FDA Approves First Treatment for Chronic Hepatitis Delta Infection

FDA Approves First Treatment for Chronic Hepatitis Delta Infection
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The U.S. Food and Drug Administration has approved Hepcludex, developed by Gilead Sciences, as the first treatment in the United States for chronic hepatitis delta virus infection.

According to the FDA, the drug, also known as bulevirtide-gmod, has been approved for adults living with chronic HDV infection who either do not have cirrhosis or have compensated cirrhosis. The approval was granted through the FDA’s accelerated approval pathway.

Hepatitis delta is considered a serious and potentially life-threatening liver infection. It affects people who are already infected with hepatitis B and can lead to liver scarring, liver cancer, liver failure, and death.

Reuters reported that Hepcludex is given as a once-daily injection and works by blocking the virus from entering liver cells, thereby slowing the spread of infection.

Clinical trial results showed that about 48 percent of patients who received the treatment achieved a meaningful improvement after 48 weeks, compared with 2 percent among those whose treatment was delayed. Gilead is required to conduct further studies to confirm the drug’s clinical benefit.