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Pediatricians report low knowledge, comfort discussing e-cigarettes
BALTIMORE – according to a recent study.
“Providers are aware of the increased prevalence, harms [of e-cigs] and [the] positive impact of counseling teens about e-cigs,” said Allison Heinly, MD, of Hasbro Children’s Hospital in Providence, R.I., and her colleagues. But, “providers are less likely to ask, advise, or assist parents [and teens] regarding e-cig use, compared to tobacco, and are less comfortable doing so.” The researchers presented their findings at the Pediatric Academic Societies annual meeting.
A variety of concerns exist regarding ingredients in e-cigarettes, Dr. Heinly noted, including nicotine, volatile organic compounds, carcinogenic chemicals, flavorings, and ultra-fine particles.
Dr. Heinly and her associates aimed to assess pediatricians’ knowledge, attitudes, and behaviors toward both teens’ and parents’ use of e-cigarettes, as well as the barrier pediatricians perceived when it came to screening and counseling those who use e-cigarettes.
Among 69 providers at a large Northeastern urban academic primary care clinic who received surveys, 62 responded, primarily residents (84%). The respondents included 44 pediatric residents, eight triple-board residents, and 10 attending physicians.
The researchers collapsed “most of the time”/“always” and “some of the time”/“never” responses into two categories.
Most of the respondents (82%) knew e-cigarettes are the most common tobacco product that youth use, and nearly all (97%) believed e-cigarettes were addictive and harmful to users’ health. In addition, most (79%) believed using e-cigarettes could be a pathway toward students beginning to use other drugs.
Even though respondents believed counseling teens about use of tobacco or e-cigarettes can reduce the likelihood that they will start using them, providers were much less likely to discuss e-cigarettes than tobacco with teens.
Nearly all the doctors (97%) reported asking teens about their use of tobacco, but only about half (52%) asked about e-cigarette use (P less than .001). And only about one in five doctors (21%) reported counseling teens about using e-cigarettes, compared with 47% of those who advised teens regarding tobacco use (P = .002).
Over a third of responding physicians (37%) reported helping adolescent patients quit using tobacco, but just 7% reported doing so with e-cigarettes (P less than .001).
Doctors overwhelmingly reported feeling comfortable talking about tobacco with teens (98%), but fewer felt comfortable discussing e-cigarettes (77%; P less than .001). Respondents similarly were less comfortable discussing e-cigarettes (55%) than tobacco (87%) with parents (P less than .001).
Very few pediatricians asked parents about their use of e-cigarettes (5%) or advised them about e-cigarettes’ harms (7%), and even fewer reported helping parents quit using them (2%). By contrast, more than half of pediatricians (60%) asked parents about smoking or advised them about tobacco use harms (52%), and nearly one-third (31%) reported helping parents quit smoking (P less than .001 for all comparisons).
The biggest barrier to discussing e-cigarettes with families was, as with discussing tobacco, not having enough time. But about twice as many respondents cited insufficient knowledge as a barrier for e-cigarettes as for tobacco (P = .003). A small percentage of respondents (less than 20%) also reported feeling unsure about the harm of e-cigarettes (P = .001).
Lack of training was a significant barrier to physicians’ discussion of e-cigarettes as well. Many more physicians reported receiving training in medical school on tobacco and traditional cigarettes (78%) than on e-cigarettes (13%), possibly because of how recently e-cigarettes have become widely available (P less than .001).
More physicians reported receiving training related to e-cigarettes during residency (36%), but it still fell well short of how many reported other tobacco and smoking training during residency (61%; P = .001).
The findings “emphasize the importance of increasing training about e-cig counseling,” Dr. Heinly and her associates concluded.
The researchers noted no external funding or disclosures.
BALTIMORE – according to a recent study.
“Providers are aware of the increased prevalence, harms [of e-cigs] and [the] positive impact of counseling teens about e-cigs,” said Allison Heinly, MD, of Hasbro Children’s Hospital in Providence, R.I., and her colleagues. But, “providers are less likely to ask, advise, or assist parents [and teens] regarding e-cig use, compared to tobacco, and are less comfortable doing so.” The researchers presented their findings at the Pediatric Academic Societies annual meeting.
A variety of concerns exist regarding ingredients in e-cigarettes, Dr. Heinly noted, including nicotine, volatile organic compounds, carcinogenic chemicals, flavorings, and ultra-fine particles.
Dr. Heinly and her associates aimed to assess pediatricians’ knowledge, attitudes, and behaviors toward both teens’ and parents’ use of e-cigarettes, as well as the barrier pediatricians perceived when it came to screening and counseling those who use e-cigarettes.
Among 69 providers at a large Northeastern urban academic primary care clinic who received surveys, 62 responded, primarily residents (84%). The respondents included 44 pediatric residents, eight triple-board residents, and 10 attending physicians.
The researchers collapsed “most of the time”/“always” and “some of the time”/“never” responses into two categories.
Most of the respondents (82%) knew e-cigarettes are the most common tobacco product that youth use, and nearly all (97%) believed e-cigarettes were addictive and harmful to users’ health. In addition, most (79%) believed using e-cigarettes could be a pathway toward students beginning to use other drugs.
Even though respondents believed counseling teens about use of tobacco or e-cigarettes can reduce the likelihood that they will start using them, providers were much less likely to discuss e-cigarettes than tobacco with teens.
Nearly all the doctors (97%) reported asking teens about their use of tobacco, but only about half (52%) asked about e-cigarette use (P less than .001). And only about one in five doctors (21%) reported counseling teens about using e-cigarettes, compared with 47% of those who advised teens regarding tobacco use (P = .002).
Over a third of responding physicians (37%) reported helping adolescent patients quit using tobacco, but just 7% reported doing so with e-cigarettes (P less than .001).
Doctors overwhelmingly reported feeling comfortable talking about tobacco with teens (98%), but fewer felt comfortable discussing e-cigarettes (77%; P less than .001). Respondents similarly were less comfortable discussing e-cigarettes (55%) than tobacco (87%) with parents (P less than .001).
Very few pediatricians asked parents about their use of e-cigarettes (5%) or advised them about e-cigarettes’ harms (7%), and even fewer reported helping parents quit using them (2%). By contrast, more than half of pediatricians (60%) asked parents about smoking or advised them about tobacco use harms (52%), and nearly one-third (31%) reported helping parents quit smoking (P less than .001 for all comparisons).
The biggest barrier to discussing e-cigarettes with families was, as with discussing tobacco, not having enough time. But about twice as many respondents cited insufficient knowledge as a barrier for e-cigarettes as for tobacco (P = .003). A small percentage of respondents (less than 20%) also reported feeling unsure about the harm of e-cigarettes (P = .001).
Lack of training was a significant barrier to physicians’ discussion of e-cigarettes as well. Many more physicians reported receiving training in medical school on tobacco and traditional cigarettes (78%) than on e-cigarettes (13%), possibly because of how recently e-cigarettes have become widely available (P less than .001).
More physicians reported receiving training related to e-cigarettes during residency (36%), but it still fell well short of how many reported other tobacco and smoking training during residency (61%; P = .001).
The findings “emphasize the importance of increasing training about e-cig counseling,” Dr. Heinly and her associates concluded.
The researchers noted no external funding or disclosures.
BALTIMORE – according to a recent study.
“Providers are aware of the increased prevalence, harms [of e-cigs] and [the] positive impact of counseling teens about e-cigs,” said Allison Heinly, MD, of Hasbro Children’s Hospital in Providence, R.I., and her colleagues. But, “providers are less likely to ask, advise, or assist parents [and teens] regarding e-cig use, compared to tobacco, and are less comfortable doing so.” The researchers presented their findings at the Pediatric Academic Societies annual meeting.
A variety of concerns exist regarding ingredients in e-cigarettes, Dr. Heinly noted, including nicotine, volatile organic compounds, carcinogenic chemicals, flavorings, and ultra-fine particles.
Dr. Heinly and her associates aimed to assess pediatricians’ knowledge, attitudes, and behaviors toward both teens’ and parents’ use of e-cigarettes, as well as the barrier pediatricians perceived when it came to screening and counseling those who use e-cigarettes.
Among 69 providers at a large Northeastern urban academic primary care clinic who received surveys, 62 responded, primarily residents (84%). The respondents included 44 pediatric residents, eight triple-board residents, and 10 attending physicians.
The researchers collapsed “most of the time”/“always” and “some of the time”/“never” responses into two categories.
Most of the respondents (82%) knew e-cigarettes are the most common tobacco product that youth use, and nearly all (97%) believed e-cigarettes were addictive and harmful to users’ health. In addition, most (79%) believed using e-cigarettes could be a pathway toward students beginning to use other drugs.
Even though respondents believed counseling teens about use of tobacco or e-cigarettes can reduce the likelihood that they will start using them, providers were much less likely to discuss e-cigarettes than tobacco with teens.
Nearly all the doctors (97%) reported asking teens about their use of tobacco, but only about half (52%) asked about e-cigarette use (P less than .001). And only about one in five doctors (21%) reported counseling teens about using e-cigarettes, compared with 47% of those who advised teens regarding tobacco use (P = .002).
Over a third of responding physicians (37%) reported helping adolescent patients quit using tobacco, but just 7% reported doing so with e-cigarettes (P less than .001).
Doctors overwhelmingly reported feeling comfortable talking about tobacco with teens (98%), but fewer felt comfortable discussing e-cigarettes (77%; P less than .001). Respondents similarly were less comfortable discussing e-cigarettes (55%) than tobacco (87%) with parents (P less than .001).
Very few pediatricians asked parents about their use of e-cigarettes (5%) or advised them about e-cigarettes’ harms (7%), and even fewer reported helping parents quit using them (2%). By contrast, more than half of pediatricians (60%) asked parents about smoking or advised them about tobacco use harms (52%), and nearly one-third (31%) reported helping parents quit smoking (P less than .001 for all comparisons).
The biggest barrier to discussing e-cigarettes with families was, as with discussing tobacco, not having enough time. But about twice as many respondents cited insufficient knowledge as a barrier for e-cigarettes as for tobacco (P = .003). A small percentage of respondents (less than 20%) also reported feeling unsure about the harm of e-cigarettes (P = .001).
Lack of training was a significant barrier to physicians’ discussion of e-cigarettes as well. Many more physicians reported receiving training in medical school on tobacco and traditional cigarettes (78%) than on e-cigarettes (13%), possibly because of how recently e-cigarettes have become widely available (P less than .001).
More physicians reported receiving training related to e-cigarettes during residency (36%), but it still fell well short of how many reported other tobacco and smoking training during residency (61%; P = .001).
The findings “emphasize the importance of increasing training about e-cig counseling,” Dr. Heinly and her associates concluded.
The researchers noted no external funding or disclosures.
REPORTING FROM PAS 2019
Key clinical point: Physicians report less training and less comfort when discussing e-cigarettes with teens and parents than when discussing tobacco products.
Major finding: 7% of physicians reported helping adolescent patients quit using e-cigarettes, compared with 37% helping with quitting tobacco use (P less than .001).
Study details: The findings are based on a cross-sectional survey of 62 pediatric residents and attendings at a large urban academic primary care clinic in the Northeast.
Disclosures: The researchers noted no external funding or disclosures.
Lack of inhaler at school a major barrier to asthma care
BALTIMORE – frequently because the parent did not provide an inhaler or did not provide a written order for one, according to new research. Only seven U.S. states have laws allowing schools to stock albuterol for students.
“Most students only have access to this lifesaving medication when they bring a personal inhaler,” Alexandra M. Sims, MD, of Children’s National Hospital in Washington and colleagues wrote in their abstract at the annual meeting of Pediatric Academic Societies. “Interventions that address medication availability may be an important step in removing obstacles to asthma care in school.”
One such option is a stock inhaler available for any students to use. National guidelines from the Centers for Disease Control and Prevention recommend that students with asthma have access to inhaled albuterol at school, yet most states do not have legislation related to albuterol stocking in schools, according to the Asthma and Allergy Foundation of America.
Not having access to rescue inhaler medication at school contributes to lost class time and referrals to the emergency department, the authors note in their background information. Yet, “in most U.S. jurisdictions, including the school district we examined, students need both a personal albuterol inhaler and a physician order to receive medication at school.”
To determine what barriers exist regarding students’ asthma care in schools, the authors sent 166 school nurses in an urban school district an anonymous survey during the 2015-2016 school year. The survey asked about 21 factors that could delay or prevent students from returning to class and asked nurses’ agreement or disagreement with 25 additional statements.
The 130 respondents made up a 78% response rate. The institutions represented by the nurses included 44% elementary schools, 9% middle schools, 16% high schools, and 32% other (such as those who may serve multiple schools).
The majority of respondents (72%) agreed that asthma is one of the biggest health problems students face, particularly among middle and high school students (P less than .05). Most (74%) also said an albuterol inhaler at school could reduce the likelihood of students with asthma needing to leave school early.
The largest barrier to students returning to class was parents not providing an albuterol inhaler and/or a written order for an inhaler despite a request from the nurse, according to 69% of the respondents (P less than .05). In high schools in particular, another barrier was students simply not bringing their inhaler to school even though they usually carry one (P less than .01).
Only 15% of nurses saw disease severity as a significant barrier, and 17% cited the staff not adequately recognizing a student’s symptoms.
The researchers did not note use of external funding or author disclosures.
BALTIMORE – frequently because the parent did not provide an inhaler or did not provide a written order for one, according to new research. Only seven U.S. states have laws allowing schools to stock albuterol for students.
“Most students only have access to this lifesaving medication when they bring a personal inhaler,” Alexandra M. Sims, MD, of Children’s National Hospital in Washington and colleagues wrote in their abstract at the annual meeting of Pediatric Academic Societies. “Interventions that address medication availability may be an important step in removing obstacles to asthma care in school.”
One such option is a stock inhaler available for any students to use. National guidelines from the Centers for Disease Control and Prevention recommend that students with asthma have access to inhaled albuterol at school, yet most states do not have legislation related to albuterol stocking in schools, according to the Asthma and Allergy Foundation of America.
Not having access to rescue inhaler medication at school contributes to lost class time and referrals to the emergency department, the authors note in their background information. Yet, “in most U.S. jurisdictions, including the school district we examined, students need both a personal albuterol inhaler and a physician order to receive medication at school.”
To determine what barriers exist regarding students’ asthma care in schools, the authors sent 166 school nurses in an urban school district an anonymous survey during the 2015-2016 school year. The survey asked about 21 factors that could delay or prevent students from returning to class and asked nurses’ agreement or disagreement with 25 additional statements.
The 130 respondents made up a 78% response rate. The institutions represented by the nurses included 44% elementary schools, 9% middle schools, 16% high schools, and 32% other (such as those who may serve multiple schools).
The majority of respondents (72%) agreed that asthma is one of the biggest health problems students face, particularly among middle and high school students (P less than .05). Most (74%) also said an albuterol inhaler at school could reduce the likelihood of students with asthma needing to leave school early.
The largest barrier to students returning to class was parents not providing an albuterol inhaler and/or a written order for an inhaler despite a request from the nurse, according to 69% of the respondents (P less than .05). In high schools in particular, another barrier was students simply not bringing their inhaler to school even though they usually carry one (P less than .01).
Only 15% of nurses saw disease severity as a significant barrier, and 17% cited the staff not adequately recognizing a student’s symptoms.
The researchers did not note use of external funding or author disclosures.
BALTIMORE – frequently because the parent did not provide an inhaler or did not provide a written order for one, according to new research. Only seven U.S. states have laws allowing schools to stock albuterol for students.
“Most students only have access to this lifesaving medication when they bring a personal inhaler,” Alexandra M. Sims, MD, of Children’s National Hospital in Washington and colleagues wrote in their abstract at the annual meeting of Pediatric Academic Societies. “Interventions that address medication availability may be an important step in removing obstacles to asthma care in school.”
One such option is a stock inhaler available for any students to use. National guidelines from the Centers for Disease Control and Prevention recommend that students with asthma have access to inhaled albuterol at school, yet most states do not have legislation related to albuterol stocking in schools, according to the Asthma and Allergy Foundation of America.
Not having access to rescue inhaler medication at school contributes to lost class time and referrals to the emergency department, the authors note in their background information. Yet, “in most U.S. jurisdictions, including the school district we examined, students need both a personal albuterol inhaler and a physician order to receive medication at school.”
To determine what barriers exist regarding students’ asthma care in schools, the authors sent 166 school nurses in an urban school district an anonymous survey during the 2015-2016 school year. The survey asked about 21 factors that could delay or prevent students from returning to class and asked nurses’ agreement or disagreement with 25 additional statements.
The 130 respondents made up a 78% response rate. The institutions represented by the nurses included 44% elementary schools, 9% middle schools, 16% high schools, and 32% other (such as those who may serve multiple schools).
The majority of respondents (72%) agreed that asthma is one of the biggest health problems students face, particularly among middle and high school students (P less than .05). Most (74%) also said an albuterol inhaler at school could reduce the likelihood of students with asthma needing to leave school early.
The largest barrier to students returning to class was parents not providing an albuterol inhaler and/or a written order for an inhaler despite a request from the nurse, according to 69% of the respondents (P less than .05). In high schools in particular, another barrier was students simply not bringing their inhaler to school even though they usually carry one (P less than .01).
Only 15% of nurses saw disease severity as a significant barrier, and 17% cited the staff not adequately recognizing a student’s symptoms.
The researchers did not note use of external funding or author disclosures.
REPORTING FROM PAS 2019
Some “slime”-related contact dermatitis is allergic
The viscous homemade children’s plaything known as “slime” has been associated with allergic, as well as irritant, contact dermatitis of the hands thanks to an array of possible compounds with which it can be made, according to a case report in Pediatric Dermatology. The report details many possible compounds causing the dermatitis reactions seen by health care professionals.
In the case, which was reported by L. Elizabeth Anderson, MD, of the Children’s Hospital of Philadelphia and colleagues, an 11-year-old girl with a history of atopic dermatitis presented with hand dermatitis that was suspected to be related to playing with slime. After her dermatitis failed to respond to strong topical steroids, she was referred for patch testing, with positivity for methylchloroisothiazolinone/methylisothiazolinone (MCI/MI). After all contact with any products containing MCI/MI was eliminated, her hand dermatitis cleared, and bodywide atopic dermatitis improved some as well.
MCI/MI and MI are among the most commonly suspected culprits in cases of slime-related contact dermatitis. Although most cases are irritant contact dermatitis, some are allergic and can be detected using patch tests. MCI/MI is included in the T.R.U.E. Test, but according to the case report, 37% of patients with allergy to MI alone will not have positive response with the T.R.U.E. Test because of the low concentrations of MI in that test. The authors of this case report also listed many other the potential allergens in popular slime recipes; however, many are not included in the T.R.U.E. Test.
“While the T.R.U.E. Test does not capture most of the potential allergens in popular slime recipes, the recently published Pediatric Baseline Patch Test Series by Yu et al. [Dermatitis. 2018;29:206-12] does and is recommended for use in patients suspected of having dermatitis secondary to slime,” Dr. Anderson and associates wrote.
SOURCE: Anderson LE et al. Pediatr Dermatol. 2019 Mar 13. doi: 10.1111/pde.13792.
The viscous homemade children’s plaything known as “slime” has been associated with allergic, as well as irritant, contact dermatitis of the hands thanks to an array of possible compounds with which it can be made, according to a case report in Pediatric Dermatology. The report details many possible compounds causing the dermatitis reactions seen by health care professionals.
In the case, which was reported by L. Elizabeth Anderson, MD, of the Children’s Hospital of Philadelphia and colleagues, an 11-year-old girl with a history of atopic dermatitis presented with hand dermatitis that was suspected to be related to playing with slime. After her dermatitis failed to respond to strong topical steroids, she was referred for patch testing, with positivity for methylchloroisothiazolinone/methylisothiazolinone (MCI/MI). After all contact with any products containing MCI/MI was eliminated, her hand dermatitis cleared, and bodywide atopic dermatitis improved some as well.
MCI/MI and MI are among the most commonly suspected culprits in cases of slime-related contact dermatitis. Although most cases are irritant contact dermatitis, some are allergic and can be detected using patch tests. MCI/MI is included in the T.R.U.E. Test, but according to the case report, 37% of patients with allergy to MI alone will not have positive response with the T.R.U.E. Test because of the low concentrations of MI in that test. The authors of this case report also listed many other the potential allergens in popular slime recipes; however, many are not included in the T.R.U.E. Test.
“While the T.R.U.E. Test does not capture most of the potential allergens in popular slime recipes, the recently published Pediatric Baseline Patch Test Series by Yu et al. [Dermatitis. 2018;29:206-12] does and is recommended for use in patients suspected of having dermatitis secondary to slime,” Dr. Anderson and associates wrote.
SOURCE: Anderson LE et al. Pediatr Dermatol. 2019 Mar 13. doi: 10.1111/pde.13792.
The viscous homemade children’s plaything known as “slime” has been associated with allergic, as well as irritant, contact dermatitis of the hands thanks to an array of possible compounds with which it can be made, according to a case report in Pediatric Dermatology. The report details many possible compounds causing the dermatitis reactions seen by health care professionals.
In the case, which was reported by L. Elizabeth Anderson, MD, of the Children’s Hospital of Philadelphia and colleagues, an 11-year-old girl with a history of atopic dermatitis presented with hand dermatitis that was suspected to be related to playing with slime. After her dermatitis failed to respond to strong topical steroids, she was referred for patch testing, with positivity for methylchloroisothiazolinone/methylisothiazolinone (MCI/MI). After all contact with any products containing MCI/MI was eliminated, her hand dermatitis cleared, and bodywide atopic dermatitis improved some as well.
MCI/MI and MI are among the most commonly suspected culprits in cases of slime-related contact dermatitis. Although most cases are irritant contact dermatitis, some are allergic and can be detected using patch tests. MCI/MI is included in the T.R.U.E. Test, but according to the case report, 37% of patients with allergy to MI alone will not have positive response with the T.R.U.E. Test because of the low concentrations of MI in that test. The authors of this case report also listed many other the potential allergens in popular slime recipes; however, many are not included in the T.R.U.E. Test.
“While the T.R.U.E. Test does not capture most of the potential allergens in popular slime recipes, the recently published Pediatric Baseline Patch Test Series by Yu et al. [Dermatitis. 2018;29:206-12] does and is recommended for use in patients suspected of having dermatitis secondary to slime,” Dr. Anderson and associates wrote.
SOURCE: Anderson LE et al. Pediatr Dermatol. 2019 Mar 13. doi: 10.1111/pde.13792.
FROM PEDIATRIC DERMATOLOGY
Consider measles vaccine booster in HIV-positive patients
LJUBLJANA, SLOVENIA – A “surprisingly low” prevalence of protective antibodies against measles is present in adolescents and adults living with HIV infection despite their prior vaccination against the resurgent disease, Raquel M. Simakawa, MD, reported at the annual meeting of the European Society for Paediatric Infectious Diseases.
“With the present concern about the global reemergence of measles, we should consider measuring measles antibodies in people living with HIV, especially those who acquired the infection vertically, and then revaccinating those with low titers,” said Dr. Simakawa of the Federal University of São Paolo.
She presented interim findings of an ongoing study of the measles immunologic status of persons living with HIV, which for this analysis included 57 patients who acquired HIV from their mother via vertical transmission and 24 with horizontally acquired HIV. The vertical-transmission group was significantly younger, with a median age of 20 years, compared with 31 years in the horizontal group, who were diagnosed with HIV infection at an average age of 24 years. The vast majority of subjects were on combination antiretroviral therapy. No detectable HIV viral load had been present for a median of 70 months in the vertical group and 25 months in the horizontal group.
Only a mere 7% of the vertical transmission group had protective levels of measles IgG antibodies as measured by enzyme-linked immunosorbent assay, as did 29% of the horizontal group. The likely explanation for the higher rate of protection in the horizontal group, she said, is that they received their routine measles vaccination before they acquired HIV infection, and some of them didn’t lose their protective antibodies during their immune system’s fight against HIV infection.
Session chair Nico G. Hartwig, MD, of Franciscus Hospital in Rotterdam, the Netherlands, posed a question: Given the sky-high rate of measles seronegativity status among the vertically transmitted HIV-positive group – the patient population pediatricians focus on – why bother to measure their measles antibody level? Why not just give them all a measles booster?
Dr. Simakawa replied that that’s worth considering in routine clinical practice now that her study has shown that this group is more vulnerable to measles because of their poor response to immunization. But the study is ongoing, with larger numbers of patients to be enrolled. Also, in the second phase of the study, which will include a control group, measles IgG antibodies will be remeasured 1 month after administration of a new dose of measles vaccine.
She reported having no financial conflicts regarding this study, conducted free of commercial support.
LJUBLJANA, SLOVENIA – A “surprisingly low” prevalence of protective antibodies against measles is present in adolescents and adults living with HIV infection despite their prior vaccination against the resurgent disease, Raquel M. Simakawa, MD, reported at the annual meeting of the European Society for Paediatric Infectious Diseases.
“With the present concern about the global reemergence of measles, we should consider measuring measles antibodies in people living with HIV, especially those who acquired the infection vertically, and then revaccinating those with low titers,” said Dr. Simakawa of the Federal University of São Paolo.
She presented interim findings of an ongoing study of the measles immunologic status of persons living with HIV, which for this analysis included 57 patients who acquired HIV from their mother via vertical transmission and 24 with horizontally acquired HIV. The vertical-transmission group was significantly younger, with a median age of 20 years, compared with 31 years in the horizontal group, who were diagnosed with HIV infection at an average age of 24 years. The vast majority of subjects were on combination antiretroviral therapy. No detectable HIV viral load had been present for a median of 70 months in the vertical group and 25 months in the horizontal group.
Only a mere 7% of the vertical transmission group had protective levels of measles IgG antibodies as measured by enzyme-linked immunosorbent assay, as did 29% of the horizontal group. The likely explanation for the higher rate of protection in the horizontal group, she said, is that they received their routine measles vaccination before they acquired HIV infection, and some of them didn’t lose their protective antibodies during their immune system’s fight against HIV infection.
Session chair Nico G. Hartwig, MD, of Franciscus Hospital in Rotterdam, the Netherlands, posed a question: Given the sky-high rate of measles seronegativity status among the vertically transmitted HIV-positive group – the patient population pediatricians focus on – why bother to measure their measles antibody level? Why not just give them all a measles booster?
Dr. Simakawa replied that that’s worth considering in routine clinical practice now that her study has shown that this group is more vulnerable to measles because of their poor response to immunization. But the study is ongoing, with larger numbers of patients to be enrolled. Also, in the second phase of the study, which will include a control group, measles IgG antibodies will be remeasured 1 month after administration of a new dose of measles vaccine.
She reported having no financial conflicts regarding this study, conducted free of commercial support.
LJUBLJANA, SLOVENIA – A “surprisingly low” prevalence of protective antibodies against measles is present in adolescents and adults living with HIV infection despite their prior vaccination against the resurgent disease, Raquel M. Simakawa, MD, reported at the annual meeting of the European Society for Paediatric Infectious Diseases.
“With the present concern about the global reemergence of measles, we should consider measuring measles antibodies in people living with HIV, especially those who acquired the infection vertically, and then revaccinating those with low titers,” said Dr. Simakawa of the Federal University of São Paolo.
She presented interim findings of an ongoing study of the measles immunologic status of persons living with HIV, which for this analysis included 57 patients who acquired HIV from their mother via vertical transmission and 24 with horizontally acquired HIV. The vertical-transmission group was significantly younger, with a median age of 20 years, compared with 31 years in the horizontal group, who were diagnosed with HIV infection at an average age of 24 years. The vast majority of subjects were on combination antiretroviral therapy. No detectable HIV viral load had been present for a median of 70 months in the vertical group and 25 months in the horizontal group.
Only a mere 7% of the vertical transmission group had protective levels of measles IgG antibodies as measured by enzyme-linked immunosorbent assay, as did 29% of the horizontal group. The likely explanation for the higher rate of protection in the horizontal group, she said, is that they received their routine measles vaccination before they acquired HIV infection, and some of them didn’t lose their protective antibodies during their immune system’s fight against HIV infection.
Session chair Nico G. Hartwig, MD, of Franciscus Hospital in Rotterdam, the Netherlands, posed a question: Given the sky-high rate of measles seronegativity status among the vertically transmitted HIV-positive group – the patient population pediatricians focus on – why bother to measure their measles antibody level? Why not just give them all a measles booster?
Dr. Simakawa replied that that’s worth considering in routine clinical practice now that her study has shown that this group is more vulnerable to measles because of their poor response to immunization. But the study is ongoing, with larger numbers of patients to be enrolled. Also, in the second phase of the study, which will include a control group, measles IgG antibodies will be remeasured 1 month after administration of a new dose of measles vaccine.
She reported having no financial conflicts regarding this study, conducted free of commercial support.
REPORTING FROM ESPID 2019
Obesity doesn’t hamper flu vaccine response in pregnancy
LJUBLJANA, SLOVENIA – ; indeed, it might actually improve their seroconversion rate, Michelle Clarke reported at the annual meeting of the European Society for Paediatric Infectious Diseases.
She presented a prospective cohort study of 90 women vaccinated against influenza during pregnancy, 24 of whom had a BMI of 30 kg/m2 or more. The impetus for the study was the investigators’ understanding that influenza in pregnancy carries an increased risk of severe complications, obesity is a known risk factor for more severe episodes of influenza, and vaccine responses could potentially be adversely affected by obesity, either because of the associated inflammatory state and altered cytokine profile or inadequate vaccine delivery via the intramuscular route. Yet the impact of obesity on vaccine responses in pregnancy has been unclear.
Blood samples obtained before and 1 month after vaccination showed similarly high-titer postvaccination seropositivity rates against influenza B, H3N2, and H1N1 regardless of the women’s weight status. Indeed, the seropositivity rate against all three influenza viruses was higher in the obese subgroup, by a margin of 92%-74%. Also, postvaccination geometric mean antibody titers were significantly higher in the obese group. Particularly impressive was the difference in H1N1 seroconversion, defined as a fourfold increase in titer 28 days after vaccination: 79% versus 55%, noted Ms. Clarke of the University of Adelaide.
Of note, influenza vaccination in the first trimester resulted in a significantly lower seropositive antibody rate than vaccination in the second or third trimesters. The implication is that gestational age at vaccination, regardless of BMI, may be an important determinant of optimal vaccine protection for mothers and their newborns. However, this tentative conclusion requires confirmation in an independent larger sample, because the patient numbers in the study were small: Seropositive antibodies to all three vaccine antigens were documented in just 7 of 12 women (58%) vaccinated in the first trimester, compared with 47 of 53 (89%) vaccinated in the second trimester and 18 of 25 (72%) in the third.
Ms. Clarke reported having no financial conflicts regarding the study, which was supported by the Women’s and Children’s Hospital Research Foundation.
LJUBLJANA, SLOVENIA – ; indeed, it might actually improve their seroconversion rate, Michelle Clarke reported at the annual meeting of the European Society for Paediatric Infectious Diseases.
She presented a prospective cohort study of 90 women vaccinated against influenza during pregnancy, 24 of whom had a BMI of 30 kg/m2 or more. The impetus for the study was the investigators’ understanding that influenza in pregnancy carries an increased risk of severe complications, obesity is a known risk factor for more severe episodes of influenza, and vaccine responses could potentially be adversely affected by obesity, either because of the associated inflammatory state and altered cytokine profile or inadequate vaccine delivery via the intramuscular route. Yet the impact of obesity on vaccine responses in pregnancy has been unclear.
Blood samples obtained before and 1 month after vaccination showed similarly high-titer postvaccination seropositivity rates against influenza B, H3N2, and H1N1 regardless of the women’s weight status. Indeed, the seropositivity rate against all three influenza viruses was higher in the obese subgroup, by a margin of 92%-74%. Also, postvaccination geometric mean antibody titers were significantly higher in the obese group. Particularly impressive was the difference in H1N1 seroconversion, defined as a fourfold increase in titer 28 days after vaccination: 79% versus 55%, noted Ms. Clarke of the University of Adelaide.
Of note, influenza vaccination in the first trimester resulted in a significantly lower seropositive antibody rate than vaccination in the second or third trimesters. The implication is that gestational age at vaccination, regardless of BMI, may be an important determinant of optimal vaccine protection for mothers and their newborns. However, this tentative conclusion requires confirmation in an independent larger sample, because the patient numbers in the study were small: Seropositive antibodies to all three vaccine antigens were documented in just 7 of 12 women (58%) vaccinated in the first trimester, compared with 47 of 53 (89%) vaccinated in the second trimester and 18 of 25 (72%) in the third.
Ms. Clarke reported having no financial conflicts regarding the study, which was supported by the Women’s and Children’s Hospital Research Foundation.
LJUBLJANA, SLOVENIA – ; indeed, it might actually improve their seroconversion rate, Michelle Clarke reported at the annual meeting of the European Society for Paediatric Infectious Diseases.
She presented a prospective cohort study of 90 women vaccinated against influenza during pregnancy, 24 of whom had a BMI of 30 kg/m2 or more. The impetus for the study was the investigators’ understanding that influenza in pregnancy carries an increased risk of severe complications, obesity is a known risk factor for more severe episodes of influenza, and vaccine responses could potentially be adversely affected by obesity, either because of the associated inflammatory state and altered cytokine profile or inadequate vaccine delivery via the intramuscular route. Yet the impact of obesity on vaccine responses in pregnancy has been unclear.
Blood samples obtained before and 1 month after vaccination showed similarly high-titer postvaccination seropositivity rates against influenza B, H3N2, and H1N1 regardless of the women’s weight status. Indeed, the seropositivity rate against all three influenza viruses was higher in the obese subgroup, by a margin of 92%-74%. Also, postvaccination geometric mean antibody titers were significantly higher in the obese group. Particularly impressive was the difference in H1N1 seroconversion, defined as a fourfold increase in titer 28 days after vaccination: 79% versus 55%, noted Ms. Clarke of the University of Adelaide.
Of note, influenza vaccination in the first trimester resulted in a significantly lower seropositive antibody rate than vaccination in the second or third trimesters. The implication is that gestational age at vaccination, regardless of BMI, may be an important determinant of optimal vaccine protection for mothers and their newborns. However, this tentative conclusion requires confirmation in an independent larger sample, because the patient numbers in the study were small: Seropositive antibodies to all three vaccine antigens were documented in just 7 of 12 women (58%) vaccinated in the first trimester, compared with 47 of 53 (89%) vaccinated in the second trimester and 18 of 25 (72%) in the third.
Ms. Clarke reported having no financial conflicts regarding the study, which was supported by the Women’s and Children’s Hospital Research Foundation.
REPORTING FROM ESPID 2019
Key clinical point: High BMI doesn’t impair influenza vaccine responses in pregnant women.
Major finding: Protective antibody levels against all three vaccine antigens were documented 1 month post vaccination in 92% of the obese and 74% of the nonobese mothers.
Study details: This was a prospective observational study of 90 women vaccinated against influenza during pregnancy, 24 of whom were obese.
Disclosures: The study was supported by the University of Adelaide Women’s and Children’s Hospital Research Foundation.
Pharmacist-prescribed hormonal contraception safe, effective
Pharmacists in Oregon with the authority to prescribe hormonal contraceptive therapy have improved access to and continuation of contraceptive therapy, based on two retrospective studies of Medicaid patients published in Obstetrics & Gynecology.
Additionally, the safety profile associated with pharmacist prescribing of hormonal contraceptive therapy was on par with that of other prescribing clinicians.
“In the first 2 years of program implementation, we found evidence that pharmacists were safely reaching new contraceptive users and [helping to meet national goals in reducing unwanted pregnancy],” Lorinda Anderson, PharmD, and colleagues, the authors of one of the studies, wrote.
In 2016, Oregon became the first state to grant pharmacists authority to prescribe hormonal contraception without requiring consultation. The findings suggest that expanding prescribing authority for contraceptive therapy to pharmacists in other states could limit barriers to access, as 90% of United States residents live within 5 miles of a pharmacy.
In one of the two studies, Maria I. Rodriguez, MD, MPH, and colleagues conducted a claims-based review of the primary outcomes of pharmacist-initiated and non-pharmacist-initiated prescriptions on unintended pregnancies in Oregon’s Medicaid program. They also evaluated secondary outcomes, such as costs and quality-adjusted life years (QALYs).
In the first 2 years after the Oregon law went into effect, 248 pharmacists wrote 1,313, or 10%, of all hormonal contraception prescriptions for women who were Medicaid recipients and were prescribed hormonal contraception by any legally allowed healthcare provider. Pharmacists prescribed hormonal contraception for 367 of the 3,614 women studied.
Based on an economic model, pharmacist-initiated hormonal contraceptive therapy prevented an estimated 51 unintended pregnancies and saved $1.6 million in the first two years following the program’s inception in Oregon. Quality of life improved with 158 QALYs per 198,100 women.
Additionally, pharmacist-provided services cost less per patient than non pharmacist health care provider-services, $28 vs. $81.
“We believe our findings to be conservative given that our model was based on use 24 months after implementation. We expect over time that knowledge of and use of contraceptive access from pharmacists will increase,” Dr. Rodriguez, of Oregon Health & Science University, Portland, and colleagues wrote.
In the second study, Dr. Anderson, of the Oregon State University, Corvallis, and colleagues pooled Oregon Medicaid pharmacy claims, eligibility, medical, diagnostic, and demographic data over the 2-year period for the 3,614 patients who received new prescriptions for transdermal and oral contraception, and the 1,313 claims filed for 367 women prescribed contraception by 162 pharmacists.
Within the first 4 months following the program’s inception in Oregon, pharmacists averaged 40 contraceptive claims per month. Over the next 7 months, claims increased to 61 and peaked at 80 claims after 18 months. Chain community pharmacies accounted for 94% of the claims; 71% of claims were in metropolitan areas.
Based on demographics, 73.8% of the women who were prescribed contraception by a pharmacist were first-time recipients. Combined oral contraception was prescribed for 90.5% of the women, and 82% of the women were 18-35 years of age. In the 180-day period prior to receiving pharmacist-prescribed contraception, 61.5% of patients were not using contraception but were attempting to engage in pharmacy-provided hormonal contraceptive care.
The researchers also examined contraceptive safety by looking at whether patients with medical contraindications (Medical Eligibility Criteria Category 3 or 4) were receiving contraindicated methods. “We found that overall adherence to the clinical algorithm for prescribing pharmacists was high. Only 12 (5%) patients were identified as having Medical Eligibility Criteria Category 3 or 4 medical conditions, and two (less than 1%) patients with medications contraindicating OC use received a prescription,” Dr. Anderson and her colleagues wrote.
They noted that the initial legislation passed in Oregon only included oral and transdermal hormonal contraception as methods pharmacists could prescribe. In 2017, with implementation in 2018, this was amended to include the vaginal ring and injection. “As the program matures, and contracts with additional insurers are implemented at pharmacies, we expect the number of pharmacist prescriptions to increase,” the authors wrote.
Dr. Rodriguez reported financial compensation from Merck, the World Health Organization, CooperSurgical, and a previous relationship with Merck. Dr. Anderson reports no conflicts of interest.
SOURCES: Rodriguez M et al. Obstet Gynecol. 2019 Jun;133(6):1238-46; Anderson A et al. Obstet Gynecol. 2019 Jun;133(6):1231-7.
Pharmacists in Oregon with the authority to prescribe hormonal contraceptive therapy have improved access to and continuation of contraceptive therapy, based on two retrospective studies of Medicaid patients published in Obstetrics & Gynecology.
Additionally, the safety profile associated with pharmacist prescribing of hormonal contraceptive therapy was on par with that of other prescribing clinicians.
“In the first 2 years of program implementation, we found evidence that pharmacists were safely reaching new contraceptive users and [helping to meet national goals in reducing unwanted pregnancy],” Lorinda Anderson, PharmD, and colleagues, the authors of one of the studies, wrote.
In 2016, Oregon became the first state to grant pharmacists authority to prescribe hormonal contraception without requiring consultation. The findings suggest that expanding prescribing authority for contraceptive therapy to pharmacists in other states could limit barriers to access, as 90% of United States residents live within 5 miles of a pharmacy.
In one of the two studies, Maria I. Rodriguez, MD, MPH, and colleagues conducted a claims-based review of the primary outcomes of pharmacist-initiated and non-pharmacist-initiated prescriptions on unintended pregnancies in Oregon’s Medicaid program. They also evaluated secondary outcomes, such as costs and quality-adjusted life years (QALYs).
In the first 2 years after the Oregon law went into effect, 248 pharmacists wrote 1,313, or 10%, of all hormonal contraception prescriptions for women who were Medicaid recipients and were prescribed hormonal contraception by any legally allowed healthcare provider. Pharmacists prescribed hormonal contraception for 367 of the 3,614 women studied.
Based on an economic model, pharmacist-initiated hormonal contraceptive therapy prevented an estimated 51 unintended pregnancies and saved $1.6 million in the first two years following the program’s inception in Oregon. Quality of life improved with 158 QALYs per 198,100 women.
Additionally, pharmacist-provided services cost less per patient than non pharmacist health care provider-services, $28 vs. $81.
“We believe our findings to be conservative given that our model was based on use 24 months after implementation. We expect over time that knowledge of and use of contraceptive access from pharmacists will increase,” Dr. Rodriguez, of Oregon Health & Science University, Portland, and colleagues wrote.
In the second study, Dr. Anderson, of the Oregon State University, Corvallis, and colleagues pooled Oregon Medicaid pharmacy claims, eligibility, medical, diagnostic, and demographic data over the 2-year period for the 3,614 patients who received new prescriptions for transdermal and oral contraception, and the 1,313 claims filed for 367 women prescribed contraception by 162 pharmacists.
Within the first 4 months following the program’s inception in Oregon, pharmacists averaged 40 contraceptive claims per month. Over the next 7 months, claims increased to 61 and peaked at 80 claims after 18 months. Chain community pharmacies accounted for 94% of the claims; 71% of claims were in metropolitan areas.
Based on demographics, 73.8% of the women who were prescribed contraception by a pharmacist were first-time recipients. Combined oral contraception was prescribed for 90.5% of the women, and 82% of the women were 18-35 years of age. In the 180-day period prior to receiving pharmacist-prescribed contraception, 61.5% of patients were not using contraception but were attempting to engage in pharmacy-provided hormonal contraceptive care.
The researchers also examined contraceptive safety by looking at whether patients with medical contraindications (Medical Eligibility Criteria Category 3 or 4) were receiving contraindicated methods. “We found that overall adherence to the clinical algorithm for prescribing pharmacists was high. Only 12 (5%) patients were identified as having Medical Eligibility Criteria Category 3 or 4 medical conditions, and two (less than 1%) patients with medications contraindicating OC use received a prescription,” Dr. Anderson and her colleagues wrote.
They noted that the initial legislation passed in Oregon only included oral and transdermal hormonal contraception as methods pharmacists could prescribe. In 2017, with implementation in 2018, this was amended to include the vaginal ring and injection. “As the program matures, and contracts with additional insurers are implemented at pharmacies, we expect the number of pharmacist prescriptions to increase,” the authors wrote.
Dr. Rodriguez reported financial compensation from Merck, the World Health Organization, CooperSurgical, and a previous relationship with Merck. Dr. Anderson reports no conflicts of interest.
SOURCES: Rodriguez M et al. Obstet Gynecol. 2019 Jun;133(6):1238-46; Anderson A et al. Obstet Gynecol. 2019 Jun;133(6):1231-7.
Pharmacists in Oregon with the authority to prescribe hormonal contraceptive therapy have improved access to and continuation of contraceptive therapy, based on two retrospective studies of Medicaid patients published in Obstetrics & Gynecology.
Additionally, the safety profile associated with pharmacist prescribing of hormonal contraceptive therapy was on par with that of other prescribing clinicians.
“In the first 2 years of program implementation, we found evidence that pharmacists were safely reaching new contraceptive users and [helping to meet national goals in reducing unwanted pregnancy],” Lorinda Anderson, PharmD, and colleagues, the authors of one of the studies, wrote.
In 2016, Oregon became the first state to grant pharmacists authority to prescribe hormonal contraception without requiring consultation. The findings suggest that expanding prescribing authority for contraceptive therapy to pharmacists in other states could limit barriers to access, as 90% of United States residents live within 5 miles of a pharmacy.
In one of the two studies, Maria I. Rodriguez, MD, MPH, and colleagues conducted a claims-based review of the primary outcomes of pharmacist-initiated and non-pharmacist-initiated prescriptions on unintended pregnancies in Oregon’s Medicaid program. They also evaluated secondary outcomes, such as costs and quality-adjusted life years (QALYs).
In the first 2 years after the Oregon law went into effect, 248 pharmacists wrote 1,313, or 10%, of all hormonal contraception prescriptions for women who were Medicaid recipients and were prescribed hormonal contraception by any legally allowed healthcare provider. Pharmacists prescribed hormonal contraception for 367 of the 3,614 women studied.
Based on an economic model, pharmacist-initiated hormonal contraceptive therapy prevented an estimated 51 unintended pregnancies and saved $1.6 million in the first two years following the program’s inception in Oregon. Quality of life improved with 158 QALYs per 198,100 women.
Additionally, pharmacist-provided services cost less per patient than non pharmacist health care provider-services, $28 vs. $81.
“We believe our findings to be conservative given that our model was based on use 24 months after implementation. We expect over time that knowledge of and use of contraceptive access from pharmacists will increase,” Dr. Rodriguez, of Oregon Health & Science University, Portland, and colleagues wrote.
In the second study, Dr. Anderson, of the Oregon State University, Corvallis, and colleagues pooled Oregon Medicaid pharmacy claims, eligibility, medical, diagnostic, and demographic data over the 2-year period for the 3,614 patients who received new prescriptions for transdermal and oral contraception, and the 1,313 claims filed for 367 women prescribed contraception by 162 pharmacists.
Within the first 4 months following the program’s inception in Oregon, pharmacists averaged 40 contraceptive claims per month. Over the next 7 months, claims increased to 61 and peaked at 80 claims after 18 months. Chain community pharmacies accounted for 94% of the claims; 71% of claims were in metropolitan areas.
Based on demographics, 73.8% of the women who were prescribed contraception by a pharmacist were first-time recipients. Combined oral contraception was prescribed for 90.5% of the women, and 82% of the women were 18-35 years of age. In the 180-day period prior to receiving pharmacist-prescribed contraception, 61.5% of patients were not using contraception but were attempting to engage in pharmacy-provided hormonal contraceptive care.
The researchers also examined contraceptive safety by looking at whether patients with medical contraindications (Medical Eligibility Criteria Category 3 or 4) were receiving contraindicated methods. “We found that overall adherence to the clinical algorithm for prescribing pharmacists was high. Only 12 (5%) patients were identified as having Medical Eligibility Criteria Category 3 or 4 medical conditions, and two (less than 1%) patients with medications contraindicating OC use received a prescription,” Dr. Anderson and her colleagues wrote.
They noted that the initial legislation passed in Oregon only included oral and transdermal hormonal contraception as methods pharmacists could prescribe. In 2017, with implementation in 2018, this was amended to include the vaginal ring and injection. “As the program matures, and contracts with additional insurers are implemented at pharmacies, we expect the number of pharmacist prescriptions to increase,” the authors wrote.
Dr. Rodriguez reported financial compensation from Merck, the World Health Organization, CooperSurgical, and a previous relationship with Merck. Dr. Anderson reports no conflicts of interest.
SOURCES: Rodriguez M et al. Obstet Gynecol. 2019 Jun;133(6):1238-46; Anderson A et al. Obstet Gynecol. 2019 Jun;133(6):1231-7.
FROM OBSTETRICS & GYNECOLOGY
C-section linked to serious infection in preschoolers
LJUBLJANA, SLOVENIA – Delivery by C-section – especially when elective – carries a significantly higher hospitalization risk for severe infection in the first 5 years of life than vaginal delivery in a study of nearly 7.3 million singleton deliveries in four asset-rich countries, David Burgner, MD, PhD, reported at the annual meeting of the European Society for Paediatric Infectious Diseases.
“This is something that obstetricians might need to consider when discussing with the family the pros and cons for an elective C-section, particularly one that isn’t otherwise indicated for the baby or the mother,” said Dr. Burgner of the Murdoch Children’s Research Institute in Melbourne.
He presented an observational study of 7.29 million singleton births in Denmark, Great Britain, Scotland, and two Australian states during 1996-2015. C-section rates ranged from a low of 17.5% in Denmark to 29.4% in Western Australia, all of which are greater than the 10%-15% rate endorsed by the World Health Organization. Elective C-section rates varied by country from 39% to 57%. Of note, pediatric hospital care in all four countries is free, so economic considerations didn’t drive admission.
The impetus for this international collaboration was to gain new insight into the differential susceptibility to childhood infection, he explained.
“We know from our clinical practice that pretty much all of the children are exposed to pretty much all potentially serious pathogens during early life. And yet it’s only a minority that develop severe infection. It’s an extremely interesting scientific question and an extremely important clinical question as to what’s driving that differential susceptibility,” according to the pediatric infectious disease specialist.
There are a number of established risk factors for infection-related hospitalization in children, including parental smoking, maternal antibiotic exposure during pregnancy, and growth measurements at birth. Dr. Burgner and coinvestigators hypothesized that another important risk factor is the nature of the microbiome transmitted from mother to baby during delivery. This postnatal microbiome varies depending upon mode of delivery: Vaginal delivery transmits the maternal enteric microbiome, which they reasoned might be through direct immunomodulation that sets up protective immune responses early in life, especially against respiratory and gastrointestinal tract infections. In contrast, delivery by C-section causes the baby to pick up the maternal skin and hospital environment microbiomes, but not the maternal enteric microbiome.
Thus, the investigators hypothesized that C-section poses a greater risk of infection-related hospitalization during the first 5 years of life than does vaginal delivery, and that elective C-section poses a higher risk than does emergency C-section because it is more likely to involve rupture of membranes.
The center-specific rates of C-section and infection-related pediatric infection, when combined into a meta-analysis, bore out the study hypothesis. Emergency C-section was associated with a 9% greater risk of infection-related hospitalization through 5 years of age than was vaginal delivery, while elective C-section was associated with a 13% increased risk, both of which were statistically significant and clinically important.
“We were quite taken with these results. We think they provide evidence that C-section is consistently associated with infection-related hospitalization. It’s an association study that can’t prove causality, but the results implicate the postnatal microbiome as the most plausible explanation in terms of what’s driving this association,” according to Dr. Burgner.
The association between C-section and infection-related hospitalization was persistent throughout the preschool years. For example, the increased risk associated with elective C-section was 16% during age 0-3 months, 20% during months 4-6, 14% in months 7-12, 13% during ages 1-2 years, and 11% among 2- to 5-year-olds, he continued.
The increased risk of severe preschool infection was highest for upper and lower respiratory tract and gastrointestinal infections, which involve the organ systems most likely to experience direct inoculation of the maternal microbiome, he noted.
Because the investigators recognized that the study results were potentially vulnerable to confounding by indication – that is, that the reason for doing a C-section might itself confer increased risk of subsequent preschool infection-related hospitalization – they repeated their analysis in a predefined low-risk subpopulation. The results closely mirrored those in the overall study population: an 8% increased risk in the emergency C-section group and a 14% increased risk with elective C-section.
Results of this large multinational study should provide further support for ongoing research aimed at supporting the infant microbiome after delivery by C-section via vaginal microbial transfer and other methods, he observed.
Dr. Burgner reported having no financial conflicts regarding the study, which was cosponsored by the National Health and Medical Research Council of Australia, the Danish Council for Independent Research, and nonprofit foundations.
LJUBLJANA, SLOVENIA – Delivery by C-section – especially when elective – carries a significantly higher hospitalization risk for severe infection in the first 5 years of life than vaginal delivery in a study of nearly 7.3 million singleton deliveries in four asset-rich countries, David Burgner, MD, PhD, reported at the annual meeting of the European Society for Paediatric Infectious Diseases.
“This is something that obstetricians might need to consider when discussing with the family the pros and cons for an elective C-section, particularly one that isn’t otherwise indicated for the baby or the mother,” said Dr. Burgner of the Murdoch Children’s Research Institute in Melbourne.
He presented an observational study of 7.29 million singleton births in Denmark, Great Britain, Scotland, and two Australian states during 1996-2015. C-section rates ranged from a low of 17.5% in Denmark to 29.4% in Western Australia, all of which are greater than the 10%-15% rate endorsed by the World Health Organization. Elective C-section rates varied by country from 39% to 57%. Of note, pediatric hospital care in all four countries is free, so economic considerations didn’t drive admission.
The impetus for this international collaboration was to gain new insight into the differential susceptibility to childhood infection, he explained.
“We know from our clinical practice that pretty much all of the children are exposed to pretty much all potentially serious pathogens during early life. And yet it’s only a minority that develop severe infection. It’s an extremely interesting scientific question and an extremely important clinical question as to what’s driving that differential susceptibility,” according to the pediatric infectious disease specialist.
There are a number of established risk factors for infection-related hospitalization in children, including parental smoking, maternal antibiotic exposure during pregnancy, and growth measurements at birth. Dr. Burgner and coinvestigators hypothesized that another important risk factor is the nature of the microbiome transmitted from mother to baby during delivery. This postnatal microbiome varies depending upon mode of delivery: Vaginal delivery transmits the maternal enteric microbiome, which they reasoned might be through direct immunomodulation that sets up protective immune responses early in life, especially against respiratory and gastrointestinal tract infections. In contrast, delivery by C-section causes the baby to pick up the maternal skin and hospital environment microbiomes, but not the maternal enteric microbiome.
Thus, the investigators hypothesized that C-section poses a greater risk of infection-related hospitalization during the first 5 years of life than does vaginal delivery, and that elective C-section poses a higher risk than does emergency C-section because it is more likely to involve rupture of membranes.
The center-specific rates of C-section and infection-related pediatric infection, when combined into a meta-analysis, bore out the study hypothesis. Emergency C-section was associated with a 9% greater risk of infection-related hospitalization through 5 years of age than was vaginal delivery, while elective C-section was associated with a 13% increased risk, both of which were statistically significant and clinically important.
“We were quite taken with these results. We think they provide evidence that C-section is consistently associated with infection-related hospitalization. It’s an association study that can’t prove causality, but the results implicate the postnatal microbiome as the most plausible explanation in terms of what’s driving this association,” according to Dr. Burgner.
The association between C-section and infection-related hospitalization was persistent throughout the preschool years. For example, the increased risk associated with elective C-section was 16% during age 0-3 months, 20% during months 4-6, 14% in months 7-12, 13% during ages 1-2 years, and 11% among 2- to 5-year-olds, he continued.
The increased risk of severe preschool infection was highest for upper and lower respiratory tract and gastrointestinal infections, which involve the organ systems most likely to experience direct inoculation of the maternal microbiome, he noted.
Because the investigators recognized that the study results were potentially vulnerable to confounding by indication – that is, that the reason for doing a C-section might itself confer increased risk of subsequent preschool infection-related hospitalization – they repeated their analysis in a predefined low-risk subpopulation. The results closely mirrored those in the overall study population: an 8% increased risk in the emergency C-section group and a 14% increased risk with elective C-section.
Results of this large multinational study should provide further support for ongoing research aimed at supporting the infant microbiome after delivery by C-section via vaginal microbial transfer and other methods, he observed.
Dr. Burgner reported having no financial conflicts regarding the study, which was cosponsored by the National Health and Medical Research Council of Australia, the Danish Council for Independent Research, and nonprofit foundations.
LJUBLJANA, SLOVENIA – Delivery by C-section – especially when elective – carries a significantly higher hospitalization risk for severe infection in the first 5 years of life than vaginal delivery in a study of nearly 7.3 million singleton deliveries in four asset-rich countries, David Burgner, MD, PhD, reported at the annual meeting of the European Society for Paediatric Infectious Diseases.
“This is something that obstetricians might need to consider when discussing with the family the pros and cons for an elective C-section, particularly one that isn’t otherwise indicated for the baby or the mother,” said Dr. Burgner of the Murdoch Children’s Research Institute in Melbourne.
He presented an observational study of 7.29 million singleton births in Denmark, Great Britain, Scotland, and two Australian states during 1996-2015. C-section rates ranged from a low of 17.5% in Denmark to 29.4% in Western Australia, all of which are greater than the 10%-15% rate endorsed by the World Health Organization. Elective C-section rates varied by country from 39% to 57%. Of note, pediatric hospital care in all four countries is free, so economic considerations didn’t drive admission.
The impetus for this international collaboration was to gain new insight into the differential susceptibility to childhood infection, he explained.
“We know from our clinical practice that pretty much all of the children are exposed to pretty much all potentially serious pathogens during early life. And yet it’s only a minority that develop severe infection. It’s an extremely interesting scientific question and an extremely important clinical question as to what’s driving that differential susceptibility,” according to the pediatric infectious disease specialist.
There are a number of established risk factors for infection-related hospitalization in children, including parental smoking, maternal antibiotic exposure during pregnancy, and growth measurements at birth. Dr. Burgner and coinvestigators hypothesized that another important risk factor is the nature of the microbiome transmitted from mother to baby during delivery. This postnatal microbiome varies depending upon mode of delivery: Vaginal delivery transmits the maternal enteric microbiome, which they reasoned might be through direct immunomodulation that sets up protective immune responses early in life, especially against respiratory and gastrointestinal tract infections. In contrast, delivery by C-section causes the baby to pick up the maternal skin and hospital environment microbiomes, but not the maternal enteric microbiome.
Thus, the investigators hypothesized that C-section poses a greater risk of infection-related hospitalization during the first 5 years of life than does vaginal delivery, and that elective C-section poses a higher risk than does emergency C-section because it is more likely to involve rupture of membranes.
The center-specific rates of C-section and infection-related pediatric infection, when combined into a meta-analysis, bore out the study hypothesis. Emergency C-section was associated with a 9% greater risk of infection-related hospitalization through 5 years of age than was vaginal delivery, while elective C-section was associated with a 13% increased risk, both of which were statistically significant and clinically important.
“We were quite taken with these results. We think they provide evidence that C-section is consistently associated with infection-related hospitalization. It’s an association study that can’t prove causality, but the results implicate the postnatal microbiome as the most plausible explanation in terms of what’s driving this association,” according to Dr. Burgner.
The association between C-section and infection-related hospitalization was persistent throughout the preschool years. For example, the increased risk associated with elective C-section was 16% during age 0-3 months, 20% during months 4-6, 14% in months 7-12, 13% during ages 1-2 years, and 11% among 2- to 5-year-olds, he continued.
The increased risk of severe preschool infection was highest for upper and lower respiratory tract and gastrointestinal infections, which involve the organ systems most likely to experience direct inoculation of the maternal microbiome, he noted.
Because the investigators recognized that the study results were potentially vulnerable to confounding by indication – that is, that the reason for doing a C-section might itself confer increased risk of subsequent preschool infection-related hospitalization – they repeated their analysis in a predefined low-risk subpopulation. The results closely mirrored those in the overall study population: an 8% increased risk in the emergency C-section group and a 14% increased risk with elective C-section.
Results of this large multinational study should provide further support for ongoing research aimed at supporting the infant microbiome after delivery by C-section via vaginal microbial transfer and other methods, he observed.
Dr. Burgner reported having no financial conflicts regarding the study, which was cosponsored by the National Health and Medical Research Council of Australia, the Danish Council for Independent Research, and nonprofit foundations.
REPORTING FROM ESPID 2019
Louisiana House passes 6-week abortion ban
about the time a heartbeat is usually detectable.
The legislation, which does not include an exception for rape or incest cases, passed by a 79-23 vote on May 29 in the Louisiana House. The bill does allow exceptions if the woman’s life is in danger, if the pregnancy poses risk of serious impairment to a woman’s body, of if the pregnancy is deemed medically futile. Democratic Gov. John Bel Edwards said he plans to sign the measure when it hits his desk.
“In 2015, I ran for governor as a pro-life candidate after serving as a pro-life legislator for 8 years,” Gov. Edwards said in a May 29 statement. “As governor, I have been true to my word and my beliefs on this issue. As I prepare to sign this bill, I call on the overwhelming bipartisan majority of legislators who voted for it to join me in continuing to build a better Louisiana that cares for the least among us and provides more opportunity for everyone.”
Six other states have enacted similar abortion bans: Alabama, Georgia, Kentucky, Mississippi, Missouri, and Ohio. While most of the laws bar abortions after a heartbeat is detected, Alabama’s measure prohibits abortion at every pregnancy stage and penalizes physicians with a Class A felony for performing an abortion and a Class C felony for attempting to perform an abortion. Alabama Gov. Kay Ivey (R) signed the bill into law on May 15.
A number of lawsuits have been filed against the bans, including a May 24 legal challenge against Alabama’s law by Planned Parenthood Federation of America and the American Civil Liberties Union (ACLU), and a May 15 legal challenge against Ohio’s law by the ACLU and Planned Parenthood of Greater Ohio.
The U.S. Supreme Court on May 28 upheld part of an Indiana law that requires burial or cremation of fetal remains after an abortion, but the justices declined to address the measure’s prohibition on abortions sought because of race, sex, or disability of the fetus.
Court analysts say it’s only a matter of time before the Supreme Court takes up one of the abortion ban cases, most likely the legal challenge against Alabama’s law. Abortion critics have been encouraged by the Supreme Court appointment of right-leaning Justice Brett M. Kavanaugh, and hope the Alabama measure will drive the Supreme Court to reconsider its central holding in Roe v. Wade, court watchers said.
about the time a heartbeat is usually detectable.
The legislation, which does not include an exception for rape or incest cases, passed by a 79-23 vote on May 29 in the Louisiana House. The bill does allow exceptions if the woman’s life is in danger, if the pregnancy poses risk of serious impairment to a woman’s body, of if the pregnancy is deemed medically futile. Democratic Gov. John Bel Edwards said he plans to sign the measure when it hits his desk.
“In 2015, I ran for governor as a pro-life candidate after serving as a pro-life legislator for 8 years,” Gov. Edwards said in a May 29 statement. “As governor, I have been true to my word and my beliefs on this issue. As I prepare to sign this bill, I call on the overwhelming bipartisan majority of legislators who voted for it to join me in continuing to build a better Louisiana that cares for the least among us and provides more opportunity for everyone.”
Six other states have enacted similar abortion bans: Alabama, Georgia, Kentucky, Mississippi, Missouri, and Ohio. While most of the laws bar abortions after a heartbeat is detected, Alabama’s measure prohibits abortion at every pregnancy stage and penalizes physicians with a Class A felony for performing an abortion and a Class C felony for attempting to perform an abortion. Alabama Gov. Kay Ivey (R) signed the bill into law on May 15.
A number of lawsuits have been filed against the bans, including a May 24 legal challenge against Alabama’s law by Planned Parenthood Federation of America and the American Civil Liberties Union (ACLU), and a May 15 legal challenge against Ohio’s law by the ACLU and Planned Parenthood of Greater Ohio.
The U.S. Supreme Court on May 28 upheld part of an Indiana law that requires burial or cremation of fetal remains after an abortion, but the justices declined to address the measure’s prohibition on abortions sought because of race, sex, or disability of the fetus.
Court analysts say it’s only a matter of time before the Supreme Court takes up one of the abortion ban cases, most likely the legal challenge against Alabama’s law. Abortion critics have been encouraged by the Supreme Court appointment of right-leaning Justice Brett M. Kavanaugh, and hope the Alabama measure will drive the Supreme Court to reconsider its central holding in Roe v. Wade, court watchers said.
about the time a heartbeat is usually detectable.
The legislation, which does not include an exception for rape or incest cases, passed by a 79-23 vote on May 29 in the Louisiana House. The bill does allow exceptions if the woman’s life is in danger, if the pregnancy poses risk of serious impairment to a woman’s body, of if the pregnancy is deemed medically futile. Democratic Gov. John Bel Edwards said he plans to sign the measure when it hits his desk.
“In 2015, I ran for governor as a pro-life candidate after serving as a pro-life legislator for 8 years,” Gov. Edwards said in a May 29 statement. “As governor, I have been true to my word and my beliefs on this issue. As I prepare to sign this bill, I call on the overwhelming bipartisan majority of legislators who voted for it to join me in continuing to build a better Louisiana that cares for the least among us and provides more opportunity for everyone.”
Six other states have enacted similar abortion bans: Alabama, Georgia, Kentucky, Mississippi, Missouri, and Ohio. While most of the laws bar abortions after a heartbeat is detected, Alabama’s measure prohibits abortion at every pregnancy stage and penalizes physicians with a Class A felony for performing an abortion and a Class C felony for attempting to perform an abortion. Alabama Gov. Kay Ivey (R) signed the bill into law on May 15.
A number of lawsuits have been filed against the bans, including a May 24 legal challenge against Alabama’s law by Planned Parenthood Federation of America and the American Civil Liberties Union (ACLU), and a May 15 legal challenge against Ohio’s law by the ACLU and Planned Parenthood of Greater Ohio.
The U.S. Supreme Court on May 28 upheld part of an Indiana law that requires burial or cremation of fetal remains after an abortion, but the justices declined to address the measure’s prohibition on abortions sought because of race, sex, or disability of the fetus.
Court analysts say it’s only a matter of time before the Supreme Court takes up one of the abortion ban cases, most likely the legal challenge against Alabama’s law. Abortion critics have been encouraged by the Supreme Court appointment of right-leaning Justice Brett M. Kavanaugh, and hope the Alabama measure will drive the Supreme Court to reconsider its central holding in Roe v. Wade, court watchers said.
HPV vaccine: Is one dose enough?
LJUBLJANA, SLOVENIA – There is good news and bad news about human papillomavirus (HPV) vaccination as a means of preventing cervical cancer.
The bad news is the HPV vaccines are projected to be in short supply, unable to meet global demand until at least 2024. The good news is that – in one study, for 11 years and counting – which would effectively double the existing supply, Aimee R. Kreimer, PhD, said at the annual meeting of the European Society for Paediatric Infectious Diseases.
These data come from post hoc analyses of major phase 3 randomized controlled trials of bivalent HPV vaccine in Costa Rica and quadrivalent vaccine in India. However, these secondary analyses aren’t considered rock solid evidence because the subjects who got a single dose weren’t randomized to that strategy, they simply for one reason or another didn’t receive the recommended additional dose or doses.
“I don’t know if these studies are enough, so several studies have been launched over the past couple of years with an eye toward generating the quality of data that would be sufficient to motivate policy change, if in fact one dose is proven to be effective,” said Dr. Kreimer, a senior scientist at the National Cancer Institute in Bethesda, Md.
The first of these formal randomized, controlled trials – a delayed second-dose study in 9- to 11-year-old U.S. boys and girls – is due to be completed next year. Four other trials ongoing in Africa and Costa Rica, all in females, are expected to report findings in 2022-2025.
Dr. Kreimer is first author of a soon-to-be-published 11-year update from the phase 3 Costa Rica HPV Vaccine Trial, which was launched prior to licensure of the GlaxoSmithKline bivalent HPV vaccine. Previous analyses showed that at both 4 and 7 years of follow-up, a single dose of the vaccine was as effective as two or three in preventing infection with HPV types 16 and 18, which are covered by the vaccine.
“Now the research question has transitioned to, ‘Will one dose be sufficiently durable?’ she explained.
The answer from this study is yes. At 11 years since receipt of the bivalent HPV vaccine, there was no difference in terms of prevalent HPV 16/18 infection between the one-, two-, and three-dose groups. To address the issue of possible selection bias in this post hoc nonrandomized comparison, Dr. Kreimer and her coinvestigators looked at rates of infection with HPV 31 and 45, which aren’t covered by the vaccine. The rates were similar regardless of the number of vaccine doses received 11 years earlier, indicating women in all three dosing groups are at similar risk for acquiring HPV infection, thus bolstering the legitimacy of the conclusion that one dose provides effective long-term protection.
Intriguingly, HPV serum antibody levels in the single-dose group have remained stable for 11 years at a level that’s only about one-quarter of that associated with three doses of the vaccine, albeit an order of magnitude greater than the level induced by natural immunity.
“This really challenges the dogma of the HPV vaccine,” according to Dr. Kreimer. “It suggests that inferior [HPV] antibodies do not necessarily mean inferior protection.”
The explanation for this phenomenon appears to be that HPV subunit vaccine mimics the shell of authentic virions so well that the immune system sees it as dangerous and mounts long-term antibody production. Also, cervical infection by HPV is a relatively slow process, allowing time for vaccine-induced antibodies to interrupt it, she said.
In contrast to the encouraging findings from this post hoc analysis and another from a phase 3 trial of quadrivalent vaccine in India, numerous phase 4 vaccine effectiveness monitoring studies have shown markedly lower vaccine effectiveness for one dose of HPV vaccine. Dr. Kreimer cautioned that this is a flawed conclusion attributable to a methodologic artifact whereby the investigators have lumped together single-dose recipients who were 17 years old or more at the time with those who were younger.
“The problem is that many people who are aged 17-18 years already have HPV infection, so when they are vaccinated it shows up as a vaccine failure. That’s not correct. These are prophylactic HPV vaccines. They’re not meant to help clear an infection,” she noted.
Stepping back, Dr. Kreimer observed that cervical cancer “is really a story of inequality.” Indeed, 90% of cervical cancers occur in low-income countries, where HPV vaccination uptake remains very low even more than a decade after licensure. When modelers project out in the future, they estimate that at current HPV vaccination levels in Sub-Saharan Africa, which has the highest cervical cancer rates in the world, it would take more than 100 years to achieve the World Health Organization goal of eliminating the malignancy.
Asked by an audience member how low a single-dose vaccine effectiveness level she considers acceptable to help reach the goal of eliminating cervical cancer in developing countries, Dr. Kreimer cautioned against the tendency to let ‘perfect’ become the enemy of ‘good.’
“I’ll remind everyone that, in this moment, very few of the target girls in the lower– and upper-lower–income countries are getting any vaccination. So I don’t think it’s a question of whether we should be going from two to one dose, I think it’s really a question of, for those who are at zero doses, how do we get them one dose? And with the HPV vaccine, we’ve even seen suggestions of herd immunity if we have 50% uptake,” she replied.
Dr. Kreimer reported having no financial conflicts regarding her presentation.
LJUBLJANA, SLOVENIA – There is good news and bad news about human papillomavirus (HPV) vaccination as a means of preventing cervical cancer.
The bad news is the HPV vaccines are projected to be in short supply, unable to meet global demand until at least 2024. The good news is that – in one study, for 11 years and counting – which would effectively double the existing supply, Aimee R. Kreimer, PhD, said at the annual meeting of the European Society for Paediatric Infectious Diseases.
These data come from post hoc analyses of major phase 3 randomized controlled trials of bivalent HPV vaccine in Costa Rica and quadrivalent vaccine in India. However, these secondary analyses aren’t considered rock solid evidence because the subjects who got a single dose weren’t randomized to that strategy, they simply for one reason or another didn’t receive the recommended additional dose or doses.
“I don’t know if these studies are enough, so several studies have been launched over the past couple of years with an eye toward generating the quality of data that would be sufficient to motivate policy change, if in fact one dose is proven to be effective,” said Dr. Kreimer, a senior scientist at the National Cancer Institute in Bethesda, Md.
The first of these formal randomized, controlled trials – a delayed second-dose study in 9- to 11-year-old U.S. boys and girls – is due to be completed next year. Four other trials ongoing in Africa and Costa Rica, all in females, are expected to report findings in 2022-2025.
Dr. Kreimer is first author of a soon-to-be-published 11-year update from the phase 3 Costa Rica HPV Vaccine Trial, which was launched prior to licensure of the GlaxoSmithKline bivalent HPV vaccine. Previous analyses showed that at both 4 and 7 years of follow-up, a single dose of the vaccine was as effective as two or three in preventing infection with HPV types 16 and 18, which are covered by the vaccine.
“Now the research question has transitioned to, ‘Will one dose be sufficiently durable?’ she explained.
The answer from this study is yes. At 11 years since receipt of the bivalent HPV vaccine, there was no difference in terms of prevalent HPV 16/18 infection between the one-, two-, and three-dose groups. To address the issue of possible selection bias in this post hoc nonrandomized comparison, Dr. Kreimer and her coinvestigators looked at rates of infection with HPV 31 and 45, which aren’t covered by the vaccine. The rates were similar regardless of the number of vaccine doses received 11 years earlier, indicating women in all three dosing groups are at similar risk for acquiring HPV infection, thus bolstering the legitimacy of the conclusion that one dose provides effective long-term protection.
Intriguingly, HPV serum antibody levels in the single-dose group have remained stable for 11 years at a level that’s only about one-quarter of that associated with three doses of the vaccine, albeit an order of magnitude greater than the level induced by natural immunity.
“This really challenges the dogma of the HPV vaccine,” according to Dr. Kreimer. “It suggests that inferior [HPV] antibodies do not necessarily mean inferior protection.”
The explanation for this phenomenon appears to be that HPV subunit vaccine mimics the shell of authentic virions so well that the immune system sees it as dangerous and mounts long-term antibody production. Also, cervical infection by HPV is a relatively slow process, allowing time for vaccine-induced antibodies to interrupt it, she said.
In contrast to the encouraging findings from this post hoc analysis and another from a phase 3 trial of quadrivalent vaccine in India, numerous phase 4 vaccine effectiveness monitoring studies have shown markedly lower vaccine effectiveness for one dose of HPV vaccine. Dr. Kreimer cautioned that this is a flawed conclusion attributable to a methodologic artifact whereby the investigators have lumped together single-dose recipients who were 17 years old or more at the time with those who were younger.
“The problem is that many people who are aged 17-18 years already have HPV infection, so when they are vaccinated it shows up as a vaccine failure. That’s not correct. These are prophylactic HPV vaccines. They’re not meant to help clear an infection,” she noted.
Stepping back, Dr. Kreimer observed that cervical cancer “is really a story of inequality.” Indeed, 90% of cervical cancers occur in low-income countries, where HPV vaccination uptake remains very low even more than a decade after licensure. When modelers project out in the future, they estimate that at current HPV vaccination levels in Sub-Saharan Africa, which has the highest cervical cancer rates in the world, it would take more than 100 years to achieve the World Health Organization goal of eliminating the malignancy.
Asked by an audience member how low a single-dose vaccine effectiveness level she considers acceptable to help reach the goal of eliminating cervical cancer in developing countries, Dr. Kreimer cautioned against the tendency to let ‘perfect’ become the enemy of ‘good.’
“I’ll remind everyone that, in this moment, very few of the target girls in the lower– and upper-lower–income countries are getting any vaccination. So I don’t think it’s a question of whether we should be going from two to one dose, I think it’s really a question of, for those who are at zero doses, how do we get them one dose? And with the HPV vaccine, we’ve even seen suggestions of herd immunity if we have 50% uptake,” she replied.
Dr. Kreimer reported having no financial conflicts regarding her presentation.
LJUBLJANA, SLOVENIA – There is good news and bad news about human papillomavirus (HPV) vaccination as a means of preventing cervical cancer.
The bad news is the HPV vaccines are projected to be in short supply, unable to meet global demand until at least 2024. The good news is that – in one study, for 11 years and counting – which would effectively double the existing supply, Aimee R. Kreimer, PhD, said at the annual meeting of the European Society for Paediatric Infectious Diseases.
These data come from post hoc analyses of major phase 3 randomized controlled trials of bivalent HPV vaccine in Costa Rica and quadrivalent vaccine in India. However, these secondary analyses aren’t considered rock solid evidence because the subjects who got a single dose weren’t randomized to that strategy, they simply for one reason or another didn’t receive the recommended additional dose or doses.
“I don’t know if these studies are enough, so several studies have been launched over the past couple of years with an eye toward generating the quality of data that would be sufficient to motivate policy change, if in fact one dose is proven to be effective,” said Dr. Kreimer, a senior scientist at the National Cancer Institute in Bethesda, Md.
The first of these formal randomized, controlled trials – a delayed second-dose study in 9- to 11-year-old U.S. boys and girls – is due to be completed next year. Four other trials ongoing in Africa and Costa Rica, all in females, are expected to report findings in 2022-2025.
Dr. Kreimer is first author of a soon-to-be-published 11-year update from the phase 3 Costa Rica HPV Vaccine Trial, which was launched prior to licensure of the GlaxoSmithKline bivalent HPV vaccine. Previous analyses showed that at both 4 and 7 years of follow-up, a single dose of the vaccine was as effective as two or three in preventing infection with HPV types 16 and 18, which are covered by the vaccine.
“Now the research question has transitioned to, ‘Will one dose be sufficiently durable?’ she explained.
The answer from this study is yes. At 11 years since receipt of the bivalent HPV vaccine, there was no difference in terms of prevalent HPV 16/18 infection between the one-, two-, and three-dose groups. To address the issue of possible selection bias in this post hoc nonrandomized comparison, Dr. Kreimer and her coinvestigators looked at rates of infection with HPV 31 and 45, which aren’t covered by the vaccine. The rates were similar regardless of the number of vaccine doses received 11 years earlier, indicating women in all three dosing groups are at similar risk for acquiring HPV infection, thus bolstering the legitimacy of the conclusion that one dose provides effective long-term protection.
Intriguingly, HPV serum antibody levels in the single-dose group have remained stable for 11 years at a level that’s only about one-quarter of that associated with three doses of the vaccine, albeit an order of magnitude greater than the level induced by natural immunity.
“This really challenges the dogma of the HPV vaccine,” according to Dr. Kreimer. “It suggests that inferior [HPV] antibodies do not necessarily mean inferior protection.”
The explanation for this phenomenon appears to be that HPV subunit vaccine mimics the shell of authentic virions so well that the immune system sees it as dangerous and mounts long-term antibody production. Also, cervical infection by HPV is a relatively slow process, allowing time for vaccine-induced antibodies to interrupt it, she said.
In contrast to the encouraging findings from this post hoc analysis and another from a phase 3 trial of quadrivalent vaccine in India, numerous phase 4 vaccine effectiveness monitoring studies have shown markedly lower vaccine effectiveness for one dose of HPV vaccine. Dr. Kreimer cautioned that this is a flawed conclusion attributable to a methodologic artifact whereby the investigators have lumped together single-dose recipients who were 17 years old or more at the time with those who were younger.
“The problem is that many people who are aged 17-18 years already have HPV infection, so when they are vaccinated it shows up as a vaccine failure. That’s not correct. These are prophylactic HPV vaccines. They’re not meant to help clear an infection,” she noted.
Stepping back, Dr. Kreimer observed that cervical cancer “is really a story of inequality.” Indeed, 90% of cervical cancers occur in low-income countries, where HPV vaccination uptake remains very low even more than a decade after licensure. When modelers project out in the future, they estimate that at current HPV vaccination levels in Sub-Saharan Africa, which has the highest cervical cancer rates in the world, it would take more than 100 years to achieve the World Health Organization goal of eliminating the malignancy.
Asked by an audience member how low a single-dose vaccine effectiveness level she considers acceptable to help reach the goal of eliminating cervical cancer in developing countries, Dr. Kreimer cautioned against the tendency to let ‘perfect’ become the enemy of ‘good.’
“I’ll remind everyone that, in this moment, very few of the target girls in the lower– and upper-lower–income countries are getting any vaccination. So I don’t think it’s a question of whether we should be going from two to one dose, I think it’s really a question of, for those who are at zero doses, how do we get them one dose? And with the HPV vaccine, we’ve even seen suggestions of herd immunity if we have 50% uptake,” she replied.
Dr. Kreimer reported having no financial conflicts regarding her presentation.
EXPERT ANALYSIS FROM ESPID 2019
Energy drinks increase BP and disrupt the heart’s electrical activity
Consuming caffeinated energy drinks leads to a prolonged QT interval and an increase in blood pressure, according to a study of young volunteers who had their hearts tested after drinking either energy drinks or placebo.
“Further investigation is warranted on whether an individual ingredient or a unique combination leads to the observed electrophysiological and hemodynamic changes,” wrote Sachin A. Shah of the University of the Pacific, Stockton, Calif., and coinvestigators. The study was published in the Journal of the American Heart Association.
To analyze electrocardiographic changes in the heart after consumption of 300 mg of caffeine plus other energy drink ingredients, the researchers assigned 34 healthy volunteers with an average age of 22 years to consume two 16-ounce bottles of either Drink A, a commercially available energy drink, Drink B, a different brand of energy drink, or a placebo drink for 3 days, followed by a 6-day washout period. Before and for 4 hours after consuming the beverages, volunteers had their hearts measured via ECG to test for differences in QT interval. Their blood pressures also were recorded.
Compared with placebo, the Drink A group had a 6.1 ms increase in QT interval and the Drink B group had a 7.7 ms rise. The maximum changes from baseline in corrected QT interval for Drink A, Drink B, and placebo were 17.9 ms, 19.6 ms, and 11.9 ms, respectively; both differences were statistically significant. Volunteers in Drink A and Drink B groups also had statistically significant increases of 5 mm Hg in systolic and 4 mm Hg in diastolic blood pressure after energy drink consumption, compared with placebo.
Both energy drinks used in the study contained caffeine (about 300 mg), taurine, glucuronolactone, and B vitamins. The investigators said that caffeine at doses under 400 mg is not expected to induce any electrocardiographic changes.
The coauthors noted their study’s limitations, including not investigating the effects of different doses and the possibility that consuming two 16-ounce bottles is an unrealistic real-world volume. That said, they noted that 16% of respondents to a 2,040-person survey admitted to consuming more than two energy drinks a day. In addition, though not every brand was tested, the researchers stated that, “the class of energy drinks, rather than one particular product, warrants use with caution.”
Dr. Shah reported serving as an expert witness in legal cases related to caffeinated energy drinks. The other authors reported no conflicts of interest.
SOURCE: Shah SA et al. J Am Heart Assoc. 2019 May 29.
Consuming caffeinated energy drinks leads to a prolonged QT interval and an increase in blood pressure, according to a study of young volunteers who had their hearts tested after drinking either energy drinks or placebo.
“Further investigation is warranted on whether an individual ingredient or a unique combination leads to the observed electrophysiological and hemodynamic changes,” wrote Sachin A. Shah of the University of the Pacific, Stockton, Calif., and coinvestigators. The study was published in the Journal of the American Heart Association.
To analyze electrocardiographic changes in the heart after consumption of 300 mg of caffeine plus other energy drink ingredients, the researchers assigned 34 healthy volunteers with an average age of 22 years to consume two 16-ounce bottles of either Drink A, a commercially available energy drink, Drink B, a different brand of energy drink, or a placebo drink for 3 days, followed by a 6-day washout period. Before and for 4 hours after consuming the beverages, volunteers had their hearts measured via ECG to test for differences in QT interval. Their blood pressures also were recorded.
Compared with placebo, the Drink A group had a 6.1 ms increase in QT interval and the Drink B group had a 7.7 ms rise. The maximum changes from baseline in corrected QT interval for Drink A, Drink B, and placebo were 17.9 ms, 19.6 ms, and 11.9 ms, respectively; both differences were statistically significant. Volunteers in Drink A and Drink B groups also had statistically significant increases of 5 mm Hg in systolic and 4 mm Hg in diastolic blood pressure after energy drink consumption, compared with placebo.
Both energy drinks used in the study contained caffeine (about 300 mg), taurine, glucuronolactone, and B vitamins. The investigators said that caffeine at doses under 400 mg is not expected to induce any electrocardiographic changes.
The coauthors noted their study’s limitations, including not investigating the effects of different doses and the possibility that consuming two 16-ounce bottles is an unrealistic real-world volume. That said, they noted that 16% of respondents to a 2,040-person survey admitted to consuming more than two energy drinks a day. In addition, though not every brand was tested, the researchers stated that, “the class of energy drinks, rather than one particular product, warrants use with caution.”
Dr. Shah reported serving as an expert witness in legal cases related to caffeinated energy drinks. The other authors reported no conflicts of interest.
SOURCE: Shah SA et al. J Am Heart Assoc. 2019 May 29.
Consuming caffeinated energy drinks leads to a prolonged QT interval and an increase in blood pressure, according to a study of young volunteers who had their hearts tested after drinking either energy drinks or placebo.
“Further investigation is warranted on whether an individual ingredient or a unique combination leads to the observed electrophysiological and hemodynamic changes,” wrote Sachin A. Shah of the University of the Pacific, Stockton, Calif., and coinvestigators. The study was published in the Journal of the American Heart Association.
To analyze electrocardiographic changes in the heart after consumption of 300 mg of caffeine plus other energy drink ingredients, the researchers assigned 34 healthy volunteers with an average age of 22 years to consume two 16-ounce bottles of either Drink A, a commercially available energy drink, Drink B, a different brand of energy drink, or a placebo drink for 3 days, followed by a 6-day washout period. Before and for 4 hours after consuming the beverages, volunteers had their hearts measured via ECG to test for differences in QT interval. Their blood pressures also were recorded.
Compared with placebo, the Drink A group had a 6.1 ms increase in QT interval and the Drink B group had a 7.7 ms rise. The maximum changes from baseline in corrected QT interval for Drink A, Drink B, and placebo were 17.9 ms, 19.6 ms, and 11.9 ms, respectively; both differences were statistically significant. Volunteers in Drink A and Drink B groups also had statistically significant increases of 5 mm Hg in systolic and 4 mm Hg in diastolic blood pressure after energy drink consumption, compared with placebo.
Both energy drinks used in the study contained caffeine (about 300 mg), taurine, glucuronolactone, and B vitamins. The investigators said that caffeine at doses under 400 mg is not expected to induce any electrocardiographic changes.
The coauthors noted their study’s limitations, including not investigating the effects of different doses and the possibility that consuming two 16-ounce bottles is an unrealistic real-world volume. That said, they noted that 16% of respondents to a 2,040-person survey admitted to consuming more than two energy drinks a day. In addition, though not every brand was tested, the researchers stated that, “the class of energy drinks, rather than one particular product, warrants use with caution.”
Dr. Shah reported serving as an expert witness in legal cases related to caffeinated energy drinks. The other authors reported no conflicts of interest.
SOURCE: Shah SA et al. J Am Heart Assoc. 2019 May 29.
FROM THE JOURNAL OF THE AMERICAN HEART ASSOCIATION
Key clinical point:
Major finding: Compared with placebo, consuming two different energy drinks led to significant QT interval increases of 6.1 ms and 7.7 ms.
Study details: A randomized, double-blind crossover study of 34 healthy volunteers who had their hearts measured via electrocardiogram after consuming energy drink or placebo.
Disclosures: Dr. Shah reported serving as an expert witness in legal cases related to caffeinated energy drinks. The other authors reported no conflicts of interest.
Source: Shah SA et al. J Am Heart Assoc. 2019 May 29.