The Food and Drug Administration has accepted a Biologics License Application for spesolimab, a selective antibody that blocks interleukin-36 receptors, for the treatment of flares in patients with generalized pustular psoriasis, according to a statement from manufacturer Boehringer Ingelheim. The FDA also granted Priority Review to spesolimab. Priority Review is a designation granted to medications that would offer significant improvement over the currently available treatments.

Generalized pustular psoriasis (GPP), though rare, is a potentially life-threatening condition that is distinct from plaque psoriasis. Throughout the course of the disease, which is caused by the accumulation of neutrophils in the skin, patients may experience persistent disease with intermittent flares or relapsing disease with recurrent flares. The neutrophil accumulation results in the eruption of sterile, yet painful pustules across all parts of the body.

“While the severity of GPP flares can vary, if left untreated they can be life threatening due to complications such as sepsis and multisystem organ failure,” and have a significant impact on quality of life, according to the company statement.

The FDA also has granted spesolimab an Orphan Drug Designation for the treatment of GPP, and a Breakthrough Therapy Designation for the treatment of GPP flares in adults.

A marketing authorization application for spesolimab for the treatment of GPP was accepted for evaluation by the European Medicines Agency in October 2021, according to a company press release issued at that time.

A protocol for a phase 2 study of spesolimab versus placebo for treating acute flares in GPP patients was published in October in BMJ Open, after a phase 1 proof-of-concept study published in 2019 showed the potential of an IL-36 receptor antagonist to improve disease scores in adults with GPP.

More information is available on the Boehringer Ingelheim website.

[email protected]

The Food and Drug Administration has accepted a Biologics License Application for spesolimab, a selective antibody that blocks interleukin-36 receptors, for the treatment of flares in patients with generalized pustular psoriasis, according to a statement from manufacturer Boehringer Ingelheim. The FDA also granted Priority Review to spesolimab. Priority Review is a designation granted to medications that would offer significant improvement over the currently available treatments.

Generalized pustular psoriasis (GPP), though rare, is a potentially life-threatening condition that is distinct from plaque psoriasis. Throughout the course of the disease, which is caused by the accumulation of neutrophils in the skin, patients may experience persistent disease with intermittent flares or relapsing disease with recurrent flares. The neutrophil accumulation results in the eruption of sterile, yet painful pustules across all parts of the body.

“While the severity of GPP flares can vary, if left untreated they can be life threatening due to complications such as sepsis and multisystem organ failure,” and have a significant impact on quality of life, according to the company statement.

The FDA also has granted spesolimab an Orphan Drug Designation for the treatment of GPP, and a Breakthrough Therapy Designation for the treatment of GPP flares in adults.

A marketing authorization application for spesolimab for the treatment of GPP was accepted for evaluation by the European Medicines Agency in October 2021, according to a company press release issued at that time.

A protocol for a phase 2 study of spesolimab versus placebo for treating acute flares in GPP patients was published in October in BMJ Open, after a phase 1 proof-of-concept study published in 2019 showed the potential of an IL-36 receptor antagonist to improve disease scores in adults with GPP.

More information is available on the Boehringer Ingelheim website.

[email protected]

The Food and Drug Administration has accepted a Biologics License Application for spesolimab, a selective antibody that blocks interleukin-36 receptors, for the treatment of flares in patients with generalized pustular psoriasis, according to a statement from manufacturer Boehringer Ingelheim. The FDA also granted Priority Review to spesolimab. Priority Review is a designation granted to medications that would offer significant improvement over the currently available treatments.

Generalized pustular psoriasis (GPP), though rare, is a potentially life-threatening condition that is distinct from plaque psoriasis. Throughout the course of the disease, which is caused by the accumulation of neutrophils in the skin, patients may experience persistent disease with intermittent flares or relapsing disease with recurrent flares. The neutrophil accumulation results in the eruption of sterile, yet painful pustules across all parts of the body.

“While the severity of GPP flares can vary, if left untreated they can be life threatening due to complications such as sepsis and multisystem organ failure,” and have a significant impact on quality of life, according to the company statement.

The FDA also has granted spesolimab an Orphan Drug Designation for the treatment of GPP, and a Breakthrough Therapy Designation for the treatment of GPP flares in adults.

A marketing authorization application for spesolimab for the treatment of GPP was accepted for evaluation by the European Medicines Agency in October 2021, according to a company press release issued at that time.

A protocol for a phase 2 study of spesolimab versus placebo for treating acute flares in GPP patients was published in October in BMJ Open, after a phase 1 proof-of-concept study published in 2019 showed the potential of an IL-36 receptor antagonist to improve disease scores in adults with GPP.

More information is available on the Boehringer Ingelheim website.

[email protected]

The Food and Drug Administration has stopped trials of oral and implant formulations of islatravir for HIV, the investigational drug’s developer, Merck, announced in a press release.

Investigational new drug applications were halted for the oral and implant formulations of islatravir, a nucleoside reverse transcriptase translocation inhibitor, for pre-exposure prophylaxis (PrEP); the injectable formulation of islatravir for treatment and prophylaxis; and the oral doravirine/islatravir (DOR/ISL) once-daily treatment, the company announced.

The FDA’s hold followed observations that total lymphocyte and T-cell counts had dropped in some participants receiving islatravir in clinical studies.

The trials have dealt a major setback to Merck’s HIV program momentum: Thirteen trials are now on hold (six on partial hold and seven on full hold). Seven of the trials were in phase 3. But primarily the news is disappointing for patients looking for options with the confounding disease.

Tristan Barber, MD, an HIV consultant with Royal Free London National Health Service Foundation Trust, told this news organization that “the hold on these studies is a blow for those hoping for longer-acting therapies for HIV treatment and prevention. Islatravir and [investigational drug] MK-8507 were being explored in oral and other formulations and potentially would offer a non-integrase, two-drug option, increasing options for people with HIV. Whilst we don’t know the clinical significance of these CD4 drops, [Merck] made the correct decision in pausing these studies until the data is clearer.”

Merck announced in November that it had stopped dosing in the phase 2 IMAGINE-DR clinical trial of islatravir in combination with MK-8507. MK-8507 and islatravir, alone and combined, are investigational and not approved for use.

In that trial as well, decreases were observed in total lymphocyte and T-cell counts in study participants randomly assigned to receive the combination. A review by the external Data Monitoring Committee determined that the drop was related to treatment with the combination.

“We are grateful to the participants and the study investigators for their ongoing contributions to this research,” Joan Butterton, MD, vice president of infectious diseases in Global Clinical Development at Merck Research Laboratories, said in a statement. “Merck continues to investigate the potential of islatravir and nucleoside reverse transcriptase translocation inhibitors and remains committed to helping to address unmet needs in HIV treatment and prevention.”

In light of the hold, no new studies using islatravir may be initiated. People currently receiving islatravir as part of the studies for PrEP, as well as injectable islatravir for treatment and prophylaxis, will no longer receive the study drug, and T-cell and lymphocyte counts will be monitored for recovery.

Those participating in the PrEP studies will be offered approved, once-daily, oral PrEP and those in studies of DOR/ISL who already started treatment will continue to receive study medication under a partial clinical hold.

A full list of the trials that have been placed on full or partial clinical holds can be found in the press release.

In an interview with this news organization, Monica Gandhi, MD, MPH, director of University of California, San Francisco’s Gladstone Center for AIDS Research, described the news of the islatravir trial holds as “very disappointing.”

“There were high hopes for this drug,” she said, adding that the hope was it would be paired with Gilead’s lenacapavir (another long-acting agent) for treatment and be able to give a once-weekly option for HIV treatment.

Lenacapavir is Gilead’s potential first-in-class, long-acting HIV-1 capsid inhibitor in development for treatment and prevention of HIV.

“Moreover,” she said, “additional hope was that, because of [islatravir’s] long half-life, it could be used as a monthly medication for pre-exposure prophylaxis.”

Gilead and Merck have decided to stop all dosing of participants in the phase 2 clinical trial evaluating an oral, weekly combination treatment of islatravir and lenacapavir in people living with HIV who are virologically suppressed on antiretroviral therapy, according to Merck’s press release.

Participants in that trial will stop taking the study drug and restart their previous antiretroviral regimen. According to the press release, both companies are considering whether a different dosing of islatravir combined with lenacapavir may become a once-weekly oral therapy option for people living with HIV.

Neither Merck nor Gilead representatives responded to request for comment by publication time.

Dr. Barber reported conference support, speaker fees, and advisory board honoraria from Gilead, Janssen, Merck, Roche, Thera, and ViiV and research/educational grants from Gilead, Roche, and ViiV. Dr. Gandhi has disclosed no relevant financial relationships.

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

The Food and Drug Administration has stopped trials of oral and implant formulations of islatravir for HIV, the investigational drug’s developer, Merck, announced in a press release.

Investigational new drug applications were halted for the oral and implant formulations of islatravir, a nucleoside reverse transcriptase translocation inhibitor, for pre-exposure prophylaxis (PrEP); the injectable formulation of islatravir for treatment and prophylaxis; and the oral doravirine/islatravir (DOR/ISL) once-daily treatment, the company announced.

The FDA’s hold followed observations that total lymphocyte and T-cell counts had dropped in some participants receiving islatravir in clinical studies.

The trials have dealt a major setback to Merck’s HIV program momentum: Thirteen trials are now on hold (six on partial hold and seven on full hold). Seven of the trials were in phase 3. But primarily the news is disappointing for patients looking for options with the confounding disease.

Tristan Barber, MD, an HIV consultant with Royal Free London National Health Service Foundation Trust, told this news organization that “the hold on these studies is a blow for those hoping for longer-acting therapies for HIV treatment and prevention. Islatravir and [investigational drug] MK-8507 were being explored in oral and other formulations and potentially would offer a non-integrase, two-drug option, increasing options for people with HIV. Whilst we don’t know the clinical significance of these CD4 drops, [Merck] made the correct decision in pausing these studies until the data is clearer.”

Merck announced in November that it had stopped dosing in the phase 2 IMAGINE-DR clinical trial of islatravir in combination with MK-8507. MK-8507 and islatravir, alone and combined, are investigational and not approved for use.

In that trial as well, decreases were observed in total lymphocyte and T-cell counts in study participants randomly assigned to receive the combination. A review by the external Data Monitoring Committee determined that the drop was related to treatment with the combination.

“We are grateful to the participants and the study investigators for their ongoing contributions to this research,” Joan Butterton, MD, vice president of infectious diseases in Global Clinical Development at Merck Research Laboratories, said in a statement. “Merck continues to investigate the potential of islatravir and nucleoside reverse transcriptase translocation inhibitors and remains committed to helping to address unmet needs in HIV treatment and prevention.”

In light of the hold, no new studies using islatravir may be initiated. People currently receiving islatravir as part of the studies for PrEP, as well as injectable islatravir for treatment and prophylaxis, will no longer receive the study drug, and T-cell and lymphocyte counts will be monitored for recovery.

Those participating in the PrEP studies will be offered approved, once-daily, oral PrEP and those in studies of DOR/ISL who already started treatment will continue to receive study medication under a partial clinical hold.

A full list of the trials that have been placed on full or partial clinical holds can be found in the press release.

In an interview with this news organization, Monica Gandhi, MD, MPH, director of University of California, San Francisco’s Gladstone Center for AIDS Research, described the news of the islatravir trial holds as “very disappointing.”

“There were high hopes for this drug,” she said, adding that the hope was it would be paired with Gilead’s lenacapavir (another long-acting agent) for treatment and be able to give a once-weekly option for HIV treatment.

Lenacapavir is Gilead’s potential first-in-class, long-acting HIV-1 capsid inhibitor in development for treatment and prevention of HIV.

“Moreover,” she said, “additional hope was that, because of [islatravir’s] long half-life, it could be used as a monthly medication for pre-exposure prophylaxis.”

Gilead and Merck have decided to stop all dosing of participants in the phase 2 clinical trial evaluating an oral, weekly combination treatment of islatravir and lenacapavir in people living with HIV who are virologically suppressed on antiretroviral therapy, according to Merck’s press release.

Participants in that trial will stop taking the study drug and restart their previous antiretroviral regimen. According to the press release, both companies are considering whether a different dosing of islatravir combined with lenacapavir may become a once-weekly oral therapy option for people living with HIV.

Neither Merck nor Gilead representatives responded to request for comment by publication time.

Dr. Barber reported conference support, speaker fees, and advisory board honoraria from Gilead, Janssen, Merck, Roche, Thera, and ViiV and research/educational grants from Gilead, Roche, and ViiV. Dr. Gandhi has disclosed no relevant financial relationships.

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

The Food and Drug Administration has stopped trials of oral and implant formulations of islatravir for HIV, the investigational drug’s developer, Merck, announced in a press release.

Investigational new drug applications were halted for the oral and implant formulations of islatravir, a nucleoside reverse transcriptase translocation inhibitor, for pre-exposure prophylaxis (PrEP); the injectable formulation of islatravir for treatment and prophylaxis; and the oral doravirine/islatravir (DOR/ISL) once-daily treatment, the company announced.

The FDA’s hold followed observations that total lymphocyte and T-cell counts had dropped in some participants receiving islatravir in clinical studies.

The trials have dealt a major setback to Merck’s HIV program momentum: Thirteen trials are now on hold (six on partial hold and seven on full hold). Seven of the trials were in phase 3. But primarily the news is disappointing for patients looking for options with the confounding disease.

Tristan Barber, MD, an HIV consultant with Royal Free London National Health Service Foundation Trust, told this news organization that “the hold on these studies is a blow for those hoping for longer-acting therapies for HIV treatment and prevention. Islatravir and [investigational drug] MK-8507 were being explored in oral and other formulations and potentially would offer a non-integrase, two-drug option, increasing options for people with HIV. Whilst we don’t know the clinical significance of these CD4 drops, [Merck] made the correct decision in pausing these studies until the data is clearer.”

Merck announced in November that it had stopped dosing in the phase 2 IMAGINE-DR clinical trial of islatravir in combination with MK-8507. MK-8507 and islatravir, alone and combined, are investigational and not approved for use.

In that trial as well, decreases were observed in total lymphocyte and T-cell counts in study participants randomly assigned to receive the combination. A review by the external Data Monitoring Committee determined that the drop was related to treatment with the combination.

“We are grateful to the participants and the study investigators for their ongoing contributions to this research,” Joan Butterton, MD, vice president of infectious diseases in Global Clinical Development at Merck Research Laboratories, said in a statement. “Merck continues to investigate the potential of islatravir and nucleoside reverse transcriptase translocation inhibitors and remains committed to helping to address unmet needs in HIV treatment and prevention.”

In light of the hold, no new studies using islatravir may be initiated. People currently receiving islatravir as part of the studies for PrEP, as well as injectable islatravir for treatment and prophylaxis, will no longer receive the study drug, and T-cell and lymphocyte counts will be monitored for recovery.

Those participating in the PrEP studies will be offered approved, once-daily, oral PrEP and those in studies of DOR/ISL who already started treatment will continue to receive study medication under a partial clinical hold.

A full list of the trials that have been placed on full or partial clinical holds can be found in the press release.

In an interview with this news organization, Monica Gandhi, MD, MPH, director of University of California, San Francisco’s Gladstone Center for AIDS Research, described the news of the islatravir trial holds as “very disappointing.”

“There were high hopes for this drug,” she said, adding that the hope was it would be paired with Gilead’s lenacapavir (another long-acting agent) for treatment and be able to give a once-weekly option for HIV treatment.

Lenacapavir is Gilead’s potential first-in-class, long-acting HIV-1 capsid inhibitor in development for treatment and prevention of HIV.

“Moreover,” she said, “additional hope was that, because of [islatravir’s] long half-life, it could be used as a monthly medication for pre-exposure prophylaxis.”

Gilead and Merck have decided to stop all dosing of participants in the phase 2 clinical trial evaluating an oral, weekly combination treatment of islatravir and lenacapavir in people living with HIV who are virologically suppressed on antiretroviral therapy, according to Merck’s press release.

Participants in that trial will stop taking the study drug and restart their previous antiretroviral regimen. According to the press release, both companies are considering whether a different dosing of islatravir combined with lenacapavir may become a once-weekly oral therapy option for people living with HIV.

Neither Merck nor Gilead representatives responded to request for comment by publication time.

Dr. Barber reported conference support, speaker fees, and advisory board honoraria from Gilead, Janssen, Merck, Roche, Thera, and ViiV and research/educational grants from Gilead, Roche, and ViiV. Dr. Gandhi has disclosed no relevant financial relationships.

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

An updated recommendation from the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) calling for universal hepatitis B vaccination of all adults aged 59 and younger has boosted the call to improve clinicians’ awareness of the increasing infection and low vaccination rates – and raise the issue with patients.

“This new recommendation from [the] ACIP will be instrumental [in] raising adult hepatitis B vaccination rates in the U.S. to levels that will allow us to finally eliminate hepatitis B in this country,” said Rita K. Kuwahara, MD, a primary care internal medicine physician and health policy fellow at Georgetown University, in Washington, D.C., in addressing the issue at the U.S. Conference on HIV/AIDS (USCHA) this month.

“We have the tools to prevent hepatitis B, and since we have such safe and highly effective vaccines to protect against community [spread], we should not have a single new infection in our nation,” she asserted.

The unanimously approved updated ACIP recommendation was issued in November and still requires adoption by the CDC director. The ACIP specifically recommends that adults aged 19 to 59 and those 60 years and older with risk factors for infection “should” receive the hepatitis B vaccine, and it further stipulates that those 60 years and older without known risk factors for hepatitis B “may” receive the vaccine.

The recommendation was previously only for adults at risk for hepatitis B infection due to a variety of factors, including sexual exposure, percutaneous or mucosal exposure to blood, hepatitis C infection, chronic liver disease, end-stage renal disease, and HIV infection.

“The number of risk factors was long, and for a busy primary care provider to have to go through a lengthy risk-based protocol like that, it may not happen,” Dr. Kuwahara told this news organization.

“Now we have a really helpful new recommendation that is simply age based, and clinicians can just tell patients that if they were born before this certain period, a hepatitis B vaccination is recommended.”

The change comes amid a troubling trajectory of hepatitis B, with up to 2.4 million individuals currently having chronic hepatitis B in the U.S. and infection rates soaring by 100% to more than 400% in states with high opioid use, such as West Virginia, Kentucky, Tennessee, and Maine, Dr. Kuwahara said.

Notably, hepatitis B is the leading cause of liver disease, and one in four individuals with unmanaged chronic hepatitis B goes on to develop liver failure and/or cirrhosis or liver cancer, which has a 5-year survival rate of only 18%.

Despite the rising infection rates, only 25%-30% of adults in the U.S. are reported to be currently vaccinated for hepatitis B, even though safe and highly effective vaccines are available, notably including a new two-dose vaccine (Heplisav-B) that can be provided over just a month (vs. other hepatitis B vaccines requiring 3 doses over 6 months).
 

Clinician awareness of low vaccination rates lacking

Dr. Kuwahara noted that awareness among clinicians of the issues surrounding hepatitis B appears low, with one small survey that she and her colleagues conducted of 30 primary care physicians showing that not one of the respondents was aware of the low vaccination rate.

Dr. Kuwahara says a key reason for the low awareness to discuss the hepatitis B vaccination with adults is the common impression that the responsibility for the vaccination lies in the hands of pediatricians.

But that’s only half correct – universal vaccination for hepatitis B in all infants and children is indeed currently the policy in the U.S. – but that was not implemented in all states until the mid-to-late ‘90s, meaning the millions of adults over the age of about 25 to 30, born before that period, are likely not fully vaccinated against hepatitis B.

“When I was in medical school, there wasn’t a lot of discussion of how low the hepatitis B vaccination rate was because everyone knew there was universal childhood vaccination, and I think there was an assumption that it had been going on for a long time,” Dr. Kuwahara said. “So I think it’s clearly a misconception, and it’s really important to improve clinician awareness around the issue.”
 

Opioid use a key factor in rising infection rates

Importantly, a large proportion of opioid users are among the population of patients born before the mid-’90s – and those adults have a particularly high risk of transmission, with data indicating that 36% of new hepatitis B infections are the result of the opioid epidemic, Dr. Kuwahara noted.

“In the opioid epidemic, we have seen some of the greatest increases in acute hepatitis B presenting in adults aged 30 to 49 years old, as most adults in this age range would not have been vaccinated as children in the U.S.,” she said.

Approximately two-thirds of individuals with chronic hepatitis B are reportedly not even aware of their infection status due to ineffective prevention and vaccination programs, adding to the spread of infection, Dr. Kuwahara said.

Meanwhile, COVID-19 has only exacerbated the problem, with record-high instances of overdoses and overdose-related deaths during the pandemic, she explained.

However, the pandemic, and specifically the sweeping innovations that have been implemented in desperate efforts to bring COVID-19 vaccines to the public, could in fact represent a critical opportunity for hepatitis B prevention, Dr. Kuwahara said.

“Significant resources and federal funding have already been invested to develop a robust infrastructure for multi-dose COVID-19 vaccine administration during the pandemic, which has resulted in millions of people across the U.S. receiving the COVID-19 vaccine in easily accessible settings within their communities,” she said.

“It is essential that we expand the infrastructure development ... so that we may use this infrastructure to administer other vaccines such as the hepatitis B vaccine to adults throughout the nation and prevent additional outbreaks.”
 

Implementation of vaccine recommendations key

Dr. Kuwahara outlined key measures that will be important in implementing the hepatitis B vaccine recommendations:

• Awareness of the hepatitis B vaccination recommendations at the primary care level: “The first step in implementing universal [guidelines] will be to ensure that health care providers, particularly in primary care, are aware of the new ACIP guidelines so that they can speak with their patients about this and appropriately order hepatitis B testing and vaccination,” she said.
• Availability of vaccines: In addition to making sure primary care clinics are well stocked with hepatitis B vaccines, the vaccines should also be available in pharmacies and other convenient nonclinical settings through community outreach, similar to COVID-19 vaccines.
• Follow-up: Systems should be established to remind patients to receive follow-up doses.
• Public funding for vaccines: Policy changes will need to occur to allocate appropriate Section 317 funding to provide hepatitis B vaccines to adults without health insurance coverage, Dr. Kuwahara said, underscoring concerns about health equity in vaccination.
• Track vaccinations: Communication should be established between places administering vaccines and primary care providers to make sure that vaccination status can be documented in a reliable setting.

Dr. Kuwahara also noted that a federal immunization information system will be essential to track vaccines across a lifespan, providing one integrated vaccine record that can be accessed even when patients travel or move to different states.

Commenting on the issue, Frank Hood, manager of hepatitis advocacy for The AIDS Institute in Washington, D.C., added that, in addition to simplifying the process, the new age-based recommendation removes the issue of perceived judgement from the advice.

“The previous recommendations were more risk based, and patients may tend to say ‘oh, I don’t have any of those behaviors,’ and there can be some stigma,” he said. “But having something that says everyone in these age groups should be or may be vaccinated just makes it much easier and covers a greater number of individuals.”

Mr. Hood further underscored the need for continued diligence in improving measures to prevent and eradicate HBV as well as other infectious diseases.

“It is imperative that the systems being built now to respond to future infectious disease outbreaks are done so in a way to equitably support the efforts and end goal of eliminating current infectious disease epidemics like viral hepatitis and HIV,” he emphasized.“Elimination can’t be achieved if we leave people behind.”

Dr. Kuwahara and Mr. Hood had no disclosures to report.

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

An updated recommendation from the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) calling for universal hepatitis B vaccination of all adults aged 59 and younger has boosted the call to improve clinicians’ awareness of the increasing infection and low vaccination rates – and raise the issue with patients.

“This new recommendation from [the] ACIP will be instrumental [in] raising adult hepatitis B vaccination rates in the U.S. to levels that will allow us to finally eliminate hepatitis B in this country,” said Rita K. Kuwahara, MD, a primary care internal medicine physician and health policy fellow at Georgetown University, in Washington, D.C., in addressing the issue at the U.S. Conference on HIV/AIDS (USCHA) this month.

“We have the tools to prevent hepatitis B, and since we have such safe and highly effective vaccines to protect against community [spread], we should not have a single new infection in our nation,” she asserted.

The unanimously approved updated ACIP recommendation was issued in November and still requires adoption by the CDC director. The ACIP specifically recommends that adults aged 19 to 59 and those 60 years and older with risk factors for infection “should” receive the hepatitis B vaccine, and it further stipulates that those 60 years and older without known risk factors for hepatitis B “may” receive the vaccine.

The recommendation was previously only for adults at risk for hepatitis B infection due to a variety of factors, including sexual exposure, percutaneous or mucosal exposure to blood, hepatitis C infection, chronic liver disease, end-stage renal disease, and HIV infection.

“The number of risk factors was long, and for a busy primary care provider to have to go through a lengthy risk-based protocol like that, it may not happen,” Dr. Kuwahara told this news organization.

“Now we have a really helpful new recommendation that is simply age based, and clinicians can just tell patients that if they were born before this certain period, a hepatitis B vaccination is recommended.”

The change comes amid a troubling trajectory of hepatitis B, with up to 2.4 million individuals currently having chronic hepatitis B in the U.S. and infection rates soaring by 100% to more than 400% in states with high opioid use, such as West Virginia, Kentucky, Tennessee, and Maine, Dr. Kuwahara said.

Notably, hepatitis B is the leading cause of liver disease, and one in four individuals with unmanaged chronic hepatitis B goes on to develop liver failure and/or cirrhosis or liver cancer, which has a 5-year survival rate of only 18%.

Despite the rising infection rates, only 25%-30% of adults in the U.S. are reported to be currently vaccinated for hepatitis B, even though safe and highly effective vaccines are available, notably including a new two-dose vaccine (Heplisav-B) that can be provided over just a month (vs. other hepatitis B vaccines requiring 3 doses over 6 months).
 

Clinician awareness of low vaccination rates lacking

Dr. Kuwahara noted that awareness among clinicians of the issues surrounding hepatitis B appears low, with one small survey that she and her colleagues conducted of 30 primary care physicians showing that not one of the respondents was aware of the low vaccination rate.

Dr. Kuwahara says a key reason for the low awareness to discuss the hepatitis B vaccination with adults is the common impression that the responsibility for the vaccination lies in the hands of pediatricians.

But that’s only half correct – universal vaccination for hepatitis B in all infants and children is indeed currently the policy in the U.S. – but that was not implemented in all states until the mid-to-late ‘90s, meaning the millions of adults over the age of about 25 to 30, born before that period, are likely not fully vaccinated against hepatitis B.

“When I was in medical school, there wasn’t a lot of discussion of how low the hepatitis B vaccination rate was because everyone knew there was universal childhood vaccination, and I think there was an assumption that it had been going on for a long time,” Dr. Kuwahara said. “So I think it’s clearly a misconception, and it’s really important to improve clinician awareness around the issue.”
 

Opioid use a key factor in rising infection rates

Importantly, a large proportion of opioid users are among the population of patients born before the mid-’90s – and those adults have a particularly high risk of transmission, with data indicating that 36% of new hepatitis B infections are the result of the opioid epidemic, Dr. Kuwahara noted.

“In the opioid epidemic, we have seen some of the greatest increases in acute hepatitis B presenting in adults aged 30 to 49 years old, as most adults in this age range would not have been vaccinated as children in the U.S.,” she said.

Approximately two-thirds of individuals with chronic hepatitis B are reportedly not even aware of their infection status due to ineffective prevention and vaccination programs, adding to the spread of infection, Dr. Kuwahara said.

Meanwhile, COVID-19 has only exacerbated the problem, with record-high instances of overdoses and overdose-related deaths during the pandemic, she explained.

However, the pandemic, and specifically the sweeping innovations that have been implemented in desperate efforts to bring COVID-19 vaccines to the public, could in fact represent a critical opportunity for hepatitis B prevention, Dr. Kuwahara said.

“Significant resources and federal funding have already been invested to develop a robust infrastructure for multi-dose COVID-19 vaccine administration during the pandemic, which has resulted in millions of people across the U.S. receiving the COVID-19 vaccine in easily accessible settings within their communities,” she said.

“It is essential that we expand the infrastructure development ... so that we may use this infrastructure to administer other vaccines such as the hepatitis B vaccine to adults throughout the nation and prevent additional outbreaks.”
 

Implementation of vaccine recommendations key

Dr. Kuwahara outlined key measures that will be important in implementing the hepatitis B vaccine recommendations:

• Awareness of the hepatitis B vaccination recommendations at the primary care level: “The first step in implementing universal [guidelines] will be to ensure that health care providers, particularly in primary care, are aware of the new ACIP guidelines so that they can speak with their patients about this and appropriately order hepatitis B testing and vaccination,” she said.
• Availability of vaccines: In addition to making sure primary care clinics are well stocked with hepatitis B vaccines, the vaccines should also be available in pharmacies and other convenient nonclinical settings through community outreach, similar to COVID-19 vaccines.
• Follow-up: Systems should be established to remind patients to receive follow-up doses.
• Public funding for vaccines: Policy changes will need to occur to allocate appropriate Section 317 funding to provide hepatitis B vaccines to adults without health insurance coverage, Dr. Kuwahara said, underscoring concerns about health equity in vaccination.
• Track vaccinations: Communication should be established between places administering vaccines and primary care providers to make sure that vaccination status can be documented in a reliable setting.

Dr. Kuwahara also noted that a federal immunization information system will be essential to track vaccines across a lifespan, providing one integrated vaccine record that can be accessed even when patients travel or move to different states.

Commenting on the issue, Frank Hood, manager of hepatitis advocacy for The AIDS Institute in Washington, D.C., added that, in addition to simplifying the process, the new age-based recommendation removes the issue of perceived judgement from the advice.

“The previous recommendations were more risk based, and patients may tend to say ‘oh, I don’t have any of those behaviors,’ and there can be some stigma,” he said. “But having something that says everyone in these age groups should be or may be vaccinated just makes it much easier and covers a greater number of individuals.”

Mr. Hood further underscored the need for continued diligence in improving measures to prevent and eradicate HBV as well as other infectious diseases.

“It is imperative that the systems being built now to respond to future infectious disease outbreaks are done so in a way to equitably support the efforts and end goal of eliminating current infectious disease epidemics like viral hepatitis and HIV,” he emphasized.“Elimination can’t be achieved if we leave people behind.”

Dr. Kuwahara and Mr. Hood had no disclosures to report.

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

An updated recommendation from the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) calling for universal hepatitis B vaccination of all adults aged 59 and younger has boosted the call to improve clinicians’ awareness of the increasing infection and low vaccination rates – and raise the issue with patients.

“This new recommendation from [the] ACIP will be instrumental [in] raising adult hepatitis B vaccination rates in the U.S. to levels that will allow us to finally eliminate hepatitis B in this country,” said Rita K. Kuwahara, MD, a primary care internal medicine physician and health policy fellow at Georgetown University, in Washington, D.C., in addressing the issue at the U.S. Conference on HIV/AIDS (USCHA) this month.

“We have the tools to prevent hepatitis B, and since we have such safe and highly effective vaccines to protect against community [spread], we should not have a single new infection in our nation,” she asserted.

The unanimously approved updated ACIP recommendation was issued in November and still requires adoption by the CDC director. The ACIP specifically recommends that adults aged 19 to 59 and those 60 years and older with risk factors for infection “should” receive the hepatitis B vaccine, and it further stipulates that those 60 years and older without known risk factors for hepatitis B “may” receive the vaccine.

The recommendation was previously only for adults at risk for hepatitis B infection due to a variety of factors, including sexual exposure, percutaneous or mucosal exposure to blood, hepatitis C infection, chronic liver disease, end-stage renal disease, and HIV infection.

“The number of risk factors was long, and for a busy primary care provider to have to go through a lengthy risk-based protocol like that, it may not happen,” Dr. Kuwahara told this news organization.

“Now we have a really helpful new recommendation that is simply age based, and clinicians can just tell patients that if they were born before this certain period, a hepatitis B vaccination is recommended.”

The change comes amid a troubling trajectory of hepatitis B, with up to 2.4 million individuals currently having chronic hepatitis B in the U.S. and infection rates soaring by 100% to more than 400% in states with high opioid use, such as West Virginia, Kentucky, Tennessee, and Maine, Dr. Kuwahara said.

Notably, hepatitis B is the leading cause of liver disease, and one in four individuals with unmanaged chronic hepatitis B goes on to develop liver failure and/or cirrhosis or liver cancer, which has a 5-year survival rate of only 18%.

Despite the rising infection rates, only 25%-30% of adults in the U.S. are reported to be currently vaccinated for hepatitis B, even though safe and highly effective vaccines are available, notably including a new two-dose vaccine (Heplisav-B) that can be provided over just a month (vs. other hepatitis B vaccines requiring 3 doses over 6 months).
 

Clinician awareness of low vaccination rates lacking

Dr. Kuwahara noted that awareness among clinicians of the issues surrounding hepatitis B appears low, with one small survey that she and her colleagues conducted of 30 primary care physicians showing that not one of the respondents was aware of the low vaccination rate.

Dr. Kuwahara says a key reason for the low awareness to discuss the hepatitis B vaccination with adults is the common impression that the responsibility for the vaccination lies in the hands of pediatricians.

But that’s only half correct – universal vaccination for hepatitis B in all infants and children is indeed currently the policy in the U.S. – but that was not implemented in all states until the mid-to-late ‘90s, meaning the millions of adults over the age of about 25 to 30, born before that period, are likely not fully vaccinated against hepatitis B.

“When I was in medical school, there wasn’t a lot of discussion of how low the hepatitis B vaccination rate was because everyone knew there was universal childhood vaccination, and I think there was an assumption that it had been going on for a long time,” Dr. Kuwahara said. “So I think it’s clearly a misconception, and it’s really important to improve clinician awareness around the issue.”
 

Opioid use a key factor in rising infection rates

Importantly, a large proportion of opioid users are among the population of patients born before the mid-’90s – and those adults have a particularly high risk of transmission, with data indicating that 36% of new hepatitis B infections are the result of the opioid epidemic, Dr. Kuwahara noted.

“In the opioid epidemic, we have seen some of the greatest increases in acute hepatitis B presenting in adults aged 30 to 49 years old, as most adults in this age range would not have been vaccinated as children in the U.S.,” she said.

Approximately two-thirds of individuals with chronic hepatitis B are reportedly not even aware of their infection status due to ineffective prevention and vaccination programs, adding to the spread of infection, Dr. Kuwahara said.

Meanwhile, COVID-19 has only exacerbated the problem, with record-high instances of overdoses and overdose-related deaths during the pandemic, she explained.

However, the pandemic, and specifically the sweeping innovations that have been implemented in desperate efforts to bring COVID-19 vaccines to the public, could in fact represent a critical opportunity for hepatitis B prevention, Dr. Kuwahara said.

“Significant resources and federal funding have already been invested to develop a robust infrastructure for multi-dose COVID-19 vaccine administration during the pandemic, which has resulted in millions of people across the U.S. receiving the COVID-19 vaccine in easily accessible settings within their communities,” she said.

“It is essential that we expand the infrastructure development ... so that we may use this infrastructure to administer other vaccines such as the hepatitis B vaccine to adults throughout the nation and prevent additional outbreaks.”
 

Implementation of vaccine recommendations key

Dr. Kuwahara outlined key measures that will be important in implementing the hepatitis B vaccine recommendations:

• Awareness of the hepatitis B vaccination recommendations at the primary care level: “The first step in implementing universal [guidelines] will be to ensure that health care providers, particularly in primary care, are aware of the new ACIP guidelines so that they can speak with their patients about this and appropriately order hepatitis B testing and vaccination,” she said.
• Availability of vaccines: In addition to making sure primary care clinics are well stocked with hepatitis B vaccines, the vaccines should also be available in pharmacies and other convenient nonclinical settings through community outreach, similar to COVID-19 vaccines.
• Follow-up: Systems should be established to remind patients to receive follow-up doses.
• Public funding for vaccines: Policy changes will need to occur to allocate appropriate Section 317 funding to provide hepatitis B vaccines to adults without health insurance coverage, Dr. Kuwahara said, underscoring concerns about health equity in vaccination.
• Track vaccinations: Communication should be established between places administering vaccines and primary care providers to make sure that vaccination status can be documented in a reliable setting.

Dr. Kuwahara also noted that a federal immunization information system will be essential to track vaccines across a lifespan, providing one integrated vaccine record that can be accessed even when patients travel or move to different states.

Commenting on the issue, Frank Hood, manager of hepatitis advocacy for The AIDS Institute in Washington, D.C., added that, in addition to simplifying the process, the new age-based recommendation removes the issue of perceived judgement from the advice.

“The previous recommendations were more risk based, and patients may tend to say ‘oh, I don’t have any of those behaviors,’ and there can be some stigma,” he said. “But having something that says everyone in these age groups should be or may be vaccinated just makes it much easier and covers a greater number of individuals.”

Mr. Hood further underscored the need for continued diligence in improving measures to prevent and eradicate HBV as well as other infectious diseases.

“It is imperative that the systems being built now to respond to future infectious disease outbreaks are done so in a way to equitably support the efforts and end goal of eliminating current infectious disease epidemics like viral hepatitis and HIV,” he emphasized.“Elimination can’t be achieved if we leave people behind.”

Dr. Kuwahara and Mr. Hood had no disclosures to report.

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

The majority of addiction specialists, including psychiatrists, believe psychedelics are promising for the treatment of substance use disorders (SUDs) and psychiatric illnesses and, with some caveats, support legalization of the substances for these indications, results of a new survey show.

This strong positive attitude is “a surprise” given previous wariness of addiction specialists regarding legalization of marijuana, noted study investigator Amanda Kim, MD, JD, of Brigham and Women’s Hospital and Harvard Medical School, Boston.

“We had hypothesized that addiction specialists would express more skepticism about psychedelics compared to nonaddiction specialists,” Dr. Kim said.

Instead, addiction experts who participated in the survey were very much in favor of psychedelics being legalized for therapeutic use, but only in a controlled setting.

The findings were presented at the annual meeting of the American Academy of Addiction Psychiatry.
 

Growing interest

In recent years, there has been increased interest in the scientific community and among the general public in the therapeutic potential of psychedelics, said Dr. Kim. Previous research has shown growing positivity about psychedelics and support for their legalization among psychiatrists, she added.

Psychedelics have been decriminalized and/or legalized in several jurisdictions. The Food and Drug Administration has granted breakthrough therapy designation for 3,4-methylenedioxymethamphetamine (MDMA) in the treatment of posttraumatic stress disorder (PTSD) and has granted the same designation to psilocybin in the treatment of major depressive disorder.

“Despite psychedelics increasingly entering the mainstream, we are unaware of any studies specifically assessing the current attitudes of physicians specializing in addictions regarding psychedelics,” Dr. Kim said.

For the study, investigators identified prospective survey participants from the AAAP directory. They also reached out to program directors of addiction medicine and addiction psychiatry fellowships.

In the anonymous online survey, respondents were asked to rate their level of agreement with 30 statements.

The analysis included 145 respondents (59% men; mean age, 46.2 years). Psychiatrists made up about two-thirds of the sample. The remainder specialized in internal and family medicine.

Most respondents had some clinical exposure to psychedelics. Almost 85% reported discussing a psychedelic experience with at least one patient.
 

Positive attitudes, concerns

Overall, participants expressed very positive attitudes regarding the therapeutic use of psychedelics. About 64% strongly agreed or agreed psychedelics show promise in treating SUDs, and 82% agreed they show promise in treating psychiatric disorders.

However, more than one-third of respondents (37.9%) expressed concern about the addictive potential of psychedelics. This is more than in previous research polling psychiatrists, possibly because the study’s “broad” definition of psychedelics included “nonclassic, nonserotonergic hallucinogens,” such as ketamine and MDMA, Dr. Kim noted.

Because ketamine and MDMA are both lumped into the hallucinogen category in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), “and both are known to have addictive potential, this may have obscured participant responses,” she added.

Some 28% of participants expressed concern about psychedelic use increasing the risk for subsequent psychiatric disorders and long-term cognitive impairment.

Almost three-quarters (74.5%) believe the therapeutic use of psychedelics should be legalized. However, most wanted legal therapeutic psychedelics to be highly regulated and administered only in controlled settings with specially trained providers.

Almost half of the sample believed therapeutic psychedelics should be legal in a variety of different contexts and by non-Western providers, in accordance with indigenous and/or spiritual traditions.

One surprising finding was that most respondents believed patients would be keen on using psychedelics to treat SUDs, said Dr. Kim.

“This may reflect evolving attitudes of both providers and patients about psychedelics, and it will be interesting to further study attitudes of patients toward the use of psychedelics to treat SUD in the future,” she added.

Attitudes toward psychedelics were generally similar for psychiatrists and nonpsychiatrists; but psychiatrists expressed greater comfort in discussing them with patients and were more likely to have observed complications of psychedelics use in their practice.

Dr. Kim said the study’s limitations included the small sample size and possible selection bias, as those with more favorable views of psychedelics may have been more likely to respond.

The study was supported by the Source Research Foundation.

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

The majority of addiction specialists, including psychiatrists, believe psychedelics are promising for the treatment of substance use disorders (SUDs) and psychiatric illnesses and, with some caveats, support legalization of the substances for these indications, results of a new survey show.

This strong positive attitude is “a surprise” given previous wariness of addiction specialists regarding legalization of marijuana, noted study investigator Amanda Kim, MD, JD, of Brigham and Women’s Hospital and Harvard Medical School, Boston.

“We had hypothesized that addiction specialists would express more skepticism about psychedelics compared to nonaddiction specialists,” Dr. Kim said.

Instead, addiction experts who participated in the survey were very much in favor of psychedelics being legalized for therapeutic use, but only in a controlled setting.

The findings were presented at the annual meeting of the American Academy of Addiction Psychiatry.
 

Growing interest

In recent years, there has been increased interest in the scientific community and among the general public in the therapeutic potential of psychedelics, said Dr. Kim. Previous research has shown growing positivity about psychedelics and support for their legalization among psychiatrists, she added.

Psychedelics have been decriminalized and/or legalized in several jurisdictions. The Food and Drug Administration has granted breakthrough therapy designation for 3,4-methylenedioxymethamphetamine (MDMA) in the treatment of posttraumatic stress disorder (PTSD) and has granted the same designation to psilocybin in the treatment of major depressive disorder.

“Despite psychedelics increasingly entering the mainstream, we are unaware of any studies specifically assessing the current attitudes of physicians specializing in addictions regarding psychedelics,” Dr. Kim said.

For the study, investigators identified prospective survey participants from the AAAP directory. They also reached out to program directors of addiction medicine and addiction psychiatry fellowships.

In the anonymous online survey, respondents were asked to rate their level of agreement with 30 statements.

The analysis included 145 respondents (59% men; mean age, 46.2 years). Psychiatrists made up about two-thirds of the sample. The remainder specialized in internal and family medicine.

Most respondents had some clinical exposure to psychedelics. Almost 85% reported discussing a psychedelic experience with at least one patient.
 

Positive attitudes, concerns

Overall, participants expressed very positive attitudes regarding the therapeutic use of psychedelics. About 64% strongly agreed or agreed psychedelics show promise in treating SUDs, and 82% agreed they show promise in treating psychiatric disorders.

However, more than one-third of respondents (37.9%) expressed concern about the addictive potential of psychedelics. This is more than in previous research polling psychiatrists, possibly because the study’s “broad” definition of psychedelics included “nonclassic, nonserotonergic hallucinogens,” such as ketamine and MDMA, Dr. Kim noted.

Because ketamine and MDMA are both lumped into the hallucinogen category in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), “and both are known to have addictive potential, this may have obscured participant responses,” she added.

Some 28% of participants expressed concern about psychedelic use increasing the risk for subsequent psychiatric disorders and long-term cognitive impairment.

Almost three-quarters (74.5%) believe the therapeutic use of psychedelics should be legalized. However, most wanted legal therapeutic psychedelics to be highly regulated and administered only in controlled settings with specially trained providers.

Almost half of the sample believed therapeutic psychedelics should be legal in a variety of different contexts and by non-Western providers, in accordance with indigenous and/or spiritual traditions.

One surprising finding was that most respondents believed patients would be keen on using psychedelics to treat SUDs, said Dr. Kim.

“This may reflect evolving attitudes of both providers and patients about psychedelics, and it will be interesting to further study attitudes of patients toward the use of psychedelics to treat SUD in the future,” she added.

Attitudes toward psychedelics were generally similar for psychiatrists and nonpsychiatrists; but psychiatrists expressed greater comfort in discussing them with patients and were more likely to have observed complications of psychedelics use in their practice.

Dr. Kim said the study’s limitations included the small sample size and possible selection bias, as those with more favorable views of psychedelics may have been more likely to respond.

The study was supported by the Source Research Foundation.

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

The majority of addiction specialists, including psychiatrists, believe psychedelics are promising for the treatment of substance use disorders (SUDs) and psychiatric illnesses and, with some caveats, support legalization of the substances for these indications, results of a new survey show.

This strong positive attitude is “a surprise” given previous wariness of addiction specialists regarding legalization of marijuana, noted study investigator Amanda Kim, MD, JD, of Brigham and Women’s Hospital and Harvard Medical School, Boston.

“We had hypothesized that addiction specialists would express more skepticism about psychedelics compared to nonaddiction specialists,” Dr. Kim said.

Instead, addiction experts who participated in the survey were very much in favor of psychedelics being legalized for therapeutic use, but only in a controlled setting.

The findings were presented at the annual meeting of the American Academy of Addiction Psychiatry.
 

Growing interest

In recent years, there has been increased interest in the scientific community and among the general public in the therapeutic potential of psychedelics, said Dr. Kim. Previous research has shown growing positivity about psychedelics and support for their legalization among psychiatrists, she added.

Psychedelics have been decriminalized and/or legalized in several jurisdictions. The Food and Drug Administration has granted breakthrough therapy designation for 3,4-methylenedioxymethamphetamine (MDMA) in the treatment of posttraumatic stress disorder (PTSD) and has granted the same designation to psilocybin in the treatment of major depressive disorder.

“Despite psychedelics increasingly entering the mainstream, we are unaware of any studies specifically assessing the current attitudes of physicians specializing in addictions regarding psychedelics,” Dr. Kim said.

For the study, investigators identified prospective survey participants from the AAAP directory. They also reached out to program directors of addiction medicine and addiction psychiatry fellowships.

In the anonymous online survey, respondents were asked to rate their level of agreement with 30 statements.

The analysis included 145 respondents (59% men; mean age, 46.2 years). Psychiatrists made up about two-thirds of the sample. The remainder specialized in internal and family medicine.

Most respondents had some clinical exposure to psychedelics. Almost 85% reported discussing a psychedelic experience with at least one patient.
 

Positive attitudes, concerns

Overall, participants expressed very positive attitudes regarding the therapeutic use of psychedelics. About 64% strongly agreed or agreed psychedelics show promise in treating SUDs, and 82% agreed they show promise in treating psychiatric disorders.

However, more than one-third of respondents (37.9%) expressed concern about the addictive potential of psychedelics. This is more than in previous research polling psychiatrists, possibly because the study’s “broad” definition of psychedelics included “nonclassic, nonserotonergic hallucinogens,” such as ketamine and MDMA, Dr. Kim noted.

Because ketamine and MDMA are both lumped into the hallucinogen category in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), “and both are known to have addictive potential, this may have obscured participant responses,” she added.

Some 28% of participants expressed concern about psychedelic use increasing the risk for subsequent psychiatric disorders and long-term cognitive impairment.

Almost three-quarters (74.5%) believe the therapeutic use of psychedelics should be legalized. However, most wanted legal therapeutic psychedelics to be highly regulated and administered only in controlled settings with specially trained providers.

Almost half of the sample believed therapeutic psychedelics should be legal in a variety of different contexts and by non-Western providers, in accordance with indigenous and/or spiritual traditions.

One surprising finding was that most respondents believed patients would be keen on using psychedelics to treat SUDs, said Dr. Kim.

“This may reflect evolving attitudes of both providers and patients about psychedelics, and it will be interesting to further study attitudes of patients toward the use of psychedelics to treat SUD in the future,” she added.

Attitudes toward psychedelics were generally similar for psychiatrists and nonpsychiatrists; but psychiatrists expressed greater comfort in discussing them with patients and were more likely to have observed complications of psychedelics use in their practice.

Dr. Kim said the study’s limitations included the small sample size and possible selection bias, as those with more favorable views of psychedelics may have been more likely to respond.

The study was supported by the Source Research Foundation.

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

The number of reported circulating vaccine-derived poliovirus (cVDPV) outbreaks more than tripled to 29 since Jan. 2017. Most (86%) of these outbreaks were caused by cVDPV2 (circulating VDPV type 2 poliovirus, which originated with the vaccine), and most occurred in Africa, according to a new study of vaccine-derived poliovirus outbreaks between Jan. 2020 and June 2021 published in the CDC’s Morbidity and Mortality Weekly Report.

The Global Polio Eradication Initiative (GPEI) was launched in 1988 and used live attenuated oral poliovirus vaccine (OPV). Since then, cases of wild poliovirus have declined more than 99.99%.

The cVDPV2 likely originated among children born in areas with poor vaccine coverage. Jay Wenger, MD, director, Polio, at the Bill and Melinda Gates Foundation, told this news organization that “the inactivated vaccines that we give in most developed countries now are good in that they provide humoral immunity, the antibodies in the bloodstream. They don’t necessarily provide mucosal immunity. They don’t make the kid’s gut immune to getting reinfected or actually immune to reproducing the virus if they get it in their gut. So we could still have a situation where everybody was vaccinated with IPV [inactivated poliovirus], but the virus could still be transmitting around because kids’ guts would still be producing the virus and there will still be transmission in your population, probably without much or any paralysis because of the IPV. As soon as that virus hit a population that was not vaccinated, they would get paralyzed.”

Dr. Wenger added, “The ideal vaccine would be an oral vaccine that didn’t mutate back and couldn’t cause these VDPVs.” Scientists developed such a vaccine, approved by the World Health Organization last year under an Emergency Use Authorization. This nOPV2 (novel oral poliovirus type 2) vaccine has been given since March 2021 in areas with the VDPD2 outbreaks. The nOPV2 should allow them to “basically stamp out the outbreaks.”

The world had almost eradicated the disease, with the last cases of polio from wild virus occurring in Nigeria, Afghanistan, and Pakistan as of 2014. Africa was declared free of wild polio in 2020 after it had been eradicated from Nigeria, which accounted for more than half of the world’s cases only a decade earlier. Now cVDPV outbreaks affect 28 African countries, plus Iran, Yemen, Afghanistan, Pakistan, Tajikistan, Malaysia, the Philippines, and Indonesia. And there was also one case in China. Globally, there were 1,335 cases of cVDPV causing paralysis during the reporting period.

The COVID-19 pandemic has had a significant impact on polio, accounting for much of this year’s increase in cases. Dr. Wenger said, “We couldn’t do any campaigns. We pretty much stopped doing outbreak response campaigns in the middle of the year because of COVID.”

The CDC report notes that many of the supplementary immunizations in response to cVDPV2 outbreaks were of “poor quality,” and prolonged delays enabled geographically expanding cVDPV2 transmission.

Steve Wassilak, MD, chief coauthor of the CDC study, told this news organization that, because of COVID, “what we’ve been lacking is a rapid response for the most part. Some of that is due to laboratory delays and shipment because of COVID’s effect on international travel.” He noted, however, that there has been good recovery in surveillance and immunization activities despite COVID. And, he added, eradication “can be done, and many outbreaks have closed even during the [COVID] outbreak.”

Dr. Wassilak said that in Nigeria, “the face of the campaign became national.” In Pakistan, much of the work is done by national and international partners.

Dr. Wenger said that in Nigeria and other challenging areas, “the approach was essentially to make direct contact with the traditional leaders and the religious leaders and the local actors in each of these populations. So, it’s really getting down to the grassroots level.” Infectious disease officials send teams to speak with individuals in the “local, traditional leader system.”

“Just talking to them actually got us a long way and giving them the information that they need. In most cases, I mean, people want to do things to help their kids,” said Dr. Wenger.

For now, the initial plan, per the CDC, is to “initiate prompt and high coverage outbreak responses with available type 2 OPV to interrupt transmission” until a better supply of nOPV2 is available, then switch to IPVs.

Dr. Wenger and Dr. Wassilak report no relevant financial relationships.

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

The number of reported circulating vaccine-derived poliovirus (cVDPV) outbreaks more than tripled to 29 since Jan. 2017. Most (86%) of these outbreaks were caused by cVDPV2 (circulating VDPV type 2 poliovirus, which originated with the vaccine), and most occurred in Africa, according to a new study of vaccine-derived poliovirus outbreaks between Jan. 2020 and June 2021 published in the CDC’s Morbidity and Mortality Weekly Report.

The Global Polio Eradication Initiative (GPEI) was launched in 1988 and used live attenuated oral poliovirus vaccine (OPV). Since then, cases of wild poliovirus have declined more than 99.99%.

The cVDPV2 likely originated among children born in areas with poor vaccine coverage. Jay Wenger, MD, director, Polio, at the Bill and Melinda Gates Foundation, told this news organization that “the inactivated vaccines that we give in most developed countries now are good in that they provide humoral immunity, the antibodies in the bloodstream. They don’t necessarily provide mucosal immunity. They don’t make the kid’s gut immune to getting reinfected or actually immune to reproducing the virus if they get it in their gut. So we could still have a situation where everybody was vaccinated with IPV [inactivated poliovirus], but the virus could still be transmitting around because kids’ guts would still be producing the virus and there will still be transmission in your population, probably without much or any paralysis because of the IPV. As soon as that virus hit a population that was not vaccinated, they would get paralyzed.”

Dr. Wenger added, “The ideal vaccine would be an oral vaccine that didn’t mutate back and couldn’t cause these VDPVs.” Scientists developed such a vaccine, approved by the World Health Organization last year under an Emergency Use Authorization. This nOPV2 (novel oral poliovirus type 2) vaccine has been given since March 2021 in areas with the VDPD2 outbreaks. The nOPV2 should allow them to “basically stamp out the outbreaks.”

The world had almost eradicated the disease, with the last cases of polio from wild virus occurring in Nigeria, Afghanistan, and Pakistan as of 2014. Africa was declared free of wild polio in 2020 after it had been eradicated from Nigeria, which accounted for more than half of the world’s cases only a decade earlier. Now cVDPV outbreaks affect 28 African countries, plus Iran, Yemen, Afghanistan, Pakistan, Tajikistan, Malaysia, the Philippines, and Indonesia. And there was also one case in China. Globally, there were 1,335 cases of cVDPV causing paralysis during the reporting period.

The COVID-19 pandemic has had a significant impact on polio, accounting for much of this year’s increase in cases. Dr. Wenger said, “We couldn’t do any campaigns. We pretty much stopped doing outbreak response campaigns in the middle of the year because of COVID.”

The CDC report notes that many of the supplementary immunizations in response to cVDPV2 outbreaks were of “poor quality,” and prolonged delays enabled geographically expanding cVDPV2 transmission.

Steve Wassilak, MD, chief coauthor of the CDC study, told this news organization that, because of COVID, “what we’ve been lacking is a rapid response for the most part. Some of that is due to laboratory delays and shipment because of COVID’s effect on international travel.” He noted, however, that there has been good recovery in surveillance and immunization activities despite COVID. And, he added, eradication “can be done, and many outbreaks have closed even during the [COVID] outbreak.”

Dr. Wassilak said that in Nigeria, “the face of the campaign became national.” In Pakistan, much of the work is done by national and international partners.

Dr. Wenger said that in Nigeria and other challenging areas, “the approach was essentially to make direct contact with the traditional leaders and the religious leaders and the local actors in each of these populations. So, it’s really getting down to the grassroots level.” Infectious disease officials send teams to speak with individuals in the “local, traditional leader system.”

“Just talking to them actually got us a long way and giving them the information that they need. In most cases, I mean, people want to do things to help their kids,” said Dr. Wenger.

For now, the initial plan, per the CDC, is to “initiate prompt and high coverage outbreak responses with available type 2 OPV to interrupt transmission” until a better supply of nOPV2 is available, then switch to IPVs.

Dr. Wenger and Dr. Wassilak report no relevant financial relationships.

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

The number of reported circulating vaccine-derived poliovirus (cVDPV) outbreaks more than tripled to 29 since Jan. 2017. Most (86%) of these outbreaks were caused by cVDPV2 (circulating VDPV type 2 poliovirus, which originated with the vaccine), and most occurred in Africa, according to a new study of vaccine-derived poliovirus outbreaks between Jan. 2020 and June 2021 published in the CDC’s Morbidity and Mortality Weekly Report.

The Global Polio Eradication Initiative (GPEI) was launched in 1988 and used live attenuated oral poliovirus vaccine (OPV). Since then, cases of wild poliovirus have declined more than 99.99%.

The cVDPV2 likely originated among children born in areas with poor vaccine coverage. Jay Wenger, MD, director, Polio, at the Bill and Melinda Gates Foundation, told this news organization that “the inactivated vaccines that we give in most developed countries now are good in that they provide humoral immunity, the antibodies in the bloodstream. They don’t necessarily provide mucosal immunity. They don’t make the kid’s gut immune to getting reinfected or actually immune to reproducing the virus if they get it in their gut. So we could still have a situation where everybody was vaccinated with IPV [inactivated poliovirus], but the virus could still be transmitting around because kids’ guts would still be producing the virus and there will still be transmission in your population, probably without much or any paralysis because of the IPV. As soon as that virus hit a population that was not vaccinated, they would get paralyzed.”

Dr. Wenger added, “The ideal vaccine would be an oral vaccine that didn’t mutate back and couldn’t cause these VDPVs.” Scientists developed such a vaccine, approved by the World Health Organization last year under an Emergency Use Authorization. This nOPV2 (novel oral poliovirus type 2) vaccine has been given since March 2021 in areas with the VDPD2 outbreaks. The nOPV2 should allow them to “basically stamp out the outbreaks.”

The world had almost eradicated the disease, with the last cases of polio from wild virus occurring in Nigeria, Afghanistan, and Pakistan as of 2014. Africa was declared free of wild polio in 2020 after it had been eradicated from Nigeria, which accounted for more than half of the world’s cases only a decade earlier. Now cVDPV outbreaks affect 28 African countries, plus Iran, Yemen, Afghanistan, Pakistan, Tajikistan, Malaysia, the Philippines, and Indonesia. And there was also one case in China. Globally, there were 1,335 cases of cVDPV causing paralysis during the reporting period.

The COVID-19 pandemic has had a significant impact on polio, accounting for much of this year’s increase in cases. Dr. Wenger said, “We couldn’t do any campaigns. We pretty much stopped doing outbreak response campaigns in the middle of the year because of COVID.”

The CDC report notes that many of the supplementary immunizations in response to cVDPV2 outbreaks were of “poor quality,” and prolonged delays enabled geographically expanding cVDPV2 transmission.

Steve Wassilak, MD, chief coauthor of the CDC study, told this news organization that, because of COVID, “what we’ve been lacking is a rapid response for the most part. Some of that is due to laboratory delays and shipment because of COVID’s effect on international travel.” He noted, however, that there has been good recovery in surveillance and immunization activities despite COVID. And, he added, eradication “can be done, and many outbreaks have closed even during the [COVID] outbreak.”

Dr. Wassilak said that in Nigeria, “the face of the campaign became national.” In Pakistan, much of the work is done by national and international partners.

Dr. Wenger said that in Nigeria and other challenging areas, “the approach was essentially to make direct contact with the traditional leaders and the religious leaders and the local actors in each of these populations. So, it’s really getting down to the grassroots level.” Infectious disease officials send teams to speak with individuals in the “local, traditional leader system.”

“Just talking to them actually got us a long way and giving them the information that they need. In most cases, I mean, people want to do things to help their kids,” said Dr. Wenger.

For now, the initial plan, per the CDC, is to “initiate prompt and high coverage outbreak responses with available type 2 OPV to interrupt transmission” until a better supply of nOPV2 is available, then switch to IPVs.

Dr. Wenger and Dr. Wassilak report no relevant financial relationships.

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

The cardiovascular and cardiometabolic effects of therapy in women with breast cancer vary based on patient factors like weight and menopausal status, according to findings from the Pathways Heart Study recently presented at the San Antonio Breast Cancer Symposium.

Fred Hutchinson Cancer Center

For example, certain chemotherapy drugs may confer higher risk in breast cancer survivors of normal weight, whereas they may lower stroke risk in those who are obese, according to Heather Greenlee, ND, PhD, a public health researcher and naturopathic physician with the Fred Hutchinson Cancer Research Center in Seattle.

In postmenopausal women with breast cancer, aromatase inhibitors may increase cardiovascular risk, while tamoxifen appears to reduce the risk of incident dyslipidemia, she said.

The findings are from separate analyses of data from studies presented during a poster discussion session at the symposium.
 

Breast cancer treatment and cardiovascular effects: The role of weight

In one analysis, Dr. Greenlee and colleagues examined outcomes in 13,582 breast cancer survivors with a median age of 60 years and median follow-up of 7 years to assess whether cardiovascular disease (CVD) risk associated with specific breast cancer therapies varies by body mass index (BMI) category at diagnosis.

Many routinely used breast cancer therapies are cardiotoxic, and being overweight or obese are known risk factors for CVD, but few studies have assessed whether BMI modifies the effect of these treatment on cardiovascular risk, Dr. Greenlee explained.

After adjusting for baseline demographic and health-related factors, and other breast cancer treatment, they found that:

• Ischemic heart disease risk was higher among normal-weight women who received anthracyclines, compared with those who did not (hazard ratio, 4.2). No other risk associations were observed for other breast cancer therapies and BMI groups.
• Heart failure/cardiomyopathy risk was higher among women with normal weight who received anthracyclines, cyclophosphamides, or left-sided radiation, compared with those who did not (HRs, 5.24, 3.27, and 2.05, respectively), and among overweight women who received anthracyclines, compared with those who did not (HR, 2.18). No risk associations were observed for women who received trastuzumab, taxanes, endocrine therapy, or radiation on any side, and no risk associations were observed for women who were obese.
• Stroke risk was higher in normal-weight women who received taxanes, cyclophosphamides, or left-sided radiation versus those who did not (HRs, 2.14, 2.35, and 1.31, respectively), and stroke risk was lower in obese women who received anthracyclines, taxanes, or cyclophosphamide, compared with those who did not (HRs, 0.32, 0.41, and 0.29, respectively). No risk associations were observed for trastuzumab, endocrine therapy, or radiation on any side, and no risk associations were observed for women who were overweight.

The lack of associations noted between treatments and heart failure risk among obese patients could be caused by the “obesity paradox” observed in prior obese populations, the investigators noted, adding that additional analyses are planned to “examine whether different dosage and duration of breast cancer therapy exposures across the BMI groups contributed to these risk associations.”
 

Breast cancer treatment and cardiometabolic effects: The role of menopausal status

In a separate analysis, Dr. Greenlee and colleagues looked at the association between endocrine therapies and cardiometabolic risk based on menopausal status.

Endocrine therapy is associated with CVD in breast cancer survivors and may be associated with developing cardiometabolic risk factors like diabetes, dyslipidemia, and hypertension, they noted, explaining that tamoxifen has mixed estrogenic and antiestrogenic activity, while aromatase inhibitors deplete endogenous estrogen.

Since most studies have compared tamoxifen with aromatase inhibitor use, it has been a challenge challenging to discern the effects of each, Dr. Greenlee said.

She and her colleagues reviewed records for 14,942 breast cancer survivors who were diagnosed between 2005 and 2013. The patients had a mean age of 61 years at baseline, and 24.9% were premenopausal at the time of diagnosis. Of the premenopausal women, 27.3% used tamoxifen, 19.2% used aromatase inhibitors, and 53.5% did not use endocrine therapy, and of the postmenopausal women, 6.6% used tamoxifen, 47.7% used aromatase inhibitors, and 45.7% did not use endocrine therapy.

After adjusting for baseline demographics and health factors, the investigators found that:

• The use of tamoxifen or aromatase inhibitors was not associated with a risk of developing diabetes, dyslipidemia, or hypertension in premenopausal women, or with a risk of developing diabetes or hypertension in postmenopausal women.
• The risk of dyslipidemia was higher in postmenopausal aromatase inhibitor users, and lower in postmenopausal tamoxifen users, compared with postmenopausal non-users of endocrine therapy (HRs, 1.15 and 0.75, respectively).

The lack of associations between endocrine therapy and CVD risk in premenopausal women may be from low power, Dr. Greenlee said, noting that analyses in larger sample sizes are needed.

She and her colleagues plan to conduct further analyses looking at treatment dosage and duration, and comparing steroidal versus nonsteroidal aromatase inhibitors.

Future studies should examine the implications of these associations on long-term CVD and how best to manage lipid profiles in postmenopausal breast cancer survivors who have a history of endocrine therapy treatment, they concluded.

This research was funded by grants from the National Cancer Institute.

[email protected]

The cardiovascular and cardiometabolic effects of therapy in women with breast cancer vary based on patient factors like weight and menopausal status, according to findings from the Pathways Heart Study recently presented at the San Antonio Breast Cancer Symposium.

Fred Hutchinson Cancer Center

For example, certain chemotherapy drugs may confer higher risk in breast cancer survivors of normal weight, whereas they may lower stroke risk in those who are obese, according to Heather Greenlee, ND, PhD, a public health researcher and naturopathic physician with the Fred Hutchinson Cancer Research Center in Seattle.

In postmenopausal women with breast cancer, aromatase inhibitors may increase cardiovascular risk, while tamoxifen appears to reduce the risk of incident dyslipidemia, she said.

The findings are from separate analyses of data from studies presented during a poster discussion session at the symposium.
 

Breast cancer treatment and cardiovascular effects: The role of weight

In one analysis, Dr. Greenlee and colleagues examined outcomes in 13,582 breast cancer survivors with a median age of 60 years and median follow-up of 7 years to assess whether cardiovascular disease (CVD) risk associated with specific breast cancer therapies varies by body mass index (BMI) category at diagnosis.

Many routinely used breast cancer therapies are cardiotoxic, and being overweight or obese are known risk factors for CVD, but few studies have assessed whether BMI modifies the effect of these treatment on cardiovascular risk, Dr. Greenlee explained.

After adjusting for baseline demographic and health-related factors, and other breast cancer treatment, they found that:

• Ischemic heart disease risk was higher among normal-weight women who received anthracyclines, compared with those who did not (hazard ratio, 4.2). No other risk associations were observed for other breast cancer therapies and BMI groups.
• Heart failure/cardiomyopathy risk was higher among women with normal weight who received anthracyclines, cyclophosphamides, or left-sided radiation, compared with those who did not (HRs, 5.24, 3.27, and 2.05, respectively), and among overweight women who received anthracyclines, compared with those who did not (HR, 2.18). No risk associations were observed for women who received trastuzumab, taxanes, endocrine therapy, or radiation on any side, and no risk associations were observed for women who were obese.
• Stroke risk was higher in normal-weight women who received taxanes, cyclophosphamides, or left-sided radiation versus those who did not (HRs, 2.14, 2.35, and 1.31, respectively), and stroke risk was lower in obese women who received anthracyclines, taxanes, or cyclophosphamide, compared with those who did not (HRs, 0.32, 0.41, and 0.29, respectively). No risk associations were observed for trastuzumab, endocrine therapy, or radiation on any side, and no risk associations were observed for women who were overweight.

The lack of associations noted between treatments and heart failure risk among obese patients could be caused by the “obesity paradox” observed in prior obese populations, the investigators noted, adding that additional analyses are planned to “examine whether different dosage and duration of breast cancer therapy exposures across the BMI groups contributed to these risk associations.”
 

Breast cancer treatment and cardiometabolic effects: The role of menopausal status

In a separate analysis, Dr. Greenlee and colleagues looked at the association between endocrine therapies and cardiometabolic risk based on menopausal status.

Endocrine therapy is associated with CVD in breast cancer survivors and may be associated with developing cardiometabolic risk factors like diabetes, dyslipidemia, and hypertension, they noted, explaining that tamoxifen has mixed estrogenic and antiestrogenic activity, while aromatase inhibitors deplete endogenous estrogen.

Since most studies have compared tamoxifen with aromatase inhibitor use, it has been a challenge challenging to discern the effects of each, Dr. Greenlee said.

She and her colleagues reviewed records for 14,942 breast cancer survivors who were diagnosed between 2005 and 2013. The patients had a mean age of 61 years at baseline, and 24.9% were premenopausal at the time of diagnosis. Of the premenopausal women, 27.3% used tamoxifen, 19.2% used aromatase inhibitors, and 53.5% did not use endocrine therapy, and of the postmenopausal women, 6.6% used tamoxifen, 47.7% used aromatase inhibitors, and 45.7% did not use endocrine therapy.

After adjusting for baseline demographics and health factors, the investigators found that:

• The use of tamoxifen or aromatase inhibitors was not associated with a risk of developing diabetes, dyslipidemia, or hypertension in premenopausal women, or with a risk of developing diabetes or hypertension in postmenopausal women.
• The risk of dyslipidemia was higher in postmenopausal aromatase inhibitor users, and lower in postmenopausal tamoxifen users, compared with postmenopausal non-users of endocrine therapy (HRs, 1.15 and 0.75, respectively).

The lack of associations between endocrine therapy and CVD risk in premenopausal women may be from low power, Dr. Greenlee said, noting that analyses in larger sample sizes are needed.

She and her colleagues plan to conduct further analyses looking at treatment dosage and duration, and comparing steroidal versus nonsteroidal aromatase inhibitors.

Future studies should examine the implications of these associations on long-term CVD and how best to manage lipid profiles in postmenopausal breast cancer survivors who have a history of endocrine therapy treatment, they concluded.

This research was funded by grants from the National Cancer Institute.

[email protected]

The cardiovascular and cardiometabolic effects of therapy in women with breast cancer vary based on patient factors like weight and menopausal status, according to findings from the Pathways Heart Study recently presented at the San Antonio Breast Cancer Symposium.

Fred Hutchinson Cancer Center

For example, certain chemotherapy drugs may confer higher risk in breast cancer survivors of normal weight, whereas they may lower stroke risk in those who are obese, according to Heather Greenlee, ND, PhD, a public health researcher and naturopathic physician with the Fred Hutchinson Cancer Research Center in Seattle.

In postmenopausal women with breast cancer, aromatase inhibitors may increase cardiovascular risk, while tamoxifen appears to reduce the risk of incident dyslipidemia, she said.

The findings are from separate analyses of data from studies presented during a poster discussion session at the symposium.
 

Breast cancer treatment and cardiovascular effects: The role of weight

In one analysis, Dr. Greenlee and colleagues examined outcomes in 13,582 breast cancer survivors with a median age of 60 years and median follow-up of 7 years to assess whether cardiovascular disease (CVD) risk associated with specific breast cancer therapies varies by body mass index (BMI) category at diagnosis.

Many routinely used breast cancer therapies are cardiotoxic, and being overweight or obese are known risk factors for CVD, but few studies have assessed whether BMI modifies the effect of these treatment on cardiovascular risk, Dr. Greenlee explained.

After adjusting for baseline demographic and health-related factors, and other breast cancer treatment, they found that:

• Ischemic heart disease risk was higher among normal-weight women who received anthracyclines, compared with those who did not (hazard ratio, 4.2). No other risk associations were observed for other breast cancer therapies and BMI groups.
• Heart failure/cardiomyopathy risk was higher among women with normal weight who received anthracyclines, cyclophosphamides, or left-sided radiation, compared with those who did not (HRs, 5.24, 3.27, and 2.05, respectively), and among overweight women who received anthracyclines, compared with those who did not (HR, 2.18). No risk associations were observed for women who received trastuzumab, taxanes, endocrine therapy, or radiation on any side, and no risk associations were observed for women who were obese.
• Stroke risk was higher in normal-weight women who received taxanes, cyclophosphamides, or left-sided radiation versus those who did not (HRs, 2.14, 2.35, and 1.31, respectively), and stroke risk was lower in obese women who received anthracyclines, taxanes, or cyclophosphamide, compared with those who did not (HRs, 0.32, 0.41, and 0.29, respectively). No risk associations were observed for trastuzumab, endocrine therapy, or radiation on any side, and no risk associations were observed for women who were overweight.

The lack of associations noted between treatments and heart failure risk among obese patients could be caused by the “obesity paradox” observed in prior obese populations, the investigators noted, adding that additional analyses are planned to “examine whether different dosage and duration of breast cancer therapy exposures across the BMI groups contributed to these risk associations.”
 

Breast cancer treatment and cardiometabolic effects: The role of menopausal status

In a separate analysis, Dr. Greenlee and colleagues looked at the association between endocrine therapies and cardiometabolic risk based on menopausal status.

Endocrine therapy is associated with CVD in breast cancer survivors and may be associated with developing cardiometabolic risk factors like diabetes, dyslipidemia, and hypertension, they noted, explaining that tamoxifen has mixed estrogenic and antiestrogenic activity, while aromatase inhibitors deplete endogenous estrogen.

Since most studies have compared tamoxifen with aromatase inhibitor use, it has been a challenge challenging to discern the effects of each, Dr. Greenlee said.

She and her colleagues reviewed records for 14,942 breast cancer survivors who were diagnosed between 2005 and 2013. The patients had a mean age of 61 years at baseline, and 24.9% were premenopausal at the time of diagnosis. Of the premenopausal women, 27.3% used tamoxifen, 19.2% used aromatase inhibitors, and 53.5% did not use endocrine therapy, and of the postmenopausal women, 6.6% used tamoxifen, 47.7% used aromatase inhibitors, and 45.7% did not use endocrine therapy.

After adjusting for baseline demographics and health factors, the investigators found that:

• The use of tamoxifen or aromatase inhibitors was not associated with a risk of developing diabetes, dyslipidemia, or hypertension in premenopausal women, or with a risk of developing diabetes or hypertension in postmenopausal women.
• The risk of dyslipidemia was higher in postmenopausal aromatase inhibitor users, and lower in postmenopausal tamoxifen users, compared with postmenopausal non-users of endocrine therapy (HRs, 1.15 and 0.75, respectively).

The lack of associations between endocrine therapy and CVD risk in premenopausal women may be from low power, Dr. Greenlee said, noting that analyses in larger sample sizes are needed.

She and her colleagues plan to conduct further analyses looking at treatment dosage and duration, and comparing steroidal versus nonsteroidal aromatase inhibitors.

Future studies should examine the implications of these associations on long-term CVD and how best to manage lipid profiles in postmenopausal breast cancer survivors who have a history of endocrine therapy treatment, they concluded.

This research was funded by grants from the National Cancer Institute.

[email protected]

To the Editor:

A 34-year-old pregnant woman at 5 weeks’ gestation was transferred to dermatology from an outside hospital with a full-body rash. Three days after noting a fever and generalized body aches, she developed a painful rash on the legs that had gradually spread to the arms, trunk, and face. Symptoms of eyelid pruritus and edema initially were improved with intravenous (IV) steroids at an emergency department visit, but they started to flare soon thereafter with worsening mucosal involvement and dysphagia. After a second visit to the emergency department and repeat treatment with IV steroids, she was transferred to our institution for a higher level of care.

The patient denied taking any new medications in the 2 months prior to the onset of the rash. Her medication history only consisted of over-the-counter prenatal vitamins, a single use of over-the-counter migraine medication (containing acetaminophen, aspirin, and caffeine as active ingredients), and a possible use of ibuprofen or acetaminophen separately. She reported ocular discomfort and blurriness, dysphagia, dysuria, and vaginal discomfort. Physical examination revealed dusky red to violaceous macules and patches that involved approximately 65% of the body surface area (BSA), with bullae involving approximately 10% BSA. The face was diffusely red and edematous with crusted erosions and scattered bullae on the cheeks. Mucosal involvement was notable for injected conjunctivae and erosions present on the upper hard palate of the mouth and lips (Figure, A). Erythematous macules with dusky centers coalescing into patches with overlying vesicles and bullae were scattered on the arms (Figure, B), hands, trunk (Figure, C), and legs. The Nikolsky sign was positive. The vulva was swollen and covered with erythematous macules with dusky centers.

To the Editor:

A 34-year-old pregnant woman at 5 weeks’ gestation was transferred to dermatology from an outside hospital with a full-body rash. Three days after noting a fever and generalized body aches, she developed a painful rash on the legs that had gradually spread to the arms, trunk, and face. Symptoms of eyelid pruritus and edema initially were improved with intravenous (IV) steroids at an emergency department visit, but they started to flare soon thereafter with worsening mucosal involvement and dysphagia. After a second visit to the emergency department and repeat treatment with IV steroids, she was transferred to our institution for a higher level of care.

The patient denied taking any new medications in the 2 months prior to the onset of the rash. Her medication history only consisted of over-the-counter prenatal vitamins, a single use of over-the-counter migraine medication (containing acetaminophen, aspirin, and caffeine as active ingredients), and a possible use of ibuprofen or acetaminophen separately. She reported ocular discomfort and blurriness, dysphagia, dysuria, and vaginal discomfort. Physical examination revealed dusky red to violaceous macules and patches that involved approximately 65% of the body surface area (BSA), with bullae involving approximately 10% BSA. The face was diffusely red and edematous with crusted erosions and scattered bullae on the cheeks. Mucosal involvement was notable for injected conjunctivae and erosions present on the upper hard palate of the mouth and lips (Figure, A). Erythematous macules with dusky centers coalescing into patches with overlying vesicles and bullae were scattered on the arms (Figure, B), hands, trunk (Figure, C), and legs. The Nikolsky sign was positive. The vulva was swollen and covered with erythematous macules with dusky centers.

To the Editor:

A 34-year-old pregnant woman at 5 weeks’ gestation was transferred to dermatology from an outside hospital with a full-body rash. Three days after noting a fever and generalized body aches, she developed a painful rash on the legs that had gradually spread to the arms, trunk, and face. Symptoms of eyelid pruritus and edema initially were improved with intravenous (IV) steroids at an emergency department visit, but they started to flare soon thereafter with worsening mucosal involvement and dysphagia. After a second visit to the emergency department and repeat treatment with IV steroids, she was transferred to our institution for a higher level of care.

The patient denied taking any new medications in the 2 months prior to the onset of the rash. Her medication history only consisted of over-the-counter prenatal vitamins, a single use of over-the-counter migraine medication (containing acetaminophen, aspirin, and caffeine as active ingredients), and a possible use of ibuprofen or acetaminophen separately. She reported ocular discomfort and blurriness, dysphagia, dysuria, and vaginal discomfort. Physical examination revealed dusky red to violaceous macules and patches that involved approximately 65% of the body surface area (BSA), with bullae involving approximately 10% BSA. The face was diffusely red and edematous with crusted erosions and scattered bullae on the cheeks. Mucosal involvement was notable for injected conjunctivae and erosions present on the upper hard palate of the mouth and lips (Figure, A). Erythematous macules with dusky centers coalescing into patches with overlying vesicles and bullae were scattered on the arms (Figure, B), hands, trunk (Figure, C), and legs. The Nikolsky sign was positive. The vulva was swollen and covered with erythematous macules with dusky centers.

Despite a flurry of publicity about its newfound cardiac risk profile, the antiseizure medication lamotrigine (Lamictal) is “still a good drug” in epilepsy and an excellent treatment for certain groups, New York University neurologist Jacqueline A. French, MD, told colleagues at the annual meeting of the American Epilepsy Society. But it’s now crucial to take special precautions in high-risk groups such as older people and heart patients.

“We need to plan more carefully when we use it, which we hate to do, as we know. But we’ve still got to do it,” said Dr. French, former president of the AES. “The risks are very small, but keep in mind that they’re not zero.”

In October 2020, the Food and Drug Administration added a warning to the lamotrigine label that said the drug “could slow ventricular conduction (widen QRS) and induce proarrhythmia, including sudden death, in patients with structural heart disease or myocardial ischemia.”

The FDA recommended avoiding the sodium channel blocker’s use “in patients who have cardiac conduction disorders (e.g., second- or third-degree heart block), ventricular arrhythmias, or cardiac disease or abnormality (e.g., myocardial ischemia, heart failure, structural heart disease, Brugada syndrome, or other sodium channelopathies). Concomitant use of other sodium channel blockers may increase the risk of proarrhythmia.”

Later, in March 2021, the FDA announced that a review of in vitro findings “showed a potential increased risk of heart rhythm problems.”

As Dr. French noted, lamotrigine remains widely prescribed even though there’s “no pharmaceutical company out there pushing [it].” It’s an especially beneficial drug for certain groups such as the elderly and women of child-bearing age, she said.

But older people are also at higher risk of drug-related heart complications because of the fact that many already have cardiac disease, Dr. French said. She highlighted a 2005 trial of lamotrigine that found 48% of 593 patients aged 60 years and older had cardiac disease.
 

Special precautions

So what should neurologists know about prescribing lamotrigine in light of the new warning? Dr. French recommended guidelines that she cowrote with the AES and International League Against Epilepsy.

• Prescribe as normal in patients under 60 with no cardiac risk factors. In patients older than 60, or younger with risk factors, consider an EKG before prescribing lamotrigine.
• “Nonspecific EKG abnormalities (e.g., nonspecific ST and T wave abnormalities) are not concerning, and should not preclude these individuals from being prescribed lamotrigine.”
• Beware of higher risk and consider consulting a cardiologist before starting treatment in patients with second- or third-degree heart block, Brugada syndrome, arrhythmogenic ventricular cardiomyopathy, left bundle branch block, and right bundle branch block with left anterior or posterior fascicular block.
• “In most cases the initial EKG can be obtained while titrating, mainly when the individual is at the first dose of 25 mg/day because lamotrigine must be titrated slowly, and because cardiac adverse events are dose related.”
• “Clinicians should consider obtaining an EKG and/or cardiology consultation in people on lamotrigine with sudden-onset syncope or presyncope with loss of muscular tone without a clear vasovagal or orthostatic cause.”

Dr. French cautioned colleagues that they shouldn’t assume that lamotrigine stands alone among sodium channel blockers in terms of cardiac risk. As she noted, the FDA is asking manufacturers of other drugs in that class to provide data. “At some point, maybe sometime in the near future, we are going to hear in this particular in vitro sense how the other sodium channel blockers do stack up, compared with lamotrigine. At presence, in the absence of the availability of all of the rest of the data, it would be incorrect to presume that lamotrigine has more cardiac effects than other sodium channel blocking antiseizure medicines or all antiseizure medicines.”

For now, she said, although the guidelines are for lamotrigine, it’s “prudent” to follow them for all sodium channel blockers.

Dr. French reported no disclosures.

Despite a flurry of publicity about its newfound cardiac risk profile, the antiseizure medication lamotrigine (Lamictal) is “still a good drug” in epilepsy and an excellent treatment for certain groups, New York University neurologist Jacqueline A. French, MD, told colleagues at the annual meeting of the American Epilepsy Society. But it’s now crucial to take special precautions in high-risk groups such as older people and heart patients.

“We need to plan more carefully when we use it, which we hate to do, as we know. But we’ve still got to do it,” said Dr. French, former president of the AES. “The risks are very small, but keep in mind that they’re not zero.”

In October 2020, the Food and Drug Administration added a warning to the lamotrigine label that said the drug “could slow ventricular conduction (widen QRS) and induce proarrhythmia, including sudden death, in patients with structural heart disease or myocardial ischemia.”

The FDA recommended avoiding the sodium channel blocker’s use “in patients who have cardiac conduction disorders (e.g., second- or third-degree heart block), ventricular arrhythmias, or cardiac disease or abnormality (e.g., myocardial ischemia, heart failure, structural heart disease, Brugada syndrome, or other sodium channelopathies). Concomitant use of other sodium channel blockers may increase the risk of proarrhythmia.”

Later, in March 2021, the FDA announced that a review of in vitro findings “showed a potential increased risk of heart rhythm problems.”

As Dr. French noted, lamotrigine remains widely prescribed even though there’s “no pharmaceutical company out there pushing [it].” It’s an especially beneficial drug for certain groups such as the elderly and women of child-bearing age, she said.

But older people are also at higher risk of drug-related heart complications because of the fact that many already have cardiac disease, Dr. French said. She highlighted a 2005 trial of lamotrigine that found 48% of 593 patients aged 60 years and older had cardiac disease.
 

Special precautions

So what should neurologists know about prescribing lamotrigine in light of the new warning? Dr. French recommended guidelines that she cowrote with the AES and International League Against Epilepsy.

• Prescribe as normal in patients under 60 with no cardiac risk factors. In patients older than 60, or younger with risk factors, consider an EKG before prescribing lamotrigine.
• “Nonspecific EKG abnormalities (e.g., nonspecific ST and T wave abnormalities) are not concerning, and should not preclude these individuals from being prescribed lamotrigine.”
• Beware of higher risk and consider consulting a cardiologist before starting treatment in patients with second- or third-degree heart block, Brugada syndrome, arrhythmogenic ventricular cardiomyopathy, left bundle branch block, and right bundle branch block with left anterior or posterior fascicular block.
• “In most cases the initial EKG can be obtained while titrating, mainly when the individual is at the first dose of 25 mg/day because lamotrigine must be titrated slowly, and because cardiac adverse events are dose related.”
• “Clinicians should consider obtaining an EKG and/or cardiology consultation in people on lamotrigine with sudden-onset syncope or presyncope with loss of muscular tone without a clear vasovagal or orthostatic cause.”

Dr. French cautioned colleagues that they shouldn’t assume that lamotrigine stands alone among sodium channel blockers in terms of cardiac risk. As she noted, the FDA is asking manufacturers of other drugs in that class to provide data. “At some point, maybe sometime in the near future, we are going to hear in this particular in vitro sense how the other sodium channel blockers do stack up, compared with lamotrigine. At presence, in the absence of the availability of all of the rest of the data, it would be incorrect to presume that lamotrigine has more cardiac effects than other sodium channel blocking antiseizure medicines or all antiseizure medicines.”

For now, she said, although the guidelines are for lamotrigine, it’s “prudent” to follow them for all sodium channel blockers.

Dr. French reported no disclosures.

Despite a flurry of publicity about its newfound cardiac risk profile, the antiseizure medication lamotrigine (Lamictal) is “still a good drug” in epilepsy and an excellent treatment for certain groups, New York University neurologist Jacqueline A. French, MD, told colleagues at the annual meeting of the American Epilepsy Society. But it’s now crucial to take special precautions in high-risk groups such as older people and heart patients.

“We need to plan more carefully when we use it, which we hate to do, as we know. But we’ve still got to do it,” said Dr. French, former president of the AES. “The risks are very small, but keep in mind that they’re not zero.”

In October 2020, the Food and Drug Administration added a warning to the lamotrigine label that said the drug “could slow ventricular conduction (widen QRS) and induce proarrhythmia, including sudden death, in patients with structural heart disease or myocardial ischemia.”

The FDA recommended avoiding the sodium channel blocker’s use “in patients who have cardiac conduction disorders (e.g., second- or third-degree heart block), ventricular arrhythmias, or cardiac disease or abnormality (e.g., myocardial ischemia, heart failure, structural heart disease, Brugada syndrome, or other sodium channelopathies). Concomitant use of other sodium channel blockers may increase the risk of proarrhythmia.”

Later, in March 2021, the FDA announced that a review of in vitro findings “showed a potential increased risk of heart rhythm problems.”

As Dr. French noted, lamotrigine remains widely prescribed even though there’s “no pharmaceutical company out there pushing [it].” It’s an especially beneficial drug for certain groups such as the elderly and women of child-bearing age, she said.

But older people are also at higher risk of drug-related heart complications because of the fact that many already have cardiac disease, Dr. French said. She highlighted a 2005 trial of lamotrigine that found 48% of 593 patients aged 60 years and older had cardiac disease.
 

Special precautions

So what should neurologists know about prescribing lamotrigine in light of the new warning? Dr. French recommended guidelines that she cowrote with the AES and International League Against Epilepsy.

• Prescribe as normal in patients under 60 with no cardiac risk factors. In patients older than 60, or younger with risk factors, consider an EKG before prescribing lamotrigine.
• “Nonspecific EKG abnormalities (e.g., nonspecific ST and T wave abnormalities) are not concerning, and should not preclude these individuals from being prescribed lamotrigine.”
• Beware of higher risk and consider consulting a cardiologist before starting treatment in patients with second- or third-degree heart block, Brugada syndrome, arrhythmogenic ventricular cardiomyopathy, left bundle branch block, and right bundle branch block with left anterior or posterior fascicular block.
• “In most cases the initial EKG can be obtained while titrating, mainly when the individual is at the first dose of 25 mg/day because lamotrigine must be titrated slowly, and because cardiac adverse events are dose related.”
• “Clinicians should consider obtaining an EKG and/or cardiology consultation in people on lamotrigine with sudden-onset syncope or presyncope with loss of muscular tone without a clear vasovagal or orthostatic cause.”

Dr. French cautioned colleagues that they shouldn’t assume that lamotrigine stands alone among sodium channel blockers in terms of cardiac risk. As she noted, the FDA is asking manufacturers of other drugs in that class to provide data. “At some point, maybe sometime in the near future, we are going to hear in this particular in vitro sense how the other sodium channel blockers do stack up, compared with lamotrigine. At presence, in the absence of the availability of all of the rest of the data, it would be incorrect to presume that lamotrigine has more cardiac effects than other sodium channel blocking antiseizure medicines or all antiseizure medicines.”

For now, she said, although the guidelines are for lamotrigine, it’s “prudent” to follow them for all sodium channel blockers.

Dr. French reported no disclosures.

Physicians at a Boston hospital adjusted medical management for nearly three-quarters of patients with infantile- or childhood-onset epilepsy who were diagnosed with genetic epilepsy, researchers reported at the annual meeting of the American Epilepsy Society. The findings provide new insight into the usefulness of genetic tests in children with epilepsy of unknown cause.

“Genetic testing is significantly impacting medical care in a population of individuals with infantile- or childhood-onset epilepsy. Genetic testing should be included as part of the standard evaluation of individuals with unexplained pediatric epilepsy as a means of achieving diagnostic precision and informing clinical management,” study lead author Isabel Haviland, MD, a neurologist with Boston Children’s Hospital/Harvard Medical School, said in an interview.

According to Dr. Haviland, the causes of epilepsy are unexplained in an estimated two-thirds of pediatric epilepsy cases. “Increasingly, when genetic testing is available, previously unexplained cases of pediatric epilepsy are being found to have single-gene etiologies,” she said. “Though a genetic diagnosis in this population has implications for medical care, the direct impact on medical management in a clinical setting has not been measured. We aimed to describe the impact of genetic diagnosis on medical management in a cohort of individuals with pediatric epilepsy.”

Researchers tracked 602 patients at Boston Children’s Hospital who received next-generation gene sequencing testing from 2012 to 2019. Of those, Dr. Haviland said, 152 (25%) had a positive result that indicated genetic epilepsy (46% female, median age of onset = 6 months [2-15 months]). These patients were included in the study.

“We documented an impact on medical management in nearly three-fourths of participants (72%),” Dr. Haviland said. “A genetic diagnosis affected at least one of four categories of medical management, including care coordination (48%), treatment (45%), counseling about a change in prognosis (28%), and change in diagnosis for a few individuals who had a prior established diagnosis (1%).”

As examples, she mentioned three cases:

• Testing revealed that a subject has a disease-causing genetic variant in a gene called PRRT2. “This gene is involved in the release of neurotransmitters in the brain,” Dr. Haviland said. “Thanks to his diagnosis, he was treated with the antiseizure medication oxcarbazepine, which is often effective for epilepsy caused by variants in this gene. He had excellent response to the medication and later became seizure free.”
• A subject had a variation in the SCN1A gene that causes types of epilepsy. “At the time of his diagnosis, there was a trial for a medication called fenfluramine being offered for individuals with SCN1A variants, and his family elected to participate,” she said. “This medication was later approved by the [Food and Drug Administration] for SCN1A-related epilepsy.”
• Testing identified disease-causing variant in the GRIN2A gene in another subject. “This gene is involved in brain cell communication,” Dr. Haviland said. “This individual was treated with memantine, which acts on the specific biological pathway affected by the gene. This treatment would not have been considered without the genetic diagnosis as it is currently only approved for Alzheimer’s disease.”

In addition, Dr. Haviland said, researchers found that “there was impact on medical management both in those with earlier age of epilepsy onset (under 2 years) and those with later age of onset, as well as both in those with developmental disorders (such as autism spectrum disorder, intellectual disability and developmental delay) and those with normal development.

As for the cost of genetic tests, Dr. Haviland pointed to a 2019 study that she said estimated epilepsy panel testing runs from $1,500 to $7,500, and the whole exome sequencing from $4,500 to $7,000. “Insurers sometimes cover testing, but not always,” she said. “In some cases, insurance will only cover testing if it is documented that results will directly alter medical management, which highlights the importance of our findings.”

No study funding was reported. Dr. Haviland and several other authors report no disclosures. One author reports consulting fees from Takeda, Zogenix, Marinus, and FOXG1 Research Foundation. Another author reports research support from the International Foundation for CDKL5 Research.

Physicians at a Boston hospital adjusted medical management for nearly three-quarters of patients with infantile- or childhood-onset epilepsy who were diagnosed with genetic epilepsy, researchers reported at the annual meeting of the American Epilepsy Society. The findings provide new insight into the usefulness of genetic tests in children with epilepsy of unknown cause.

“Genetic testing is significantly impacting medical care in a population of individuals with infantile- or childhood-onset epilepsy. Genetic testing should be included as part of the standard evaluation of individuals with unexplained pediatric epilepsy as a means of achieving diagnostic precision and informing clinical management,” study lead author Isabel Haviland, MD, a neurologist with Boston Children’s Hospital/Harvard Medical School, said in an interview.

According to Dr. Haviland, the causes of epilepsy are unexplained in an estimated two-thirds of pediatric epilepsy cases. “Increasingly, when genetic testing is available, previously unexplained cases of pediatric epilepsy are being found to have single-gene etiologies,” she said. “Though a genetic diagnosis in this population has implications for medical care, the direct impact on medical management in a clinical setting has not been measured. We aimed to describe the impact of genetic diagnosis on medical management in a cohort of individuals with pediatric epilepsy.”

Researchers tracked 602 patients at Boston Children’s Hospital who received next-generation gene sequencing testing from 2012 to 2019. Of those, Dr. Haviland said, 152 (25%) had a positive result that indicated genetic epilepsy (46% female, median age of onset = 6 months [2-15 months]). These patients were included in the study.

“We documented an impact on medical management in nearly three-fourths of participants (72%),” Dr. Haviland said. “A genetic diagnosis affected at least one of four categories of medical management, including care coordination (48%), treatment (45%), counseling about a change in prognosis (28%), and change in diagnosis for a few individuals who had a prior established diagnosis (1%).”

As examples, she mentioned three cases:

• Testing revealed that a subject has a disease-causing genetic variant in a gene called PRRT2. “This gene is involved in the release of neurotransmitters in the brain,” Dr. Haviland said. “Thanks to his diagnosis, he was treated with the antiseizure medication oxcarbazepine, which is often effective for epilepsy caused by variants in this gene. He had excellent response to the medication and later became seizure free.”
• A subject had a variation in the SCN1A gene that causes types of epilepsy. “At the time of his diagnosis, there was a trial for a medication called fenfluramine being offered for individuals with SCN1A variants, and his family elected to participate,” she said. “This medication was later approved by the [Food and Drug Administration] for SCN1A-related epilepsy.”
• Testing identified disease-causing variant in the GRIN2A gene in another subject. “This gene is involved in brain cell communication,” Dr. Haviland said. “This individual was treated with memantine, which acts on the specific biological pathway affected by the gene. This treatment would not have been considered without the genetic diagnosis as it is currently only approved for Alzheimer’s disease.”

In addition, Dr. Haviland said, researchers found that “there was impact on medical management both in those with earlier age of epilepsy onset (under 2 years) and those with later age of onset, as well as both in those with developmental disorders (such as autism spectrum disorder, intellectual disability and developmental delay) and those with normal development.

As for the cost of genetic tests, Dr. Haviland pointed to a 2019 study that she said estimated epilepsy panel testing runs from $1,500 to $7,500, and the whole exome sequencing from $4,500 to $7,000. “Insurers sometimes cover testing, but not always,” she said. “In some cases, insurance will only cover testing if it is documented that results will directly alter medical management, which highlights the importance of our findings.”

No study funding was reported. Dr. Haviland and several other authors report no disclosures. One author reports consulting fees from Takeda, Zogenix, Marinus, and FOXG1 Research Foundation. Another author reports research support from the International Foundation for CDKL5 Research.

Physicians at a Boston hospital adjusted medical management for nearly three-quarters of patients with infantile- or childhood-onset epilepsy who were diagnosed with genetic epilepsy, researchers reported at the annual meeting of the American Epilepsy Society. The findings provide new insight into the usefulness of genetic tests in children with epilepsy of unknown cause.

“Genetic testing is significantly impacting medical care in a population of individuals with infantile- or childhood-onset epilepsy. Genetic testing should be included as part of the standard evaluation of individuals with unexplained pediatric epilepsy as a means of achieving diagnostic precision and informing clinical management,” study lead author Isabel Haviland, MD, a neurologist with Boston Children’s Hospital/Harvard Medical School, said in an interview.

According to Dr. Haviland, the causes of epilepsy are unexplained in an estimated two-thirds of pediatric epilepsy cases. “Increasingly, when genetic testing is available, previously unexplained cases of pediatric epilepsy are being found to have single-gene etiologies,” she said. “Though a genetic diagnosis in this population has implications for medical care, the direct impact on medical management in a clinical setting has not been measured. We aimed to describe the impact of genetic diagnosis on medical management in a cohort of individuals with pediatric epilepsy.”

Researchers tracked 602 patients at Boston Children’s Hospital who received next-generation gene sequencing testing from 2012 to 2019. Of those, Dr. Haviland said, 152 (25%) had a positive result that indicated genetic epilepsy (46% female, median age of onset = 6 months [2-15 months]). These patients were included in the study.

“We documented an impact on medical management in nearly three-fourths of participants (72%),” Dr. Haviland said. “A genetic diagnosis affected at least one of four categories of medical management, including care coordination (48%), treatment (45%), counseling about a change in prognosis (28%), and change in diagnosis for a few individuals who had a prior established diagnosis (1%).”

As examples, she mentioned three cases:

• Testing revealed that a subject has a disease-causing genetic variant in a gene called PRRT2. “This gene is involved in the release of neurotransmitters in the brain,” Dr. Haviland said. “Thanks to his diagnosis, he was treated with the antiseizure medication oxcarbazepine, which is often effective for epilepsy caused by variants in this gene. He had excellent response to the medication and later became seizure free.”
• A subject had a variation in the SCN1A gene that causes types of epilepsy. “At the time of his diagnosis, there was a trial for a medication called fenfluramine being offered for individuals with SCN1A variants, and his family elected to participate,” she said. “This medication was later approved by the [Food and Drug Administration] for SCN1A-related epilepsy.”
• Testing identified disease-causing variant in the GRIN2A gene in another subject. “This gene is involved in brain cell communication,” Dr. Haviland said. “This individual was treated with memantine, which acts on the specific biological pathway affected by the gene. This treatment would not have been considered without the genetic diagnosis as it is currently only approved for Alzheimer’s disease.”

In addition, Dr. Haviland said, researchers found that “there was impact on medical management both in those with earlier age of epilepsy onset (under 2 years) and those with later age of onset, as well as both in those with developmental disorders (such as autism spectrum disorder, intellectual disability and developmental delay) and those with normal development.

As for the cost of genetic tests, Dr. Haviland pointed to a 2019 study that she said estimated epilepsy panel testing runs from $1,500 to $7,500, and the whole exome sequencing from $4,500 to $7,000. “Insurers sometimes cover testing, but not always,” she said. “In some cases, insurance will only cover testing if it is documented that results will directly alter medical management, which highlights the importance of our findings.”

No study funding was reported. Dr. Haviland and several other authors report no disclosures. One author reports consulting fees from Takeda, Zogenix, Marinus, and FOXG1 Research Foundation. Another author reports research support from the International Foundation for CDKL5 Research.

An analysis of hospitalized patients with COVID-19 finds that those with no history of epilepsy had more than 3 times the odds of suffering a new-onset seizure than patients with epilepsy were to have breakthrough seizures (odds radio [OR] 3.15, P < .0001), researchers reported at the annual meeting of the American Epilepsy Society.

“If you have COVID and you have a seizure, it’s more likely that you’re having it for the first time, and it’s not as likely that you have epilepsy,” study lead author Neeraj Singh, MD, a neurologist at the New York-based Northwell Health system, said in an interview. “That’s new. We don’t normally see that when someone has a bacterial or viral infection. It’s demonstrating that this infection is having direct effect on the brain and brain signals.”

According to Dr. Singh, there’s little data about seizures in patients with COVID-19 because doctors have focused on other symptoms. A 2021 multicenter study found that electrographic seizures were detected in 9.6% of 197 patients with COVID-19 who were referred for cEEG.

For the new study, Dr. Singh and a colleague tracked 917 patients with COVID-19 in the Northwell Health system who were treated from Feb. 14 to June 14, 2020, with antiepileptic medication. Of the patients, 451 had a history of epilepsy, and 466 did not.

According to Dr. Singh, 27.6% of the patients without a history of epilepsy had new-onset seizures, while 10.1% of the patients with history of epilepsy had breakthrough seizures. The difference in odds was more than threefold after adjustment. (Among all COVID-19 patients, he said, perhaps 8%-16% had seizures).

The researchers also found that patients with new-onset seizures stayed in the hospital much longer (average, 26.9 days) than any patients with a known history of epilepsy (12.8 days, P < .0001, for those who had breakthrough seizures and 10.9 days, P < .0001, for those who didn’t).

In addition, the researchers found that having any seizures – new-onset or breakthrough – was linked to higher risk of death (OR 1.41, P = .03).

Antiseizure medications are key treatments for these patients, Dr. Singh said. As for the patients with new-onset seizures who recover from COVID-19, Dr. Singh said, “it’s suspected that these people are going to have a new diagnosis of epilepsy, not just a one-time seizure.”

The findings suggest that some patients with epilepsy are protected against COVID-19-related seizures because they take antiepileptic medications that “protect the brain from getting a trigger for an abnormal signal that leads to a seizure,” he said. “That’s one possibility.”

What can neurologists learn from the study? Dr. Singh recommends a “lower threshold” to recommend or approve EEGs in patients with COVID-19 who are confused/altered when they come in, especially if this is not normal. “They may actually be having silent seizures that no one’s noticing,” he said.

No study funding was reported. The authors reported no relevant disclosures.

An analysis of hospitalized patients with COVID-19 finds that those with no history of epilepsy had more than 3 times the odds of suffering a new-onset seizure than patients with epilepsy were to have breakthrough seizures (odds radio [OR] 3.15, P < .0001), researchers reported at the annual meeting of the American Epilepsy Society.

“If you have COVID and you have a seizure, it’s more likely that you’re having it for the first time, and it’s not as likely that you have epilepsy,” study lead author Neeraj Singh, MD, a neurologist at the New York-based Northwell Health system, said in an interview. “That’s new. We don’t normally see that when someone has a bacterial or viral infection. It’s demonstrating that this infection is having direct effect on the brain and brain signals.”

According to Dr. Singh, there’s little data about seizures in patients with COVID-19 because doctors have focused on other symptoms. A 2021 multicenter study found that electrographic seizures were detected in 9.6% of 197 patients with COVID-19 who were referred for cEEG.

For the new study, Dr. Singh and a colleague tracked 917 patients with COVID-19 in the Northwell Health system who were treated from Feb. 14 to June 14, 2020, with antiepileptic medication. Of the patients, 451 had a history of epilepsy, and 466 did not.

According to Dr. Singh, 27.6% of the patients without a history of epilepsy had new-onset seizures, while 10.1% of the patients with history of epilepsy had breakthrough seizures. The difference in odds was more than threefold after adjustment. (Among all COVID-19 patients, he said, perhaps 8%-16% had seizures).

The researchers also found that patients with new-onset seizures stayed in the hospital much longer (average, 26.9 days) than any patients with a known history of epilepsy (12.8 days, P < .0001, for those who had breakthrough seizures and 10.9 days, P < .0001, for those who didn’t).

In addition, the researchers found that having any seizures – new-onset or breakthrough – was linked to higher risk of death (OR 1.41, P = .03).

Antiseizure medications are key treatments for these patients, Dr. Singh said. As for the patients with new-onset seizures who recover from COVID-19, Dr. Singh said, “it’s suspected that these people are going to have a new diagnosis of epilepsy, not just a one-time seizure.”

The findings suggest that some patients with epilepsy are protected against COVID-19-related seizures because they take antiepileptic medications that “protect the brain from getting a trigger for an abnormal signal that leads to a seizure,” he said. “That’s one possibility.”

What can neurologists learn from the study? Dr. Singh recommends a “lower threshold” to recommend or approve EEGs in patients with COVID-19 who are confused/altered when they come in, especially if this is not normal. “They may actually be having silent seizures that no one’s noticing,” he said.

No study funding was reported. The authors reported no relevant disclosures.

An analysis of hospitalized patients with COVID-19 finds that those with no history of epilepsy had more than 3 times the odds of suffering a new-onset seizure than patients with epilepsy were to have breakthrough seizures (odds radio [OR] 3.15, P < .0001), researchers reported at the annual meeting of the American Epilepsy Society.

“If you have COVID and you have a seizure, it’s more likely that you’re having it for the first time, and it’s not as likely that you have epilepsy,” study lead author Neeraj Singh, MD, a neurologist at the New York-based Northwell Health system, said in an interview. “That’s new. We don’t normally see that when someone has a bacterial or viral infection. It’s demonstrating that this infection is having direct effect on the brain and brain signals.”

According to Dr. Singh, there’s little data about seizures in patients with COVID-19 because doctors have focused on other symptoms. A 2021 multicenter study found that electrographic seizures were detected in 9.6% of 197 patients with COVID-19 who were referred for cEEG.

For the new study, Dr. Singh and a colleague tracked 917 patients with COVID-19 in the Northwell Health system who were treated from Feb. 14 to June 14, 2020, with antiepileptic medication. Of the patients, 451 had a history of epilepsy, and 466 did not.

According to Dr. Singh, 27.6% of the patients without a history of epilepsy had new-onset seizures, while 10.1% of the patients with history of epilepsy had breakthrough seizures. The difference in odds was more than threefold after adjustment. (Among all COVID-19 patients, he said, perhaps 8%-16% had seizures).

The researchers also found that patients with new-onset seizures stayed in the hospital much longer (average, 26.9 days) than any patients with a known history of epilepsy (12.8 days, P < .0001, for those who had breakthrough seizures and 10.9 days, P < .0001, for those who didn’t).

In addition, the researchers found that having any seizures – new-onset or breakthrough – was linked to higher risk of death (OR 1.41, P = .03).

Antiseizure medications are key treatments for these patients, Dr. Singh said. As for the patients with new-onset seizures who recover from COVID-19, Dr. Singh said, “it’s suspected that these people are going to have a new diagnosis of epilepsy, not just a one-time seizure.”

The findings suggest that some patients with epilepsy are protected against COVID-19-related seizures because they take antiepileptic medications that “protect the brain from getting a trigger for an abnormal signal that leads to a seizure,” he said. “That’s one possibility.”

What can neurologists learn from the study? Dr. Singh recommends a “lower threshold” to recommend or approve EEGs in patients with COVID-19 who are confused/altered when they come in, especially if this is not normal. “They may actually be having silent seizures that no one’s noticing,” he said.

No study funding was reported. The authors reported no relevant disclosures.