Gilead HDV Treatment Hepcludex Gets FDA Accelerated Approval

Editor’s Take: The U.S. approval of Gilead’s HDV treatment could impact as many as 80,000 patients.

Gilead Sciences’ Hepcludex (bulevirtide-gmod) gained accelerated approval from the U.S. FDA for treatment of adults with hepatitis delta virus (HDV). The treatment, in 8.5-mg dose, is the first and only approved for chronic HDV infection in the United States.

What HDV Is, How Hepcludex Helps

HDV occurs only as a co-infection in individuals who have chronic hepatitis B virus (HBV). Chronic HDV is viral hepatitis in its most severe form. It causes markedly higher risks of rapid disease progression—e.g., liver fibrosis, cirrhosis, and hepatic decompensation. Mortality rates can be as high as 50% within five years in cirrhotic patients.

In the United States, HDV affects an estimated approximate 2% to 4% of individuals with chronic HBV. That means anywhere from 40,000 to 80,000 people. Potentially 12 million people may be affected worldwide.

FDA Looks at Trial Data

The FDA based its decision primarily on data from a pivotal, controlled Phase III trial. In this study, Hepcludex reduced HDV RNA and normalized alanine aminotransferase (ALT).

Patients received treatment for up to 144 weeks, followed by 96 weeks of off-treatment follow-up. Hepcludex met its primary endpoint, Gilead said, at week 48, demonstrating a statistically significant improvement versus a control group.

Gilead’s Response

Applauding the FDA’s first approval of such a treatment was Gilead Chief Medical Officer Dietmar Berger, MD, PhD.

“The approval of Hepcludex represents a historic milestone for people living with HDV in the United States,” Berger said. “This reflects years of close engagement with the FDA and the application of rigorous science to address a serious disease … We have the opportunity to deliver a meaningful clinical advancement that has the potential to change the trajectory of HDV.”

Improvement in disease-related clinical outcomes has not been established; continued approval may be contingent on verification in a confirmatory trial.