Final results of MYR301: a randomised phase 3 study evaluating the efficacy and safety of up to 144 weeks of bulevirtide monotherapy for chronic hepatitis Delta and 96 weeks of posttreatment follow-up

Q: What type of study is this?

This is a RCT study (also classified as: Phase 3).

H. Wedemeyer; Soo Aleman; Antje Blank; Pietro Andreoné; Pavel Bogomolov; Vladimir Chulanov; N. Mamonova; N Geyvandova; Vitaly Morozov; Olga Sagalova; T.V. Stepanova; Annemarie Berger; Sandra Ciesek; Katja Deterding; Andrew H. Lichtman; D Manuilov; Renée-Claude Mercier; Sarah Arterburn; Florence Christian-Cox; S Tseng; Anu Osinusi; J.S. zur Wiesch; Markus Cornberg; Stefan Zeuzem; Maurizia Brunetto; Pietro Lampertico

doi:10.1055/s-0045-1810987

Key Points

Bulevirtide treatment demonstrated sustained efficacy and safety up to 144 weeks for chronic hepatitis delta.
Patients undergoing bulevirtide monotherapy had consistent results throughout the 144-week observation period.
Phase 3 study employed randomised methods to rigorously assess bulevirtide's impact on chronic hepatitis delta.
The findings support bulevirtide as a viable long-term treatment option, indicating its potential in clinical practice.

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Implication

Randomised phase 3 study evaluated efficacy and safety of bulevirtide in chronic hepatitis delta, revealing long-term benefits.

Abstract

Introduction: Bulevirtide (BLV) 2 mg/day (d) is approved in Europe, Australia, and Russia for the treatment of compensated chronic hepatitis delta (CHD). In MYR301, a Phase 3 study evaluating BLV monotherapy for 2 to 3 years, BLV treatment was safe and effective through 144 weeks (W).

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Wedemeyer et al. (2025) studied this question.

synapsesocial.com/papers/68c195559b7b07f3a0618e5b https://doi.org/10.1055/s-0045-1810987

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Final results of MYR301: a randomised phase 3 study evaluating the efficacy and safety of up to 144 weeks of bulevirtide monotherapy for chronic hepatitis Delta and 96 weeks of posttreatment follow-up

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Discussion

Cite This Study

Final results of MYR301: a randomised phase 3 study evaluating the efficacy and safety of up to 144 weeks of bulevirtide monotherapy for chronic hepatitis Delta and 96 weeks of posttreatment follow-up

Key Points

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Implication

Abstract

Discussion

Cite This Study

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