144 Weeks of bulevirtide monotherapy for chronic hepatitis D: Final and post-treatment results from a phase III randomized trial.
Heiner Wedemeyer, Soo Aleman, Antje Blank et al.
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In 30 seconds
This phase III, multicentre randomized trial evaluated bulevirtide monotherapy in 150 patients with compensated chronic hepatitis D, comparing immediate 2 mg/day or 10 mg/day treatment for 144 weeks with delayed treatment followed by 10 mg/day for 96 weeks. At treatment end, virologic response rates were 73%, 76%, and 92%, respectively; after 96 weeks off treatment, they had declined to 33%, 30%, and 32%. Among patients with undetectable HDV RNA at treatment end, 23/64 (36%) maintained undetectability throughout follow-up. Post-treatment hepatic serious adverse events occurred in 20/142 (14%), resolving in 17/20 (85%).
Key findings
- At treatment end, virologic response was 73%, 76%, and 92% in the 2 mg, 10 mg, and delayed-treatment/10 mg groups, respectively.
- After 96 weeks of follow-up off treatment, virologic response rates were 33%, 30%, and 32%; combined response was 24% across groups.
- Sustained HDV RNA undetectability through follow-up occurred in 23/64 (36%) patients undetectable at treatment end; longer continuous undetectability at treatment end was the strongest predictor.
- Post-treatment hepatic serious adverse events occurred in 20/142 (14%) patients and resolved in 17/20 (85%).
Why it matters
The findings show that responses achieved during prolonged bulevirtide treatment often diminish after discontinuation, while a subset of patients with undetectable HDV RNA at treatment end maintained that response during follow-up. This distinction is relevant when considering the durability of virologic control and the uncertainty around stopping therapy; the study also reports post-treatment hepatic serious adverse events and their resolution.
What to keep in mind
The abstract reports outcomes through 96 weeks after treatment discontinuation; longer-term outcomes remain unknown.