In a major breakthrough for liver disease treatment, Gilead Sciences has received accelerated approval from the U.S. FDA for Hepcludex (bulevirtide-gmod), making it the first and only approved therapy for chronic Hepatitis Delta Virus (HDV) infection in the United States.
Chronic HDV is considered the most aggressive form of viral hepatitis because it can rapidly progress to liver cirrhosis, liver failure, liver cancer, and death. The infection occurs only in people already infected with Hepatitis B virus (HBV), making disease management particularly difficult. According to estimates cited by Gilead, around 40,000 to 80,000 people in the United States may be living with HDV infection.
The newly approved therapy, Hepcludex, is a first-in-class entry inhibitor designed to block the virus from entering liver cells. The medicine is administered as a once-daily subcutaneous injection and has been approved for adults with chronic HDV infection who either do not have cirrhosis or have compensated cirrhosis.
FDA approval was supported primarily by results from the Phase 3 MYR301 clinical study. At 48 weeks, patients treated with Hepcludex showed significantly better virologic and biochemical responses compared with the delayed-treatment control group. Long-term data also indicated that viral suppression improved over time, with undetectable HDV RNA rates increasing during extended treatment.
Medical experts have described the approval as a historic milestone because no FDA-approved treatment previously existed for HDV infection. The FDA stated that the approval helps address a serious unmet medical need for patients suffering from this life-threatening disease.
Hepcludex had already received approval in Europe earlier, but this marks its first authorization in the United States. The FDA granted accelerated approval based on surrogate endpoints including reduction in HDV RNA levels and normalization of ALT liver enzyme levels. Gilead will continue additional studies to confirm long-term clinical benefits.
