Hepcludex Approval Brings First US Treatment

What Is Hepcludex and Why Does It Matter for Hepatitis D?

Hepcludex is the brand name for bulevirtide-gmod, an injectable antiviral approved for adults with chronic hepatitis delta virus infection who have no cirrhosis or compensated cirrhosis. The FDA approval addresses a major treatment gap: until now, patients in the United States had no approved drug specifically for chronic HDV.

Hepatitis D is unusual because it requires hepatitis B virus to replicate. WHO states that HDV affects nearly 5% of people with chronic hepatitis B globally, an estimated 12 million people, and describes chronic HDV as the most severe form of chronic viral hepatitis because it can progress faster toward cirrhosis, liver cancer and liver-related death.

How Does Bulevirtide Treat Chronic HDV Infection?

Bulevirtide targets the sodium taurocholate cotransporting polypeptide, or NTCP, a bile-acid transporter on liver cells that hepatitis B and hepatitis D use during viral entry. By blocking that route, the drug is designed to limit new infection of hepatocytes and lower the burden of active HDV replication over time.

The FDA based efficacy on the MYR301 phase 3 trial, in which patients received Hepcludex 8.5 mg once daily or entered a delayed-treatment arm. At week 48, 48% of patients in the Hepcludex group achieved the combined response endpoint, compared with 2% in the delayed-treatment group; the endpoint included HDV RNA suppression and ALT normalization.

Who Should Be Tested for Hepatitis D After This Approval?

Because HDV cannot occur without hepatitis B, the approval is likely to renew attention on hepatitis B diagnosis, HDV screening and linkage to liver care. People with chronic HBV, unexplained worsening liver tests, cirrhosis, injection-drug exposure, hemodialysis exposure, or other blood-borne infection risks may need evaluation under clinical guidelines.

The approval does not replace prevention. Hepatitis B vaccination prevents HBV infection and therefore also prevents hepatitis D infection. For people already living with HBV and HDV, treatment decisions should be individualized by specialists who can assess cirrhosis status, viral load, liver enzymes, drug risks and monitoring needs.