What is it prescribed for?
Hepcludex is prescribed for adults with chronic hepatitis delta virus (HDV) infection who do not have cirrhosis or who have compensated cirrhosis. Hepatitis D is considered the most severe form of viral hepatitis and only occurs in people who also have hepatitis B infection. The disease can progress quickly and may lead to liver scarring, liver failure, liver cancer, or death. Until now, patients in the United States had no FDA-approved treatment specifically for chronic HDV infection. Hepcludex is important because it became the first FDA-approved therapy for HDV, offering a new option for a serious disease with very limited treatments. The FDA approved Hepcludex on May 22, 2026.
What is the name of the drug and what does it do?
The medication is Hepcludex® (bulevirtide-gmod), given as a once-daily injection under the skin. It is an antiviral medicine designed to stop hepatitis delta virus from entering liver cells. Unlike older approaches that mainly tried to control inflammation, Hepcludex directly targets an important step in the viral life cycle. The treatment is approved under the FDA’s accelerated approval pathway because studies showed improvements in viral levels and liver inflammation markers.
How does it work?
Hepcludex is a viral entry inhibitor that blocks a receptor on liver cells called the sodium taurocholate co-transporting polypeptide (NTCP). Both hepatitis B and hepatitis D viruses use this receptor to enter liver cells.
By blocking NTCP, Hepcludex:
- Prevents HDV from entering healthy liver cells
- Slows the spread of infection inside the liver
- Helps reduce liver inflammation and damage
This targeted mechanism is different from traditional antiviral medicines and represents a new treatment strategy for hepatitis D.
What did the research discover?
The approval of Hepcludex was based mainly on the Phase 3 MYR301 clinical trial. In this study, patients receiving Hepcludex showed significant improvements compared with delayed-treatment patients.
Researchers found:
- Many patients had major reductions in HDV viral levels
- Some patients achieved undetectable HDV RNA levels
- Liver inflammation markers such as ALT improved
- Benefits increased with longer treatment duration
At Week 48, nearly half of treated patients achieved the study’s combined response goal, compared with very few patients in the delayed-treatment group. These findings supported accelerated FDA approval.
What are some of the side effects?
The most common side effects included:
- Injection-site reactions
- Headache
- Abdominal pain
- Fatigue
- Itching (pruritus)
The prescribing information also includes a boxed warning. Stopping Hepcludex may cause severe worsening of hepatitis D and hepatitis B infection. Because of this risk, patients need careful monitoring for several months after treatment is stopped. Serious allergic reactions, including anaphylaxis, have also been reported.
What are the dosage recommendations and how is it prescribed?
The recommended dose of Hepcludex is 8.5 mg injected under the skin once daily. Treatment should continue as long as the patient is benefiting from therapy, although the best treatment duration is still unknown.
Important treatment instructions include:
- Patients or caregivers may be trained to give injections at home
- Liver function and viral levels must be monitored regularly
- Patients should not stop treatment without medical supervision
- Follow-up testing is recommended for at least six months after discontinuation
Because Hepcludex is approved under accelerated approval, additional studies are ongoing to confirm long-term clinical benefits.
Source:
Hepcludex® (bulevirtide-gmod) for injection, for subcutaneous use [prescribing information]. Foster City (CA): Gilead Sciences, Inc.; 2026. Available from: https://www.gilead.com/-/media/files/pdfs/medicines/hdv/hepcludex/hepcludex_pi.pdf. Accessed by: June 6, 2026.
