A history of prior depressive illness conferred a sevenfold increased risk of developing treatment-limiting mood symptoms in patients on isotretinoin for acne in a large Scottish observational study, Sanaa Butt, MD, reported at the virtual annual congress of the European Academy of Dermatology and Venereology.

© Ocskay Bence/Fotolia.com

This was, however, the sole identifiable risk factor for treatment-limiting depressive symptoms in acne patients on isotretinoin in the study of 3,151 consecutive acne patients taking isotretinoin. There was no significant difference between those who did or did not develop depression on the oral retinoid in terms of age, gender, or daily dose of the drug at the time it was discontinued.

“Depressive symptoms occurred at any time from the date of initiation of isotretinoin up to 6 months into therapy, with no identifiable peak time period,” said Dr. Butt, a dermatologist with the U.K. National Health Service Tayside district at Ninewells Hospital, Dundee, Scotland. “Lower doses appear not to be protective,” she added.

The Tayside district has a catchment of roughly 450,000 people. The local population tends to stay put because Tayside is an economically disadvantaged and remote part of Scotland. There are very few private practice dermatologists in the area, so Dr. Butt and coinvestigators are confident their observational study of NHS patients captured the great majority of isotretinoin users in northern Scotland.

The investigators utilized software to analyze the contents of more than 8,000 digitized letters exchanged between NHS Tayside dermatologists and general practitioners during 2005-2018, zeroing in on 3,151 consecutive patients on isotretinoin for acne and 158 on the drug for other conditions, most often rosacea or folliculitis. They then drilled down further through the letters, electronically searching for key words such as suicide, depression, and anxiety. In this way, they ultimately identified 30 patients who discontinued the drug because they developed depressive symptoms. All 30 were on the drug for acne.

The annual incidence of treatment-limiting depressive mood changes was 0.96%, a figure that remained steady over the 13-year study period, even though prescribing of isotretinoin increased over time. This flat incidence rate effectively rules out the potential for confounding because of assessor bias, especially since many different NHS dermatologists were prescribing the drug, Dr. Butt said.

Half of acne patients prescribed isotretinoin were female and 50% were male. And 15 cases of treatment discontinuation caused by development of depressive symptoms occurred in females, 15 in males. A history of past depressive illness was present in 9.3% of females who started on isotretinoin and in 4.5% of the males. The relative risk of treatment-limiting depressive mood changes was increased 790% among females with a prior history of depressive illness and 440% in males with such a history.

Dr. Butt reported having no financial conflicts regarding her NHS-funded study.

[email protected]

A history of prior depressive illness conferred a sevenfold increased risk of developing treatment-limiting mood symptoms in patients on isotretinoin for acne in a large Scottish observational study, Sanaa Butt, MD, reported at the virtual annual congress of the European Academy of Dermatology and Venereology.

© Ocskay Bence/Fotolia.com

This was, however, the sole identifiable risk factor for treatment-limiting depressive symptoms in acne patients on isotretinoin in the study of 3,151 consecutive acne patients taking isotretinoin. There was no significant difference between those who did or did not develop depression on the oral retinoid in terms of age, gender, or daily dose of the drug at the time it was discontinued.

“Depressive symptoms occurred at any time from the date of initiation of isotretinoin up to 6 months into therapy, with no identifiable peak time period,” said Dr. Butt, a dermatologist with the U.K. National Health Service Tayside district at Ninewells Hospital, Dundee, Scotland. “Lower doses appear not to be protective,” she added.

The Tayside district has a catchment of roughly 450,000 people. The local population tends to stay put because Tayside is an economically disadvantaged and remote part of Scotland. There are very few private practice dermatologists in the area, so Dr. Butt and coinvestigators are confident their observational study of NHS patients captured the great majority of isotretinoin users in northern Scotland.

The investigators utilized software to analyze the contents of more than 8,000 digitized letters exchanged between NHS Tayside dermatologists and general practitioners during 2005-2018, zeroing in on 3,151 consecutive patients on isotretinoin for acne and 158 on the drug for other conditions, most often rosacea or folliculitis. They then drilled down further through the letters, electronically searching for key words such as suicide, depression, and anxiety. In this way, they ultimately identified 30 patients who discontinued the drug because they developed depressive symptoms. All 30 were on the drug for acne.

The annual incidence of treatment-limiting depressive mood changes was 0.96%, a figure that remained steady over the 13-year study period, even though prescribing of isotretinoin increased over time. This flat incidence rate effectively rules out the potential for confounding because of assessor bias, especially since many different NHS dermatologists were prescribing the drug, Dr. Butt said.

Half of acne patients prescribed isotretinoin were female and 50% were male. And 15 cases of treatment discontinuation caused by development of depressive symptoms occurred in females, 15 in males. A history of past depressive illness was present in 9.3% of females who started on isotretinoin and in 4.5% of the males. The relative risk of treatment-limiting depressive mood changes was increased 790% among females with a prior history of depressive illness and 440% in males with such a history.

Dr. Butt reported having no financial conflicts regarding her NHS-funded study.

[email protected]

A history of prior depressive illness conferred a sevenfold increased risk of developing treatment-limiting mood symptoms in patients on isotretinoin for acne in a large Scottish observational study, Sanaa Butt, MD, reported at the virtual annual congress of the European Academy of Dermatology and Venereology.

© Ocskay Bence/Fotolia.com

This was, however, the sole identifiable risk factor for treatment-limiting depressive symptoms in acne patients on isotretinoin in the study of 3,151 consecutive acne patients taking isotretinoin. There was no significant difference between those who did or did not develop depression on the oral retinoid in terms of age, gender, or daily dose of the drug at the time it was discontinued.

“Depressive symptoms occurred at any time from the date of initiation of isotretinoin up to 6 months into therapy, with no identifiable peak time period,” said Dr. Butt, a dermatologist with the U.K. National Health Service Tayside district at Ninewells Hospital, Dundee, Scotland. “Lower doses appear not to be protective,” she added.

The Tayside district has a catchment of roughly 450,000 people. The local population tends to stay put because Tayside is an economically disadvantaged and remote part of Scotland. There are very few private practice dermatologists in the area, so Dr. Butt and coinvestigators are confident their observational study of NHS patients captured the great majority of isotretinoin users in northern Scotland.

The investigators utilized software to analyze the contents of more than 8,000 digitized letters exchanged between NHS Tayside dermatologists and general practitioners during 2005-2018, zeroing in on 3,151 consecutive patients on isotretinoin for acne and 158 on the drug for other conditions, most often rosacea or folliculitis. They then drilled down further through the letters, electronically searching for key words such as suicide, depression, and anxiety. In this way, they ultimately identified 30 patients who discontinued the drug because they developed depressive symptoms. All 30 were on the drug for acne.

The annual incidence of treatment-limiting depressive mood changes was 0.96%, a figure that remained steady over the 13-year study period, even though prescribing of isotretinoin increased over time. This flat incidence rate effectively rules out the potential for confounding because of assessor bias, especially since many different NHS dermatologists were prescribing the drug, Dr. Butt said.

Half of acne patients prescribed isotretinoin were female and 50% were male. And 15 cases of treatment discontinuation caused by development of depressive symptoms occurred in females, 15 in males. A history of past depressive illness was present in 9.3% of females who started on isotretinoin and in 4.5% of the males. The relative risk of treatment-limiting depressive mood changes was increased 790% among females with a prior history of depressive illness and 440% in males with such a history.

Dr. Butt reported having no financial conflicts regarding her NHS-funded study.

[email protected]

The Diagnosis: Monilethrix

Trichoscopy showed a beaded appearance of the hair shafts (Figure, A). Light microscopy demonstrated normal medullated nodes of hair coupled with internodal, thin, nonmedullated hair at regular intervals (Figure, B). Clinical and trichoscopic findings led to a diagnosis of monilethrix.

Monilethrix is a genetic hair disorder characterized by regular periodic thinning of the hair shafts, giving the strands a beaded appearance. The hair tends to break at these constricted parts, resulting in short hairs. Nodosities represent the normal hair shaft, whereas the constricted points are the site of the defect. The hair tends to be normal at birth and then becomes short, fragile, and brittle within months, leading to hypotrichosis, particularly on the occipital scalp.¹ Monilethrix also may involve the eyebrows and eyelashes in addition to scalp hair. Follicular hyperkeratotic papules with perifollicular erythema frequently are noted on the occipital area. Monilethrix can be inherited in an autosomal-dominant fashion with mutations involving KRT81, KRT83, and KRT86, which code for the type II hair keratins Hb1, Hb3, and Hb6, respectively. The autosomal-recessive form is caused by mutations in the DSG4 gene, coding for the desmoglein 4 protein.2 Trichoscopy or light microscopy is essential to establish a diagnosis of monilethrix. Trichoscopy is an easy and rapid tool that is utilized to illustrate the beaded appearance of the hair shafts.³ Light microscopy shows the distinctive nodes that are medullated, with a normal hair diameter alternating with the internodes, or constrictions, that are nonmedullated and represent the sites of fracture.¹ Monilethrix can improve by puberty. There is no definitive treatment; however, some patients show considerable improvement on minoxidil.⁴ Treatment with minoxidil was initiated in this patient; however, she was lost to follow-up.

Genetic hair disorders are rare and can be an isolated phenomenon or part of concurrent genetic syndromes. Therefore, thorough clinical examination of other ectodermal structures such as the nails and teeth is crucial as well as obtaining a detailed family history and review of systems to exclude other syndromes.² Hypotrichosis simplex is characterized by hair loss exclusively on the scalp, sparing other ectodermal structures and with no systemic abnormalities. Ectodermal dysplasia is a heterogeneous group of disorders affecting not only the hair but also the teeth, nails, and sweat glands.² Pili torti is another rare genetic hair disorder that is characterized by twisting of the hair fiber on its own axis. It presents clinically as sparse, depigmented, lusterless hair that is easily broken. Light microscopy demonstrates twists of hair at irregular intervals. Pili annulati is characterized by bright and dark bands when viewed with reflected light. Unlike monilethrix, there is no fragility, and the hair can grow long.⁵

The Diagnosis: Monilethrix

Trichoscopy showed a beaded appearance of the hair shafts (Figure, A). Light microscopy demonstrated normal medullated nodes of hair coupled with internodal, thin, nonmedullated hair at regular intervals (Figure, B). Clinical and trichoscopic findings led to a diagnosis of monilethrix.

Monilethrix is a genetic hair disorder characterized by regular periodic thinning of the hair shafts, giving the strands a beaded appearance. The hair tends to break at these constricted parts, resulting in short hairs. Nodosities represent the normal hair shaft, whereas the constricted points are the site of the defect. The hair tends to be normal at birth and then becomes short, fragile, and brittle within months, leading to hypotrichosis, particularly on the occipital scalp.¹ Monilethrix also may involve the eyebrows and eyelashes in addition to scalp hair. Follicular hyperkeratotic papules with perifollicular erythema frequently are noted on the occipital area. Monilethrix can be inherited in an autosomal-dominant fashion with mutations involving KRT81, KRT83, and KRT86, which code for the type II hair keratins Hb1, Hb3, and Hb6, respectively. The autosomal-recessive form is caused by mutations in the DSG4 gene, coding for the desmoglein 4 protein.2 Trichoscopy or light microscopy is essential to establish a diagnosis of monilethrix. Trichoscopy is an easy and rapid tool that is utilized to illustrate the beaded appearance of the hair shafts.³ Light microscopy shows the distinctive nodes that are medullated, with a normal hair diameter alternating with the internodes, or constrictions, that are nonmedullated and represent the sites of fracture.¹ Monilethrix can improve by puberty. There is no definitive treatment; however, some patients show considerable improvement on minoxidil.⁴ Treatment with minoxidil was initiated in this patient; however, she was lost to follow-up.

Genetic hair disorders are rare and can be an isolated phenomenon or part of concurrent genetic syndromes. Therefore, thorough clinical examination of other ectodermal structures such as the nails and teeth is crucial as well as obtaining a detailed family history and review of systems to exclude other syndromes.² Hypotrichosis simplex is characterized by hair loss exclusively on the scalp, sparing other ectodermal structures and with no systemic abnormalities. Ectodermal dysplasia is a heterogeneous group of disorders affecting not only the hair but also the teeth, nails, and sweat glands.² Pili torti is another rare genetic hair disorder that is characterized by twisting of the hair fiber on its own axis. It presents clinically as sparse, depigmented, lusterless hair that is easily broken. Light microscopy demonstrates twists of hair at irregular intervals. Pili annulati is characterized by bright and dark bands when viewed with reflected light. Unlike monilethrix, there is no fragility, and the hair can grow long.⁵

The Diagnosis: Monilethrix

Trichoscopy showed a beaded appearance of the hair shafts (Figure, A). Light microscopy demonstrated normal medullated nodes of hair coupled with internodal, thin, nonmedullated hair at regular intervals (Figure, B). Clinical and trichoscopic findings led to a diagnosis of monilethrix.

Monilethrix is a genetic hair disorder characterized by regular periodic thinning of the hair shafts, giving the strands a beaded appearance. The hair tends to break at these constricted parts, resulting in short hairs. Nodosities represent the normal hair shaft, whereas the constricted points are the site of the defect. The hair tends to be normal at birth and then becomes short, fragile, and brittle within months, leading to hypotrichosis, particularly on the occipital scalp.¹ Monilethrix also may involve the eyebrows and eyelashes in addition to scalp hair. Follicular hyperkeratotic papules with perifollicular erythema frequently are noted on the occipital area. Monilethrix can be inherited in an autosomal-dominant fashion with mutations involving KRT81, KRT83, and KRT86, which code for the type II hair keratins Hb1, Hb3, and Hb6, respectively. The autosomal-recessive form is caused by mutations in the DSG4 gene, coding for the desmoglein 4 protein.2 Trichoscopy or light microscopy is essential to establish a diagnosis of monilethrix. Trichoscopy is an easy and rapid tool that is utilized to illustrate the beaded appearance of the hair shafts.³ Light microscopy shows the distinctive nodes that are medullated, with a normal hair diameter alternating with the internodes, or constrictions, that are nonmedullated and represent the sites of fracture.¹ Monilethrix can improve by puberty. There is no definitive treatment; however, some patients show considerable improvement on minoxidil.⁴ Treatment with minoxidil was initiated in this patient; however, she was lost to follow-up.

Genetic hair disorders are rare and can be an isolated phenomenon or part of concurrent genetic syndromes. Therefore, thorough clinical examination of other ectodermal structures such as the nails and teeth is crucial as well as obtaining a detailed family history and review of systems to exclude other syndromes.² Hypotrichosis simplex is characterized by hair loss exclusively on the scalp, sparing other ectodermal structures and with no systemic abnormalities. Ectodermal dysplasia is a heterogeneous group of disorders affecting not only the hair but also the teeth, nails, and sweat glands.² Pili torti is another rare genetic hair disorder that is characterized by twisting of the hair fiber on its own axis. It presents clinically as sparse, depigmented, lusterless hair that is easily broken. Light microscopy demonstrates twists of hair at irregular intervals. Pili annulati is characterized by bright and dark bands when viewed with reflected light. Unlike monilethrix, there is no fragility, and the hair can grow long.⁵

The high price of direct-acting antiviral (DAA) oral medications has made patient access challenging despite the availability of multiple effective treatment options for hepatitis C virus (HCV). Has there been any recent progress in making these treatments more affordable to patients? 

Dr. Jakab:  Certainly. We used to have great difficulty getting these medications to our patients, regardless of whether they were covered by private insurance or through the United States Department of Veterans Affairs (VA). The last few years have been amazing, not only in terms of availability of more regimens that are equally effective in curing HCV, but also in terms of patient access. I think this is capitalism at its best. Having competition—more regimens on the market—has helped drive the prices down.

These regimens are expensive, but very few patients actually pay the sticker price because the insurance plans end up negotiating a much better fee for a preferred regimen. The reality is considerably better now than it used to be even a few years ago, with more effective regimens available, and at an affordable price.

There is not much transparency in terms of pricing, so it is usually difficult to figure it out how much one insurance plan pays versus another. From the patient's perspective the progress is visible and translated in many patients being cured from HCV.

Have any of your patients faced other treatment access challenges unrelated to financial cost?

Dr. Jakab:  Historically, when the first DAAs became available, there were certain requirements put forward by insurance companies before these medications were approved given their high price at that time. Unfortunately, some of them are still in effect.

Providers still must document their clinical evaluation and laboratory testing before these medications get approved, which is important for clinical care, but some insurance plans will only cover HCV treatment for patients with advanced (stage 3 or 4) fibrosis.

Another requirement that pains me a lot—though again, great progress has been made—has to do with sobriety for patients who use drugs or alcohol. Some plans require 3 to 6 months of sobriety, or for the patient to be connected to a substance use disorder clinic or a relapse program.

There have also been some restrictions regarding which providers could prescribe these medications. Initially this was limited to hepatology, gastroenterology, or infectious disease specialists. Given the fact that the current DAA regimens are so easy to use due to their short duration of treatment and minimal side effects, more providers are comfortable with prescribing these medications. It certainly helps that CDC recommendations support the expansion of the provider pool to include primary care providers and substance use disorder providers. Physician assistants and APRNs have been increasingly involved in prescribing these medications as well. Pharmacists help us get the approval from the insurance companies, but PharmDs also treat many HCV patients.

Certain states are ahead of others in terms of eliminating Medicaid requirements that decrease patient access to HCV medications. I am lucky to be in Connecticut, which is one of the states where Medicaid restrictions have pretty much been lifted in terms of fibrosis staging or sobriety or prescriber requirements. This progress had a lot to do with patient and provider advocacy. Back in 2015 the New Haven Legal Assistance lobbied the state’s policymakers and Medicaid leadership to change these requirements. For patients covered by commercial insurance plans there are some requirements still in place, but overall, it is much better.

I have also witnessed the revolution of HCV treatment at the VA. A few years back we were restricting the use of these medications for patients with advanced fibrosis. Now the VA has all the available medications on the formulary, and there are no restrictions in terms of fibrosis staging, or sobriety requirements.

How has your team at the West Haven VA helped patients access HCV care through collaboration with other providers?

Dr. Jakab: It has been amazing to see how innovative people can be. It is true that if there is a will, there is a way. We finally had those medications so effective in curing HCV but were faced with challenges getting them to our patients. There was a huge effort throughout the VA, which is the national leader in the treatment of HCV, with more than 100,000 veterans cured. VA Connecticut was part of the movement: we expanded our liver clinic team to include a nurse practitioner, a PharmD, RN care coordinators, and a health psychologist. This way we could help our patients overcome many psychosocial or medical barriers and get them successfully treated.

The last step was going where the patients were. We realized that some patients who would benefit from treatment would not necessarily engage with us in liver clinic, even if they kept up with seeing their primary care physician. So instead of trying to get the patients into the liver clinic, we developed a program called HELP C, which stands for “HEpatitis C Leaders in Primary Care. The purpose of the program was to educate primary care providers interested in treating HCV. We continue to provide support for them through teleconferences or being available for any questions. This way we could indirectly treat patients with HCV without having them come to the liver clinic.

We also collaborated with our colleagues from substance use disorder clinics, to make sure they are updated in terms of ease of HCV treatment and need to screen for HCV in these high-risk patients.

Is there any other action that physicians can take to help improve HCV treatment accessibility for their patients?

Dr. Jakab: Education of patients, providers and policy makers is most important, and a lot of that responsibility is on those of us who are already helping patients to get to their HCV cure. It has to do with breaking barriers. Many providers still have misconceptions, for example, when it comes to patients who are actively using drugs. They feel that we should not spend resources on these patients because of their lack of engagement in terms of treatment of their substance use disorder and risk of relapse. However, we do have data proving that even patients who are actively injecting drugs achieve a high level of compliance with medications and a high level of cure in the range of 95% or so. Having the sobriety requirement on some insurance plans is a significant barrier to treatment, and it does not help select the patients who will successfully achieve HCV cure. All patients should be treated. In fact, by focusing on this high-risk category of patients, society benefits overall because by decreasing the HCV burden, we get closer to HCV eradication.

It is also important that the providers who are interested in treating HCV get familiar with the paperwork required to get these medications approved, also partnering with subspecialty pharmacies particularly when dealing with commercial insurances. In addition, there are assistance programs for patients who do not have insurance, or they are underinsured, or they get denied by their insurance plan. At the end of the day, helping a patient to get treated is worth the extra time spent with bureaucracy.

I would also encourage providers to continue looking for innovative approaches, and to try to develop multidisciplinary programs. Care coordination—partnering with pharmacy, psychology, and social work subspecialties—is what worked best for us at the West Haven VA. We were able to treat patients that were written off many times before; patients who suffered homelessness, struggled with medication adherence for their high blood pressure, or diabetes. They were patients about whom everybody said, “You guys are crazy. They will never get the treatment completed, never mind getting cured of HCV.” But they did—so it is all about advocating for your patients and partnering with the right people.

The high price of direct-acting antiviral (DAA) oral medications has made patient access challenging despite the availability of multiple effective treatment options for hepatitis C virus (HCV). Has there been any recent progress in making these treatments more affordable to patients? 

Dr. Jakab:  Certainly. We used to have great difficulty getting these medications to our patients, regardless of whether they were covered by private insurance or through the United States Department of Veterans Affairs (VA). The last few years have been amazing, not only in terms of availability of more regimens that are equally effective in curing HCV, but also in terms of patient access. I think this is capitalism at its best. Having competition—more regimens on the market—has helped drive the prices down.

These regimens are expensive, but very few patients actually pay the sticker price because the insurance plans end up negotiating a much better fee for a preferred regimen. The reality is considerably better now than it used to be even a few years ago, with more effective regimens available, and at an affordable price.

There is not much transparency in terms of pricing, so it is usually difficult to figure it out how much one insurance plan pays versus another. From the patient's perspective the progress is visible and translated in many patients being cured from HCV.

Have any of your patients faced other treatment access challenges unrelated to financial cost?

Dr. Jakab:  Historically, when the first DAAs became available, there were certain requirements put forward by insurance companies before these medications were approved given their high price at that time. Unfortunately, some of them are still in effect.

Providers still must document their clinical evaluation and laboratory testing before these medications get approved, which is important for clinical care, but some insurance plans will only cover HCV treatment for patients with advanced (stage 3 or 4) fibrosis.

Another requirement that pains me a lot—though again, great progress has been made—has to do with sobriety for patients who use drugs or alcohol. Some plans require 3 to 6 months of sobriety, or for the patient to be connected to a substance use disorder clinic or a relapse program.

There have also been some restrictions regarding which providers could prescribe these medications. Initially this was limited to hepatology, gastroenterology, or infectious disease specialists. Given the fact that the current DAA regimens are so easy to use due to their short duration of treatment and minimal side effects, more providers are comfortable with prescribing these medications. It certainly helps that CDC recommendations support the expansion of the provider pool to include primary care providers and substance use disorder providers. Physician assistants and APRNs have been increasingly involved in prescribing these medications as well. Pharmacists help us get the approval from the insurance companies, but PharmDs also treat many HCV patients.

Certain states are ahead of others in terms of eliminating Medicaid requirements that decrease patient access to HCV medications. I am lucky to be in Connecticut, which is one of the states where Medicaid restrictions have pretty much been lifted in terms of fibrosis staging or sobriety or prescriber requirements. This progress had a lot to do with patient and provider advocacy. Back in 2015 the New Haven Legal Assistance lobbied the state’s policymakers and Medicaid leadership to change these requirements. For patients covered by commercial insurance plans there are some requirements still in place, but overall, it is much better.

I have also witnessed the revolution of HCV treatment at the VA. A few years back we were restricting the use of these medications for patients with advanced fibrosis. Now the VA has all the available medications on the formulary, and there are no restrictions in terms of fibrosis staging, or sobriety requirements.

How has your team at the West Haven VA helped patients access HCV care through collaboration with other providers?

Dr. Jakab: It has been amazing to see how innovative people can be. It is true that if there is a will, there is a way. We finally had those medications so effective in curing HCV but were faced with challenges getting them to our patients. There was a huge effort throughout the VA, which is the national leader in the treatment of HCV, with more than 100,000 veterans cured. VA Connecticut was part of the movement: we expanded our liver clinic team to include a nurse practitioner, a PharmD, RN care coordinators, and a health psychologist. This way we could help our patients overcome many psychosocial or medical barriers and get them successfully treated.

The last step was going where the patients were. We realized that some patients who would benefit from treatment would not necessarily engage with us in liver clinic, even if they kept up with seeing their primary care physician. So instead of trying to get the patients into the liver clinic, we developed a program called HELP C, which stands for “HEpatitis C Leaders in Primary Care. The purpose of the program was to educate primary care providers interested in treating HCV. We continue to provide support for them through teleconferences or being available for any questions. This way we could indirectly treat patients with HCV without having them come to the liver clinic.

We also collaborated with our colleagues from substance use disorder clinics, to make sure they are updated in terms of ease of HCV treatment and need to screen for HCV in these high-risk patients.

Is there any other action that physicians can take to help improve HCV treatment accessibility for their patients?

Dr. Jakab: Education of patients, providers and policy makers is most important, and a lot of that responsibility is on those of us who are already helping patients to get to their HCV cure. It has to do with breaking barriers. Many providers still have misconceptions, for example, when it comes to patients who are actively using drugs. They feel that we should not spend resources on these patients because of their lack of engagement in terms of treatment of their substance use disorder and risk of relapse. However, we do have data proving that even patients who are actively injecting drugs achieve a high level of compliance with medications and a high level of cure in the range of 95% or so. Having the sobriety requirement on some insurance plans is a significant barrier to treatment, and it does not help select the patients who will successfully achieve HCV cure. All patients should be treated. In fact, by focusing on this high-risk category of patients, society benefits overall because by decreasing the HCV burden, we get closer to HCV eradication.

It is also important that the providers who are interested in treating HCV get familiar with the paperwork required to get these medications approved, also partnering with subspecialty pharmacies particularly when dealing with commercial insurances. In addition, there are assistance programs for patients who do not have insurance, or they are underinsured, or they get denied by their insurance plan. At the end of the day, helping a patient to get treated is worth the extra time spent with bureaucracy.

I would also encourage providers to continue looking for innovative approaches, and to try to develop multidisciplinary programs. Care coordination—partnering with pharmacy, psychology, and social work subspecialties—is what worked best for us at the West Haven VA. We were able to treat patients that were written off many times before; patients who suffered homelessness, struggled with medication adherence for their high blood pressure, or diabetes. They were patients about whom everybody said, “You guys are crazy. They will never get the treatment completed, never mind getting cured of HCV.” But they did—so it is all about advocating for your patients and partnering with the right people.

The high price of direct-acting antiviral (DAA) oral medications has made patient access challenging despite the availability of multiple effective treatment options for hepatitis C virus (HCV). Has there been any recent progress in making these treatments more affordable to patients? 

Dr. Jakab:  Certainly. We used to have great difficulty getting these medications to our patients, regardless of whether they were covered by private insurance or through the United States Department of Veterans Affairs (VA). The last few years have been amazing, not only in terms of availability of more regimens that are equally effective in curing HCV, but also in terms of patient access. I think this is capitalism at its best. Having competition—more regimens on the market—has helped drive the prices down.

These regimens are expensive, but very few patients actually pay the sticker price because the insurance plans end up negotiating a much better fee for a preferred regimen. The reality is considerably better now than it used to be even a few years ago, with more effective regimens available, and at an affordable price.

There is not much transparency in terms of pricing, so it is usually difficult to figure it out how much one insurance plan pays versus another. From the patient's perspective the progress is visible and translated in many patients being cured from HCV.

Have any of your patients faced other treatment access challenges unrelated to financial cost?

Dr. Jakab:  Historically, when the first DAAs became available, there were certain requirements put forward by insurance companies before these medications were approved given their high price at that time. Unfortunately, some of them are still in effect.

Providers still must document their clinical evaluation and laboratory testing before these medications get approved, which is important for clinical care, but some insurance plans will only cover HCV treatment for patients with advanced (stage 3 or 4) fibrosis.

Another requirement that pains me a lot—though again, great progress has been made—has to do with sobriety for patients who use drugs or alcohol. Some plans require 3 to 6 months of sobriety, or for the patient to be connected to a substance use disorder clinic or a relapse program.

There have also been some restrictions regarding which providers could prescribe these medications. Initially this was limited to hepatology, gastroenterology, or infectious disease specialists. Given the fact that the current DAA regimens are so easy to use due to their short duration of treatment and minimal side effects, more providers are comfortable with prescribing these medications. It certainly helps that CDC recommendations support the expansion of the provider pool to include primary care providers and substance use disorder providers. Physician assistants and APRNs have been increasingly involved in prescribing these medications as well. Pharmacists help us get the approval from the insurance companies, but PharmDs also treat many HCV patients.

Certain states are ahead of others in terms of eliminating Medicaid requirements that decrease patient access to HCV medications. I am lucky to be in Connecticut, which is one of the states where Medicaid restrictions have pretty much been lifted in terms of fibrosis staging or sobriety or prescriber requirements. This progress had a lot to do with patient and provider advocacy. Back in 2015 the New Haven Legal Assistance lobbied the state’s policymakers and Medicaid leadership to change these requirements. For patients covered by commercial insurance plans there are some requirements still in place, but overall, it is much better.

I have also witnessed the revolution of HCV treatment at the VA. A few years back we were restricting the use of these medications for patients with advanced fibrosis. Now the VA has all the available medications on the formulary, and there are no restrictions in terms of fibrosis staging, or sobriety requirements.

How has your team at the West Haven VA helped patients access HCV care through collaboration with other providers?

Dr. Jakab: It has been amazing to see how innovative people can be. It is true that if there is a will, there is a way. We finally had those medications so effective in curing HCV but were faced with challenges getting them to our patients. There was a huge effort throughout the VA, which is the national leader in the treatment of HCV, with more than 100,000 veterans cured. VA Connecticut was part of the movement: we expanded our liver clinic team to include a nurse practitioner, a PharmD, RN care coordinators, and a health psychologist. This way we could help our patients overcome many psychosocial or medical barriers and get them successfully treated.

The last step was going where the patients were. We realized that some patients who would benefit from treatment would not necessarily engage with us in liver clinic, even if they kept up with seeing their primary care physician. So instead of trying to get the patients into the liver clinic, we developed a program called HELP C, which stands for “HEpatitis C Leaders in Primary Care. The purpose of the program was to educate primary care providers interested in treating HCV. We continue to provide support for them through teleconferences or being available for any questions. This way we could indirectly treat patients with HCV without having them come to the liver clinic.

We also collaborated with our colleagues from substance use disorder clinics, to make sure they are updated in terms of ease of HCV treatment and need to screen for HCV in these high-risk patients.

Is there any other action that physicians can take to help improve HCV treatment accessibility for their patients?

Dr. Jakab: Education of patients, providers and policy makers is most important, and a lot of that responsibility is on those of us who are already helping patients to get to their HCV cure. It has to do with breaking barriers. Many providers still have misconceptions, for example, when it comes to patients who are actively using drugs. They feel that we should not spend resources on these patients because of their lack of engagement in terms of treatment of their substance use disorder and risk of relapse. However, we do have data proving that even patients who are actively injecting drugs achieve a high level of compliance with medications and a high level of cure in the range of 95% or so. Having the sobriety requirement on some insurance plans is a significant barrier to treatment, and it does not help select the patients who will successfully achieve HCV cure. All patients should be treated. In fact, by focusing on this high-risk category of patients, society benefits overall because by decreasing the HCV burden, we get closer to HCV eradication.

It is also important that the providers who are interested in treating HCV get familiar with the paperwork required to get these medications approved, also partnering with subspecialty pharmacies particularly when dealing with commercial insurances. In addition, there are assistance programs for patients who do not have insurance, or they are underinsured, or they get denied by their insurance plan. At the end of the day, helping a patient to get treated is worth the extra time spent with bureaucracy.

I would also encourage providers to continue looking for innovative approaches, and to try to develop multidisciplinary programs. Care coordination—partnering with pharmacy, psychology, and social work subspecialties—is what worked best for us at the West Haven VA. We were able to treat patients that were written off many times before; patients who suffered homelessness, struggled with medication adherence for their high blood pressure, or diabetes. They were patients about whom everybody said, “You guys are crazy. They will never get the treatment completed, never mind getting cured of HCV.” But they did—so it is all about advocating for your patients and partnering with the right people.

SARS-CoV-2 infection posed increased risk for pregnant women in terms of severe disease and poor pregnancy outcomes including preterm birth, based on data from two studies published in the Centers for Disease Control and Prevention’s Morbidity and Mortality Weekly Report.

In a study of birth and infant outcomes, rates of preterm birth (less than 37 weeks’ gestational age) were higher among women with confirmed SARS-CoV-2 infections compared with the national average (12.9% vs. 10.2%) wrote Kate R. Woodworth, MD, and colleagues of the CDC COVID-19 Response Pregnancy and Linked Outcomes Team.

The researchers collected information on pregnancy and infant outcomes from 16 jurisdictions through the Surveillance for Emerging Threats to Mothers and Babies Network (SET-NET). The study included 5,252 women with laboratory-confirmed SARS-CoV-2 infection reported during March 29–Oct. 14, 2020.

Overall, 12.9% of the 3,912 live births with known gestational age were preterm. A total of 610 infants were tested for SARS-CoV-2, and 2.6% were positive. Most of these perinatal infections (85%) occurred among infants born to women with SARS-CoV-2 infection within 1 week of delivery.

Half of the infants with positive test results were preterm, possibly reflecting higher screening rates in the ICU, the researchers said. “These findings also support the growing evidence that although severe COVID-19 does occur in neonates the majority of term neonates experience asymptomatic infection or mild disease; however, information on long term outcomes among exposed infants is unknown.”

Address disparities that amplify risk

The study findings were limited by several factors including inconsistent symptom reporting, overrepresentation of Hispanic women, and incomplete information on pregnancy loss, Dr. Woodworth and associates noted. However, the results add to the knowledge about the impact of COVID-19 disease on pregnancy by providing a large, population-based cohort with completed pregnancy outcomes as well as infant testing.

“SET-NET will continue to follow pregnancies affected by SARS-CoV-2 through completion of pregnancy and infants until age 6 months to guide clinical and public health practice,” the researchers noted. “Longer-term investigation into solutions to alleviate underlying inequities in social determinants of health associated with disparities in maternal morbidity, mortality, and adverse pregnancy outcomes, and effectively addressing these inequities, could reduce the prevalence of conditions and experiences that might amplify risks from COVID-19,” they added.

Severe disease and death increased in pregnant women

In a second study published in the MMWR, Laura D. Zambrano, PhD, and colleagues, also of the CDC COVID-19 Response Pregnancy and Linked Outcomes Team, compared data on 23,434 reportedly pregnant and 386,028 nonpregnant women of reproductive age (15-44 years) with confirmed and symptomatic SARS-CoV-2 infections reported to the CDC between Jan. 22, 2020, and Oct. 3, 2020.

After adjustment for age, race, and underlying medical conditions, pregnant women with COVID-19 disease were significantly more likely than were nonpregnant women to be admitted to intensive care (10.5 per 1,000 cases vs. 3.9 per 1,000 cases), to receive invasive ventilation (2.9 vs. 1.1), receive extracorporeal membrane oxygenation (0.7 vs. 0.3) and to die (1.5 vs. 1.2).

“Irrespective of pregnancy status, ICU admissions, receipt of invasive ventilation, and death occurred more often among women aged 35-44 years than among those aged 15-24 years,” Dr. Zambrano and associates noted. In addition, non-Hispanic Black and Black women comprised 14.1% of the study population but accounted for 36.6% of deaths overall (9 in pregnant women and 167 in nonpregnant women).

The findings in the study of characteristics were limited by several factors including the voluntary reporting of COVID-19 cases, potential reporting bias, and inadequate time to assess severe cases, the researchers noted. However, “data from previous influenza pandemics, including 2009 H1N1, have shown that pregnant women are at increased risk for severe outcomes including death and the absolute risks for severe outcomes were higher than in this study of COVID-19 during pregnancy.”

“Pregnant women should be informed of their risk for severe COVID-19–associated illness and the warning signs of severe COVID-19,” Dr. Zambrano and associates said. “Providers who care for pregnant women should be familiar with guidelines for medical management of COVID-19, including considerations for management of COVID-19 in pregnancy.”

More data needed for informed counseling

“It is important to conduct research trials involving pregnant women so that we have reliable data regarding outcomes with which to counsel women,” Angela Bianco, MD, a maternal fetal medicine specialist at Mount Sinai Hospital in New York, said in an interview.

“Often pregnant women are excluded from research trials, but the impact of the current public health crisis affects all persons regardless of pregnancy status,” she said.

Dr. Bianco said that she was not surprised by the findings of either study. “In fact, our own research produced similar results.”

“These recent publications found that age-matched pregnant versus nonpregnant women had more severe manifestations of COVID-19, and specifically that pregnant women had a higher risk of requiring ventilation and intensive care admission, as well as higher risk of death,” she said. “Previous studies examining the effect of other SARS viruses have demonstrated that pregnancy is associated with worse outcomes; these findings are likely attributable to the relative state of immunosuppression in pregnancy.” Also, “one of these trials found a greater risk of premature birth in women with COVID-19; this may largely be attributable to iatrogenic delivery due to maternal illness as opposed to spontaneous preterm birth,” Dr. Bianco explained.

“Data are emerging regarding the impact of SARS-CoV-2 on pregnancy outcomes, however information remains limited,” Dr. Bianco noted. “Clinicians need to make patients aware that SARS-CoV-2 infection during pregnancy is associated with a greater risk of severe illness requiring intensive care and/or ventilatory support and even death; however, the precise rates remain unknown. “COVID-19 during pregnancy may result in a preterm birth, but at this time the rate of fetal infection remains unknown,” she said. “Clinicians need to reinforce the importance of physical distancing, mask use, and proper hand hygiene, particularly in this vulnerable population.”

Dr. Bianco emphasized: “Longitudinal studies assessing the impact of SARS-CoV-2 infection at various gestational age periods are needed, as at this time most of the available data includes women with SARS-CoV-2 infection around the time of delivery. Long-term infant outcomes are needed, as well as studies assessing the risk of fetal infection.”

The studies were supported by the Centers for Disease Control and Prevention. The researchers had no financial conflicts to disclose. Dr. Bianco had no relevant financial disclosures.

SOURCE: Woodworth KR et al. MMWR. 2020 Nov 2. doi: 10.15585/mmwr.mm6944e2; Zambrano LD et al. MMWR. 2020 Nov 2. doi: 10.15585/mmwr.mm6944e3.

SARS-CoV-2 infection posed increased risk for pregnant women in terms of severe disease and poor pregnancy outcomes including preterm birth, based on data from two studies published in the Centers for Disease Control and Prevention’s Morbidity and Mortality Weekly Report.

In a study of birth and infant outcomes, rates of preterm birth (less than 37 weeks’ gestational age) were higher among women with confirmed SARS-CoV-2 infections compared with the national average (12.9% vs. 10.2%) wrote Kate R. Woodworth, MD, and colleagues of the CDC COVID-19 Response Pregnancy and Linked Outcomes Team.

The researchers collected information on pregnancy and infant outcomes from 16 jurisdictions through the Surveillance for Emerging Threats to Mothers and Babies Network (SET-NET). The study included 5,252 women with laboratory-confirmed SARS-CoV-2 infection reported during March 29–Oct. 14, 2020.

Overall, 12.9% of the 3,912 live births with known gestational age were preterm. A total of 610 infants were tested for SARS-CoV-2, and 2.6% were positive. Most of these perinatal infections (85%) occurred among infants born to women with SARS-CoV-2 infection within 1 week of delivery.

Half of the infants with positive test results were preterm, possibly reflecting higher screening rates in the ICU, the researchers said. “These findings also support the growing evidence that although severe COVID-19 does occur in neonates the majority of term neonates experience asymptomatic infection or mild disease; however, information on long term outcomes among exposed infants is unknown.”

Address disparities that amplify risk

The study findings were limited by several factors including inconsistent symptom reporting, overrepresentation of Hispanic women, and incomplete information on pregnancy loss, Dr. Woodworth and associates noted. However, the results add to the knowledge about the impact of COVID-19 disease on pregnancy by providing a large, population-based cohort with completed pregnancy outcomes as well as infant testing.

“SET-NET will continue to follow pregnancies affected by SARS-CoV-2 through completion of pregnancy and infants until age 6 months to guide clinical and public health practice,” the researchers noted. “Longer-term investigation into solutions to alleviate underlying inequities in social determinants of health associated with disparities in maternal morbidity, mortality, and adverse pregnancy outcomes, and effectively addressing these inequities, could reduce the prevalence of conditions and experiences that might amplify risks from COVID-19,” they added.

Severe disease and death increased in pregnant women

In a second study published in the MMWR, Laura D. Zambrano, PhD, and colleagues, also of the CDC COVID-19 Response Pregnancy and Linked Outcomes Team, compared data on 23,434 reportedly pregnant and 386,028 nonpregnant women of reproductive age (15-44 years) with confirmed and symptomatic SARS-CoV-2 infections reported to the CDC between Jan. 22, 2020, and Oct. 3, 2020.

After adjustment for age, race, and underlying medical conditions, pregnant women with COVID-19 disease were significantly more likely than were nonpregnant women to be admitted to intensive care (10.5 per 1,000 cases vs. 3.9 per 1,000 cases), to receive invasive ventilation (2.9 vs. 1.1), receive extracorporeal membrane oxygenation (0.7 vs. 0.3) and to die (1.5 vs. 1.2).

“Irrespective of pregnancy status, ICU admissions, receipt of invasive ventilation, and death occurred more often among women aged 35-44 years than among those aged 15-24 years,” Dr. Zambrano and associates noted. In addition, non-Hispanic Black and Black women comprised 14.1% of the study population but accounted for 36.6% of deaths overall (9 in pregnant women and 167 in nonpregnant women).

The findings in the study of characteristics were limited by several factors including the voluntary reporting of COVID-19 cases, potential reporting bias, and inadequate time to assess severe cases, the researchers noted. However, “data from previous influenza pandemics, including 2009 H1N1, have shown that pregnant women are at increased risk for severe outcomes including death and the absolute risks for severe outcomes were higher than in this study of COVID-19 during pregnancy.”

“Pregnant women should be informed of their risk for severe COVID-19–associated illness and the warning signs of severe COVID-19,” Dr. Zambrano and associates said. “Providers who care for pregnant women should be familiar with guidelines for medical management of COVID-19, including considerations for management of COVID-19 in pregnancy.”

More data needed for informed counseling

“It is important to conduct research trials involving pregnant women so that we have reliable data regarding outcomes with which to counsel women,” Angela Bianco, MD, a maternal fetal medicine specialist at Mount Sinai Hospital in New York, said in an interview.

“Often pregnant women are excluded from research trials, but the impact of the current public health crisis affects all persons regardless of pregnancy status,” she said.

Dr. Bianco said that she was not surprised by the findings of either study. “In fact, our own research produced similar results.”

“These recent publications found that age-matched pregnant versus nonpregnant women had more severe manifestations of COVID-19, and specifically that pregnant women had a higher risk of requiring ventilation and intensive care admission, as well as higher risk of death,” she said. “Previous studies examining the effect of other SARS viruses have demonstrated that pregnancy is associated with worse outcomes; these findings are likely attributable to the relative state of immunosuppression in pregnancy.” Also, “one of these trials found a greater risk of premature birth in women with COVID-19; this may largely be attributable to iatrogenic delivery due to maternal illness as opposed to spontaneous preterm birth,” Dr. Bianco explained.

“Data are emerging regarding the impact of SARS-CoV-2 on pregnancy outcomes, however information remains limited,” Dr. Bianco noted. “Clinicians need to make patients aware that SARS-CoV-2 infection during pregnancy is associated with a greater risk of severe illness requiring intensive care and/or ventilatory support and even death; however, the precise rates remain unknown. “COVID-19 during pregnancy may result in a preterm birth, but at this time the rate of fetal infection remains unknown,” she said. “Clinicians need to reinforce the importance of physical distancing, mask use, and proper hand hygiene, particularly in this vulnerable population.”

Dr. Bianco emphasized: “Longitudinal studies assessing the impact of SARS-CoV-2 infection at various gestational age periods are needed, as at this time most of the available data includes women with SARS-CoV-2 infection around the time of delivery. Long-term infant outcomes are needed, as well as studies assessing the risk of fetal infection.”

The studies were supported by the Centers for Disease Control and Prevention. The researchers had no financial conflicts to disclose. Dr. Bianco had no relevant financial disclosures.

SOURCE: Woodworth KR et al. MMWR. 2020 Nov 2. doi: 10.15585/mmwr.mm6944e2; Zambrano LD et al. MMWR. 2020 Nov 2. doi: 10.15585/mmwr.mm6944e3.

SARS-CoV-2 infection posed increased risk for pregnant women in terms of severe disease and poor pregnancy outcomes including preterm birth, based on data from two studies published in the Centers for Disease Control and Prevention’s Morbidity and Mortality Weekly Report.

In a study of birth and infant outcomes, rates of preterm birth (less than 37 weeks’ gestational age) were higher among women with confirmed SARS-CoV-2 infections compared with the national average (12.9% vs. 10.2%) wrote Kate R. Woodworth, MD, and colleagues of the CDC COVID-19 Response Pregnancy and Linked Outcomes Team.

The researchers collected information on pregnancy and infant outcomes from 16 jurisdictions through the Surveillance for Emerging Threats to Mothers and Babies Network (SET-NET). The study included 5,252 women with laboratory-confirmed SARS-CoV-2 infection reported during March 29–Oct. 14, 2020.

Overall, 12.9% of the 3,912 live births with known gestational age were preterm. A total of 610 infants were tested for SARS-CoV-2, and 2.6% were positive. Most of these perinatal infections (85%) occurred among infants born to women with SARS-CoV-2 infection within 1 week of delivery.

Half of the infants with positive test results were preterm, possibly reflecting higher screening rates in the ICU, the researchers said. “These findings also support the growing evidence that although severe COVID-19 does occur in neonates the majority of term neonates experience asymptomatic infection or mild disease; however, information on long term outcomes among exposed infants is unknown.”

Address disparities that amplify risk

The study findings were limited by several factors including inconsistent symptom reporting, overrepresentation of Hispanic women, and incomplete information on pregnancy loss, Dr. Woodworth and associates noted. However, the results add to the knowledge about the impact of COVID-19 disease on pregnancy by providing a large, population-based cohort with completed pregnancy outcomes as well as infant testing.

“SET-NET will continue to follow pregnancies affected by SARS-CoV-2 through completion of pregnancy and infants until age 6 months to guide clinical and public health practice,” the researchers noted. “Longer-term investigation into solutions to alleviate underlying inequities in social determinants of health associated with disparities in maternal morbidity, mortality, and adverse pregnancy outcomes, and effectively addressing these inequities, could reduce the prevalence of conditions and experiences that might amplify risks from COVID-19,” they added.

Severe disease and death increased in pregnant women

In a second study published in the MMWR, Laura D. Zambrano, PhD, and colleagues, also of the CDC COVID-19 Response Pregnancy and Linked Outcomes Team, compared data on 23,434 reportedly pregnant and 386,028 nonpregnant women of reproductive age (15-44 years) with confirmed and symptomatic SARS-CoV-2 infections reported to the CDC between Jan. 22, 2020, and Oct. 3, 2020.

After adjustment for age, race, and underlying medical conditions, pregnant women with COVID-19 disease were significantly more likely than were nonpregnant women to be admitted to intensive care (10.5 per 1,000 cases vs. 3.9 per 1,000 cases), to receive invasive ventilation (2.9 vs. 1.1), receive extracorporeal membrane oxygenation (0.7 vs. 0.3) and to die (1.5 vs. 1.2).

“Irrespective of pregnancy status, ICU admissions, receipt of invasive ventilation, and death occurred more often among women aged 35-44 years than among those aged 15-24 years,” Dr. Zambrano and associates noted. In addition, non-Hispanic Black and Black women comprised 14.1% of the study population but accounted for 36.6% of deaths overall (9 in pregnant women and 167 in nonpregnant women).

The findings in the study of characteristics were limited by several factors including the voluntary reporting of COVID-19 cases, potential reporting bias, and inadequate time to assess severe cases, the researchers noted. However, “data from previous influenza pandemics, including 2009 H1N1, have shown that pregnant women are at increased risk for severe outcomes including death and the absolute risks for severe outcomes were higher than in this study of COVID-19 during pregnancy.”

“Pregnant women should be informed of their risk for severe COVID-19–associated illness and the warning signs of severe COVID-19,” Dr. Zambrano and associates said. “Providers who care for pregnant women should be familiar with guidelines for medical management of COVID-19, including considerations for management of COVID-19 in pregnancy.”

More data needed for informed counseling

“It is important to conduct research trials involving pregnant women so that we have reliable data regarding outcomes with which to counsel women,” Angela Bianco, MD, a maternal fetal medicine specialist at Mount Sinai Hospital in New York, said in an interview.

“Often pregnant women are excluded from research trials, but the impact of the current public health crisis affects all persons regardless of pregnancy status,” she said.

Dr. Bianco said that she was not surprised by the findings of either study. “In fact, our own research produced similar results.”

“These recent publications found that age-matched pregnant versus nonpregnant women had more severe manifestations of COVID-19, and specifically that pregnant women had a higher risk of requiring ventilation and intensive care admission, as well as higher risk of death,” she said. “Previous studies examining the effect of other SARS viruses have demonstrated that pregnancy is associated with worse outcomes; these findings are likely attributable to the relative state of immunosuppression in pregnancy.” Also, “one of these trials found a greater risk of premature birth in women with COVID-19; this may largely be attributable to iatrogenic delivery due to maternal illness as opposed to spontaneous preterm birth,” Dr. Bianco explained.

“Data are emerging regarding the impact of SARS-CoV-2 on pregnancy outcomes, however information remains limited,” Dr. Bianco noted. “Clinicians need to make patients aware that SARS-CoV-2 infection during pregnancy is associated with a greater risk of severe illness requiring intensive care and/or ventilatory support and even death; however, the precise rates remain unknown. “COVID-19 during pregnancy may result in a preterm birth, but at this time the rate of fetal infection remains unknown,” she said. “Clinicians need to reinforce the importance of physical distancing, mask use, and proper hand hygiene, particularly in this vulnerable population.”

Dr. Bianco emphasized: “Longitudinal studies assessing the impact of SARS-CoV-2 infection at various gestational age periods are needed, as at this time most of the available data includes women with SARS-CoV-2 infection around the time of delivery. Long-term infant outcomes are needed, as well as studies assessing the risk of fetal infection.”

The studies were supported by the Centers for Disease Control and Prevention. The researchers had no financial conflicts to disclose. Dr. Bianco had no relevant financial disclosures.

SOURCE: Woodworth KR et al. MMWR. 2020 Nov 2. doi: 10.15585/mmwr.mm6944e2; Zambrano LD et al. MMWR. 2020 Nov 2. doi: 10.15585/mmwr.mm6944e3.

Coaching is a new topic in medicine. I first heard about coaching several years ago and met the term with skepticism. I was unsure how coaching was different than mentoring or advising and I wondered about its usefulness. However, the reason that I even started to learn about coaching was because I was struggling. I had finally arrived in my career, I had my dream job with two healthy kids, a perfect house, and good marriage. I kept hearing the refrain in my head: “Is this all there is?” I had this arrival fallacy that after all this striving and straining that I would finally be content. I felt unfulfilled and was dissatisfied with where I was that was affecting all parts of my life.

As I was wrestling with these thoughts, I had an opportunity to become a coach to residents around the country through the Association of Women Surgeons. I discussed with them what fills them up, what gets them down, how to set goals, and what their goals were for the year, as well as imposter syndrome. Impostor syndrome is defined as a pattern in which an individual doubts their accomplishments or talents and has a persistent internalized fear of being exposed as a “fraud.” Despite external evidence of their competence, those experiencing this phenomenon remain convinced that they are fooling everyone around them and do not deserve all they have achieved. Individuals incorrectly attribute their success to luck or interpret it as a result of deceiving others into thinking they are more intelligent than they perceive themselves to be. Imposter syndrome is prevalent and deep in medicine. As perfectionists, we are especially vulnerable to imposter syndrome as we set unrealistic ideals for ourselves. When we fail to reach these ideals, we feel like frauds, setting up this cycle of self-doubt that is toxic. When we feel that we can’t achieve the goals that we are striving for we will always find ourselves lacking. There is a slow, insidious erosion of self over the years. Imposter syndrome is well documented in medicine and is even felt as early as medical school.^1,2

When I began coaching these residents the most profound thing that came out of these sessions was that my life was getting better – I knew what filled me up, what got me down, what my goals were for the year, and how I still deal with imposter syndrome. Coaching gave me a framework for helping determine what I wanted for the rest of my life. As I began coaching, I started learning all the ways in which I could figure out my values, my personal and professional goals, and perhaps most importantly, my relationships with myself and others.

Another perspective on coaching is to look at a professional athlete such as Tom Brady, one of the greatest quarterbacks of all time. He has a quarterback coach. No coach is going to be a better quarterback than Tom Brady. A coach for him is to be there as an advocate, break his fundamentals down technically, and help him improve upon what he already knows. A coach also identifies strengths and weaknesses, and helps him capitalize on both by bringing awareness, reflection, accountability, and support. If world-class athletes still want and benefit from coaching in a sport they have already mastered, coaching for physicians is just another tool to help us improve our abilities in and out of medicine.

The way I visualize coaching in medicine is a conscious effort to notice and evaluate how our thoughts affect our experiences and how our perspective shows up in the results of our lives. Coaching is more encompassing than advising or mentoring. It is about examining deeply held beliefs to see if they are really serving us, if they are in line with our values and how we want to live our lives.

Coaching has also been validated in medicine in several papers. In an article by Dyrbye et al. in JAMA Internal Medicine, measures of emotional exhaustion and burnout decreased in physicians who were coached and increased in those who were not.³ In another study from this year by McGonagle et al., a randomized, controlled trial showed that primary care physicians who had sessions (as short as 6 weeks) to address burnout, psychological capital, and job satisfaction experienced an improvement in measures which persisted for 6 months after intervention.⁴ Numerous other articles in medicine also exist to demonstrate the effect of coaching on mitigating burnout at an institutional level.

Physicians are inherently driven by their love of learning. As physicians, we love getting to the root cause of any problem and coming up with creative solutions. Any challenge we have, or just wanting to improve the quality of our lives, can be addressed with coaching. As perpetual students we can use coaching to truly master ourselves.

Dr. Shah is associate professor of surgery, Rush University Medical Center, Chicago. Instagram: ami.shahmdcoaching.

References

1. Gottlieb M et al. Med Educ. 2020 Feb;54(2):116-24.

2. Villwock JA et al. Int J Med Educ. 2016 Oct 31;7:364-9.

3. Dyrbye LN et al. JAMA Intern Med. 2019 Aug 5;179(10):1406-14.

4. McGonagle AK et al. J Occup Health Psychol. 2020 Apr 16. doi: 10.1037/ocp0000180.

Coaching is a new topic in medicine. I first heard about coaching several years ago and met the term with skepticism. I was unsure how coaching was different than mentoring or advising and I wondered about its usefulness. However, the reason that I even started to learn about coaching was because I was struggling. I had finally arrived in my career, I had my dream job with two healthy kids, a perfect house, and good marriage. I kept hearing the refrain in my head: “Is this all there is?” I had this arrival fallacy that after all this striving and straining that I would finally be content. I felt unfulfilled and was dissatisfied with where I was that was affecting all parts of my life.

As I was wrestling with these thoughts, I had an opportunity to become a coach to residents around the country through the Association of Women Surgeons. I discussed with them what fills them up, what gets them down, how to set goals, and what their goals were for the year, as well as imposter syndrome. Impostor syndrome is defined as a pattern in which an individual doubts their accomplishments or talents and has a persistent internalized fear of being exposed as a “fraud.” Despite external evidence of their competence, those experiencing this phenomenon remain convinced that they are fooling everyone around them and do not deserve all they have achieved. Individuals incorrectly attribute their success to luck or interpret it as a result of deceiving others into thinking they are more intelligent than they perceive themselves to be. Imposter syndrome is prevalent and deep in medicine. As perfectionists, we are especially vulnerable to imposter syndrome as we set unrealistic ideals for ourselves. When we fail to reach these ideals, we feel like frauds, setting up this cycle of self-doubt that is toxic. When we feel that we can’t achieve the goals that we are striving for we will always find ourselves lacking. There is a slow, insidious erosion of self over the years. Imposter syndrome is well documented in medicine and is even felt as early as medical school.^1,2

When I began coaching these residents the most profound thing that came out of these sessions was that my life was getting better – I knew what filled me up, what got me down, what my goals were for the year, and how I still deal with imposter syndrome. Coaching gave me a framework for helping determine what I wanted for the rest of my life. As I began coaching, I started learning all the ways in which I could figure out my values, my personal and professional goals, and perhaps most importantly, my relationships with myself and others.

Another perspective on coaching is to look at a professional athlete such as Tom Brady, one of the greatest quarterbacks of all time. He has a quarterback coach. No coach is going to be a better quarterback than Tom Brady. A coach for him is to be there as an advocate, break his fundamentals down technically, and help him improve upon what he already knows. A coach also identifies strengths and weaknesses, and helps him capitalize on both by bringing awareness, reflection, accountability, and support. If world-class athletes still want and benefit from coaching in a sport they have already mastered, coaching for physicians is just another tool to help us improve our abilities in and out of medicine.

The way I visualize coaching in medicine is a conscious effort to notice and evaluate how our thoughts affect our experiences and how our perspective shows up in the results of our lives. Coaching is more encompassing than advising or mentoring. It is about examining deeply held beliefs to see if they are really serving us, if they are in line with our values and how we want to live our lives.

Coaching has also been validated in medicine in several papers. In an article by Dyrbye et al. in JAMA Internal Medicine, measures of emotional exhaustion and burnout decreased in physicians who were coached and increased in those who were not.³ In another study from this year by McGonagle et al., a randomized, controlled trial showed that primary care physicians who had sessions (as short as 6 weeks) to address burnout, psychological capital, and job satisfaction experienced an improvement in measures which persisted for 6 months after intervention.⁴ Numerous other articles in medicine also exist to demonstrate the effect of coaching on mitigating burnout at an institutional level.

Physicians are inherently driven by their love of learning. As physicians, we love getting to the root cause of any problem and coming up with creative solutions. Any challenge we have, or just wanting to improve the quality of our lives, can be addressed with coaching. As perpetual students we can use coaching to truly master ourselves.

Dr. Shah is associate professor of surgery, Rush University Medical Center, Chicago. Instagram: ami.shahmdcoaching.

References

1. Gottlieb M et al. Med Educ. 2020 Feb;54(2):116-24.

2. Villwock JA et al. Int J Med Educ. 2016 Oct 31;7:364-9.

3. Dyrbye LN et al. JAMA Intern Med. 2019 Aug 5;179(10):1406-14.

4. McGonagle AK et al. J Occup Health Psychol. 2020 Apr 16. doi: 10.1037/ocp0000180.

Coaching is a new topic in medicine. I first heard about coaching several years ago and met the term with skepticism. I was unsure how coaching was different than mentoring or advising and I wondered about its usefulness. However, the reason that I even started to learn about coaching was because I was struggling. I had finally arrived in my career, I had my dream job with two healthy kids, a perfect house, and good marriage. I kept hearing the refrain in my head: “Is this all there is?” I had this arrival fallacy that after all this striving and straining that I would finally be content. I felt unfulfilled and was dissatisfied with where I was that was affecting all parts of my life.

As I was wrestling with these thoughts, I had an opportunity to become a coach to residents around the country through the Association of Women Surgeons. I discussed with them what fills them up, what gets them down, how to set goals, and what their goals were for the year, as well as imposter syndrome. Impostor syndrome is defined as a pattern in which an individual doubts their accomplishments or talents and has a persistent internalized fear of being exposed as a “fraud.” Despite external evidence of their competence, those experiencing this phenomenon remain convinced that they are fooling everyone around them and do not deserve all they have achieved. Individuals incorrectly attribute their success to luck or interpret it as a result of deceiving others into thinking they are more intelligent than they perceive themselves to be. Imposter syndrome is prevalent and deep in medicine. As perfectionists, we are especially vulnerable to imposter syndrome as we set unrealistic ideals for ourselves. When we fail to reach these ideals, we feel like frauds, setting up this cycle of self-doubt that is toxic. When we feel that we can’t achieve the goals that we are striving for we will always find ourselves lacking. There is a slow, insidious erosion of self over the years. Imposter syndrome is well documented in medicine and is even felt as early as medical school.^1,2

When I began coaching these residents the most profound thing that came out of these sessions was that my life was getting better – I knew what filled me up, what got me down, what my goals were for the year, and how I still deal with imposter syndrome. Coaching gave me a framework for helping determine what I wanted for the rest of my life. As I began coaching, I started learning all the ways in which I could figure out my values, my personal and professional goals, and perhaps most importantly, my relationships with myself and others.

Another perspective on coaching is to look at a professional athlete such as Tom Brady, one of the greatest quarterbacks of all time. He has a quarterback coach. No coach is going to be a better quarterback than Tom Brady. A coach for him is to be there as an advocate, break his fundamentals down technically, and help him improve upon what he already knows. A coach also identifies strengths and weaknesses, and helps him capitalize on both by bringing awareness, reflection, accountability, and support. If world-class athletes still want and benefit from coaching in a sport they have already mastered, coaching for physicians is just another tool to help us improve our abilities in and out of medicine.

The way I visualize coaching in medicine is a conscious effort to notice and evaluate how our thoughts affect our experiences and how our perspective shows up in the results of our lives. Coaching is more encompassing than advising or mentoring. It is about examining deeply held beliefs to see if they are really serving us, if they are in line with our values and how we want to live our lives.

Coaching has also been validated in medicine in several papers. In an article by Dyrbye et al. in JAMA Internal Medicine, measures of emotional exhaustion and burnout decreased in physicians who were coached and increased in those who were not.³ In another study from this year by McGonagle et al., a randomized, controlled trial showed that primary care physicians who had sessions (as short as 6 weeks) to address burnout, psychological capital, and job satisfaction experienced an improvement in measures which persisted for 6 months after intervention.⁴ Numerous other articles in medicine also exist to demonstrate the effect of coaching on mitigating burnout at an institutional level.

Physicians are inherently driven by their love of learning. As physicians, we love getting to the root cause of any problem and coming up with creative solutions. Any challenge we have, or just wanting to improve the quality of our lives, can be addressed with coaching. As perpetual students we can use coaching to truly master ourselves.

Dr. Shah is associate professor of surgery, Rush University Medical Center, Chicago. Instagram: ami.shahmdcoaching.

References

1. Gottlieb M et al. Med Educ. 2020 Feb;54(2):116-24.

2. Villwock JA et al. Int J Med Educ. 2016 Oct 31;7:364-9.

3. Dyrbye LN et al. JAMA Intern Med. 2019 Aug 5;179(10):1406-14.

4. McGonagle AK et al. J Occup Health Psychol. 2020 Apr 16. doi: 10.1037/ocp0000180.

A gene-replacement therapy called AT132 significantly decreases dependence on a ventilator among children with X-linked myotubular myopathy, according to research presented at the 2020 CNS-ICNA Conjoint Meeting, which was held virtually this year. The treatment also appears to improve patients’ motor function significantly and help them to achieve motor milestones.

belchonock/Thinkstock

The results come from a phase 1/2 study of two doses of AT132. Three of 17 patients who received the higher dose had fatal liver dysfunction. The researchers are investigating these cases and will communicate their findings.

X-linked myotubular myopathy is a rare and often fatal neuromuscular disease. Mutations in MTM1, which encodes the myotubularin enzyme that is required for the development and function of skeletal muscle, cause the disease, which affects about one in 50,000 to one in 40,000 newborn boys. The disease is associated with profound muscle weakness and impairment of neuromuscular and respiratory function. Patients with X-linked myotubular myopathy achieve motor milestones much later or not at all, and most require a ventilator or a feeding tube. The mortality by age 18 months is approximately 50%.
 

The ASPIRO trial

Investigators theorized that muscle tissue would be an appropriate therapeutic target because it does not display dystrophic or inflammatory changes in most patients. They identified adeno-associated virus AAV8 as a potential carrier for gene therapy, since it targets skeletal muscle effectively.

Nancy L. Kuntz, MD, an attending physician at Ann and Robert H. Lurie Children’s Hospital of Chicago, and colleagues conducted the ASPIRO trial to examine AT132 as a potential treatment for X-linked myotubular myopathy. Eligible patients were younger than 5 years or had previously enrolled in a natural history study of the disease, required ventilator support at baseline, and had no clinically significant underlying liver disease. Patients were randomly assigned to 1 × 10¹⁴ vg/kg of AAT132, 3 × 10¹⁴ vg/kg of AT132, or delayed treatment. Participants assigned to delayed treatment served as the study’s control group.

The study’s primary end points were safety and change in hours of daily ventilator support from baseline to week 24 after dosing. The investigators also examined a respiratory endpoint (i.e., maximal inspiratory pressure [MIP]) and neuromuscular endpoints (i.e., motor milestones, CHOP INTEND score, and muscle biopsy).
 

Treatment improved respiratory function

As of July 28, Dr. Kuntz and colleagues had enrolled 23 patients in the trial. Six participants received the lower dose of therapy, and 17 received the higher dose. Median age was 1.7 years for the low-dose group and 2.6 years for the high-dose group.

Patients assigned to receive the higher dose of therapy received treatment more recently than the low-dose group, and not all of the former have reached 48 weeks since treatment, said Dr. Kuntz. Fewer efficacy data are thus available for the high-dose group.

Each dose of AT132 was associated with a significantly greater decrease from baseline in least squares mean daily hours of ventilator dependence, compared with the control condition. At week 48, the mean reduction was approximately 19 hours/day for patients receiving 1 × 10¹⁴ vg/kg of AAT132 and approximately 13 hours per day for patients receiving 3 × 10¹⁴ vg/kg of AT132. The investigators did not perform a statistical comparison of the two doses because of differing protocols for ventilator weaning between groups. All six patients who received the lower dose achieved ventilator independence, as did one patient who received the higher dose.

In addition, all treated patients had significantly greater increases from baseline in least squares mean MIP, compared with controls. The mean increase was 45.7 cmH₂O for the low-dose group, 46.1 cmH₂O for the high-dose group, and −8.0 cmH₂O for controls.

Before treatment, most patients had not achieved any of the motor milestones that investigators assessed. After treatment, five of six patients receiving the low dose achieved independent walking, as did one in 10 patients receiving the high dose. No controls achieved this milestone. Treated patients also had significantly greater increases from baseline in least squares mean CHOP INTEND scores, compared with controls. At least at one time point, five of six patients receiving the low dose, six of 10 patients receiving the high dose, and one control patient achieved the mean score observed in healthy infants.

Patients in both treatment arms had improvements in muscle pathology at weeks 24 and 48, including improvements in organelle localization and fiber size. In addition, patients in both treatment arms had continued detectable vector copies and myotubularin protein expression at both time points.
 

Deaths under investigation

In the low-dose group, one patient had four serious treatment-emergent adverse events, and in the high-dose group, eight patients had 27 serious treatment-emergent adverse events. The three patients in the high-dose group who developed fatal liver dysfunction were among the older, heavier patients in the study and, consequently, received among the highest total doses of treatment. These patients had evidence of likely preexisting intrahepatic cholestasis.

“This clinical trial is on hold pending discussions between regulatory agencies and the study sponsor regarding additional recruitment and the duration of follow-up,” said Dr. Kuntz.

Audentes Therapeutics, which is developing AT132, funded the trial. Dr. Kuntz had no conflicts of interest.

[email protected]

SOURCE: Bönnemann CG et al. CNS-ICNA 2020, Abstract P.62.

A gene-replacement therapy called AT132 significantly decreases dependence on a ventilator among children with X-linked myotubular myopathy, according to research presented at the 2020 CNS-ICNA Conjoint Meeting, which was held virtually this year. The treatment also appears to improve patients’ motor function significantly and help them to achieve motor milestones.

belchonock/Thinkstock

The results come from a phase 1/2 study of two doses of AT132. Three of 17 patients who received the higher dose had fatal liver dysfunction. The researchers are investigating these cases and will communicate their findings.

X-linked myotubular myopathy is a rare and often fatal neuromuscular disease. Mutations in MTM1, which encodes the myotubularin enzyme that is required for the development and function of skeletal muscle, cause the disease, which affects about one in 50,000 to one in 40,000 newborn boys. The disease is associated with profound muscle weakness and impairment of neuromuscular and respiratory function. Patients with X-linked myotubular myopathy achieve motor milestones much later or not at all, and most require a ventilator or a feeding tube. The mortality by age 18 months is approximately 50%.
 

The ASPIRO trial

Investigators theorized that muscle tissue would be an appropriate therapeutic target because it does not display dystrophic or inflammatory changes in most patients. They identified adeno-associated virus AAV8 as a potential carrier for gene therapy, since it targets skeletal muscle effectively.

Nancy L. Kuntz, MD, an attending physician at Ann and Robert H. Lurie Children’s Hospital of Chicago, and colleagues conducted the ASPIRO trial to examine AT132 as a potential treatment for X-linked myotubular myopathy. Eligible patients were younger than 5 years or had previously enrolled in a natural history study of the disease, required ventilator support at baseline, and had no clinically significant underlying liver disease. Patients were randomly assigned to 1 × 10¹⁴ vg/kg of AAT132, 3 × 10¹⁴ vg/kg of AT132, or delayed treatment. Participants assigned to delayed treatment served as the study’s control group.

The study’s primary end points were safety and change in hours of daily ventilator support from baseline to week 24 after dosing. The investigators also examined a respiratory endpoint (i.e., maximal inspiratory pressure [MIP]) and neuromuscular endpoints (i.e., motor milestones, CHOP INTEND score, and muscle biopsy).
 

Treatment improved respiratory function

As of July 28, Dr. Kuntz and colleagues had enrolled 23 patients in the trial. Six participants received the lower dose of therapy, and 17 received the higher dose. Median age was 1.7 years for the low-dose group and 2.6 years for the high-dose group.

Patients assigned to receive the higher dose of therapy received treatment more recently than the low-dose group, and not all of the former have reached 48 weeks since treatment, said Dr. Kuntz. Fewer efficacy data are thus available for the high-dose group.

Each dose of AT132 was associated with a significantly greater decrease from baseline in least squares mean daily hours of ventilator dependence, compared with the control condition. At week 48, the mean reduction was approximately 19 hours/day for patients receiving 1 × 10¹⁴ vg/kg of AAT132 and approximately 13 hours per day for patients receiving 3 × 10¹⁴ vg/kg of AT132. The investigators did not perform a statistical comparison of the two doses because of differing protocols for ventilator weaning between groups. All six patients who received the lower dose achieved ventilator independence, as did one patient who received the higher dose.

In addition, all treated patients had significantly greater increases from baseline in least squares mean MIP, compared with controls. The mean increase was 45.7 cmH₂O for the low-dose group, 46.1 cmH₂O for the high-dose group, and −8.0 cmH₂O for controls.

Before treatment, most patients had not achieved any of the motor milestones that investigators assessed. After treatment, five of six patients receiving the low dose achieved independent walking, as did one in 10 patients receiving the high dose. No controls achieved this milestone. Treated patients also had significantly greater increases from baseline in least squares mean CHOP INTEND scores, compared with controls. At least at one time point, five of six patients receiving the low dose, six of 10 patients receiving the high dose, and one control patient achieved the mean score observed in healthy infants.

Patients in both treatment arms had improvements in muscle pathology at weeks 24 and 48, including improvements in organelle localization and fiber size. In addition, patients in both treatment arms had continued detectable vector copies and myotubularin protein expression at both time points.
 

Deaths under investigation

In the low-dose group, one patient had four serious treatment-emergent adverse events, and in the high-dose group, eight patients had 27 serious treatment-emergent adverse events. The three patients in the high-dose group who developed fatal liver dysfunction were among the older, heavier patients in the study and, consequently, received among the highest total doses of treatment. These patients had evidence of likely preexisting intrahepatic cholestasis.

“This clinical trial is on hold pending discussions between regulatory agencies and the study sponsor regarding additional recruitment and the duration of follow-up,” said Dr. Kuntz.

Audentes Therapeutics, which is developing AT132, funded the trial. Dr. Kuntz had no conflicts of interest.

[email protected]

SOURCE: Bönnemann CG et al. CNS-ICNA 2020, Abstract P.62.

A gene-replacement therapy called AT132 significantly decreases dependence on a ventilator among children with X-linked myotubular myopathy, according to research presented at the 2020 CNS-ICNA Conjoint Meeting, which was held virtually this year. The treatment also appears to improve patients’ motor function significantly and help them to achieve motor milestones.

belchonock/Thinkstock

The results come from a phase 1/2 study of two doses of AT132. Three of 17 patients who received the higher dose had fatal liver dysfunction. The researchers are investigating these cases and will communicate their findings.

X-linked myotubular myopathy is a rare and often fatal neuromuscular disease. Mutations in MTM1, which encodes the myotubularin enzyme that is required for the development and function of skeletal muscle, cause the disease, which affects about one in 50,000 to one in 40,000 newborn boys. The disease is associated with profound muscle weakness and impairment of neuromuscular and respiratory function. Patients with X-linked myotubular myopathy achieve motor milestones much later or not at all, and most require a ventilator or a feeding tube. The mortality by age 18 months is approximately 50%.
 

The ASPIRO trial

Investigators theorized that muscle tissue would be an appropriate therapeutic target because it does not display dystrophic or inflammatory changes in most patients. They identified adeno-associated virus AAV8 as a potential carrier for gene therapy, since it targets skeletal muscle effectively.

Nancy L. Kuntz, MD, an attending physician at Ann and Robert H. Lurie Children’s Hospital of Chicago, and colleagues conducted the ASPIRO trial to examine AT132 as a potential treatment for X-linked myotubular myopathy. Eligible patients were younger than 5 years or had previously enrolled in a natural history study of the disease, required ventilator support at baseline, and had no clinically significant underlying liver disease. Patients were randomly assigned to 1 × 10¹⁴ vg/kg of AAT132, 3 × 10¹⁴ vg/kg of AT132, or delayed treatment. Participants assigned to delayed treatment served as the study’s control group.

The study’s primary end points were safety and change in hours of daily ventilator support from baseline to week 24 after dosing. The investigators also examined a respiratory endpoint (i.e., maximal inspiratory pressure [MIP]) and neuromuscular endpoints (i.e., motor milestones, CHOP INTEND score, and muscle biopsy).
 

Treatment improved respiratory function

As of July 28, Dr. Kuntz and colleagues had enrolled 23 patients in the trial. Six participants received the lower dose of therapy, and 17 received the higher dose. Median age was 1.7 years for the low-dose group and 2.6 years for the high-dose group.

Patients assigned to receive the higher dose of therapy received treatment more recently than the low-dose group, and not all of the former have reached 48 weeks since treatment, said Dr. Kuntz. Fewer efficacy data are thus available for the high-dose group.

Each dose of AT132 was associated with a significantly greater decrease from baseline in least squares mean daily hours of ventilator dependence, compared with the control condition. At week 48, the mean reduction was approximately 19 hours/day for patients receiving 1 × 10¹⁴ vg/kg of AAT132 and approximately 13 hours per day for patients receiving 3 × 10¹⁴ vg/kg of AT132. The investigators did not perform a statistical comparison of the two doses because of differing protocols for ventilator weaning between groups. All six patients who received the lower dose achieved ventilator independence, as did one patient who received the higher dose.

In addition, all treated patients had significantly greater increases from baseline in least squares mean MIP, compared with controls. The mean increase was 45.7 cmH₂O for the low-dose group, 46.1 cmH₂O for the high-dose group, and −8.0 cmH₂O for controls.

Before treatment, most patients had not achieved any of the motor milestones that investigators assessed. After treatment, five of six patients receiving the low dose achieved independent walking, as did one in 10 patients receiving the high dose. No controls achieved this milestone. Treated patients also had significantly greater increases from baseline in least squares mean CHOP INTEND scores, compared with controls. At least at one time point, five of six patients receiving the low dose, six of 10 patients receiving the high dose, and one control patient achieved the mean score observed in healthy infants.

Patients in both treatment arms had improvements in muscle pathology at weeks 24 and 48, including improvements in organelle localization and fiber size. In addition, patients in both treatment arms had continued detectable vector copies and myotubularin protein expression at both time points.
 

Deaths under investigation

In the low-dose group, one patient had four serious treatment-emergent adverse events, and in the high-dose group, eight patients had 27 serious treatment-emergent adverse events. The three patients in the high-dose group who developed fatal liver dysfunction were among the older, heavier patients in the study and, consequently, received among the highest total doses of treatment. These patients had evidence of likely preexisting intrahepatic cholestasis.

“This clinical trial is on hold pending discussions between regulatory agencies and the study sponsor regarding additional recruitment and the duration of follow-up,” said Dr. Kuntz.

Audentes Therapeutics, which is developing AT132, funded the trial. Dr. Kuntz had no conflicts of interest.

[email protected]

SOURCE: Bönnemann CG et al. CNS-ICNA 2020, Abstract P.62.

A new report of mother-to-fetus transmission of SARS-CoV-2 through umbilical cord blood adds to a small but growing body of evidence that the virus can be transmitted in utero.

Further, this case suggests such infections may not be easily detectable in neonates until days after birth.
 

The data

In a report published in the Journal of The Pediatric Infectious Diseases Society, Isabelle Von Kohorn, MD, PhD, of Holy Cross Health in Silver Spring, Md., and colleagues, described a case of neonatal infection with SARS-CoV-2 in a boy delivered by C-section at 34 weeks to a mother diagnosed with COVID-19 some 14 hours before. The newborn was immediately removed to a neonatal ICU and reunited with his mother a week later, once the mother had recovered.

Dr. Von Kohorn and colleagues reported that, while the infant’s nasopharyngeal swab test for SARS-CoV-2 was negative at 24 hours after birth, repeat molecular tests (using different assays) from 49 hours on were positive and indicated an increasing viral burden, although the infant never developed symptoms of COVID-19. In addition to being found in the nasopharynx, viral RNA also was detected in cord blood and in urine. No viral RNA was found in the placenta.

The circumstances of the birth, and the care taken to keep mother and her infant at a safe distance along with masking of the mother, made it “extremely unlikely” that the infant acquired his infection by the respiratory route, Dr. Von Kohorn and colleagues wrote.

“While we cannot rule out microscopic maternal blood contamination of cord blood in this or any other delivery, cord blood collection procedures are designed to avoid gross contamination with maternal blood. Microscopic contamination would not explain the RNA levels observed in our patient’s cord blood,” they wrote.

Clinicians should note that a neonate born to a mother with COVID-19 may take time to test positive for SARS-CoV-2 , the investigators argued, though the current recommendation of the American Academy of Pediatrics is to test nasopharyngeal secretions of well newborns at 24 and 48 hours but not again in the absence of symptoms. “This case suggests that some cases of SARS-CoV-2 in newborns may be detectable only after 48 hours of life.”

The authors hypothesized that virus transmitted by cord blood “seeded the nasopharynx and required 2 days for incubation and replication sufficient for detection.”
 

Some perspective

In an interview, Andrea Edlow, MD, A maternal-fetal medicine specialist at Massachusetts General Hospital in Boston, called the findings provocative if not definitive in establishing in utero or vertical transmission of SARS-CoV-2 in the same way that a Nature Communications case report did in July 2020. In that case, of a baby born to a mother with COVID-19, virus was seen at high levels in the placenta.

With the current case, “the absence of detectable virus in the placenta is certainly inconsistent/confusing if the authors claim hematogenous spread from mother to baby,” Dr. Edlow commented, “but the authors do offer plausible explanations, such as examination of limited areas within the placenta (when we know infection is likely to be patchy) and possible degradation of RNA prior to attempting to measure placental viral presence.”

Dr. Von Kohorn and colleagues’ study was funded by the National Institutes of Health, and the investigators disclosed no financial conflicts of interest. Dr. Edlow had no relevant financial disclosures.

SOURCE: Von Kohorn I et al. J Pediat Inf Dis Soc. 2020 Oct 22. doi: 10.1093/jpids/piaa127

A new report of mother-to-fetus transmission of SARS-CoV-2 through umbilical cord blood adds to a small but growing body of evidence that the virus can be transmitted in utero.

Further, this case suggests such infections may not be easily detectable in neonates until days after birth.
 

The data

In a report published in the Journal of The Pediatric Infectious Diseases Society, Isabelle Von Kohorn, MD, PhD, of Holy Cross Health in Silver Spring, Md., and colleagues, described a case of neonatal infection with SARS-CoV-2 in a boy delivered by C-section at 34 weeks to a mother diagnosed with COVID-19 some 14 hours before. The newborn was immediately removed to a neonatal ICU and reunited with his mother a week later, once the mother had recovered.

Dr. Von Kohorn and colleagues reported that, while the infant’s nasopharyngeal swab test for SARS-CoV-2 was negative at 24 hours after birth, repeat molecular tests (using different assays) from 49 hours on were positive and indicated an increasing viral burden, although the infant never developed symptoms of COVID-19. In addition to being found in the nasopharynx, viral RNA also was detected in cord blood and in urine. No viral RNA was found in the placenta.

The circumstances of the birth, and the care taken to keep mother and her infant at a safe distance along with masking of the mother, made it “extremely unlikely” that the infant acquired his infection by the respiratory route, Dr. Von Kohorn and colleagues wrote.

“While we cannot rule out microscopic maternal blood contamination of cord blood in this or any other delivery, cord blood collection procedures are designed to avoid gross contamination with maternal blood. Microscopic contamination would not explain the RNA levels observed in our patient’s cord blood,” they wrote.

Clinicians should note that a neonate born to a mother with COVID-19 may take time to test positive for SARS-CoV-2 , the investigators argued, though the current recommendation of the American Academy of Pediatrics is to test nasopharyngeal secretions of well newborns at 24 and 48 hours but not again in the absence of symptoms. “This case suggests that some cases of SARS-CoV-2 in newborns may be detectable only after 48 hours of life.”

The authors hypothesized that virus transmitted by cord blood “seeded the nasopharynx and required 2 days for incubation and replication sufficient for detection.”
 

Some perspective

In an interview, Andrea Edlow, MD, A maternal-fetal medicine specialist at Massachusetts General Hospital in Boston, called the findings provocative if not definitive in establishing in utero or vertical transmission of SARS-CoV-2 in the same way that a Nature Communications case report did in July 2020. In that case, of a baby born to a mother with COVID-19, virus was seen at high levels in the placenta.

With the current case, “the absence of detectable virus in the placenta is certainly inconsistent/confusing if the authors claim hematogenous spread from mother to baby,” Dr. Edlow commented, “but the authors do offer plausible explanations, such as examination of limited areas within the placenta (when we know infection is likely to be patchy) and possible degradation of RNA prior to attempting to measure placental viral presence.”

Dr. Von Kohorn and colleagues’ study was funded by the National Institutes of Health, and the investigators disclosed no financial conflicts of interest. Dr. Edlow had no relevant financial disclosures.

SOURCE: Von Kohorn I et al. J Pediat Inf Dis Soc. 2020 Oct 22. doi: 10.1093/jpids/piaa127

A new report of mother-to-fetus transmission of SARS-CoV-2 through umbilical cord blood adds to a small but growing body of evidence that the virus can be transmitted in utero.

Further, this case suggests such infections may not be easily detectable in neonates until days after birth.
 

The data

In a report published in the Journal of The Pediatric Infectious Diseases Society, Isabelle Von Kohorn, MD, PhD, of Holy Cross Health in Silver Spring, Md., and colleagues, described a case of neonatal infection with SARS-CoV-2 in a boy delivered by C-section at 34 weeks to a mother diagnosed with COVID-19 some 14 hours before. The newborn was immediately removed to a neonatal ICU and reunited with his mother a week later, once the mother had recovered.

Dr. Von Kohorn and colleagues reported that, while the infant’s nasopharyngeal swab test for SARS-CoV-2 was negative at 24 hours after birth, repeat molecular tests (using different assays) from 49 hours on were positive and indicated an increasing viral burden, although the infant never developed symptoms of COVID-19. In addition to being found in the nasopharynx, viral RNA also was detected in cord blood and in urine. No viral RNA was found in the placenta.

The circumstances of the birth, and the care taken to keep mother and her infant at a safe distance along with masking of the mother, made it “extremely unlikely” that the infant acquired his infection by the respiratory route, Dr. Von Kohorn and colleagues wrote.

“While we cannot rule out microscopic maternal blood contamination of cord blood in this or any other delivery, cord blood collection procedures are designed to avoid gross contamination with maternal blood. Microscopic contamination would not explain the RNA levels observed in our patient’s cord blood,” they wrote.

Clinicians should note that a neonate born to a mother with COVID-19 may take time to test positive for SARS-CoV-2 , the investigators argued, though the current recommendation of the American Academy of Pediatrics is to test nasopharyngeal secretions of well newborns at 24 and 48 hours but not again in the absence of symptoms. “This case suggests that some cases of SARS-CoV-2 in newborns may be detectable only after 48 hours of life.”

The authors hypothesized that virus transmitted by cord blood “seeded the nasopharynx and required 2 days for incubation and replication sufficient for detection.”
 

Some perspective

In an interview, Andrea Edlow, MD, A maternal-fetal medicine specialist at Massachusetts General Hospital in Boston, called the findings provocative if not definitive in establishing in utero or vertical transmission of SARS-CoV-2 in the same way that a Nature Communications case report did in July 2020. In that case, of a baby born to a mother with COVID-19, virus was seen at high levels in the placenta.

With the current case, “the absence of detectable virus in the placenta is certainly inconsistent/confusing if the authors claim hematogenous spread from mother to baby,” Dr. Edlow commented, “but the authors do offer plausible explanations, such as examination of limited areas within the placenta (when we know infection is likely to be patchy) and possible degradation of RNA prior to attempting to measure placental viral presence.”

Dr. Von Kohorn and colleagues’ study was funded by the National Institutes of Health, and the investigators disclosed no financial conflicts of interest. Dr. Edlow had no relevant financial disclosures.

SOURCE: Von Kohorn I et al. J Pediat Inf Dis Soc. 2020 Oct 22. doi: 10.1093/jpids/piaa127

Home spirometry has become increasingly used among cystic fibrosis patients during the COVID-19 pandemic, and new research suggests that home devices perform reasonably well. Forced expiratory volume in 1 second (FEV₁) values were a bit lower than values seen in clinical spirometry performed in the same patient at a nearby time point, but the procedure reliably picked up decreases in FEV₁, potentially helping patients and clinicians spot exacerbations early.

“Home spirometry was sort of a curiosity that was slowly working its way into cystic fibrosis research in 2019, and then all of a sudden in 2020 it became front and center as the only way to continue with clinical monitoring and research in many cases,” Alexander Paynter, MS, a biostatistician at the Cystic Fibrosis Foundation’s Therapeutic Development Network Coordinating Center, said during a talk at the virtual North American Cystic Fibrosis Conference.

To better determine how closely home spirometry matches clinical spirometry, Mr. Paynter and his colleagues analyzed data from the eICE study, which included 267 cystic fibrosis patients aged 14 and over at 14 cystic fibrosis centers. They were randomized to use home spirometry as an early intervention to detect exacerbations, or to continue usual clinic care with visits to the clinic every 3 months. The dataset includes twice-weekly home spirometry values, with a full-year of follow-up data. The researchers compared the home spirometry data to the clinical data closest in time to it. Clinic spirometry data with no corresponding home data within 7 days were discarded.

There was an estimated difference of –2.01 mL between home and clinic tests, with home spirometry producing lower values (95% confidence interval, –3.56 to –0.45). “There is actually a bias in home spirometry as compared to clinic spirometry,” concluded Mr. Paynter.

One explanation for lower values in home spirometry is that users are inexperienced with the device. If that’s true, then agreement should improve over time, but the researchers didn’t see strong evidence of that. Among 44 patients who completed five clinical visits, there was a difference of –2.97 (standard deviation [SD], 10.51) at baseline, –1.66 at 3 months (SD, 13.49), –3.7 at 6 months (SD, 12.44), –0.86 at 9 months (SD, 13.73), and –0.53 at 12 months (SD, 13.35). Though there was improvement over time, “we don’t find a lot of evidence that this bias completely resolves,” said Mr. Paynter.

In fact, a more likely explanation is the presence of coaching by a technician during clinical spirometry, according to Robert J. Giusti, MD, clinical professor of pediatrics and director of the Pediatric Cystic Fibrosis Center at New York University. “When they’re doing it at home, they don’t do it with the same effort, so I think that coaching through telemedicine during the home spirometry would make that difference disappear,” he said when asked to comment on the study.

SOURCE: Alex Paynter et al. NACFC 2020. Poster 643.

Home spirometry has become increasingly used among cystic fibrosis patients during the COVID-19 pandemic, and new research suggests that home devices perform reasonably well. Forced expiratory volume in 1 second (FEV₁) values were a bit lower than values seen in clinical spirometry performed in the same patient at a nearby time point, but the procedure reliably picked up decreases in FEV₁, potentially helping patients and clinicians spot exacerbations early.

“Home spirometry was sort of a curiosity that was slowly working its way into cystic fibrosis research in 2019, and then all of a sudden in 2020 it became front and center as the only way to continue with clinical monitoring and research in many cases,” Alexander Paynter, MS, a biostatistician at the Cystic Fibrosis Foundation’s Therapeutic Development Network Coordinating Center, said during a talk at the virtual North American Cystic Fibrosis Conference.

To better determine how closely home spirometry matches clinical spirometry, Mr. Paynter and his colleagues analyzed data from the eICE study, which included 267 cystic fibrosis patients aged 14 and over at 14 cystic fibrosis centers. They were randomized to use home spirometry as an early intervention to detect exacerbations, or to continue usual clinic care with visits to the clinic every 3 months. The dataset includes twice-weekly home spirometry values, with a full-year of follow-up data. The researchers compared the home spirometry data to the clinical data closest in time to it. Clinic spirometry data with no corresponding home data within 7 days were discarded.

There was an estimated difference of –2.01 mL between home and clinic tests, with home spirometry producing lower values (95% confidence interval, –3.56 to –0.45). “There is actually a bias in home spirometry as compared to clinic spirometry,” concluded Mr. Paynter.

One explanation for lower values in home spirometry is that users are inexperienced with the device. If that’s true, then agreement should improve over time, but the researchers didn’t see strong evidence of that. Among 44 patients who completed five clinical visits, there was a difference of –2.97 (standard deviation [SD], 10.51) at baseline, –1.66 at 3 months (SD, 13.49), –3.7 at 6 months (SD, 12.44), –0.86 at 9 months (SD, 13.73), and –0.53 at 12 months (SD, 13.35). Though there was improvement over time, “we don’t find a lot of evidence that this bias completely resolves,” said Mr. Paynter.

In fact, a more likely explanation is the presence of coaching by a technician during clinical spirometry, according to Robert J. Giusti, MD, clinical professor of pediatrics and director of the Pediatric Cystic Fibrosis Center at New York University. “When they’re doing it at home, they don’t do it with the same effort, so I think that coaching through telemedicine during the home spirometry would make that difference disappear,” he said when asked to comment on the study.

SOURCE: Alex Paynter et al. NACFC 2020. Poster 643.

Home spirometry has become increasingly used among cystic fibrosis patients during the COVID-19 pandemic, and new research suggests that home devices perform reasonably well. Forced expiratory volume in 1 second (FEV₁) values were a bit lower than values seen in clinical spirometry performed in the same patient at a nearby time point, but the procedure reliably picked up decreases in FEV₁, potentially helping patients and clinicians spot exacerbations early.

“Home spirometry was sort of a curiosity that was slowly working its way into cystic fibrosis research in 2019, and then all of a sudden in 2020 it became front and center as the only way to continue with clinical monitoring and research in many cases,” Alexander Paynter, MS, a biostatistician at the Cystic Fibrosis Foundation’s Therapeutic Development Network Coordinating Center, said during a talk at the virtual North American Cystic Fibrosis Conference.

To better determine how closely home spirometry matches clinical spirometry, Mr. Paynter and his colleagues analyzed data from the eICE study, which included 267 cystic fibrosis patients aged 14 and over at 14 cystic fibrosis centers. They were randomized to use home spirometry as an early intervention to detect exacerbations, or to continue usual clinic care with visits to the clinic every 3 months. The dataset includes twice-weekly home spirometry values, with a full-year of follow-up data. The researchers compared the home spirometry data to the clinical data closest in time to it. Clinic spirometry data with no corresponding home data within 7 days were discarded.

There was an estimated difference of –2.01 mL between home and clinic tests, with home spirometry producing lower values (95% confidence interval, –3.56 to –0.45). “There is actually a bias in home spirometry as compared to clinic spirometry,” concluded Mr. Paynter.

One explanation for lower values in home spirometry is that users are inexperienced with the device. If that’s true, then agreement should improve over time, but the researchers didn’t see strong evidence of that. Among 44 patients who completed five clinical visits, there was a difference of –2.97 (standard deviation [SD], 10.51) at baseline, –1.66 at 3 months (SD, 13.49), –3.7 at 6 months (SD, 12.44), –0.86 at 9 months (SD, 13.73), and –0.53 at 12 months (SD, 13.35). Though there was improvement over time, “we don’t find a lot of evidence that this bias completely resolves,” said Mr. Paynter.

In fact, a more likely explanation is the presence of coaching by a technician during clinical spirometry, according to Robert J. Giusti, MD, clinical professor of pediatrics and director of the Pediatric Cystic Fibrosis Center at New York University. “When they’re doing it at home, they don’t do it with the same effort, so I think that coaching through telemedicine during the home spirometry would make that difference disappear,” he said when asked to comment on the study.

SOURCE: Alex Paynter et al. NACFC 2020. Poster 643.

As COVID-19 cases surge in the United States, one Texas veterinarian has been quietly tracking the spread of the disease – not in people, but in their pets.

Since June, Dr. Sarah Hamer and her team at Texas A&M University have tested hundreds of animals from area households where humans contracted COVID-19. They’ve swabbed dogs and cats, sure, but also pet hamsters and guinea pigs, looking for signs of infection. “We’re open to all of it,” said Dr. Hamer, a professor of epidemiology, who has found at least 19 cases of infection.

One pet that tested positive was Phoenix, a 7-year-old part Siamese cat owned by Kaitlyn Romoser, who works in a university lab. Ms. Romoser, 23, was confirmed to have COVID-19 twice, once in March and again in September. The second time she was much sicker, she said, and Phoenix was her constant companion.

“If I would have known animals were just getting it everywhere, I would have tried to distance myself, but he will not distance himself from me,” Ms. Romoser said. “He sleeps in my bed with me. There was absolutely no social distancing.”

Across the country, veterinarians and other researchers are scouring the animal kingdom for signs of the virus that causes COVID-19. At least 2,000 animals in the U.S. have been tested for the coronavirus since the pandemic began, according to federal records. Cats and dogs that were exposed to sick owners represent most of the animals tested and 80% of the positive cases found.

But scientists have cast a wide net investigating other animals that could be at risk. In states from California to Florida, researchers have tested species ranging from farmed minks and zoo cats to unexpected critters like dolphins, armadillos, and anteaters.

The U.S. Department of Agriculture keeps an official tally of confirmed animal COVID cases that stands at several dozen. But that list is a vast undercount of actual infections. In Utah and Wisconsin, for instance, more than 14,000 minks died in recent weeks after contracting COVID infections initially spread by humans.

So far, there’s limited evidence that animals are transmitting the virus to people. Veterinarians emphasize that pet owners appear to be in no danger from their animal companions and should continue to love and care for them. But scientists say continued testing is one way to remain vigilant in the face of a previously unknown pathogen.

“We just know that coronaviruses, as a family, infect a lot of species, mostly mammals,” said Dr. Peter Rabinowitz, a professor of environmental and occupational health sciences and the director of the University of Washington Center for One Health Research in Seattle. “It makes sense to take a species-spanning approach and look at a wide spectrum.”

Much of the testing has been rooted in scientific curiosity. Since the pandemic began, a major puzzle has been how the virus, which likely originated in bats, spread to humans. A leading theory is that it jumped to an intermediate species, still unknown, and then to people.

In April, a 4-year-old Malayan tiger at the Bronx Zoo tested positive for COVID-19 in a first-of-its-kind case after seven big cats showed signs of respiratory illness. The tiger, Nadia, contracted the virus from a caretaker, federal health officials said. Four other tigers and three African lions were also confirmed to be infected.

In Washington state, the site of the first U.S. outbreak in humans, scientists rushed to design a COVID test for animals in March, said Charlie Powell, a spokesperson for the Washington State University College of Veterinary Medicine, Pullman. “We knew with warm-blooded animals, housed together, there’s going to be some cross-infection,” he said. Tests for animals use different reagent compounds than those used for tests in people, so they don’t deplete the human supply, Mr. Powell added.

Since spring, the Washington Animal Disease Diagnostic Laboratory has tested nearly 80 animals, including 38 dogs, 29 cats, 2 ferrets, a camel, and 2 tamanduas, a type of anteater. The lab also tested six minks from the outbreak in Utah, five of which accounted for the lab’s only positive tests.

All told, nearly 1,400 animals have been tested for COVID-19 through the National Animal Health Laboratory Network or private labs, said Lyndsay Cole, a spokesperson for the USDA’s Animal and Plant Health Inspection Service. More than 400 animals have been tested through the National Veterinary Services Laboratories. At least 250 more have been tested through academic research projects.

Most of the tests have been in household cats and dogs with suspicious respiratory symptoms. In June, the USDA reported that a dog in New York was the first pet dog to test positive for the coronavirus after falling ill and struggling to breathe. The dog, a 7-year-old German shepherd named Buddy, later died. Officials determined he’d contracted the virus from his owner.

Neither the Centers for Disease Control and Prevention nor the USDA recommends routine testing for house pets or other animals – but that hasn’t stopped owners from asking, said Dr. Douglas Kratt, president of the American Veterinary Medical Association.

“The questions have become a little more consistent at my practice,” he said. “People do want to know about COVID-19 and their pets. Can their pet pick it up at a clinic or boarding or in doggie day care?”

The answer, so far, is that humans are the primary source of infection in pets. In September, a small, unpublished study from the University of Guelph in Canada found that companion cats and dogs appeared to be infected by their sick owners, judging by antibodies to the coronavirus detected in their blood.

In Texas, Dr. Hamer started testing animals from households where someone had contracted COVID-19 to learn more about transmission pathways. “Right now, we’re very much trying to describe what’s happening in nature,” she said.

So far, most of the animals – including Phoenix, Ms. Romoser’s cat – have shown no signs of illness or disease. That’s true so far for many species of animals tested for COVID-19, veterinarians said. Most nonhuman creatures appear to weather COVID infection with mild symptoms like sniffles and lethargy, if any.

Still, owners should apply best practices for avoiding COVID infection to pets, too, Dr. Kratt said. Don’t let pets come into contact with unfamiliar animals, he suggested. Owners should wash their hands frequently and avoid nuzzling and other very close contact, if possible.

Cats appear to be more susceptible to COVID-19 than dogs, researchers said. And minks, which are farmed in the U.S. and elsewhere for their fur, appear quite vulnerable.

In the meantime, the list of creatures tested for COVID-19 – whether for illness or science – is growing. In Florida, 22 animals had been tested as of early October, including 3 wild dolphins, 2 civets, 2 clouded leopards, a gorilla, an orangutan, an alpaca, and a bush baby, state officials said.

In California, 29 animals had been tested by the end of September, including a meerkat, a monkey, and a coatimundi, a member of the raccoon family.

In Seattle, a plan to test orcas, or killer whales, in Puget Sound was called off at the last minute after a member of the scientific team was exposed to COVID-19 and had to quarantine, said Dr. Joe Gaydos, a senior wildlife veterinarian and science director for the SeaDoc Society, a conservation program at the University of California-Davis. The group missed its September window to locate the animals and obtain breath and fecal samples for analysis.

No one thinks marine animals will play a big role in the pandemic decimating the human population, Dr. Gaydos said. But testing many creatures on both land and sea is vital.

“We don’t know what this virus is going to do or can do,” Dr. Gaydos said.

Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.

As COVID-19 cases surge in the United States, one Texas veterinarian has been quietly tracking the spread of the disease – not in people, but in their pets.

Since June, Dr. Sarah Hamer and her team at Texas A&M University have tested hundreds of animals from area households where humans contracted COVID-19. They’ve swabbed dogs and cats, sure, but also pet hamsters and guinea pigs, looking for signs of infection. “We’re open to all of it,” said Dr. Hamer, a professor of epidemiology, who has found at least 19 cases of infection.

One pet that tested positive was Phoenix, a 7-year-old part Siamese cat owned by Kaitlyn Romoser, who works in a university lab. Ms. Romoser, 23, was confirmed to have COVID-19 twice, once in March and again in September. The second time she was much sicker, she said, and Phoenix was her constant companion.

“If I would have known animals were just getting it everywhere, I would have tried to distance myself, but he will not distance himself from me,” Ms. Romoser said. “He sleeps in my bed with me. There was absolutely no social distancing.”

Across the country, veterinarians and other researchers are scouring the animal kingdom for signs of the virus that causes COVID-19. At least 2,000 animals in the U.S. have been tested for the coronavirus since the pandemic began, according to federal records. Cats and dogs that were exposed to sick owners represent most of the animals tested and 80% of the positive cases found.

But scientists have cast a wide net investigating other animals that could be at risk. In states from California to Florida, researchers have tested species ranging from farmed minks and zoo cats to unexpected critters like dolphins, armadillos, and anteaters.

The U.S. Department of Agriculture keeps an official tally of confirmed animal COVID cases that stands at several dozen. But that list is a vast undercount of actual infections. In Utah and Wisconsin, for instance, more than 14,000 minks died in recent weeks after contracting COVID infections initially spread by humans.

So far, there’s limited evidence that animals are transmitting the virus to people. Veterinarians emphasize that pet owners appear to be in no danger from their animal companions and should continue to love and care for them. But scientists say continued testing is one way to remain vigilant in the face of a previously unknown pathogen.

“We just know that coronaviruses, as a family, infect a lot of species, mostly mammals,” said Dr. Peter Rabinowitz, a professor of environmental and occupational health sciences and the director of the University of Washington Center for One Health Research in Seattle. “It makes sense to take a species-spanning approach and look at a wide spectrum.”

Much of the testing has been rooted in scientific curiosity. Since the pandemic began, a major puzzle has been how the virus, which likely originated in bats, spread to humans. A leading theory is that it jumped to an intermediate species, still unknown, and then to people.

In April, a 4-year-old Malayan tiger at the Bronx Zoo tested positive for COVID-19 in a first-of-its-kind case after seven big cats showed signs of respiratory illness. The tiger, Nadia, contracted the virus from a caretaker, federal health officials said. Four other tigers and three African lions were also confirmed to be infected.

In Washington state, the site of the first U.S. outbreak in humans, scientists rushed to design a COVID test for animals in March, said Charlie Powell, a spokesperson for the Washington State University College of Veterinary Medicine, Pullman. “We knew with warm-blooded animals, housed together, there’s going to be some cross-infection,” he said. Tests for animals use different reagent compounds than those used for tests in people, so they don’t deplete the human supply, Mr. Powell added.

Since spring, the Washington Animal Disease Diagnostic Laboratory has tested nearly 80 animals, including 38 dogs, 29 cats, 2 ferrets, a camel, and 2 tamanduas, a type of anteater. The lab also tested six minks from the outbreak in Utah, five of which accounted for the lab’s only positive tests.

All told, nearly 1,400 animals have been tested for COVID-19 through the National Animal Health Laboratory Network or private labs, said Lyndsay Cole, a spokesperson for the USDA’s Animal and Plant Health Inspection Service. More than 400 animals have been tested through the National Veterinary Services Laboratories. At least 250 more have been tested through academic research projects.

Most of the tests have been in household cats and dogs with suspicious respiratory symptoms. In June, the USDA reported that a dog in New York was the first pet dog to test positive for the coronavirus after falling ill and struggling to breathe. The dog, a 7-year-old German shepherd named Buddy, later died. Officials determined he’d contracted the virus from his owner.

Neither the Centers for Disease Control and Prevention nor the USDA recommends routine testing for house pets or other animals – but that hasn’t stopped owners from asking, said Dr. Douglas Kratt, president of the American Veterinary Medical Association.

“The questions have become a little more consistent at my practice,” he said. “People do want to know about COVID-19 and their pets. Can their pet pick it up at a clinic or boarding or in doggie day care?”

The answer, so far, is that humans are the primary source of infection in pets. In September, a small, unpublished study from the University of Guelph in Canada found that companion cats and dogs appeared to be infected by their sick owners, judging by antibodies to the coronavirus detected in their blood.

In Texas, Dr. Hamer started testing animals from households where someone had contracted COVID-19 to learn more about transmission pathways. “Right now, we’re very much trying to describe what’s happening in nature,” she said.

So far, most of the animals – including Phoenix, Ms. Romoser’s cat – have shown no signs of illness or disease. That’s true so far for many species of animals tested for COVID-19, veterinarians said. Most nonhuman creatures appear to weather COVID infection with mild symptoms like sniffles and lethargy, if any.

Still, owners should apply best practices for avoiding COVID infection to pets, too, Dr. Kratt said. Don’t let pets come into contact with unfamiliar animals, he suggested. Owners should wash their hands frequently and avoid nuzzling and other very close contact, if possible.

Cats appear to be more susceptible to COVID-19 than dogs, researchers said. And minks, which are farmed in the U.S. and elsewhere for their fur, appear quite vulnerable.

In the meantime, the list of creatures tested for COVID-19 – whether for illness or science – is growing. In Florida, 22 animals had been tested as of early October, including 3 wild dolphins, 2 civets, 2 clouded leopards, a gorilla, an orangutan, an alpaca, and a bush baby, state officials said.

In California, 29 animals had been tested by the end of September, including a meerkat, a monkey, and a coatimundi, a member of the raccoon family.

In Seattle, a plan to test orcas, or killer whales, in Puget Sound was called off at the last minute after a member of the scientific team was exposed to COVID-19 and had to quarantine, said Dr. Joe Gaydos, a senior wildlife veterinarian and science director for the SeaDoc Society, a conservation program at the University of California-Davis. The group missed its September window to locate the animals and obtain breath and fecal samples for analysis.

No one thinks marine animals will play a big role in the pandemic decimating the human population, Dr. Gaydos said. But testing many creatures on both land and sea is vital.

“We don’t know what this virus is going to do or can do,” Dr. Gaydos said.

Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.

As COVID-19 cases surge in the United States, one Texas veterinarian has been quietly tracking the spread of the disease – not in people, but in their pets.

Since June, Dr. Sarah Hamer and her team at Texas A&M University have tested hundreds of animals from area households where humans contracted COVID-19. They’ve swabbed dogs and cats, sure, but also pet hamsters and guinea pigs, looking for signs of infection. “We’re open to all of it,” said Dr. Hamer, a professor of epidemiology, who has found at least 19 cases of infection.

One pet that tested positive was Phoenix, a 7-year-old part Siamese cat owned by Kaitlyn Romoser, who works in a university lab. Ms. Romoser, 23, was confirmed to have COVID-19 twice, once in March and again in September. The second time she was much sicker, she said, and Phoenix was her constant companion.

“If I would have known animals were just getting it everywhere, I would have tried to distance myself, but he will not distance himself from me,” Ms. Romoser said. “He sleeps in my bed with me. There was absolutely no social distancing.”

Across the country, veterinarians and other researchers are scouring the animal kingdom for signs of the virus that causes COVID-19. At least 2,000 animals in the U.S. have been tested for the coronavirus since the pandemic began, according to federal records. Cats and dogs that were exposed to sick owners represent most of the animals tested and 80% of the positive cases found.

But scientists have cast a wide net investigating other animals that could be at risk. In states from California to Florida, researchers have tested species ranging from farmed minks and zoo cats to unexpected critters like dolphins, armadillos, and anteaters.

The U.S. Department of Agriculture keeps an official tally of confirmed animal COVID cases that stands at several dozen. But that list is a vast undercount of actual infections. In Utah and Wisconsin, for instance, more than 14,000 minks died in recent weeks after contracting COVID infections initially spread by humans.

So far, there’s limited evidence that animals are transmitting the virus to people. Veterinarians emphasize that pet owners appear to be in no danger from their animal companions and should continue to love and care for them. But scientists say continued testing is one way to remain vigilant in the face of a previously unknown pathogen.

“We just know that coronaviruses, as a family, infect a lot of species, mostly mammals,” said Dr. Peter Rabinowitz, a professor of environmental and occupational health sciences and the director of the University of Washington Center for One Health Research in Seattle. “It makes sense to take a species-spanning approach and look at a wide spectrum.”

Much of the testing has been rooted in scientific curiosity. Since the pandemic began, a major puzzle has been how the virus, which likely originated in bats, spread to humans. A leading theory is that it jumped to an intermediate species, still unknown, and then to people.

In April, a 4-year-old Malayan tiger at the Bronx Zoo tested positive for COVID-19 in a first-of-its-kind case after seven big cats showed signs of respiratory illness. The tiger, Nadia, contracted the virus from a caretaker, federal health officials said. Four other tigers and three African lions were also confirmed to be infected.

In Washington state, the site of the first U.S. outbreak in humans, scientists rushed to design a COVID test for animals in March, said Charlie Powell, a spokesperson for the Washington State University College of Veterinary Medicine, Pullman. “We knew with warm-blooded animals, housed together, there’s going to be some cross-infection,” he said. Tests for animals use different reagent compounds than those used for tests in people, so they don’t deplete the human supply, Mr. Powell added.

Since spring, the Washington Animal Disease Diagnostic Laboratory has tested nearly 80 animals, including 38 dogs, 29 cats, 2 ferrets, a camel, and 2 tamanduas, a type of anteater. The lab also tested six minks from the outbreak in Utah, five of which accounted for the lab’s only positive tests.

All told, nearly 1,400 animals have been tested for COVID-19 through the National Animal Health Laboratory Network or private labs, said Lyndsay Cole, a spokesperson for the USDA’s Animal and Plant Health Inspection Service. More than 400 animals have been tested through the National Veterinary Services Laboratories. At least 250 more have been tested through academic research projects.

Most of the tests have been in household cats and dogs with suspicious respiratory symptoms. In June, the USDA reported that a dog in New York was the first pet dog to test positive for the coronavirus after falling ill and struggling to breathe. The dog, a 7-year-old German shepherd named Buddy, later died. Officials determined he’d contracted the virus from his owner.

Neither the Centers for Disease Control and Prevention nor the USDA recommends routine testing for house pets or other animals – but that hasn’t stopped owners from asking, said Dr. Douglas Kratt, president of the American Veterinary Medical Association.

“The questions have become a little more consistent at my practice,” he said. “People do want to know about COVID-19 and their pets. Can their pet pick it up at a clinic or boarding or in doggie day care?”

The answer, so far, is that humans are the primary source of infection in pets. In September, a small, unpublished study from the University of Guelph in Canada found that companion cats and dogs appeared to be infected by their sick owners, judging by antibodies to the coronavirus detected in their blood.

In Texas, Dr. Hamer started testing animals from households where someone had contracted COVID-19 to learn more about transmission pathways. “Right now, we’re very much trying to describe what’s happening in nature,” she said.

So far, most of the animals – including Phoenix, Ms. Romoser’s cat – have shown no signs of illness or disease. That’s true so far for many species of animals tested for COVID-19, veterinarians said. Most nonhuman creatures appear to weather COVID infection with mild symptoms like sniffles and lethargy, if any.

Still, owners should apply best practices for avoiding COVID infection to pets, too, Dr. Kratt said. Don’t let pets come into contact with unfamiliar animals, he suggested. Owners should wash their hands frequently and avoid nuzzling and other very close contact, if possible.

Cats appear to be more susceptible to COVID-19 than dogs, researchers said. And minks, which are farmed in the U.S. and elsewhere for their fur, appear quite vulnerable.

In the meantime, the list of creatures tested for COVID-19 – whether for illness or science – is growing. In Florida, 22 animals had been tested as of early October, including 3 wild dolphins, 2 civets, 2 clouded leopards, a gorilla, an orangutan, an alpaca, and a bush baby, state officials said.

In California, 29 animals had been tested by the end of September, including a meerkat, a monkey, and a coatimundi, a member of the raccoon family.

In Seattle, a plan to test orcas, or killer whales, in Puget Sound was called off at the last minute after a member of the scientific team was exposed to COVID-19 and had to quarantine, said Dr. Joe Gaydos, a senior wildlife veterinarian and science director for the SeaDoc Society, a conservation program at the University of California-Davis. The group missed its September window to locate the animals and obtain breath and fecal samples for analysis.

No one thinks marine animals will play a big role in the pandemic decimating the human population, Dr. Gaydos said. But testing many creatures on both land and sea is vital.

“We don’t know what this virus is going to do or can do,” Dr. Gaydos said.

Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.

As Emily Brown stood in a food pantry looking at her options, she felt alone. Up to that point, she had never struggled financially. But there she was, desperate to find safe food for her young daughter with food allergies. What she found was a jar of salsa and some potatoes.

“That was all that was available,” said Ms. Brown, who lives in Kansas City, Kansas. “It was just a desperate place.”

When she became a parent, Ms. Brown left her job for lack of child care that would accommodate her daughter’s allergies to peanuts, tree nuts, milk, eggs, wheat, and soy. When she and her husband then turned to a federal food assistance program, they found few allowable allergy substitutions. The closest allergy support group she could find was an hour away. She was almost always the only Black parent, and the only poor parent, there.

Ms. Brown called national food allergy advocacy organizations to ask for guidance to help poor families find safe food and medical resources, but she said she was told that wasn’t their focus. Support groups, fundraising activities, and advocacy efforts, plus clinical and research outreach, were targeted at wealthier – and White – families. Advertising rarely reflected families that looked like hers. She felt unseen.

“In many ways, food allergy is an invisible disease. The burden of the disease, the activities and energy it takes to avoid allergens, are mostly invisible to those not impacted,” Ms. Brown said. “Black and other minority patients often lack voice and visibility in the health care system. Add the additional burden of an invisible condition and you are in a really vulnerable position.”

An estimated 6 million children in the United States have food allergies, 40% of them with more than one. Though limited research has been done on race and class breakdowns, recent studies show that poor children and some groups of minority children not only have a higher incidence of food allergies than White children, but their families also have more difficulty accessing appropriate child care, safe food, medical care, and lifesaving medicine like epinephrine for them.

Black children are 7% more likely to have food allergies than white children, according to a 2020 study by Dr. Ruchi Gupta, MD, at Northwestern University, Chicago. To be sure, the study shows that Asian children are 24% more likely than White children to have food allergies. But Black and Hispanic children are disproportionately more likely to live in poor communities, to have asthma, and to suffer from systemic racism in the delivery of medical care.

And finding allergen-free food to keep allergic kids safe can be costly – in both time and money.

“Many times, a mother is frank and says: ‘I have $20-$40 to buy groceries for the week, and if I buy these foods that you are telling me to buy, I will not be able to feed my entire family,’” said Carla Davis, MD, director of the food allergy program at Houston’s Texas Children’s Hospital. “If you are diagnosed with a food allergy and you don’t have disposable income or disposable time, there is really no way that you will be able to alter your diet in a way that your child is going to stay away from their allergen.”

Fed up with the lack of support, Ms. Brown founded the Food Equality Initiative advocacy organization in 2014. It offers an online marketplace to income-eligible families in Kansas and Missouri who, with a doctor’s note about the allergy, can order free allergy-safe food to fit their needs.

Nationwide, though, families’ needs far outstrip what her group can offer – and the problem has gotten worse amid the economic squeeze of the COVID pandemic. Job losses and business closures have exacerbated the barriers to finding and affording nutritious food, according to a report from Feeding America, an association of food banks.

Ms. Brown said her organization more than doubled its clientele in March through August, compared with the same period in 2019. And though it currently serves only Missouri and Kansas, she said the organization has been fielding an increasing number of calls from across the country since the pandemic began.

For low-income minorities, who live disproportionately in food deserts, fresh and allergy-friendly foods can be especially expensive and difficult to find in the best of times.

Food assistance programs are heavily weighted to prepackaged and processed foods, which often include the very ingredients that are problematic. Black children are more likely to be allergic to wheat and soy than White children, and both Black and Hispanic children are more likely to be allergic to corn, shellfish, and fish, according to a 2016 study.

Some programs allow few allergy substitutions. For example, the federal Special Supplemental Nutrition Program for Women, Infants, and Children allows only canned beans as a substitute for peanut butter. While nutritionally similar, beans are not as easy to pack for a kid’s lunch. Ms. Brown questions why WIC won’t allow a seed butter, such as sunflower butter, instead. She said they are nutritionally and functionally similar and are offered as allergy substitutions in other food programs.

Making matters worse, low-income households pay more than twice as much as higher-income families for the emergency medical care their children receive for their allergies, according to a 2016 study by Dr. Gupta. The kids often arrive at the hospital in more distress because they lack safe food and allergy medications – and because asthma, which disproportionately hits Black and Puerto Rican children and low-income communities, complicates allergic reactions.

“So, in these vulnerable populations, it’s like a double whammy, and we see that reflected in the data,” said Lakiea Wright-Bello, MD, a medical director in specialty diagnostics at Thermo Fisher Scientific and an allergist at Brigham and Women’s Hospital in Boston.

Thomas and Dina Silvera, who are Black and Latina, lived this horror firsthand. After their 3-year-old son, Elijah-Alavi, died as a result of a dairy allergy when fed a grilled cheese instead of his allergen-free food at his preschool, they launched the Elijah-Alavi Foundation to address the dearth of information about food allergies and the critical lack of culturally sensitive medical care in low-income communities.

“We started it for a cause, not because we wanted to, but because we had to,” said Thomas Silvera. “Our main focus is to bring to underserved communities – especially communities of color – this information at no cost to them.”

Recently, other advocacy groups, including Food Allergy Research & Education, a national advocacy organization, also have started to turn their attention to a lack of access and support in poor and minority communities. When Lisa Gable, who is White, took over at the group known as FARE in 2018, she began to diversify the organization internally and to make it more inclusive.

“There wasn’t a big tent when I walked in the door,” said Ms. Gable. “What we have been focused on doing is trying to find partners and relationships that will allow us to diversify those engaged in the community, because it has not been a diverse community.”

FARE has funded research into the cost of food allergies. It is also expanding its patient registry, which collects data for research, as well as its clinical network of medical institutions to include more diverse communities.

Dr. Gupta is now leading one of the first studies funded by the National Institutes of Health to investigate food allergy in children by race and ethnicity. It looks at all aspects of food allergies, including family life, management, access to care, and genetics.

“That’s a big deal,” said Dr. Gupta. “Because if we really want to improve food allergy management, care and understanding, we really need to understand how it impacts different groups. And that hasn’t been done.”

KHN (Kaiser Health News) is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.

As Emily Brown stood in a food pantry looking at her options, she felt alone. Up to that point, she had never struggled financially. But there she was, desperate to find safe food for her young daughter with food allergies. What she found was a jar of salsa and some potatoes.

“That was all that was available,” said Ms. Brown, who lives in Kansas City, Kansas. “It was just a desperate place.”

When she became a parent, Ms. Brown left her job for lack of child care that would accommodate her daughter’s allergies to peanuts, tree nuts, milk, eggs, wheat, and soy. When she and her husband then turned to a federal food assistance program, they found few allowable allergy substitutions. The closest allergy support group she could find was an hour away. She was almost always the only Black parent, and the only poor parent, there.

Ms. Brown called national food allergy advocacy organizations to ask for guidance to help poor families find safe food and medical resources, but she said she was told that wasn’t their focus. Support groups, fundraising activities, and advocacy efforts, plus clinical and research outreach, were targeted at wealthier – and White – families. Advertising rarely reflected families that looked like hers. She felt unseen.

“In many ways, food allergy is an invisible disease. The burden of the disease, the activities and energy it takes to avoid allergens, are mostly invisible to those not impacted,” Ms. Brown said. “Black and other minority patients often lack voice and visibility in the health care system. Add the additional burden of an invisible condition and you are in a really vulnerable position.”

An estimated 6 million children in the United States have food allergies, 40% of them with more than one. Though limited research has been done on race and class breakdowns, recent studies show that poor children and some groups of minority children not only have a higher incidence of food allergies than White children, but their families also have more difficulty accessing appropriate child care, safe food, medical care, and lifesaving medicine like epinephrine for them.

Black children are 7% more likely to have food allergies than white children, according to a 2020 study by Dr. Ruchi Gupta, MD, at Northwestern University, Chicago. To be sure, the study shows that Asian children are 24% more likely than White children to have food allergies. But Black and Hispanic children are disproportionately more likely to live in poor communities, to have asthma, and to suffer from systemic racism in the delivery of medical care.

And finding allergen-free food to keep allergic kids safe can be costly – in both time and money.

“Many times, a mother is frank and says: ‘I have $20-$40 to buy groceries for the week, and if I buy these foods that you are telling me to buy, I will not be able to feed my entire family,’” said Carla Davis, MD, director of the food allergy program at Houston’s Texas Children’s Hospital. “If you are diagnosed with a food allergy and you don’t have disposable income or disposable time, there is really no way that you will be able to alter your diet in a way that your child is going to stay away from their allergen.”

Fed up with the lack of support, Ms. Brown founded the Food Equality Initiative advocacy organization in 2014. It offers an online marketplace to income-eligible families in Kansas and Missouri who, with a doctor’s note about the allergy, can order free allergy-safe food to fit their needs.

Nationwide, though, families’ needs far outstrip what her group can offer – and the problem has gotten worse amid the economic squeeze of the COVID pandemic. Job losses and business closures have exacerbated the barriers to finding and affording nutritious food, according to a report from Feeding America, an association of food banks.

Ms. Brown said her organization more than doubled its clientele in March through August, compared with the same period in 2019. And though it currently serves only Missouri and Kansas, she said the organization has been fielding an increasing number of calls from across the country since the pandemic began.

For low-income minorities, who live disproportionately in food deserts, fresh and allergy-friendly foods can be especially expensive and difficult to find in the best of times.

Food assistance programs are heavily weighted to prepackaged and processed foods, which often include the very ingredients that are problematic. Black children are more likely to be allergic to wheat and soy than White children, and both Black and Hispanic children are more likely to be allergic to corn, shellfish, and fish, according to a 2016 study.

Some programs allow few allergy substitutions. For example, the federal Special Supplemental Nutrition Program for Women, Infants, and Children allows only canned beans as a substitute for peanut butter. While nutritionally similar, beans are not as easy to pack for a kid’s lunch. Ms. Brown questions why WIC won’t allow a seed butter, such as sunflower butter, instead. She said they are nutritionally and functionally similar and are offered as allergy substitutions in other food programs.

Making matters worse, low-income households pay more than twice as much as higher-income families for the emergency medical care their children receive for their allergies, according to a 2016 study by Dr. Gupta. The kids often arrive at the hospital in more distress because they lack safe food and allergy medications – and because asthma, which disproportionately hits Black and Puerto Rican children and low-income communities, complicates allergic reactions.

“So, in these vulnerable populations, it’s like a double whammy, and we see that reflected in the data,” said Lakiea Wright-Bello, MD, a medical director in specialty diagnostics at Thermo Fisher Scientific and an allergist at Brigham and Women’s Hospital in Boston.

Thomas and Dina Silvera, who are Black and Latina, lived this horror firsthand. After their 3-year-old son, Elijah-Alavi, died as a result of a dairy allergy when fed a grilled cheese instead of his allergen-free food at his preschool, they launched the Elijah-Alavi Foundation to address the dearth of information about food allergies and the critical lack of culturally sensitive medical care in low-income communities.

“We started it for a cause, not because we wanted to, but because we had to,” said Thomas Silvera. “Our main focus is to bring to underserved communities – especially communities of color – this information at no cost to them.”

Recently, other advocacy groups, including Food Allergy Research & Education, a national advocacy organization, also have started to turn their attention to a lack of access and support in poor and minority communities. When Lisa Gable, who is White, took over at the group known as FARE in 2018, she began to diversify the organization internally and to make it more inclusive.

“There wasn’t a big tent when I walked in the door,” said Ms. Gable. “What we have been focused on doing is trying to find partners and relationships that will allow us to diversify those engaged in the community, because it has not been a diverse community.”

FARE has funded research into the cost of food allergies. It is also expanding its patient registry, which collects data for research, as well as its clinical network of medical institutions to include more diverse communities.

Dr. Gupta is now leading one of the first studies funded by the National Institutes of Health to investigate food allergy in children by race and ethnicity. It looks at all aspects of food allergies, including family life, management, access to care, and genetics.

“That’s a big deal,” said Dr. Gupta. “Because if we really want to improve food allergy management, care and understanding, we really need to understand how it impacts different groups. And that hasn’t been done.”

KHN (Kaiser Health News) is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.

As Emily Brown stood in a food pantry looking at her options, she felt alone. Up to that point, she had never struggled financially. But there she was, desperate to find safe food for her young daughter with food allergies. What she found was a jar of salsa and some potatoes.

“That was all that was available,” said Ms. Brown, who lives in Kansas City, Kansas. “It was just a desperate place.”

When she became a parent, Ms. Brown left her job for lack of child care that would accommodate her daughter’s allergies to peanuts, tree nuts, milk, eggs, wheat, and soy. When she and her husband then turned to a federal food assistance program, they found few allowable allergy substitutions. The closest allergy support group she could find was an hour away. She was almost always the only Black parent, and the only poor parent, there.

Ms. Brown called national food allergy advocacy organizations to ask for guidance to help poor families find safe food and medical resources, but she said she was told that wasn’t their focus. Support groups, fundraising activities, and advocacy efforts, plus clinical and research outreach, were targeted at wealthier – and White – families. Advertising rarely reflected families that looked like hers. She felt unseen.

“In many ways, food allergy is an invisible disease. The burden of the disease, the activities and energy it takes to avoid allergens, are mostly invisible to those not impacted,” Ms. Brown said. “Black and other minority patients often lack voice and visibility in the health care system. Add the additional burden of an invisible condition and you are in a really vulnerable position.”

An estimated 6 million children in the United States have food allergies, 40% of them with more than one. Though limited research has been done on race and class breakdowns, recent studies show that poor children and some groups of minority children not only have a higher incidence of food allergies than White children, but their families also have more difficulty accessing appropriate child care, safe food, medical care, and lifesaving medicine like epinephrine for them.

Black children are 7% more likely to have food allergies than white children, according to a 2020 study by Dr. Ruchi Gupta, MD, at Northwestern University, Chicago. To be sure, the study shows that Asian children are 24% more likely than White children to have food allergies. But Black and Hispanic children are disproportionately more likely to live in poor communities, to have asthma, and to suffer from systemic racism in the delivery of medical care.

And finding allergen-free food to keep allergic kids safe can be costly – in both time and money.

“Many times, a mother is frank and says: ‘I have $20-$40 to buy groceries for the week, and if I buy these foods that you are telling me to buy, I will not be able to feed my entire family,’” said Carla Davis, MD, director of the food allergy program at Houston’s Texas Children’s Hospital. “If you are diagnosed with a food allergy and you don’t have disposable income or disposable time, there is really no way that you will be able to alter your diet in a way that your child is going to stay away from their allergen.”

Fed up with the lack of support, Ms. Brown founded the Food Equality Initiative advocacy organization in 2014. It offers an online marketplace to income-eligible families in Kansas and Missouri who, with a doctor’s note about the allergy, can order free allergy-safe food to fit their needs.

Nationwide, though, families’ needs far outstrip what her group can offer – and the problem has gotten worse amid the economic squeeze of the COVID pandemic. Job losses and business closures have exacerbated the barriers to finding and affording nutritious food, according to a report from Feeding America, an association of food banks.

Ms. Brown said her organization more than doubled its clientele in March through August, compared with the same period in 2019. And though it currently serves only Missouri and Kansas, she said the organization has been fielding an increasing number of calls from across the country since the pandemic began.

For low-income minorities, who live disproportionately in food deserts, fresh and allergy-friendly foods can be especially expensive and difficult to find in the best of times.

Food assistance programs are heavily weighted to prepackaged and processed foods, which often include the very ingredients that are problematic. Black children are more likely to be allergic to wheat and soy than White children, and both Black and Hispanic children are more likely to be allergic to corn, shellfish, and fish, according to a 2016 study.

Some programs allow few allergy substitutions. For example, the federal Special Supplemental Nutrition Program for Women, Infants, and Children allows only canned beans as a substitute for peanut butter. While nutritionally similar, beans are not as easy to pack for a kid’s lunch. Ms. Brown questions why WIC won’t allow a seed butter, such as sunflower butter, instead. She said they are nutritionally and functionally similar and are offered as allergy substitutions in other food programs.

Making matters worse, low-income households pay more than twice as much as higher-income families for the emergency medical care their children receive for their allergies, according to a 2016 study by Dr. Gupta. The kids often arrive at the hospital in more distress because they lack safe food and allergy medications – and because asthma, which disproportionately hits Black and Puerto Rican children and low-income communities, complicates allergic reactions.

“So, in these vulnerable populations, it’s like a double whammy, and we see that reflected in the data,” said Lakiea Wright-Bello, MD, a medical director in specialty diagnostics at Thermo Fisher Scientific and an allergist at Brigham and Women’s Hospital in Boston.

Thomas and Dina Silvera, who are Black and Latina, lived this horror firsthand. After their 3-year-old son, Elijah-Alavi, died as a result of a dairy allergy when fed a grilled cheese instead of his allergen-free food at his preschool, they launched the Elijah-Alavi Foundation to address the dearth of information about food allergies and the critical lack of culturally sensitive medical care in low-income communities.

“We started it for a cause, not because we wanted to, but because we had to,” said Thomas Silvera. “Our main focus is to bring to underserved communities – especially communities of color – this information at no cost to them.”

Recently, other advocacy groups, including Food Allergy Research & Education, a national advocacy organization, also have started to turn their attention to a lack of access and support in poor and minority communities. When Lisa Gable, who is White, took over at the group known as FARE in 2018, she began to diversify the organization internally and to make it more inclusive.

“There wasn’t a big tent when I walked in the door,” said Ms. Gable. “What we have been focused on doing is trying to find partners and relationships that will allow us to diversify those engaged in the community, because it has not been a diverse community.”

FARE has funded research into the cost of food allergies. It is also expanding its patient registry, which collects data for research, as well as its clinical network of medical institutions to include more diverse communities.

Dr. Gupta is now leading one of the first studies funded by the National Institutes of Health to investigate food allergy in children by race and ethnicity. It looks at all aspects of food allergies, including family life, management, access to care, and genetics.

“That’s a big deal,” said Dr. Gupta. “Because if we really want to improve food allergy management, care and understanding, we really need to understand how it impacts different groups. And that hasn’t been done.”

KHN (Kaiser Health News) is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.