FDA granted accelerated approval to Gilead Sciences’ Hepcludex (bulevirtide-gmod) for adults living with chronic hepatitis delta virus (HDV) infection, marking the first approved therapy for the disease in the United States.

The approval represents a significant milestone in viral hepatitis treatment, addressing a long-standing unmet need in a patient population with limited therapeutic options and high rates of severe liver complications.

What is hepatitis delta virus?

HDV is considered the most aggressive form of viral hepatitis and occurs only in people infected with hepatitis B virus (HBV).¹ Patients with chronic HDV face substantially increased risks of rapid liver disease progression, cirrhosis, liver failure, and mortality compared with HBV infection alone.

What is Hepcludex’s approval based on?

FDA granted accelerated approval for Hepcludex based primarily on data from its pivotal Phase III MYR301 study, which showed statistically significant improvements in combined virologic and biochemical responses at 48 weeks compared with a delayed-treatment control group.² The decision was also supported by reductions in HDV RNA levels and normalization of alanine aminotransferase (ALT), a marker of liver inflammation.¹

The MYR301 trial evaluated Hepcludex treatment for up to 144 weeks, followed by 96 weeks of off-treatment follow-up. The therapy demonstrated sustained efficacy and was generally well tolerated throughout long-term treatment exposure, according to the company.¹

Despite the accelerated approval, improvement in long-term clinical outcomes has yet to be established, and continued approval may depend on confirmatory trial data demonstrating clinical benefit.¹

“Hepatitis delta virus is associated with rapid progression of liver disease and a high risk of serious or even life-threatening liver-related complications,” said Ira Jacobson, MD, of NYU Grossman School of Medicine. “The approval of Hepcludex for chronic HDV represents a critical advancement, introducing a long-awaited option that begins to address a significant unmet medical need.”

Why is the approval significant?

The approval expands Gilead’s liver disease portfolio and further positions the company in specialty viral diseases beyond HIV and hepatitis C, areas where Gilead has historically maintained a dominant commercial presence.¹

According to Gilead, chronic HDV is estimated to affect approximately 40,000 to 80,000 people in the United States, based on studies suggesting 2% to 4% of individuals with chronic HBV are also infected with HDV.¹

“The approval of Hepcludex represents a historic milestone for people living with HDV in the United States,” said Dietmar Berger, MD, PhD, chief medical officer at Gilead Sciences. “With Hepcludex, we now have the opportunity to deliver a meaningful clinical advancement that has the potential to change the trajectory of HDV for patients in the U.S.”

Hepcludex is approved in the U.S. for adults with chronic HDV infection who do not have cirrhosis or who have compensated cirrhosis. The drug has already been approved in parts of Europe and other international markets at a lower 2 mg dose prior to FDA’s decision of approval.

Sources

1. FDA Grants Accelerated Approval to Gilead’s Hepcludex® (bulevirtide-gmod), the First and Only Approved Treatment for Chronic Hepatitis Delta Virus (HDV) Gilead Sciences May 22, 2026 https://www.businesswire.com/news/home/20260522569258/en/FDA-Grants-Accelerated-Approval-to-Gileads-Hepcludex-bulevirtide-gmod-the-First-and-Only-Approved-Treatment-for-Chronic-Hepatitis-Delta-Virus-HDV
2. Study to Assess Efficacy and Safety of Bulevirtide in Participants With Chronic Hepatitis Delta (CHD) National Library of Medicine August 22, 2025 https://clinicaltrials.gov/study/NCT03852719?term=MYR301&rank=1