On May 22, 2026, the U.S. Food and Drug Administration (FDA) made a historic decision. For the first time in history, the agency approved the injectable drug Hepcludex® (bulevirtide-gmod), developed specifically to treat chronic hepatitis D (delta) in adult patients.
Until then, there had been no officially approved treatment for this serious disease in the United States. The drug received “breakthrough therapy” designation and underwent an accelerated approval process, underscoring the critical need for this medication among patients.
The hepatitis D virus (HDV) is a so-called “satellite virus.” It cannot replicate in the human body on its own. Infection is only possible in the presence of the hepatitis B virus (HBV).
When these two viruses act together (coinfection), the disease progresses much more aggressively:
📢 Important diagnostic rule: Anyone diagnosed with “chronic hepatitis B” must be tested for hepatitis D (delta).
The efficacy of treating hepatitis D with the new drug was evaluated in a large-scale Phase 3 study (MYR301). Patients received Hepcludex injections once daily.
The results showed impressive progress compared to the group that temporarily did not receive treatment:
| Duration of treatment | Reduction of viral load (HDV RNA) to undetectable levels | Combined response (virus under control + normalization of ALT liver enzymes) |
| 48 weeks | 20% of patients (vs. 0% in the untreated group) | 48% of patients (vs. 2% in the untreated group) |
| 96 weeks | 36% of patients | Indicators improved steadily |
| 144 weeks | 50% of patients | Half of the participants achieved a sustained result |
Safety and precautions: Like any serious therapy, Hepcludex has side effects (reactions at the injection site, headache, fatigue). The main caution doctors issue concerns discontinuing the course without medical supervision: this can cause a severe flare-up of hepatitis B and D. Therefore, treatment must be strictly supervised by an experienced infectious disease specialist.
This drug has been known in the European Union for a long time. The European Commission approved Hepcludex (buleviride) back in July 2020 and subsequently granted it standard medical use status.
However, there is an important difference in treatment approaches:
For the Ukrainian medical community and patients, the FDA’s decision is a powerful advocacy tool. We now have official confirmation: chronic hepatitis D is no longer an incurable disease; modern antiviral therapy exists and works.
Thanks to the efforts of the BCD team, since the start of the full-scale war, more than 10 patients from Ukraine have been able to receive free Hepcludex treatment under health insurance in Germany and the Czech Republic.
However, for those who remain in Ukraine, access to the medication is still limited due to its extremely high cost and the lack of government procurement programs.
Today, BCD identifies three key areas of focus in Ukraine:
If you or your loved ones are living with a diagnosis of hepatitis B, don’t wait.
News on the FDA website here.
