A Study of Different Combination Regimens Including JNJ-73763989 and/or JNJ-56136379 for the Treatment of Chronic Hepatitis B Virus Infection

Summary

The purpose of this study is to establish the dose-response relationship for antiviral activity of 3 dose levels of JNJ-73763989+nucleos(t)ide analog (NA) and to evaluate the efficacy of combination regimens of JNJ-73763989+NA (with and without JNJ-56136379) and of JNJ-56136379+NA.

Timeline

Start

2019-08-01

Primary completion

2021-03-29

Completion

2022-04-26

Outcome

Met primary endpoint

registry Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA vs Arm 6: Placebo + Placebo + NA; p = 0.027; Difference of proportions 7.4 NCT03982186 ↗

Publications

• Verbinnen T, Lathouwers E, Jezorwski J, Biermer M, Augustyns I, Grant C, Agarwal K, Yuen MF, De Meyer S, Lenz O. Viral sequence analysis of chronic hepatitis B patients treated with the siRNA JNJ-73763989 in phase II clinical trials. JHEP Rep. 2025 Oct 9;7(12):101618. doi: 10.1016/j.jhepr.2025.101618. eCollection 2025 Dec.
• Yuen MF, Asselah T, Jacobson IM, Brunetto MR, Janssen HLA, Takehara T, Hou JL, Kakuda TN, Lambrecht T, Beumont M, Kalmeijer R, Guinard-Azadian C, Mayer C, Jezorwski J, Verbinnen T, Lenz O, Shukla U, Biermer M; REEF-1 Study Group. Efficacy and safety of the siRNA JNJ-73763989 and the capsid assembly modulator JNJ-56136379 (bersacapavir) with nucleos(t)ide analogues for the treatment of chronic hepatitis B virus infection (REEF-1): a multicentre, double-blind, active-controlled, randomised, phase 2b trial. Lancet Gastroenterol Hepatol. 2023 Sep;8(9):790-802. doi: 10.1016/S2468-1253(23)00148-6. Epub 2023 Jul 10.

Drugs

Indications