A Study Evaluating ABI-H0731+ Entecavir vs Entecavir Alone for the Treatment of Viremic HBeAg-positive Participants With Chronic Hepatitis B Virus Infection (cHBV)

Phase 2 Completed 25 enrolled Assembly Biosciences

RandomizedParallel-groupTriple-blindTreatment

Summary

The purpose of this study is to determine if ABI-H0731 given in combination with a standard of care (SOC) entecavir (ETV) is safe and effective in participants with chronic hepatitis B infection (cHBV)

Timeline

Start: 2018-06-19
Primary completion: 2019-06-21
Completion: 2019-06-21

Outcome

Met primary endpoint

registry analysis (other test); ABI-H0731 + SOC ETV vs Placebo + SOC ETV; p = 0.0077; LS Mean Difference -1.154 (95% CI -1.986 to -0.322); Repeated measures analysis NCT03577171 ↗

registry analysis (other test); ABI-H0731 + SOC ETV vs Placebo + SOC ETV; p = 0.0084; LS Mean Difference -1.141 (95% CI -1.973 to -0.309); Repeated measures analysis NCT03577171 ↗

release “In Study 202 (Rx naïve patients), greater mean log10 declines in HBV DNA (5.27 vs 3.99; p=0.017)” assemblybio.com ↗

Publications

Sulkowski MS, Agarwal K, Ma X, Nguyen TT, Schiff ER, Hann HL, Dieterich DT, Nahass RG, Park JS, Chan S, Han SB, Gane EJ, Bennett M, Alves K, Evanchik M, Yan R, Huang Q, Lopatin U, Colonno R, Ma J, Knox SJ, Stamm LM, Bonacini M, Jacobson IM, Ayoub WS, Weilert F, Ravendhran N, Ramji A, Kwo PY, Elkhashab M, Hassanein T, Bae HS, Lalezari JP, Fung SK, Yuen MF. Safety and efficacy of vebicorvir administered with entecavir in treatment-naive patients with chronic hepatitis B virus infection. J Hepatol. 2022 Nov;77(5):1265-1275. doi: 10.1016/j.jhep.2022.05.027. Epub 2022 Jun 11.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Vebicorvir	Small molecule	300 mg	Oral
Background	ETV	Unknown	0.5 mg	Oral