Hep B Blog

Results from Hepatitis Delta Clinical Trials Announced at International Liver Congress 2022

London, UK was the host city for this year’s annual International Liver Congress (ILC), the yearly meeting of the European Association for the Study of the Liver (EASL), which took place from June 22nd-26th. This meeting provides an opportunity for those working to address liver diseases around the world to gather in one location and exchange ideas, present research, and work to advance diagnosis, prevention, treatment, and elimination of these serious conditions. This year’s meeting saw significant attention given to hepatitis delta, as new treatments continue to move through the pipeline and more widespread approval for prescription of current treatments is sought. Below is a quick snapshot of some of the presentations!

The US-based pharmaceutical company Gilead Sciences, Inc. demonstrated with results from a Phase 3 clinical trial that treatment with Hepcludex (bulevirtide), the first medication ever approved for hepatitis delta (HDV), has been shown to achieve significant response in chronic HDV. After 48 weeks, 48% of study participants who received different doses of treatment with Hepcludex achieved virological response (meaning a decline in hepatitis delta viral load, ALT normalization, and a change in liver stiffness), compared to only 2% of those who had not received any treatment. When compared to results from clinical trials after 24 weeks, response rates to HDV only improved, showing the drug to be even more effective over time. Throughout the clinical trials, there have been no adverse events reported that are attributable to this treatment.

Hepcludex has also been found to have a positive impact on the quality of life of individuals living with hepatitis delta, and their overall ability to manage the condition. There were improvements found in health distress, performance of daily activities related to hepatitis, emotional impact of hepatitis, and ability to work. This data reinforces the efficacy and safety of Hepcludex and hopefully strengthens the case for approving the drug in more parts of the world.

“As the most severe form of viral hepatitis, HDV presents a significant disease burden with high healthcare-related costs and until recently, no approved treatment options,” said Heiner Wedemeyer, MD, Director, Clinic for Gastroenterology, Hepatology and Endocrinology at Hannover Medical School, and principal investigator of the study. “These results presented at ILC 2022 not only highlight the important clinical role that bulevirtide has to play as a safe and effective treatment option for chronic HDV, but critically also demonstrate that with prolonged treatment, we can achieve higher response rates so we can better manage this rare, life-threatening disease in more people.”

Presently, Hepcludex has been conditionally approved by the European Commission for prescription in France, Germany, and Austria. It has not yet been approved by the United States Food and Drug Administration (FDA) or in other countries. A Biologics License Application was submitted by Gilead to the FDA in late 2021 for injection of 2mg of Hepcludex to treat adults with HDV and compensated liver disease. Hepcludex had previously been granted Breakthrough Therapy and Orphan Drug designations by the FDA and PRIority MEdicines (PRIME) scheme eligibility by the European Medicines Agency (EMA).

The second company to present their research findings at the ILC was US-based Eiger BioPharmaceuticals, Inc. The two primary hepatitis delta drugs that they have in the pipeline are called lonafarnib and peginterferon lambda. One abstract presentation indicated that peginterferon lambda (lambda) had better antiviral activity and tolerability than peginterferon alfa (the previous version of this drug that has been used as the only somewhat effective, but off-label treatment for hepatitis delta since the early 1980s). Lambda has been shown to block production of new hepatitis delta virus very effectively. Additionally, lambda in combination with lonafarnib was found to lower levels of HDV RNA and decrease its production and release, more effectively than lambda by itself. Patterns in HBV DNA, hepatitis B surface antigen, and ALT were also observed as part of this study. In its Phase 3 D-LIVR study, which is assessing the safety and efficacy of lonafarnib in combination with ritonavir, with and without peginterferon alfa, Eiger has assembled the largest cohort of global participants in an HDV study, and therefore the largest body of data. Results from this study are anticipated by the end of 2022.

The final piece of big hepatitis delta news to come out of the conference was the announcement from Vir Biotechnology Inc. that they are beginning a Phase 2 clinical trial for VIR-2218 in combination with VIR-3434 for the treatment of chronic hepatitis delta. Initial data from this study is anticipated in 2023.

Hepatitis delta is now receiving more attention than ever before and there is only more hope as new treatments are created, investigated, approved, and made available. For a complete overview of hepatitis delta, including basic information, resources, clinical trial opportunities, and a complete list of drugs that are in the pipeline, visit www.hepdconnect.org.

References

https://www.gilead.com/news-and-press/press-room/press-releases/2022/6/treatment-with-hepcludex-bulevirtide-meets-primary-endpoint-and-achieves-significant-response-in-chronic-hepatitis-delta-virus-at-48-weeks

https://www.streetinsider.com/Corporate+News/Vir+Biotechnology+Inc.+%28VIR%29+Announces+New+Clinical+Data+From+its+Broad+Hepatitis+B+Program/20256465.html

https://www.prnewswire.com/news-releases/eiger-biopharmaceuticals-announces-results-from-multiple-presentations-at-the-european-association-for-the-study-of-the-liver-easl-international-liver-congress-2022-301576119.html

What Are You Doing for World Hepatitis Day?

 

What Are You Doing For World Hepatitis Day?

Every July 28, we celebrate World Hepatitis Day in honor of Dr. Baruch Blumberg’s birthday. Dr. Blumberg discovered the hepatitis B virus in 1967 and subsequently developed the hepatitis B vaccine two years later in 1969. We commemorate World Hepatitis Day by raising awareness about viral hepatitis. With almost 300 million individuals living with hepatitis B worldwide, it is so important to bring awareness to this preventable and treatable disease to create meaningful change. This year, the World Hepatitis Alliance’s theme is Hepatitis Can’t Wait.  Their campaign highlights how we cannot wait to get tested, vaccinated, reduce stigma and discrimination, and we can’t wait to act. You can join their campaign here.

The Hepatitis B Foundation is dedicated to raising the profile of hepatitis B as an urgent public health problem, improving the quality of life for those living with hepatitis B and working towards eliminating hepatitis B related stigma and discrimination. This year we are elevating the voice of individuals living with hepatitis B by highlighting five new #BtheVoice videos from real people living in Nigeria. These audio recordings were captured by Catherine Freeland, MPH, Associate Director of Public Health at the Hepatitis B Foundation during a recent trip to Nigeria where she worked on enhancing and the need for timely birth dose to prevent mother to child transmission of hepatitis B.

We believe that elevating the voices of those who have hepatitis B is the best way to spread awareness for the need to find a cure, provide screening and treatment and work to fight stigma and discrimination. You can watch the videos here.

So, what will you do today to honor World Hepatitis Day?

It can be as simple as sharing hepatitis B related information on Facebook, Instagram, Twitter, WeChat, or WhatsApp. You could tell your friends and family about hepatitis B and how it impacts your life or people in your community. You can get involved with the Hepatitis Can’t Wait campaign by doing 1-minute actions, 10-minute actions, or longer actions! Your actions can be as simple as sharing a post on social media or more involved like getting in contact with your policymaker to encourage viral hepatitis prioritization.
Listen and Learn

Listen to our podcast: B Heppy! This podcast is part of our 300 Million Reasons campaign, a movement to improve awareness about hepatitis B and liver cancer worldwide, to promote engagement of key stakeholders, and to empower people impacted by hepatitis B to become vocal advocates. There are almost 300 million people around the world living with chronic hepatitis B infection, and we want to make sure each and every voice is heard.

We recently highlighted what other community organizations are doing to address hepatitis B in their in their regions– check it out here!

Become an Advocate

Become a Hep B Advocate! Sign up below to receive the latest news and updates about hep B policy issues, learn about upcoming advocacy events, and be notified of opportunities to take action and show your support for our policy initiatives. We’ll provide resources, information, and tools to help you:

  • Communicate effectively with your elected officials
  • Educate and engage your community on hepatitis B policy issues
  • Recruit and organize other hepatitis B advocates and champions in your community
  • Promote and participate in ongoing national, state, and local advocacy efforts

We recently learned that Optum has decided to remove Vemlidy as a covered medication for treating chronic hepatitis B from its health insurance plan. This action can have detrimental effects to people living with hepatitis B. In response to this decision, the Hepatitis B Foundation and Hep B United have drafted a letter urging Optum to reconsider its decision and immediately reinstate Vemlidy back on its formulary plan. Read the full letter here.

Happy World Hepatitis Day! Remember: Hepatitis Can’t Wait, Act Now!

 

Questions: info@hepb.org