Hepatitis Month in Review: May

Bulevirtide Approved as First US Treatment for Chronic Hepatitis Delta Virus

The FDA approved bulevirtide-gmod (Hepcludex; Gilead Sciences) injection on May 22, 2026, marking a historic regulatory milestone: the first approved treatment for chronic hepatitis delta virus (HDV) infection in the United States.¹ The approval covers adults without cirrhosis or with compensated cirrhosis and was granted to Gilead Sciences, Inc. under the FDA's Accelerated Approval pathway, with Priority Review, Breakthrough Therapy Designation, and Orphan-Drug Designation all previously conferred on the agent.

What the FDA Approval of Bulevirtide (Hepcludex) Means for Chronic Hepatitis D Treatment

Last month, the FDA’s accelerated approval of bulevirtide (Hepcludex) for the treatment of chronic hepatitis delta virus (HDV) infection, marked a significant milestone for patients living with the most severe forms of viral hepatitis.

Chronic hepatitis delta is associated with accelerated progression to liver cirrhosis, liver failure, and liver-related mortality compared with hepatitis B infection alone. Until now, treatment options have been limited, often relying on off-label therapies with inconsistent efficacy and tolerability.

"Having an approved therapy truly changes the conversation for patients," said Anu Osinusi, MD, vice president of Clinical Research for Hepatitis, Respiratory, and Emerging Viruses at Gilead. "It gives physicians a treatment specifically developed for this disease, and for people living with hepatitis delta, this really is an important step forward."

Combining Technology and Novel Educator Touchpoints to Enable Greater Hepatitis C Screening

Hepatitis C continues to pose a major public health challenge in the United States, with millions of individuals living with chronic infection. One of the biggest challenges is that many individuals remain undiagnosed due to low screening rates and the disease’s often silent progression. As health systems look for ways to improve detection and linkage to care, new approaches that combine technology with patient-centered outreach are gaining traction.

Pruthvi Patel, MD MPH, associate professor of medicine, the Icahn School of Medicine at Mount Sinai, emphasizes the urgency of improving screening and treatment uptake, particularly given the availability of highly effective therapies.

“Hepatitis C remains an incredibly significant burden of chronic viral hepatitis in the United States,” Patel explained, noting that most infected individuals will not clear the virus on their own and may remain asymptomatic until serious complications arise.

Viral Hepatitis Awareness Month Highlights Need for Testing for Individuals With SUD

May is a significant month around hepatitis as it is recognized as Viral Hepatitis Awareness Month, with May 19, designated as National Hepatitis Testing Day. One group that has been challenged by hepatitis are people with substance use disorder (SUD), who continue to face a significant burden from chronic hepatitis C infections due to increased exposure risks and limited access to consistent healthcare, according to Stephanie Spivack, MD, associate program director of the fellowship program and assistant professor of clinical medicine at Lewis Katz School of Medicine at Temple University.

“People with substance use disorder carry a big burden of the chronic hepatitis C that we're seeing, because they have unique risk factors for being exposed to hepatitis C,” said Spivack. “They are not connected to the healthcare setting in the way that many other people are, so they're not regularly getting tested potentially, and they might not be linked to some resources for testing and treatment.”

In a previous interview with Contagion, Spivack explained she works with different specialties at her institution to try to find creative ways to provide people with care, especially as there may be barriers for them to stay for their full treatment course.