funding from Gilead Sciences. Farrington, Dr. Bazzi, Ms. Houston, Mr. Freire, and Mr. Reilly reported no relevant financial relationships.

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

Not that long ago, a man in his mid-20s whom Morgan Farrington calls Kiddo showed up at her house with a fever, chills, and nausea. He was increasingly out of it. These were all signs of an abscess from missing a vein and using someone else’s syringe, said Farrington, founder of Goodworks, in Huntsville, Alabama.

But it wasn’t just an abscess. It was four blood clots and sepsis. He’d been craving his next fix of heroin so hard, and the relief that comes from the act of shooting up itself, that he’d dug a 3-day-old blood shot – a used syringe with someone else’s blood in it – out of the garbage and had used it.

“He was almost dead,” said Farrington. “Another day, maybe two, he would have been dead, for sure, for sure.”

Farrington gets it. She has her own history of injection drug use. She knows the compulsion to, in her words, “shoot up sugar water just to get a hit.” And that’s fine, she said. “I just wish that he would do so with his own safety in mind.”

So when he got out of the hospital a few weeks later, Farrington talked to him about not just clean syringes but also HIV pre-exposure prophylaxis (PrEP), the daily HIV prevention pills that have been found to be up to 84% protective against HIV in people who inject drugs. Both approaches – syringe services and PrEP – play a key role in the president’s new National HIV/AIDS Strategy. The strategy calls for expanding access to both services in traditional and nontraditional settings but doesn’t include mechanisms for that to happen.

Of the 1.2 million people in the U.S. who could benefit from PrEP, according to the Centers for Disease Control and Prevention, 23% are using it. But according to data published in 2020, just 0% and 5% of people who inject drugs who could benefit are using it. And most, like the guy Farrington continues to talk to, don’t even know it exists.
 

People who inject drugs are willing, clinicians may not be

Clinicians have a role to play, but right now, many clinicians act as gatekeepers, picking and choosing whom they’ll offer PrEP to. In 2014, just 1% of PrEP prescribers said they had prescribed the prevention pill to people who inject drugs. And recent data published in AIDS and Behavior showed that clinicians who expressed negative attitudes about people who injected drugs were less likely to offer to prescribe PrEP to a theoretical man who injected drugs asking for PrEP. There was a paradox in there, however: Clinicians were also more likely to think men who inject drugs were at high risk for acquiring HIV. But they also believed those men would be less likely to adhere, less safety conscious, and less responsible than gay and bisexual men. So, the investigators found that despite need, clinicians were more likely to prescribe to men at risk via sex than men at risk via injection drug use.

According to the CDC, to qualify for PrEP, the only requirements for people who inject drugs are testing negative for HIV and not sharing injection equipment – whether their injecting partners have confirmed HIV or whether their HIV status is unknown.

“As long as PrEP is a prescription, medication providers are really going to determine who accesses PrEP and who does not,” said study lead author Sarah Calabrese, PhD, assistant professor of psychiatry at George Washington University. “Even if you do anticipate that a patient might have adherence struggles. The solution is not withholding something that could be beneficial to them. The solution is supporting them to take that beneficial medication.”

And it appears that providers and regular people like Farrington have stepped into the access vacuum, with a decidedly harm-reduction approach: syringe services programs. While there’s no national data on how many people receive PrEP through needle exchange programs, those programs are the natural place to offer other health care services, said Hansel Tookes, MD, assistant professor of medicine at the University of Miami and founder of the Infectious Disease Elimination Act (IDEA) Syringe Exchange program and clinic. At the clinic, 80% of the people living with HIV have undetectable viral loads – a sign of good adherence to medication and general health. Previous research suggests that when people who inject drugs find out about PrEP, 57% are game for trying it. But early work suggests that people who inject drugs might need to access PrEP in a different way from other people who use PrEP.

Dr. Tookes is currently conducting a study looking at whether referring people who inject drugs out from needle exchanges to PrEP prescribers is as effective as offering it on site at the exchanges.

“My experience in the past 5 years of being faculty at the university and being a cofounder of a program like IDEA is that we really, if we’re going to be successful with engaging people who inject drugs in things like PrEP, we have to, like all things harm reduction, meet them where they’re at, both physically and mentally, and on their own terms,” said Dr. Tookes. “What better place than a syringe services program?”
 

Where people are: the exchanges

That’s where community health worker Farrington and others come in. More than 400 syringe access programs that exist in North America have PrEP programs, according to the North American Syringe Exchange Network (NASEN), and 86 of them report offering access to PrEP, either directly or through referrals. It’s an HIV prevention one-two punch: PrEP protects a person once they are exposed to HIV, and needle exchanges themselves reduce HIV transmission rates by reducing the odds that people will engage in behavior that exposes them to the virus in the first place.

So far, PrEP access for people who inject drugs looks different everywhere. At Las Vegas’ Huntridge Family Clinic, people can come to the lobby and pick up clean supplies from a syringe exchange vending machine, and while they’re there, talk to nurse practitioner Rob Phoenix, MSN, APRN, about HIV prevention.

In Cincinnati, where Adam Reilly, CDCA, runs a Ryan White–funded PrEP program out of the nonprofit Caracole, PrEP navigators go out with the syringe services vans run by the county health department and can connect them with providers willing to prescribe it. In Alabama, where needle exchanges are illegal, Farrington works as a community health worker through the North Alabama Area Health Education Center to go in to Huntsville’s legal tent cities to offer HIV and hepatitis C testing and tell them about PrEP. In Philadelphia, Drexel University, the city Department of Health, and Prevention Point Philadelphia co-offer PrEP through Prevention Point, which increased the number of people who inject drugs taking PrEP from just two to three a year to 584 times in 2021, according to Andres Freire, director of harm reduction health services at Prevention Point Philadelphia.

“Co-locating a PrEP clinic with our syringe-services program is the most effective means of delivering care to people who use drugs,” he said. “It is a friendly, nonstigmatizing place, as well as a place where individuals are already coming for services.”

At Dr. Tookes’ IDEA clinic and its PrEP study, people who inject drugs can not only get clean supplies, they can get a PrEP prescription on site and store their medications at the exchange so they don’t get stolen or used by others. And that idea didn’t come from him.

“It was one of my patients,” he said. “That person gave me an idea that impacted the health of hundreds of people in Miami.”

Indeed, Boston Health Care for the Homeless Program does the same. New data showed that what really worked for people who injected drugs in the group was not just medication storage on site but also PrEP prescriptions that lasted just a week at a time, or even same-day prescribing, as well as the program’s PrEP nurses showing up in person to their communities. That program managed to get PrEP referrals to 239 people, 152 of whom started taking PrEP. Six months later, 22 people were still using it.

But Dr. Tookes’s is a rare study on PrEP among people who inject drugs. The only data so far on the efficacy of PrEP for this group come from a 2013 study out of Thailand. Angela Bazzi, PhD, an associate professor of family medicine and public health at the University of California, San Diego, who studied the Boston program, said the dearth of research into effective ways of getting PrEP to people who inject drugs is fueling a negative feedback loop, where people who inject drugs and their providers largely don’t know about the HIV prevention pills, don’t see research on it, and therefore think it won’t work in people who inject drugs.

“There’s been a systematic exclusion of people who inject drugs from HIV prevention drug trials,” Dr. Bazzi told this news organization. Together with colleagues she wrote a viewpoint on the issue that was published in the International Journal of Drug Policy. “It really extends into effectiveness research, public health research, and clinical practice. We argued that the stigma surrounding addiction is the key driver of this.”

This is especially important, she said, because the U.S. Food and Drug Administration had been expected to make an approval decision on an injectable form of PrEP by Jan. 2021. That drug, cabotegravir, has been found to work for a month at a time. Injection drug users were excluded from the primary clinical trial of that drug, though a ViiV Healthcare spokesperson said the company is planning an after-market study in people who inject drugs some time in the future.
 

An incomplete solution

But syringe services aren’t enough, said Mr. Reilly. For one thing, public funding of PrEP programs can limit things like where navigators can send people. For instance, in Ohio, Mr. Reilly’s team can cover the costs of PrEP for people who inject drugs – but only with certain providers. State law prohibits them from contracting with Planned Parenthood.

Also, syringe services aren’t available everywhere. In Pennsylvania, where syringe services are legal only in the counties containing Philadelphia and Pittsburgh, the state’s two large cities, funding for basic syringe services precludes expanding services to offer PrEP.

“A lot of our focus has to stay with making sure our folks have access to the harm-reduction supplies they need, because the number of people we are seeing has grown exponentially during the pandemic,” said Katie Houston, a coordinator for Prevention Point Pittsburgh, which tries to address its clients’s PrEP needs by holding syringe-services distribution at a local clinic that provides PrEP. “Getting funding for our core supplies like syringes, crack pipes, and the works is extremely difficult because many grants/foundations don’t want to fund these supplies. And with the growing number of SSPs, the funding that has been available is being spread thin.”

And that means that traditional clinicians still have an important role to play, said Mr. Reilly.

“Syringe services programs are supposed to now provide treatment for hepatitis C and make sure people get on PrEP?” he said. “That seems like medical providers’s job.”

As for Farrington, operating as a solo health worker without the benefit of exchanges to help people like the young man who came to her house that night, she’ll keep going in to tent city and inviting sick people who inject drugs into her home to offer them what she can. She can’t legally offer syringe services. But she can keep checking in on people and offering them the help that’s available.

Recently, she saw that young man again. He was in a better place. He had found a place to live for the winter, so he wouldn’t have to stay in the hammock in someone’s yard when the temperatures dipped. And that was going a long way to stabilize everything else in his life. He’s still shooting up, she said, but having housing is making it easier for him to moderate his use. As for PrEP, he hasn’t started on that, either. But Farrington hasn’t given up hope.

“Not yet,” she said.

Dr. Tookes reports receiving research funding from Gilead Sciences. Dr. Calabrese reports receiving conference travel funding from Gilead Sciences. Farrington, Dr. Bazzi, Ms. Houston, Mr. Freire, and Mr. Reilly reported no relevant financial relationships.

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

Background: TXA is an anti-fibrinolytic agent that decreases surgical bleeding and reduces death resulting from bleeding in trauma and postpartum hemorrhage. A 2012 Cochrane review suggested a reduction in mortality with use of TXA in patients with GI bleed, but previous trials were small with a high risk of bias.

There was an increase in venous thromboembolism (VTE; deep vein thrombosis or pulmonary embolism) in the TXA group versus the placebo group (0.8% with TXA and 0.4% with placebo; RR, 1.85; 95% CI, 1.15-2.98), as well as an increase in seizure events (0.6% with TXA and 0.4% with placebo; RR, 1.73; 95% CI, 1.03–2.93).

Bottom line: TXA did not reduce mortality risk in patients with upper or lower GI bleeding and should not be used in the routine management of GI bleed.

Citation: Roberts I et al. Effects of a high-dose 24-h infusion of tranexamic acid on death and thromboembolic events in patients with acute gastrointestinal bleeding (HALT-IT): an international randomised, double-blind, placebo-controlled trial. Lancet. 2020;395(10241):1927-1936. doi: 10.1016/S0140-6736(20)30848-5.

Dr. Chung is a hospitalist in the Division of Hospital Medicine, Mount Sinai Health System, New York.

Background: TXA is an anti-fibrinolytic agent that decreases surgical bleeding and reduces death resulting from bleeding in trauma and postpartum hemorrhage. A 2012 Cochrane review suggested a reduction in mortality with use of TXA in patients with GI bleed, but previous trials were small with a high risk of bias.

There was an increase in venous thromboembolism (VTE; deep vein thrombosis or pulmonary embolism) in the TXA group versus the placebo group (0.8% with TXA and 0.4% with placebo; RR, 1.85; 95% CI, 1.15-2.98), as well as an increase in seizure events (0.6% with TXA and 0.4% with placebo; RR, 1.73; 95% CI, 1.03–2.93).

Bottom line: TXA did not reduce mortality risk in patients with upper or lower GI bleeding and should not be used in the routine management of GI bleed.

Citation: Roberts I et al. Effects of a high-dose 24-h infusion of tranexamic acid on death and thromboembolic events in patients with acute gastrointestinal bleeding (HALT-IT): an international randomised, double-blind, placebo-controlled trial. Lancet. 2020;395(10241):1927-1936. doi: 10.1016/S0140-6736(20)30848-5.

Dr. Chung is a hospitalist in the Division of Hospital Medicine, Mount Sinai Health System, New York.

Background: TXA is an anti-fibrinolytic agent that decreases surgical bleeding and reduces death resulting from bleeding in trauma and postpartum hemorrhage. A 2012 Cochrane review suggested a reduction in mortality with use of TXA in patients with GI bleed, but previous trials were small with a high risk of bias.

There was an increase in venous thromboembolism (VTE; deep vein thrombosis or pulmonary embolism) in the TXA group versus the placebo group (0.8% with TXA and 0.4% with placebo; RR, 1.85; 95% CI, 1.15-2.98), as well as an increase in seizure events (0.6% with TXA and 0.4% with placebo; RR, 1.73; 95% CI, 1.03–2.93).

Bottom line: TXA did not reduce mortality risk in patients with upper or lower GI bleeding and should not be used in the routine management of GI bleed.

Citation: Roberts I et al. Effects of a high-dose 24-h infusion of tranexamic acid on death and thromboembolic events in patients with acute gastrointestinal bleeding (HALT-IT): an international randomised, double-blind, placebo-controlled trial. Lancet. 2020;395(10241):1927-1936. doi: 10.1016/S0140-6736(20)30848-5.

Dr. Chung is a hospitalist in the Division of Hospital Medicine, Mount Sinai Health System, New York.

The risk of bullying and teasing is higher in children and young people with poorer asthma control, an international study reported. Published online in the Archives of Disease in Childhood, the Room to Breathe survey of 943 children in six countries found 9.9% had experienced asthma-related bullying or teasing (n = 93).

Children with well-controlled disease, however, were less likely to report being victimized by asthma-related bullying/teasing: odds ratio, 0.51; 95% confidence interval, 0.23-0.84; P = .006).

“It’s important for pediatricians to recognize that children and young people with asthma commonly report bullying or teasing as a result of their condition,” Will Carroll, MD, of the Paediatric Respiratory Service at Staffordshire Children’s Hospital at Royal Stoke, Stoke-on-Trent, England, told this news organization. “Pediatricians should talk to children themselves with asthma about this and not just their parents, and efforts should be made to improve asthma control whenever possible.”

Though common and potentially long-lasting in its effects, bullying is rarely addressed by health care professionals, the U.K. authors said.

But things may differ in the United States. According to Mark Welles, MD, a pediatrician at Cohen Children’s Medical Center at Northwell Health in Queen’s, N.Y., and regional cochair of the American Academy of Pediatrics antibullying committee, young doctors here are trained to ask about bullying when seeing a child, no matter what the reason for the visit. “It’s important to build a rapport with the child, and you need to ask about the disease they may have but also generally ask, ‘How are things at school? Is everyone nice to you?’ It is becoming more common practice to ask this,” said Dr. Welles, who was not involved with the U.K. research.

The U.K. study drew on unpublished data from the Room to Breathe survey conducted by Dr. Carroll’s group during 2008-2009 in Canada, the United Kingdom, Greece, Hungary, South Africa, and the Netherlands. Only 358 of 930 (38.5%) children were found to be well controlled according to current Global Initiative for Asthma symptom-control criteria.

The analysis also found a highly significant association (P < .0001) between Childhood Asthma Control Test (C-ACT) score and reported bullying/teasing, with bullied children having lower scores. C-ACT–defined controlled asthma scores of 20 or higher were significantly associated with a lower risk of bullying (OR, 0.46; 95% CI, 0.28-0.76; P = .001).

In other study findings, harassment was more common in children whose asthma was serious enough to entail activity restriction (OR, 1.74; 95% CI, 1.11-2.75; P = .010) and who described their asthma as “bad” (OR, 3.02; 95% CI, 1.86-4.85; P < .001), as well as those whose parents reported ongoing asthma-related health worries (OR, 1.64; 95% CI, 1.04-2.58; P = .024).

“When a child is clearly different from others, such as having bad asthma or being limited in activities due to asthma, they stand out more and are more frequently bullied,” said Tracy Evian Waasdorp, PhD, MSEd, director of research for school-based bullying and social-emotional learning at Children’s Hospital of Philadelphia, and also not a participant in the U.K. study.

In contrast to the 10% bullying rate in Dr. Carroll’s study, Dr. Waasdorp referred to a CHOP analysis of more than 64,000 youth from a Northeastern state in which those with asthma were 40% more likely to be victims of in-person bullying and 70% were more likely to be cyberbullied than youth without asthma. “Having a medical condition can therefore put you at risk of being bullied regardless of what country you live in,” she said.

CHOP policy encourages practitioners to routinely ask about bullying and to provide handouts and resources for parents, she added.

Interestingly, the U.K. investigators found that open public use of spacers was not associated with asthma-related bullying, nor was parental worry at diagnosis or parental concern about steroid use.

But according to Dr. Welles, “Kids may be using the inhaler in front of other kids, and they may be embarrassed and not want to be seen as different. So they may not use the inhaler when needed for gym class or sports, forcing them to sit out and then potentially be bullied again. It’s a vicious cycle.”

Previous research has identified the bullying and teasing of children with food allergies.

Behaviors have included allergy-specific harassment such as smearing peanut butter on a youngster’s forehead or putting peanut butter cookie crumbs in a child’s lunch box.

“In our survey we asked the question ‘Have you been teased or bullied because of your asthma?’ but we didn’t ask what form this took,” Dr. Carroll said. “But we were surprised at just how many children said yes. It’s time for more research, I think.”

“There are never enough studies around this,” added Dr. Welles. “Bullying, whether because of asthma or otherwise, has the potential for long-term effects well into adulthood.”

In the meantime, asthma consultations should incorporate specific questions about bullying. They should also be child focused in order to gain a representative appreciation of asthma control and its effect on the child’s life.

“As pediatricians, we need to be continuously supporting parents and find the help they need to address any mental health issues,” Dr. Welles said. “Every pediatrician and parent needs to be aware and recognize when something is different in their child’s life. Please don’t ignore it.”

Dr. Waasdorp stressed that school and other communities should be aware that children with asthma may be at increased risk for aggression and harmful interactions related to their asthma. “Programming to reduce bullying should focus broadly on shifting the climate so that bullying is not perceived to be normative and on improving ‘upstander,’ or positive bystander, responses.” she said.

The original survey was funded by Nycomed (Zurich). No additional funding was requested for the current analysis. Dr. Carroll reported personal fees from GlaxoSmithKline, Novartis, and Trudell Medical International outside the submitted work. Dr. Welles and Dr. Waasdorp disclosed no competing interests relevant to their comments.

The risk of bullying and teasing is higher in children and young people with poorer asthma control, an international study reported. Published online in the Archives of Disease in Childhood, the Room to Breathe survey of 943 children in six countries found 9.9% had experienced asthma-related bullying or teasing (n = 93).

Children with well-controlled disease, however, were less likely to report being victimized by asthma-related bullying/teasing: odds ratio, 0.51; 95% confidence interval, 0.23-0.84; P = .006).

“It’s important for pediatricians to recognize that children and young people with asthma commonly report bullying or teasing as a result of their condition,” Will Carroll, MD, of the Paediatric Respiratory Service at Staffordshire Children’s Hospital at Royal Stoke, Stoke-on-Trent, England, told this news organization. “Pediatricians should talk to children themselves with asthma about this and not just their parents, and efforts should be made to improve asthma control whenever possible.”

Though common and potentially long-lasting in its effects, bullying is rarely addressed by health care professionals, the U.K. authors said.

But things may differ in the United States. According to Mark Welles, MD, a pediatrician at Cohen Children’s Medical Center at Northwell Health in Queen’s, N.Y., and regional cochair of the American Academy of Pediatrics antibullying committee, young doctors here are trained to ask about bullying when seeing a child, no matter what the reason for the visit. “It’s important to build a rapport with the child, and you need to ask about the disease they may have but also generally ask, ‘How are things at school? Is everyone nice to you?’ It is becoming more common practice to ask this,” said Dr. Welles, who was not involved with the U.K. research.

The U.K. study drew on unpublished data from the Room to Breathe survey conducted by Dr. Carroll’s group during 2008-2009 in Canada, the United Kingdom, Greece, Hungary, South Africa, and the Netherlands. Only 358 of 930 (38.5%) children were found to be well controlled according to current Global Initiative for Asthma symptom-control criteria.

The analysis also found a highly significant association (P < .0001) between Childhood Asthma Control Test (C-ACT) score and reported bullying/teasing, with bullied children having lower scores. C-ACT–defined controlled asthma scores of 20 or higher were significantly associated with a lower risk of bullying (OR, 0.46; 95% CI, 0.28-0.76; P = .001).

In other study findings, harassment was more common in children whose asthma was serious enough to entail activity restriction (OR, 1.74; 95% CI, 1.11-2.75; P = .010) and who described their asthma as “bad” (OR, 3.02; 95% CI, 1.86-4.85; P < .001), as well as those whose parents reported ongoing asthma-related health worries (OR, 1.64; 95% CI, 1.04-2.58; P = .024).

“When a child is clearly different from others, such as having bad asthma or being limited in activities due to asthma, they stand out more and are more frequently bullied,” said Tracy Evian Waasdorp, PhD, MSEd, director of research for school-based bullying and social-emotional learning at Children’s Hospital of Philadelphia, and also not a participant in the U.K. study.

In contrast to the 10% bullying rate in Dr. Carroll’s study, Dr. Waasdorp referred to a CHOP analysis of more than 64,000 youth from a Northeastern state in which those with asthma were 40% more likely to be victims of in-person bullying and 70% were more likely to be cyberbullied than youth without asthma. “Having a medical condition can therefore put you at risk of being bullied regardless of what country you live in,” she said.

CHOP policy encourages practitioners to routinely ask about bullying and to provide handouts and resources for parents, she added.

Interestingly, the U.K. investigators found that open public use of spacers was not associated with asthma-related bullying, nor was parental worry at diagnosis or parental concern about steroid use.

But according to Dr. Welles, “Kids may be using the inhaler in front of other kids, and they may be embarrassed and not want to be seen as different. So they may not use the inhaler when needed for gym class or sports, forcing them to sit out and then potentially be bullied again. It’s a vicious cycle.”

Previous research has identified the bullying and teasing of children with food allergies.

Behaviors have included allergy-specific harassment such as smearing peanut butter on a youngster’s forehead or putting peanut butter cookie crumbs in a child’s lunch box.

“In our survey we asked the question ‘Have you been teased or bullied because of your asthma?’ but we didn’t ask what form this took,” Dr. Carroll said. “But we were surprised at just how many children said yes. It’s time for more research, I think.”

“There are never enough studies around this,” added Dr. Welles. “Bullying, whether because of asthma or otherwise, has the potential for long-term effects well into adulthood.”

In the meantime, asthma consultations should incorporate specific questions about bullying. They should also be child focused in order to gain a representative appreciation of asthma control and its effect on the child’s life.

“As pediatricians, we need to be continuously supporting parents and find the help they need to address any mental health issues,” Dr. Welles said. “Every pediatrician and parent needs to be aware and recognize when something is different in their child’s life. Please don’t ignore it.”

Dr. Waasdorp stressed that school and other communities should be aware that children with asthma may be at increased risk for aggression and harmful interactions related to their asthma. “Programming to reduce bullying should focus broadly on shifting the climate so that bullying is not perceived to be normative and on improving ‘upstander,’ or positive bystander, responses.” she said.

The original survey was funded by Nycomed (Zurich). No additional funding was requested for the current analysis. Dr. Carroll reported personal fees from GlaxoSmithKline, Novartis, and Trudell Medical International outside the submitted work. Dr. Welles and Dr. Waasdorp disclosed no competing interests relevant to their comments.

The risk of bullying and teasing is higher in children and young people with poorer asthma control, an international study reported. Published online in the Archives of Disease in Childhood, the Room to Breathe survey of 943 children in six countries found 9.9% had experienced asthma-related bullying or teasing (n = 93).

Children with well-controlled disease, however, were less likely to report being victimized by asthma-related bullying/teasing: odds ratio, 0.51; 95% confidence interval, 0.23-0.84; P = .006).

“It’s important for pediatricians to recognize that children and young people with asthma commonly report bullying or teasing as a result of their condition,” Will Carroll, MD, of the Paediatric Respiratory Service at Staffordshire Children’s Hospital at Royal Stoke, Stoke-on-Trent, England, told this news organization. “Pediatricians should talk to children themselves with asthma about this and not just their parents, and efforts should be made to improve asthma control whenever possible.”

Though common and potentially long-lasting in its effects, bullying is rarely addressed by health care professionals, the U.K. authors said.

But things may differ in the United States. According to Mark Welles, MD, a pediatrician at Cohen Children’s Medical Center at Northwell Health in Queen’s, N.Y., and regional cochair of the American Academy of Pediatrics antibullying committee, young doctors here are trained to ask about bullying when seeing a child, no matter what the reason for the visit. “It’s important to build a rapport with the child, and you need to ask about the disease they may have but also generally ask, ‘How are things at school? Is everyone nice to you?’ It is becoming more common practice to ask this,” said Dr. Welles, who was not involved with the U.K. research.

The U.K. study drew on unpublished data from the Room to Breathe survey conducted by Dr. Carroll’s group during 2008-2009 in Canada, the United Kingdom, Greece, Hungary, South Africa, and the Netherlands. Only 358 of 930 (38.5%) children were found to be well controlled according to current Global Initiative for Asthma symptom-control criteria.

The analysis also found a highly significant association (P < .0001) between Childhood Asthma Control Test (C-ACT) score and reported bullying/teasing, with bullied children having lower scores. C-ACT–defined controlled asthma scores of 20 or higher were significantly associated with a lower risk of bullying (OR, 0.46; 95% CI, 0.28-0.76; P = .001).

In other study findings, harassment was more common in children whose asthma was serious enough to entail activity restriction (OR, 1.74; 95% CI, 1.11-2.75; P = .010) and who described their asthma as “bad” (OR, 3.02; 95% CI, 1.86-4.85; P < .001), as well as those whose parents reported ongoing asthma-related health worries (OR, 1.64; 95% CI, 1.04-2.58; P = .024).

“When a child is clearly different from others, such as having bad asthma or being limited in activities due to asthma, they stand out more and are more frequently bullied,” said Tracy Evian Waasdorp, PhD, MSEd, director of research for school-based bullying and social-emotional learning at Children’s Hospital of Philadelphia, and also not a participant in the U.K. study.

In contrast to the 10% bullying rate in Dr. Carroll’s study, Dr. Waasdorp referred to a CHOP analysis of more than 64,000 youth from a Northeastern state in which those with asthma were 40% more likely to be victims of in-person bullying and 70% were more likely to be cyberbullied than youth without asthma. “Having a medical condition can therefore put you at risk of being bullied regardless of what country you live in,” she said.

CHOP policy encourages practitioners to routinely ask about bullying and to provide handouts and resources for parents, she added.

Interestingly, the U.K. investigators found that open public use of spacers was not associated with asthma-related bullying, nor was parental worry at diagnosis or parental concern about steroid use.

But according to Dr. Welles, “Kids may be using the inhaler in front of other kids, and they may be embarrassed and not want to be seen as different. So they may not use the inhaler when needed for gym class or sports, forcing them to sit out and then potentially be bullied again. It’s a vicious cycle.”

Previous research has identified the bullying and teasing of children with food allergies.

Behaviors have included allergy-specific harassment such as smearing peanut butter on a youngster’s forehead or putting peanut butter cookie crumbs in a child’s lunch box.

“In our survey we asked the question ‘Have you been teased or bullied because of your asthma?’ but we didn’t ask what form this took,” Dr. Carroll said. “But we were surprised at just how many children said yes. It’s time for more research, I think.”

“There are never enough studies around this,” added Dr. Welles. “Bullying, whether because of asthma or otherwise, has the potential for long-term effects well into adulthood.”

In the meantime, asthma consultations should incorporate specific questions about bullying. They should also be child focused in order to gain a representative appreciation of asthma control and its effect on the child’s life.

“As pediatricians, we need to be continuously supporting parents and find the help they need to address any mental health issues,” Dr. Welles said. “Every pediatrician and parent needs to be aware and recognize when something is different in their child’s life. Please don’t ignore it.”

Dr. Waasdorp stressed that school and other communities should be aware that children with asthma may be at increased risk for aggression and harmful interactions related to their asthma. “Programming to reduce bullying should focus broadly on shifting the climate so that bullying is not perceived to be normative and on improving ‘upstander,’ or positive bystander, responses.” she said.

The original survey was funded by Nycomed (Zurich). No additional funding was requested for the current analysis. Dr. Carroll reported personal fees from GlaxoSmithKline, Novartis, and Trudell Medical International outside the submitted work. Dr. Welles and Dr. Waasdorp disclosed no competing interests relevant to their comments.

A single dose of human papillomavirus (HPV) vaccine was highly effective at preventing oncogenic infection, rivaling the protection offered by multidose regimens, according to results from the KEN SHE trial, based in Kenya.

The findings, published on the preprint server Research Square and presented Nov. 17 at the 34th International Papillomavirus Conference in Toronto, bring “renewed energy to the push to make cervical cancer the first cancer to be wiped out globally,” according to co–principal investigator Ruanne V. Barnabas, PhD, a professor of global health at the University of Washington, Seattle.

Decision-makers will consider these findings, which have not yet been peer-reviewed, along with other evidence to determine if dosing-schedule changes are warranted, she told this news organization.

In a press release, Samuel Kariuki, PhD, acting director general, Kenya Medical Research Institute, who was not involved in the research, called the findings a “game changer” that could “substantially reduce the incidence of HPV-attributable cervical cancer.”

Between 2018 and 2019, Dr. Barnabas and her colleagues enrolled 2,275 sexually active, HPV-vaccine–naive women in Kenya in their study. The women, 15-20 years of age, were randomly assigned to receive a bivalent vaccine (HPV 16/18), a nonavalent vaccine (HPV 16/18/31/33/45/52/58/6/11), or a vaccine against meningococcal meningitis.

Most participants (57%) were between 15 and 17 years of age, and 61% reported one lifetime sexual partner. The women underwent genital and cervical swabs at enrollment to test for HPV DNA and had blood drawn to test for antibodies. During 18 months of follow-up, they had cervical swabs every 6 months and a vaginal swab at 3 months to test for HPV DNA.

The researchers detected 38 persistent HPV 16/18 infections in women who had tested negative for HPV 16/18 antibodies at enrollment and for HPV 16/18 DNA at enrollment and month 3 – one in each of the HPV-vaccine groups and 36 in the meningococcal group. This infection rate corresponded to a vaccine efficacy of 97.5% (P < .001) against HPV 16/18 for both the bivalent and nonavalent vaccines, which is “comparable to that seen in multidose vaccine trials,” the researchers write.

Among women negative for HPV 16/18/31/33/45/52/58 at the beginning of the trial, 33 had persistent infections: four in the nonavalent vaccine group and 29 in the meningococcal group, demonstrating an efficacy of 89% (P < .001) against all seven oncogenic strains contained in the vaccine.

Even if women tested positive for one strain of HPV, the vaccine protected them from other strains of the virus, the investigators noted.

Serious adverse events occurred in 4.5%-5.2% of participants across the study arms.

The KEN SHE trial comes 15 years after the U.S. Food and Drug Administration approved the first HPV vaccine – Merck’s Gardasil. Two others, Cervarix and Gardasil-9, have since been approved, but cost and supply issues have inhibited coverage, particularly in areas where the cervical cancer burden is high, the researchers noted.

Recent data indicate that just 15% of girls globally are vaccinated against HPV, but a single-dose vaccine would “simplify logistics and decrease costs,” thereby improving the chances of reaching the World Health Organization goal of vaccinating 90% of 15-year-old girls against HPV by 2030, Dr. Barnabas said in a press release about the trial.

Co–principal investigator Nelly Mugo, MBChB, MPH, senior principal clinical research scientist with the Center for Clinical Research at the Kenya Medical Research Institute in Nairobi, further emphasized the importance of the findings, noting in the press release that the “trial brings new energy to the elimination of cervical cancer. It brings great hope to the women living in countries like Kenya, who have a high burden of the disease.”

Dr. Mugo is also an associate research professor of global health at the University of Washington, Seattle.

Dr. Barnabas said women have been given multiple doses of the HPV vaccine because of “gaps in evidence for the effectiveness of a single-dose vaccine and concerns about clinically meaningful differences in efficacy.

“Observational data suggested that the single-dose HPV vaccine could have good efficacy, but because the data were not from randomized trials, that could have been from chance,” she explained, noting, however, that “sufficient evidence supported the decrease in doses from three to two doses for girls 15 years of age and younger.”

Going forward, the researchers will conduct immunobridging studies to other populations and will continue follow-up to assess the durability of single-dose efficacy, Dr. Barnabas said.

“The results from the KEN SHE trial support the use of single-dose HPV vaccination to increase access and coverage,” she concluded.

The KEN SHE trial was funded by the Bill & Melinda Gates Foundation (BMGF). Dr. Barnabas reports grants from BMGF and grants from King K. Holmes Professorship in STDs and AIDS during the conduct of the study, and grants from BMGF, National Institutes of Health, and manuscript and abstract writing support from Regeneron Pharmaceuticals outside the submitted work.

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

A single dose of human papillomavirus (HPV) vaccine was highly effective at preventing oncogenic infection, rivaling the protection offered by multidose regimens, according to results from the KEN SHE trial, based in Kenya.

The findings, published on the preprint server Research Square and presented Nov. 17 at the 34th International Papillomavirus Conference in Toronto, bring “renewed energy to the push to make cervical cancer the first cancer to be wiped out globally,” according to co–principal investigator Ruanne V. Barnabas, PhD, a professor of global health at the University of Washington, Seattle.

Decision-makers will consider these findings, which have not yet been peer-reviewed, along with other evidence to determine if dosing-schedule changes are warranted, she told this news organization.

In a press release, Samuel Kariuki, PhD, acting director general, Kenya Medical Research Institute, who was not involved in the research, called the findings a “game changer” that could “substantially reduce the incidence of HPV-attributable cervical cancer.”

Between 2018 and 2019, Dr. Barnabas and her colleagues enrolled 2,275 sexually active, HPV-vaccine–naive women in Kenya in their study. The women, 15-20 years of age, were randomly assigned to receive a bivalent vaccine (HPV 16/18), a nonavalent vaccine (HPV 16/18/31/33/45/52/58/6/11), or a vaccine against meningococcal meningitis.

Most participants (57%) were between 15 and 17 years of age, and 61% reported one lifetime sexual partner. The women underwent genital and cervical swabs at enrollment to test for HPV DNA and had blood drawn to test for antibodies. During 18 months of follow-up, they had cervical swabs every 6 months and a vaginal swab at 3 months to test for HPV DNA.

The researchers detected 38 persistent HPV 16/18 infections in women who had tested negative for HPV 16/18 antibodies at enrollment and for HPV 16/18 DNA at enrollment and month 3 – one in each of the HPV-vaccine groups and 36 in the meningococcal group. This infection rate corresponded to a vaccine efficacy of 97.5% (P < .001) against HPV 16/18 for both the bivalent and nonavalent vaccines, which is “comparable to that seen in multidose vaccine trials,” the researchers write.

Among women negative for HPV 16/18/31/33/45/52/58 at the beginning of the trial, 33 had persistent infections: four in the nonavalent vaccine group and 29 in the meningococcal group, demonstrating an efficacy of 89% (P < .001) against all seven oncogenic strains contained in the vaccine.

Even if women tested positive for one strain of HPV, the vaccine protected them from other strains of the virus, the investigators noted.

Serious adverse events occurred in 4.5%-5.2% of participants across the study arms.

The KEN SHE trial comes 15 years after the U.S. Food and Drug Administration approved the first HPV vaccine – Merck’s Gardasil. Two others, Cervarix and Gardasil-9, have since been approved, but cost and supply issues have inhibited coverage, particularly in areas where the cervical cancer burden is high, the researchers noted.

Recent data indicate that just 15% of girls globally are vaccinated against HPV, but a single-dose vaccine would “simplify logistics and decrease costs,” thereby improving the chances of reaching the World Health Organization goal of vaccinating 90% of 15-year-old girls against HPV by 2030, Dr. Barnabas said in a press release about the trial.

Co–principal investigator Nelly Mugo, MBChB, MPH, senior principal clinical research scientist with the Center for Clinical Research at the Kenya Medical Research Institute in Nairobi, further emphasized the importance of the findings, noting in the press release that the “trial brings new energy to the elimination of cervical cancer. It brings great hope to the women living in countries like Kenya, who have a high burden of the disease.”

Dr. Mugo is also an associate research professor of global health at the University of Washington, Seattle.

Dr. Barnabas said women have been given multiple doses of the HPV vaccine because of “gaps in evidence for the effectiveness of a single-dose vaccine and concerns about clinically meaningful differences in efficacy.

“Observational data suggested that the single-dose HPV vaccine could have good efficacy, but because the data were not from randomized trials, that could have been from chance,” she explained, noting, however, that “sufficient evidence supported the decrease in doses from three to two doses for girls 15 years of age and younger.”

Going forward, the researchers will conduct immunobridging studies to other populations and will continue follow-up to assess the durability of single-dose efficacy, Dr. Barnabas said.

“The results from the KEN SHE trial support the use of single-dose HPV vaccination to increase access and coverage,” she concluded.

The KEN SHE trial was funded by the Bill & Melinda Gates Foundation (BMGF). Dr. Barnabas reports grants from BMGF and grants from King K. Holmes Professorship in STDs and AIDS during the conduct of the study, and grants from BMGF, National Institutes of Health, and manuscript and abstract writing support from Regeneron Pharmaceuticals outside the submitted work.

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

A single dose of human papillomavirus (HPV) vaccine was highly effective at preventing oncogenic infection, rivaling the protection offered by multidose regimens, according to results from the KEN SHE trial, based in Kenya.

The findings, published on the preprint server Research Square and presented Nov. 17 at the 34th International Papillomavirus Conference in Toronto, bring “renewed energy to the push to make cervical cancer the first cancer to be wiped out globally,” according to co–principal investigator Ruanne V. Barnabas, PhD, a professor of global health at the University of Washington, Seattle.

Decision-makers will consider these findings, which have not yet been peer-reviewed, along with other evidence to determine if dosing-schedule changes are warranted, she told this news organization.

In a press release, Samuel Kariuki, PhD, acting director general, Kenya Medical Research Institute, who was not involved in the research, called the findings a “game changer” that could “substantially reduce the incidence of HPV-attributable cervical cancer.”

Between 2018 and 2019, Dr. Barnabas and her colleagues enrolled 2,275 sexually active, HPV-vaccine–naive women in Kenya in their study. The women, 15-20 years of age, were randomly assigned to receive a bivalent vaccine (HPV 16/18), a nonavalent vaccine (HPV 16/18/31/33/45/52/58/6/11), or a vaccine against meningococcal meningitis.

Most participants (57%) were between 15 and 17 years of age, and 61% reported one lifetime sexual partner. The women underwent genital and cervical swabs at enrollment to test for HPV DNA and had blood drawn to test for antibodies. During 18 months of follow-up, they had cervical swabs every 6 months and a vaginal swab at 3 months to test for HPV DNA.

The researchers detected 38 persistent HPV 16/18 infections in women who had tested negative for HPV 16/18 antibodies at enrollment and for HPV 16/18 DNA at enrollment and month 3 – one in each of the HPV-vaccine groups and 36 in the meningococcal group. This infection rate corresponded to a vaccine efficacy of 97.5% (P < .001) against HPV 16/18 for both the bivalent and nonavalent vaccines, which is “comparable to that seen in multidose vaccine trials,” the researchers write.

Among women negative for HPV 16/18/31/33/45/52/58 at the beginning of the trial, 33 had persistent infections: four in the nonavalent vaccine group and 29 in the meningococcal group, demonstrating an efficacy of 89% (P < .001) against all seven oncogenic strains contained in the vaccine.

Even if women tested positive for one strain of HPV, the vaccine protected them from other strains of the virus, the investigators noted.

Serious adverse events occurred in 4.5%-5.2% of participants across the study arms.

The KEN SHE trial comes 15 years after the U.S. Food and Drug Administration approved the first HPV vaccine – Merck’s Gardasil. Two others, Cervarix and Gardasil-9, have since been approved, but cost and supply issues have inhibited coverage, particularly in areas where the cervical cancer burden is high, the researchers noted.

Recent data indicate that just 15% of girls globally are vaccinated against HPV, but a single-dose vaccine would “simplify logistics and decrease costs,” thereby improving the chances of reaching the World Health Organization goal of vaccinating 90% of 15-year-old girls against HPV by 2030, Dr. Barnabas said in a press release about the trial.

Co–principal investigator Nelly Mugo, MBChB, MPH, senior principal clinical research scientist with the Center for Clinical Research at the Kenya Medical Research Institute in Nairobi, further emphasized the importance of the findings, noting in the press release that the “trial brings new energy to the elimination of cervical cancer. It brings great hope to the women living in countries like Kenya, who have a high burden of the disease.”

Dr. Mugo is also an associate research professor of global health at the University of Washington, Seattle.

Dr. Barnabas said women have been given multiple doses of the HPV vaccine because of “gaps in evidence for the effectiveness of a single-dose vaccine and concerns about clinically meaningful differences in efficacy.

“Observational data suggested that the single-dose HPV vaccine could have good efficacy, but because the data were not from randomized trials, that could have been from chance,” she explained, noting, however, that “sufficient evidence supported the decrease in doses from three to two doses for girls 15 years of age and younger.”

Going forward, the researchers will conduct immunobridging studies to other populations and will continue follow-up to assess the durability of single-dose efficacy, Dr. Barnabas said.

“The results from the KEN SHE trial support the use of single-dose HPV vaccination to increase access and coverage,” she concluded.

The KEN SHE trial was funded by the Bill & Melinda Gates Foundation (BMGF). Dr. Barnabas reports grants from BMGF and grants from King K. Holmes Professorship in STDs and AIDS during the conduct of the study, and grants from BMGF, National Institutes of Health, and manuscript and abstract writing support from Regeneron Pharmaceuticals outside the submitted work.

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

To the Editor:

Drug reaction with eosinophilia and systemic symptoms (DRESS) syndrome, or drug-induced hypersensitivity syndrome, is a serious and potentially fatal multiorgan drug hypersensitivity reaction. Drug reaction with eosinophilia and systemic symptoms syndrome shares many clinical features with viral exanthems and may be difficult to diagnose in the setting of atopic dermatitis (AD) in which children may have baseline eosinophilia from an atopic diathesis. The cutaneous exanthema also may be variable in presentation, further complicating diagnosis.^1,2

A 3-year-old boy with AD since infancy and a history of anaphylaxis to peanuts presented to the emergency department with reported fever, rash, sore throat, and decreased oral intake. Ten days prior, the patient was treated for cellulitis of the left foot with a 7-day course of cefdinir with complete resolution of symptoms. Four days prior to admission, the patient started developing “bumps” on the face and fevers. He was seen at an outside facility, where a rapid test for Streptococcus was negative, and the patient was treated with ibuprofen and fluids for a presumed viral exanthem. The rash subsequently spread to involve the trunk and extremities. On the day of admission, the patient had a positive rapid test for Streptococcus and was referred to the emergency department with concern for superinfected eczema and eczema herpeticum. The patient recently traveled to Puerto Rico, where he had contact with an aunt with active herpes zoster but no other sick contacts. The patient’s immunizations were reported to be up-to-date.

Physical examination revealed the patient was afebrile but irritable and had erythematous crusted papules and patches on the face, arms, and legs, as well as erythematous dry patches on the chest, abdomen, and back (Figure). There were no conjunctival erythematous or oral erosions. The patient was admitted to the hospital for presumed superinfected AD and possible eczema herpeticum. He was started on intravenous clindamycin and acyclovir.

The following day, the patient had new facial edema and fever (temperature, 102.8 °F [39.36 °C]) in addition to palpable mobile cervical, axillary, and inguinal lymphadenopathy. He also was noted to have notably worsening eosinophilia from 1288 (14%) to 2570 (29.2%) cells/µL (reference range, 0%–5%) and new-onset transaminitis. Herpes and varicella-zoster direct fluorescent antibody tests, culture, and serum polymerase chain reaction were all negative, and acyclovir was discontinued. Repeat laboratory tests 12 hours later showed a continued uptrend in transaminitis. Serologies for acute and chronic cytomegalovirus; Epstein-Barr virus; and hepatitis A, B, and C were all nonreactive. The patient was started on intravenous methylprednisolone 1 mg/kg daily for suspected DRESS syndrome likely due to cefdinir.

The patient’s eosinophilia completely resolved (from approximately 2600 to 100 cells/µL) after 1 dose of steroids, and his transaminitis trended down over the next few days. He remained afebrile for the remainder of his admission, and his facial swelling and rash continued to improve. Bacterial culture from the skin grew oxacillin-susceptible Staphylococcus aureus and group A Streptococcus pyogenes. A blood culture was negative. The patient was discharged home to complete a 10-day course of clindamycin and was given topical steroids for the eczema. He continued on oral prednisolone 1 mg/kg daily for 10 days, after which the dose was tapered down for a total 1-month course of systemic corticosteroids. At 1-month follow-up after completing the course of steroids, he was doing well with normal hepatic enzyme levels and no recurrence of fever, facial edema, or rash. He continues to be followed for management of the AD.

Drug reaction with eosinophilia and systemic symptoms syndrome is a serious systemic adverse drug reaction, with high morbidity and even mortality, estimated at 10% in the adult population, though more specific pediatric mortality data are not available.^1,2 The exact pathogenesis of DRESS syndrome has not been elucidated. Certain human leukocyte antigen class I alleles are predisposed to the development of DRESS syndrome, but there has not been a human leukocyte antigen subtype identified with beta-lactam–associated DRESS syndrome. Some studies have demonstrated a reactivation of human herpesvirus 6, human herpesvirus 7, and Epstein-Barr virus.³ One study involving 40 patients with DRESS syndrome identified viremia in 76% (29/38) of patients and identified CD8⁺ T-cell populations directed toward viral epitopes.³ Finally, DRESS syndrome may be related to the slow detoxification and elimination of intermediary products of offending medications that serve as an immunogenic stimulus for the inflammatory cascade.²

In adults, DRESS syndrome was first identified in association with phenytoin, but more recently other drugs have been identified, including other aromatic anticonvulsants (ie, lamotrigine, phenobarbital, carbamazepine), allopurinol, sulfonamides, antiretrovirals (particularly abacavir), and minocycline.² In a 3-year pediatric prospective study, 11 cases of DRESS syndrome were identified: 4 cases due to lamotrigine, and 3 caused by penicillins.⁴ The trigger in our patient’s case was the beta-lactam, third-generation cephalosporin cefdinir, and his symptoms developed within 6 days of starting the medication. Many articles report that beta-lactams are a rare cause of DRESS syndrome, with only a handful of cases reported.^1,5,6

The diagnosis of DRESS syndrome often can be delayed, as children present acutely febrile and toxic appearing. Unlike many adverse drug reactions, DRESS syndrome does not show rapid resolution with withdrawal of the causative agent, further complicating the diagnosis. The typical onset of DRESS syndrome generally ranges from 2 to 6 weeks after the initiation of the offending drug; however, faster onset of symptoms, similar to our case, has been noted in antibiotic-triggered cases. In the prospective pediatric series by Sasidharanpillai et al,⁴ the average time to onset among 3 antibiotic-triggered DRESS cases was 5.8 days vs 23.9 days among the 4 cases of lamotrigine-associated DRESS syndrome.

Our patient demonstrated the classic features of DRESS syndrome, including fever, rash, lymphadenopathy, facial edema, peripheral eosinophilia, atypical lymphocytosis, and hepatitis. Based on the proposed RegiSCAR scoring system, our patient was classified as a “definite” case of DRESS syndrome.^1,7 Other hematologic findings in DRESS syndrome may include thrombocytopenia and anemia. The liver is the most commonly affected internal organ in DRESS syndrome, with pneumonitis, carditis, and nephritis reported less frequently.¹ The pattern of liver injury in our patient was mixed (hepatocellular and cholestatic), the second most common pattern in patients with DRESS syndrome (the cholestatic pattern is most common).⁸

The exanthem of DRESS syndrome can vary in morphology, with up to 7% of patients reported to have eczemalike lesions in the multinational prospective RegiSCAR study.¹ Other entities in the differential diagnosis for our patient included Kawasaki disease, where conjunctivitis and strawberry tongue are classically present, as well as erythrodermic AD, where internal organ involvement is not common.² Our patient’s exanthem initially was considered to be a flare of AD with superimposed bacterial infection and possible eczema herpeticum. Although bacterial cultures did grow Staphylococcus and Streptococcus, viral studies were all negative, and this alone would not have explained the facial edema, rapidly rising eosinophil count, and transaminitis. The dramatic drop in his eosinophil count and decrease in hepatic enzymes after 1 dose of intravenous methylprednisolone also supported the diagnosis of DRESS syndrome.

Treatment recommendations remain largely anecdotal. Early systemic steroids generally are accepted as the first line of therapy, with a slow taper. Although the average required duration of systemic steroids in 1 series of adults was reported at 50.1 days,⁹ the duration was shorter (21–35 days) in a series of pediatric patients.⁴ Our patient’s clinical symptoms and laboratory values normalized after completing a 1-month steroid taper. Other therapies have been tried for recalcitrant cases, including intravenous immunoglobulin, plasmapheresis, rituximab, and valganciclovir.²

Early clinical recognition of the signs and symptoms of DRESS syndrome in the setting of a new medication can decrease morbidity and mortality. Although DRESS syndrome in pediatric patients presents with many similar clinical features as in adults, it may be a greater diagnostic challenge. As in adult cases, timely administration of systemic corticosteroids and tapering based on clinical signs and symptoms can lead to resolution of the hypersensitivity syndrome.

To the Editor:

Drug reaction with eosinophilia and systemic symptoms (DRESS) syndrome, or drug-induced hypersensitivity syndrome, is a serious and potentially fatal multiorgan drug hypersensitivity reaction. Drug reaction with eosinophilia and systemic symptoms syndrome shares many clinical features with viral exanthems and may be difficult to diagnose in the setting of atopic dermatitis (AD) in which children may have baseline eosinophilia from an atopic diathesis. The cutaneous exanthema also may be variable in presentation, further complicating diagnosis.^1,2

A 3-year-old boy with AD since infancy and a history of anaphylaxis to peanuts presented to the emergency department with reported fever, rash, sore throat, and decreased oral intake. Ten days prior, the patient was treated for cellulitis of the left foot with a 7-day course of cefdinir with complete resolution of symptoms. Four days prior to admission, the patient started developing “bumps” on the face and fevers. He was seen at an outside facility, where a rapid test for Streptococcus was negative, and the patient was treated with ibuprofen and fluids for a presumed viral exanthem. The rash subsequently spread to involve the trunk and extremities. On the day of admission, the patient had a positive rapid test for Streptococcus and was referred to the emergency department with concern for superinfected eczema and eczema herpeticum. The patient recently traveled to Puerto Rico, where he had contact with an aunt with active herpes zoster but no other sick contacts. The patient’s immunizations were reported to be up-to-date.

Physical examination revealed the patient was afebrile but irritable and had erythematous crusted papules and patches on the face, arms, and legs, as well as erythematous dry patches on the chest, abdomen, and back (Figure). There were no conjunctival erythematous or oral erosions. The patient was admitted to the hospital for presumed superinfected AD and possible eczema herpeticum. He was started on intravenous clindamycin and acyclovir.

The following day, the patient had new facial edema and fever (temperature, 102.8 °F [39.36 °C]) in addition to palpable mobile cervical, axillary, and inguinal lymphadenopathy. He also was noted to have notably worsening eosinophilia from 1288 (14%) to 2570 (29.2%) cells/µL (reference range, 0%–5%) and new-onset transaminitis. Herpes and varicella-zoster direct fluorescent antibody tests, culture, and serum polymerase chain reaction were all negative, and acyclovir was discontinued. Repeat laboratory tests 12 hours later showed a continued uptrend in transaminitis. Serologies for acute and chronic cytomegalovirus; Epstein-Barr virus; and hepatitis A, B, and C were all nonreactive. The patient was started on intravenous methylprednisolone 1 mg/kg daily for suspected DRESS syndrome likely due to cefdinir.

The patient’s eosinophilia completely resolved (from approximately 2600 to 100 cells/µL) after 1 dose of steroids, and his transaminitis trended down over the next few days. He remained afebrile for the remainder of his admission, and his facial swelling and rash continued to improve. Bacterial culture from the skin grew oxacillin-susceptible Staphylococcus aureus and group A Streptococcus pyogenes. A blood culture was negative. The patient was discharged home to complete a 10-day course of clindamycin and was given topical steroids for the eczema. He continued on oral prednisolone 1 mg/kg daily for 10 days, after which the dose was tapered down for a total 1-month course of systemic corticosteroids. At 1-month follow-up after completing the course of steroids, he was doing well with normal hepatic enzyme levels and no recurrence of fever, facial edema, or rash. He continues to be followed for management of the AD.

Drug reaction with eosinophilia and systemic symptoms syndrome is a serious systemic adverse drug reaction, with high morbidity and even mortality, estimated at 10% in the adult population, though more specific pediatric mortality data are not available.^1,2 The exact pathogenesis of DRESS syndrome has not been elucidated. Certain human leukocyte antigen class I alleles are predisposed to the development of DRESS syndrome, but there has not been a human leukocyte antigen subtype identified with beta-lactam–associated DRESS syndrome. Some studies have demonstrated a reactivation of human herpesvirus 6, human herpesvirus 7, and Epstein-Barr virus.³ One study involving 40 patients with DRESS syndrome identified viremia in 76% (29/38) of patients and identified CD8⁺ T-cell populations directed toward viral epitopes.³ Finally, DRESS syndrome may be related to the slow detoxification and elimination of intermediary products of offending medications that serve as an immunogenic stimulus for the inflammatory cascade.²

In adults, DRESS syndrome was first identified in association with phenytoin, but more recently other drugs have been identified, including other aromatic anticonvulsants (ie, lamotrigine, phenobarbital, carbamazepine), allopurinol, sulfonamides, antiretrovirals (particularly abacavir), and minocycline.² In a 3-year pediatric prospective study, 11 cases of DRESS syndrome were identified: 4 cases due to lamotrigine, and 3 caused by penicillins.⁴ The trigger in our patient’s case was the beta-lactam, third-generation cephalosporin cefdinir, and his symptoms developed within 6 days of starting the medication. Many articles report that beta-lactams are a rare cause of DRESS syndrome, with only a handful of cases reported.^1,5,6

The diagnosis of DRESS syndrome often can be delayed, as children present acutely febrile and toxic appearing. Unlike many adverse drug reactions, DRESS syndrome does not show rapid resolution with withdrawal of the causative agent, further complicating the diagnosis. The typical onset of DRESS syndrome generally ranges from 2 to 6 weeks after the initiation of the offending drug; however, faster onset of symptoms, similar to our case, has been noted in antibiotic-triggered cases. In the prospective pediatric series by Sasidharanpillai et al,⁴ the average time to onset among 3 antibiotic-triggered DRESS cases was 5.8 days vs 23.9 days among the 4 cases of lamotrigine-associated DRESS syndrome.

Our patient demonstrated the classic features of DRESS syndrome, including fever, rash, lymphadenopathy, facial edema, peripheral eosinophilia, atypical lymphocytosis, and hepatitis. Based on the proposed RegiSCAR scoring system, our patient was classified as a “definite” case of DRESS syndrome.^1,7 Other hematologic findings in DRESS syndrome may include thrombocytopenia and anemia. The liver is the most commonly affected internal organ in DRESS syndrome, with pneumonitis, carditis, and nephritis reported less frequently.¹ The pattern of liver injury in our patient was mixed (hepatocellular and cholestatic), the second most common pattern in patients with DRESS syndrome (the cholestatic pattern is most common).⁸

The exanthem of DRESS syndrome can vary in morphology, with up to 7% of patients reported to have eczemalike lesions in the multinational prospective RegiSCAR study.¹ Other entities in the differential diagnosis for our patient included Kawasaki disease, where conjunctivitis and strawberry tongue are classically present, as well as erythrodermic AD, where internal organ involvement is not common.² Our patient’s exanthem initially was considered to be a flare of AD with superimposed bacterial infection and possible eczema herpeticum. Although bacterial cultures did grow Staphylococcus and Streptococcus, viral studies were all negative, and this alone would not have explained the facial edema, rapidly rising eosinophil count, and transaminitis. The dramatic drop in his eosinophil count and decrease in hepatic enzymes after 1 dose of intravenous methylprednisolone also supported the diagnosis of DRESS syndrome.

Treatment recommendations remain largely anecdotal. Early systemic steroids generally are accepted as the first line of therapy, with a slow taper. Although the average required duration of systemic steroids in 1 series of adults was reported at 50.1 days,⁹ the duration was shorter (21–35 days) in a series of pediatric patients.⁴ Our patient’s clinical symptoms and laboratory values normalized after completing a 1-month steroid taper. Other therapies have been tried for recalcitrant cases, including intravenous immunoglobulin, plasmapheresis, rituximab, and valganciclovir.²

Early clinical recognition of the signs and symptoms of DRESS syndrome in the setting of a new medication can decrease morbidity and mortality. Although DRESS syndrome in pediatric patients presents with many similar clinical features as in adults, it may be a greater diagnostic challenge. As in adult cases, timely administration of systemic corticosteroids and tapering based on clinical signs and symptoms can lead to resolution of the hypersensitivity syndrome.

To the Editor:

Drug reaction with eosinophilia and systemic symptoms (DRESS) syndrome, or drug-induced hypersensitivity syndrome, is a serious and potentially fatal multiorgan drug hypersensitivity reaction. Drug reaction with eosinophilia and systemic symptoms syndrome shares many clinical features with viral exanthems and may be difficult to diagnose in the setting of atopic dermatitis (AD) in which children may have baseline eosinophilia from an atopic diathesis. The cutaneous exanthema also may be variable in presentation, further complicating diagnosis.^1,2

A 3-year-old boy with AD since infancy and a history of anaphylaxis to peanuts presented to the emergency department with reported fever, rash, sore throat, and decreased oral intake. Ten days prior, the patient was treated for cellulitis of the left foot with a 7-day course of cefdinir with complete resolution of symptoms. Four days prior to admission, the patient started developing “bumps” on the face and fevers. He was seen at an outside facility, where a rapid test for Streptococcus was negative, and the patient was treated with ibuprofen and fluids for a presumed viral exanthem. The rash subsequently spread to involve the trunk and extremities. On the day of admission, the patient had a positive rapid test for Streptococcus and was referred to the emergency department with concern for superinfected eczema and eczema herpeticum. The patient recently traveled to Puerto Rico, where he had contact with an aunt with active herpes zoster but no other sick contacts. The patient’s immunizations were reported to be up-to-date.

Physical examination revealed the patient was afebrile but irritable and had erythematous crusted papules and patches on the face, arms, and legs, as well as erythematous dry patches on the chest, abdomen, and back (Figure). There were no conjunctival erythematous or oral erosions. The patient was admitted to the hospital for presumed superinfected AD and possible eczema herpeticum. He was started on intravenous clindamycin and acyclovir.

The following day, the patient had new facial edema and fever (temperature, 102.8 °F [39.36 °C]) in addition to palpable mobile cervical, axillary, and inguinal lymphadenopathy. He also was noted to have notably worsening eosinophilia from 1288 (14%) to 2570 (29.2%) cells/µL (reference range, 0%–5%) and new-onset transaminitis. Herpes and varicella-zoster direct fluorescent antibody tests, culture, and serum polymerase chain reaction were all negative, and acyclovir was discontinued. Repeat laboratory tests 12 hours later showed a continued uptrend in transaminitis. Serologies for acute and chronic cytomegalovirus; Epstein-Barr virus; and hepatitis A, B, and C were all nonreactive. The patient was started on intravenous methylprednisolone 1 mg/kg daily for suspected DRESS syndrome likely due to cefdinir.

The patient’s eosinophilia completely resolved (from approximately 2600 to 100 cells/µL) after 1 dose of steroids, and his transaminitis trended down over the next few days. He remained afebrile for the remainder of his admission, and his facial swelling and rash continued to improve. Bacterial culture from the skin grew oxacillin-susceptible Staphylococcus aureus and group A Streptococcus pyogenes. A blood culture was negative. The patient was discharged home to complete a 10-day course of clindamycin and was given topical steroids for the eczema. He continued on oral prednisolone 1 mg/kg daily for 10 days, after which the dose was tapered down for a total 1-month course of systemic corticosteroids. At 1-month follow-up after completing the course of steroids, he was doing well with normal hepatic enzyme levels and no recurrence of fever, facial edema, or rash. He continues to be followed for management of the AD.

Drug reaction with eosinophilia and systemic symptoms syndrome is a serious systemic adverse drug reaction, with high morbidity and even mortality, estimated at 10% in the adult population, though more specific pediatric mortality data are not available.^1,2 The exact pathogenesis of DRESS syndrome has not been elucidated. Certain human leukocyte antigen class I alleles are predisposed to the development of DRESS syndrome, but there has not been a human leukocyte antigen subtype identified with beta-lactam–associated DRESS syndrome. Some studies have demonstrated a reactivation of human herpesvirus 6, human herpesvirus 7, and Epstein-Barr virus.³ One study involving 40 patients with DRESS syndrome identified viremia in 76% (29/38) of patients and identified CD8⁺ T-cell populations directed toward viral epitopes.³ Finally, DRESS syndrome may be related to the slow detoxification and elimination of intermediary products of offending medications that serve as an immunogenic stimulus for the inflammatory cascade.²

In adults, DRESS syndrome was first identified in association with phenytoin, but more recently other drugs have been identified, including other aromatic anticonvulsants (ie, lamotrigine, phenobarbital, carbamazepine), allopurinol, sulfonamides, antiretrovirals (particularly abacavir), and minocycline.² In a 3-year pediatric prospective study, 11 cases of DRESS syndrome were identified: 4 cases due to lamotrigine, and 3 caused by penicillins.⁴ The trigger in our patient’s case was the beta-lactam, third-generation cephalosporin cefdinir, and his symptoms developed within 6 days of starting the medication. Many articles report that beta-lactams are a rare cause of DRESS syndrome, with only a handful of cases reported.^1,5,6

The diagnosis of DRESS syndrome often can be delayed, as children present acutely febrile and toxic appearing. Unlike many adverse drug reactions, DRESS syndrome does not show rapid resolution with withdrawal of the causative agent, further complicating the diagnosis. The typical onset of DRESS syndrome generally ranges from 2 to 6 weeks after the initiation of the offending drug; however, faster onset of symptoms, similar to our case, has been noted in antibiotic-triggered cases. In the prospective pediatric series by Sasidharanpillai et al,⁴ the average time to onset among 3 antibiotic-triggered DRESS cases was 5.8 days vs 23.9 days among the 4 cases of lamotrigine-associated DRESS syndrome.

Our patient demonstrated the classic features of DRESS syndrome, including fever, rash, lymphadenopathy, facial edema, peripheral eosinophilia, atypical lymphocytosis, and hepatitis. Based on the proposed RegiSCAR scoring system, our patient was classified as a “definite” case of DRESS syndrome.^1,7 Other hematologic findings in DRESS syndrome may include thrombocytopenia and anemia. The liver is the most commonly affected internal organ in DRESS syndrome, with pneumonitis, carditis, and nephritis reported less frequently.¹ The pattern of liver injury in our patient was mixed (hepatocellular and cholestatic), the second most common pattern in patients with DRESS syndrome (the cholestatic pattern is most common).⁸

The exanthem of DRESS syndrome can vary in morphology, with up to 7% of patients reported to have eczemalike lesions in the multinational prospective RegiSCAR study.¹ Other entities in the differential diagnosis for our patient included Kawasaki disease, where conjunctivitis and strawberry tongue are classically present, as well as erythrodermic AD, where internal organ involvement is not common.² Our patient’s exanthem initially was considered to be a flare of AD with superimposed bacterial infection and possible eczema herpeticum. Although bacterial cultures did grow Staphylococcus and Streptococcus, viral studies were all negative, and this alone would not have explained the facial edema, rapidly rising eosinophil count, and transaminitis. The dramatic drop in his eosinophil count and decrease in hepatic enzymes after 1 dose of intravenous methylprednisolone also supported the diagnosis of DRESS syndrome.

Treatment recommendations remain largely anecdotal. Early systemic steroids generally are accepted as the first line of therapy, with a slow taper. Although the average required duration of systemic steroids in 1 series of adults was reported at 50.1 days,⁹ the duration was shorter (21–35 days) in a series of pediatric patients.⁴ Our patient’s clinical symptoms and laboratory values normalized after completing a 1-month steroid taper. Other therapies have been tried for recalcitrant cases, including intravenous immunoglobulin, plasmapheresis, rituximab, and valganciclovir.²

Early clinical recognition of the signs and symptoms of DRESS syndrome in the setting of a new medication can decrease morbidity and mortality. Although DRESS syndrome in pediatric patients presents with many similar clinical features as in adults, it may be a greater diagnostic challenge. As in adult cases, timely administration of systemic corticosteroids and tapering based on clinical signs and symptoms can lead to resolution of the hypersensitivity syndrome.