Bucks Co.-Based Hepatitis B Foundation Reacts To Approval Of Game Changing Drug

DOYLESTOWN, PA – The U.S. Food and Drug Administration (FDA) announced on May 22 that it has approved Gilead’s drug Hepcludex (bulevirtide), to treat chronic hepatitis delta in the U.S.

This is the first drug ever approved for hepatitis delta virus (HDV) and follows approvals in the European Union and United Kingdom. It is a major milestone for people in the U.S. living with hepatitis B/hepatitis delta co-infection. Experts estimate that about 4 percent of people living with hepatitis B in the U.S. also have hepatitis D, which is about 80,000 people.

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HDV is the most serious form of viral hepatitis infection, which can accelerate the development of cirrhosis and liver cancer. Hepatitis delta can cause a significant reduction in quality of life for people living with the disease, along with serious negative clinical outcomes.

“Until now, there was very little that we could do to prevent cirrhosis and liver cancer for people living with hepatitis delta in the U.S.,” said Chari A. Cohen, DrPH, MPH, president of the Hepatitis B Foundation. “All of us at the Hepatitis B Foundation are optimistic that the FDA’s approval of Hepcludex will be a game changer, leading to improved HDV screening, diagnosis, care and treatment across the U.S.”

Bulevirtide was developed by Stephan Urban, Ph.D, and his team at the Heidelberg University Hospital and the German Center for Infection Research (DZIF). Dr. Urban, a globally recognized virologist, was awarded the Hepatitis B Foundation’s Baruch S. Blumberg Prize, its highest honor, in 2023.

Hepcludex blocks a peptide that the virus uses to enter liver cells, thereby blocking entry into cells. Phase 3 clinical trial results showed that Hepcludex led to a reduction in hepatitis D RNA in the blood, as well as normalization of ALT. The drug is given as a once daily injection and has been FDA approved for people living with hepatitis delta who do not have cirrhosis, or who have compensated cirrhosis.

The Foundation will be ramping up efforts to help improve awareness, screening and linkage to care for hepatitis delta in the U.S.