The Epclusa and Mavyret combination pills are now indicated for kids as young as age 3.
June 11, 2021 • By Liz Highleyman   hep magazine

On June 10, the Food and Drug Administration (FDA) extended its approval of Epclusa (sofosbuvir/velpatasvir) and Mavyret (glecaprevir/pibrentasvir) for the treatment of hepatitis C in children ages 3 and older. Both combination pills are effective against all genotypes of hepatitis C virus (HCV).

Hepatitis C is uncommon among children, affecting an estimated 50,000 kids in the United States and some 3 to 5 million children worldwide, but it is a growing concern due to rising hep C rates among women of childbearing age. Pregnant women can transmit HCV to their infants during gestation or delivery, and experts recommend that they should be tested for the virus during each pregnancy. Most children born with HCV will develop chronic infection, which can lead to serious liver disease.


The FDA first approved Gilead Sciences’ Epclusa for adults in 2016 and extended the indication to children ages 6 and older in 2020. Now, the 12-week treatment is approved for pediatric patients ages 3 and up without cirrhosis or with compensated cirrhosis; those with decompensated cirrhosis can take Epclusa in combination with ribavirin. The latest approval covers two strengths of an oral pellet formulation of Epclusa developed for young children who can’t swallow tablets; the recommended dosage is based on body weight.

TO CONTINUE READING: https://www.hepmag.com/article/fda-approves-two-hepatitis-treatments-younger-children

Tatyana Kushner, Catherina A. Chappell
Tatyana Kushner, MD, MSCE
Icahn School of Medicine at Mount Sinai
Tatyana.kushner@mssm.edu

Catherine A. Chappell, MD
University of Pittsburgh
chappellca@upmc.edu

This article has been accepted for publication and undergone full peer review but has not been
through the copyediting, typesetting, pagination and proofreading process, which may lead to
differences between this version and the Version of Record. Please cite this article as doi:
10.1002/HEP.31885
This article is protected by copyright. All rights reserved

We read with great interest the Special Article by Jhaveri et al. entitled “Responsible Inclusion of
Pregnant Individuals in Eradicating Hepatitis C virus.”1 This article is timely and draws attention to
pregnant women, a subpopulation that has been ignored in the study of hepatitis C (HCV) treatment.
Pregnancy is an ideal window of opportunity due to the high engagement in healthcare of
reproductive-aged women. The AASLD/ IDSA, USPSTF and CDC now all recommended universal
HCV screening during pregnancy which will lead to increased diagnosis of HCV during pregnancy.
However, the American College of Obstetrics and Gynecology (ACOG) has been hesitant to
recommend universal screening due to the lack of treatment available during pregnancy.2 Jhaveri et
al. identified only one pharmacokinetic study of sofosbuvir/ledipasvir, which demonstrated safety,
tolerability, and effectiveness of direct-acting antiviral (DAA) therapy in nine pregnant women.
Guidance from the AASLD/ IDSA suggests that “women who become pregnant while on DAA
therapy should discuss the risks versus benefits of continuing treatment with their physicians.”3 This
“guidance” puts providers in the difficult position of providing advice with minimal published data on
DAA safety in pregnancy.
We agree with Jhaveri et al. that a clinical trial of HCV treatment during pregnancy ideally should be
sponsored by the NIH, leading a public-private partnership in coordination with the FDA. However,
there is no clear funding mechanism from NIH for larger trials for HCV DAAs and no NIH network of
study sites in high HCV prevalence areas. If the NIH/FDA truly supports ethical research in pregnant
women then they should dedicate funding or require industry to include pregnant women in studies
prior to FDA approval for medications. An alternative approach would be a larger industry sponsored
study which evaluates the use of a pangenotypic DAA regimen during pregnancy. This strategy
would require the pharmaceutical company to have a commitment to the health pregnant women (an
honorable cause), yet could be in opposition to a successful business strategy particularly for
medications that are closer to the patent expiration date. A critical first step would be to compare
DAA treatment compared to the current standard of care (no treatment) on pregnancy and neonatal
outcomes to convince providers that treatment is as safe as no treatment. Additionally, a registry of
outcomes after first trimester DAA exposure, similar to the antiretroviral pregnancy registry
(http://www.apregistry.com) is needed even with a larger study to determine the effect of exposure
early in pregnancy. Pregnant women with HCV prefer to be treated during pregnancy4. Jhavari, et al.
provides a strong call to action for us in the field and our NIH, FDA and industry partners to
determine the best way to get the evidence that is desperately needed.
es
1. Jhaveri R, Yee LM, Antala S, et al. Responsible Inclusion of Pregnant Individuals in Eradicating
Hepatitis C Virus. Hepatology 2021.
2. https://www.acog.org/clinical/clinical-guidance/practiceadvisory/
articles/2020/04/screening-for-hepatitis-c-virus-infection
3. AASLD-IDSA. HCV testing and linkage to care. Recommendations for testing, managing, and
treating hepatitis C. https://www.hcvguidelines.org/unique-populations/pregnancy.
[Accessed on April 7, 2021]
4. Kushner T, Cohen J, Tien PC, et al. Evaluating Women's Preferences for Hepatitis C Treatment
During Pregnancy. Hepatol Commun 2018;2:1306-1310.

Meet the birth workers helping transgender parents bring babies into the world and break stigmas.
June 2, 2021, 1:42 PM EDT / Source: TODAY
By Rheana Murray

When Kayden Coleman was pregnant with his now 10-month-old daughter, no one held the door for him, fussed over his growing belly or made him feel special in the way that pregnant women are sometimes treated.
In a way, he feels as though he missed out on "the perks" of pregnancy, he said. In another, he's relieved no one knew the truth. As a transgender man, he felt safer that way.
"I didn't have to walk around in fear, worrying that people wanted to inflict violence on me," Coleman, who lives in Houston, told TODAY. "They thought I had a beer belly."
Coleman, who also has a 7-year-old daughter, is one of a growing number of advocates trying to educate the public — and the medical community — about what it is like to navigate pregnancy, childbirth and the postpartum experience as a trans person, and dispel stereotypes about trans people that he said even health care workers believe. Trans people already face high rates of violence, discrimination and harassment; in the world of pregnancy and childbirth, their struggles are only magnified.
The 34-year-old called both of his pregnancies "very tumultuous."
"There was a lot of trauma," he said. "Most of that came from inside the birthing world, with medical professionals. There was a lot of questioning about my identity, a lot of misgendering. Being told I shouldn't be in spaces I was seeking care from because they were considered women's spaces. I was offered an abortion a ridiculous amount of times."

TO CONTINUE READING: https://www.today.com/health/trans-parents-say-medical-system-isn-t-set-their-pregnancies-t218691

Krishen Samuel 28 May 2021  ​NAM aidsmap

Swiss men living with HIV approach the risk of re-infection with hepatitis C after cure in different ways, based on recent qualitative research by Dr Patrizia Künzler-Heule and colleagues from the Universities of Basel and Zurich. They describe three distinct groups: those who choose to avoid risks and aim not to get re-infected, those who minimise risks and chance re-infection and those who accept risks and the possibility of re-infection and repeated treatment.
The World Health Organization (WHO) has set a target to eliminate hepatitis C as a public health threat by 2030. This has been made possible by a newer form of treatment – direct acting antivirals. This treatment can cure infection and reduce the risk of liver complications. Men who have sex with men (MSM) living with HIV represent an important risk group for hepatitis C infection, with an estimated prevalence as high as 39%. While many in this group are successfully treated for hepatitis C, they frequently become re-infected later.
The studyAs part of the Swiss HCVree trial, MSM living with HIV and hepatitis C received direct-acting antivirals for hepatitis C. Men reporting sexual risk behaviour also received behavioural counselling aimed at teaching risk reduction strategies. Of those who had received counselling, a subset of 17 participants were interviewed six to 12 months later, regarding their views on the cure, the behavioural intervention, their risk behaviours and any subsequent changes. The results were published in BMC Infectious Diseases.
Glossary
reinfection
cure
antiviral
direct-acting antiviral (DAA)
anxietyThe men had a median age of 44, the majority were White (94%) and nearly half were college educated (47%). The median time since HIV diagnosis was 10.9 years, while the median time since hepatitis C diagnosis was 1.6 years. Most men had had one hepatitis C infection (76%) and had never been treated for it prior to participating in the trial (59%), while six of the men had received prior interferon treatment and one had received direct acting antivirals previously.

TO CONTINUE READING:  https://www.aidsmap.com/news/may-2021/what-happens-after-curing-hepatitis-c-avoiding-minimising-or-accepting-risks-re

Keith Alcorn
Published:21 May 2021 INFOHEP

Global targets for reducing deaths from viral hepatitis will not be met without massively accelerating universal access to testing and treatment, the World Health Organization said yesterday in a review of progress towards elimination of hepatitis B and C.The Global progress report on HIV, viral hepatitis and sexually transmitted infections, 2021 provides a snapshot of recent statistics on viral hepatitis testing and treatment, as well as recommendations for actions to accelerate progress towards elimination of viral hepatitis.
Around 1.4 million people died from viral hepatitis in 2016, 1.75 million people were newly infected with hepatitis C in 2015 and 1.1 million people were newly infected with hepatitis B in 2017, the most recent years for which the World Health Organization has collated data.
The report reveals that rates of viral hepatitis diagnosis remain low in all regions of the world. Less than one percent of people with hepatitis B in Africa and 2.3% of people with hepatitis B in the Western Pacific region have been diagnosed. Although hepatitis C diagnosis rates are higher in some regions – 36% in the Americas and 21% in the Western Pacific – WHO estimated that only 19% of people with hepatitis C knew their hepatitis C status at the end of 2017.
WHO estimates that $6 billion a year needs to be spent on viral hepatitis testing to achieve the elimination targets by 2030. Innovations in point-of-care testing are also needed to improve access to testing and to simplify linkage to care.
Five million people had been treated for hepatitis C using direct-acting antivirals by the end of 2017. WHO estimates that 9.4 million people are receiving treatment for chronic hepatitis C virus infection, a more than nine fold increase since 2015. 
Lack of finance for viral hepatitis testing and treatment remains a major challenge for many countries but WHO points to successes in the development of national strategies for hepatitis elimination in Asia and the Eastern Mediterranean region, as well as the inclusion of hepatitis B treatment in China’s national insurance scheme.

​TO CONTINUE READING: http://infohep.org/WHO-says-2030-hepatitis-elimination-targets-will-not-be-met-without-massive-scale-up-of-testing-and-treatment/page/3549672/

MAY 18, 2021 • PRESIDENTIAL ACTIONS

​Our efforts to combat the COVID-19 pandemic over the past year have reinforced many public health lessons, including the importance of communication, community engagement, and a comprehensive testing strategy to reduce the spread of infection.  These same lessons hold true for another epidemic affecting our Nation:  the silent epidemic of viral hepatitis.  Viral hepatitis is a serious, preventable public health threat that puts people who are infected at increased risk for serious disease and death.  When left undiagnosed and untreated, hepatitis B and hepatitis C can cause liver cirrhosis, liver cancer, and even early death.  Hepatitis D, which occurs only among individuals infected with hepatitis B, can also cause serious liver disease.  On this National Hepatitis Testing Day, I call on all Americans who are at risk for hepatitis to get tested, and for all health care providers to educate their patients about viral hepatitis.
Our Nation has set a goal to eliminate viral hepatitis by 2030.  Thanks to Federal investment in medical research, we have the technology and tools to provide safe and effective hepatitis vaccines and therapeutics that can reduce mortality and even lead to a cure.  Despite this progress, an estimated 2.4 million Americans are living with hepatitis C, and more than 860,000 are living with hepatitis B — many of whom unknowingly suffer its effects.  Approximately 200,000 Americans are infected with hepatitis D every year.  Infection with hepatitis D in an individual already infected with hepatitis B — known as superinfection — leads to a more rapid progression towards liver cancer.  We must increase prevention, testing, and awareness to provide people the life-saving treatment they need.  Because of the Affordable Care Act, most health insurance plans must cover hepatitis B and hepatitis C testing with no cost-sharing.
The Centers for Disease Control and Prevention recommends screening and testing for hepatitis B, hepatitis C, and hepatitis D based on risk, health status, and pregnancy.  It is important we implement these recommendations to ensure proper treatment and help stop the spread of hepatitis.  For more information on the recommendations, visit cdc.gov/hepatitis.

My Administration is committed to addressing the health disparities and health inequities, which, as with so many health metrics, are also seen with viral hepatitis.  Viral hepatitis disproportionately impacts Black and brown Americans, Indigenous persons, Asian Americans, Native Hawaiians, and Pacific Islanders.  The interplay of factors such as poverty, inadequate housing and transportation, food insecurity, access to care, access to addiction treatment and mental health care, medical mistrust, language and cultural barriers, stigma, and discrimination must be addressed if we are to eliminate these health disparities and advance health equity.  The recently released Viral Hepatitis National Strategic Plan:  A Roadmap to Elimination is focused on making sure more people living with viral hepatitis are tested and aware of their status and providing a roadmap for quality care and treatment.  To read more about the plan, visit hhs.gov/hepatitis. 
The viral hepatitis epidemic is also linked with other public health threats, including HIV, sexually transmitted infections, and opioid use.  Our response to the public health challenges of viral hepatitis, HIV, sexually transmitted infections, and substance use disorders will require a focus on the people and places where these risk factors intersect, and doing more to test people for viral hepatitis and other infections.  We also need to scale-up vaccinations, testing, and care in settings where people at risk receive other services.  Implementing point-of-care testing in outreach settings, utilizing clinical decision support tools, and increasing provider awareness and training for implementing testing recommendations will help improve diagnoses and awareness.  The ability to reduce viral hepatitis infections will depend on integrated strategies and a comprehensive approach to address our ongoing challenges.
Viral hepatitis exacts a significant toll on our Nation’s health, and the stigma and discrimination associated with the disease further impair the quality of life among those affected.  Today, we reaffirm our commitment to ensuring everyone knows their viral hepatitis status, has access to high quality care and treatment, and lives free from stigma and discrimination.

NOW, THEREFORE, I, JOSEPH R. BIDEN JR., President of the United States of America, by virtue of the authority vested in me by the Constitution and the laws of the United States, do hereby proclaim May 19, 2021, as National Hepatitis Testing Day.  I encourage all Americans to join in activities that will increase awareness about viral hepatitis and increase viral hepatitis testing. 
IN WITNESS WHEREOF, I have hereunto set my hand this eighteenth day of May, in the year of our Lord two thousand twenty-one, and of the Independence of the United States of America the two hundred and forty-fifth.

JOSEPH R. BIDEN JR.

​https://www.whitehouse.gov/briefing-room/presidential-actions/2021/05/18/a-proclamation-on-national-hepatitis-testing-day-2021/

HHS uses authority under Title IX of Civil Rights Act, cites Supreme Court ruling last year prohibiting discrimination against LGBT workers

By Tarini Parti
May 10, 2021 12:35 pm ET, THE WALL STREET JOURNAL

The Biden administration said it would enforce legal protections against discrimination for gay and transgender patients seeking healthcare under the Affordable Care Act, reversing a Trump-era policy that sought to more narrowly define the scope of sex discrimination under the health law.
The Department of Health and Human Services said Monday that the administration was using its authority under Title IX of the Civil Rights Act to enforce the ACA’s prohibition based on sex discrimination. HHS Secretary Xavier Becerra said the department’s decision was based on a Supreme Court ruling last year that allows the agency to interpret the antidiscrimination section of the ACA, which bans bias “on the basis of race, color, national origin, sex, age or disability,” in a more expansive way.
The Supreme Court ruling in Bostock v. Clayton County said a bedrock federal civil-rights law prohibited employers from discriminating against workers on the basis of their sexual orientation or gender identity. The 6-3 opinion, by Justice Neil Gorsuch, rejected administration arguments that federal civil rights law provides no protection to LGBT employees.
TO CONTINUE READING: https://www.wsj.com/articles/biden-administration-reverses-trump-era-rollback-of-gay-transgender-protections-in-health-care-11620664532?mod=hp_lead_pos12&fbclid=IwAR2dZ9MbYrRCY588pNwtrCaQjXGbZR7MqXTSsaemDf7EUKv4D-l1b68n-K0r
​

May 7, 2021
Kenny Walter

The CDC currently recommends every pregnant woman screened for hepatitis C virus.

New research shows only screening for hepatitis C virus (HCV) by risk in pregnant women results in a large percentage of missed diagnoses.
A team, led by Elisa T. Bushman, Center for Women's Reproductive Health, University of Alabama at Birmingham, examined whether universal screening is linked to increased HCV diagnoses and postpartum linkage to HCV care compared to risk-based screening.
Current recommendations from the US Centers for Disease Control and Prevention (CDC) and the US Preventive Services Task Force (USPSTF) call for universal hepatitis c virus screening in pregnant women.In addition, the Society for Maternal-Fetal Medicine (SMFM) and American College of Obstetricians and Gynecologists (ACOG) recommend risk-based screening for HCV in pregnancy.
In the retrospective cohort study, the researchers examined pregnant women who were screening for hepatitis C at a single tertiary-care center. The patients were split into 2 cohorts—women managed with risk-based screenings between January 2014 and October 2016 and women universally screened between November 2016 and December 2018.
ScreeningsScreening was performed with ELISA antibody testing, which was viremia confirmed with HCV ribonucleic acid (RNA) polymerase chain reaction (PCR) tests.
The researchers sought primary outcomes of the rate of HCV screen positivity and postpartum linkage to care.
Overall, there were 16,489 women included in the study between 2014-2018, 7039 of which were screened for HCV. Of the patients screened, 266 were part of the risk-based cohort and 6773 were part of the universal screening cohort.
Positive RateThere was a 29% (n = 76) positivity rate for HCV antibody screening (HCVAb + ) in the risk-based cohort and 1.3% (n = 90) in the universal cohort.
However, only 69% (n = 62) of HCVAb+ women in the universal cohort met the criteria for risk-based testing and of the remaining 28 women, 21% (n=6) had active viremia (HCV RNA+).
The researchers also found 64% (n = 103) of the HCVAb+ women were HCV RNA+—51 of 266 (19%) in the risk-based and 52 of 6773 (0.8%) in the universal cohort.
In addition, 75% (n = 125) of HCVAb+ womenwere referred postpartum for HCV evaluation and 27% (n = 34) were linked to care and only 9% (n =10) of women with viremia-initiated treatment within 1 year of delivery.
“Universal HCV screening in pregnancy identified an additional 31% of HCVAb+ women compared with risk-based screening,” the authors wrote. “Given low rates of HCV follow-up and treatment regardless of screening modality, further studies are needed to address barriers to postpartum linkage to care.”

​TO CONTINUE READING:https://www.hcplive.com/view/universal-screening-hcv-option-pregnant-women

SCREENING AND TESTING POLICY
Keith Alcorn Published 27 April 2021 INFOhEP

Testing for hepatitis C among gay and bisexual men with HIV who are at higher risk of acquiring hepatitis C is falling short of recommendations, a study of a large US cohort of people in regular HIV care shows.
The findings are published in the journal Open Forum Infectious Diseases.
Hepatitis C can be cured by a short course of direct-acting antiviral treatment and the World Health Organization has set targets for testing and treatment coverage by 2030 with the aim of eliminating hepatitis C. Left undiagnosed and untreated, hepatitis C may eventually lead to liver damage or liver cancer.
Hepatitis C elimination partially depends on targeting groups of people with high hepatitis C prevalence, such as people who inject drugs and people with HIV, through intensified screening, linkage to care and treatment. This strategy, known as micro-elimination, has demonstrated strong progress towards elimination targets in some countries, notably Switzerland and Spain.
In the United States, up to 30% of 1.1 million people living with HIV are estimated to be co-infected with hepatitis C. It’s unclear what proportion remain undiagnosed. The US Centers for Disease Control and Prevention (CDC), the HIV Medicine Association and the National Institutes of Health recommended routine testing for hepatitis C in people with HIV in 2009. In 2015 CDC recommended that people with HIV should be screened annually if they were at high risk of acquiring hepatitis C.
There is little information about how well this guidance is being implemented in the United States, especially among people at higher risk of hepatitis C acquisition.
Investigators from the HIV Outpatients Study set out to analyse hepatitis C testing in their own cohort among gay and bisexual men with HIV. Ongoing sexual transmission of hepatitis C is especially concentrated among gay and bisexual men who are HIV positive, due in part to condomless sex between men with HIV.
The HIV Outpatients Study follows people with HIV receiving HIV care at nine clinics in six large US cities. This analysis looked at all gay and bisexual men receiving at least two years of care at a participating clinic between 2011 and 2019. It excluded people who inject drugs or people who had already tested positive for hepatitis C antibodies.
​TO CONTINUE READING: http://infohep.org/page/3549636/

MARCH 25, 2021  HEPVU

HepVu  spoke with Dr. Gregory Dore about the barriers to Hepatitis C treatment among people who inject drugs in the U.S. and Australia.

Gregory Dore, MD is a Scientia Professor and the Head of Viral Hepatitis Clinical Research Program at the Kirby Institute at the University of New South Wales Sydney in Australia.
Q: Your career focuses on Hepatitis C and other infectious diseases, especially among marginalized populations such as people who use drugs and people who experience homelessness. What led you to focus on these diseases and populations?
I worked in East Africa at a mission hospital in the early ‘90s before I completed my training in infectious diseases. I was involved in HIV care at St. Vincent’s Hospital in Sydney, Australia during the height of the AIDS epidemic in the early- to mid-1990s. During that period in Australia, HIV was predominantly affecting Gay and Bisexual Men and people who inject drugs.
During the ‘90s, in Australia and many other countries, Hepatitis C was mainly managed by liver specialists. My previous experience with HIV gave me a real passion for improving the lives of marginalized populations, such as people who inject drugs. I saw Hepatitis C as an opportunity because there weren’t a lot of people from infectious diseases and public health getting involved in that work during the mid-to late ‘90s. I set up the Hepatitis C services at St. Vincent’s Hospital in 1999 and began my professional journey in Hepatitis C research and clinical care.
Q: You recently co-authored a commentary on the barriers to Hepatitis C treatment faced by persons who inject drugs in the U.S., published in The Journal of Infectious Diseases. The paper states that barriers to Hepatitis C care exist at the “systems level, as well as the level of medical providers and patients.” Could you talk about these barriers and how they impact the Hepatitis C epidemic in Australia and the U.S.?
Australia is very different from the U.S. One of the key differences is that although Australia is a federation of states, there’s a lot of federal leadership and strategic direction in public health. There has been a bipartisan approach to support public health strategies, including fighting HIV and Hepatitis C. This collaborative approach enabled us to have a very public health-centered and nonpolitical approach to HIV prevention, starting in the ‘80s and ‘90s. A major component of this approach was broad harm reduction. Needle syringe programs with federal government funding were in place from the early ‘90s, a stark difference to the situation in the U.S.
In the U.S., federal funding has not been able to be used to purchase needles and syringes for harm reduction programs. Australia provided resources for these programs because we felt it was important to protect highly marginalized populations by reducing their individual risks while not judging people for their lifestyle. The lack of federal funding in the U.S. is a system level issue that affects prevention services and public health infrastructure. This infrastructure is crucial, especially when marginalized populations may not have access to routine healthcare.

​TO CONTINUE READING: https://hepvu.org/gregory-dore-hepatitis-c-treatment-barriers/?fbclid=IwAR3BTHORIp3G-p0PLvvc3CjtkFhR7QRwTq4Sn0FKSG4zk5RvMoVcKd3nBlU