Showing papers by "Richard J. Colonno published in 2022"
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TL;DR: In this paper , the authors evaluated the safety and efficacy of VBR in combination with entecavir (ETV) in treatment-naïve patients with chronic hepatitis B infection (cHBV).
13 citations
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TL;DR: In this article , the authors evaluated the efficacy and safety of the investigational core inhibitor, vebicorvir (VBR), in virologically suppressed patients on NrtIs.
11 citations
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TL;DR: ABI-H2158 in cHBV patients following 14 days of dosing was well tolerated and demonstrated potent antiviral activity, and safety and pharmacokinetics supported future QD dosing.
Abstract: Treatment for chronic hepatitis B virus infection (cHBV) is mostly indefinite, with new finite‐duration therapies needed. We report safety, pharmacokinetics and antiviral activity of the investigational HBV core inhibitor ABI‐H2158. This Phase 1a/b study (NCT03714152) had three parts: Part A, participants received a single ascending oral dose of ABI‐H2158 (5–500 mg) or placebo; Part B, participants received multiple doses of ABI‐H2158 300 mg once (QD) or twice (BID) daily or placebo, for 10 days; Part C, cHBV patients received ABI‐H2158 (100, 300, or 500 mg QD or 300 mg BID) or placebo, for 14 days. Ninety‐three participants enrolled. In Parts A/B, there were no serious adverse events (SAEs) or deaths, and all treatment‐emergent AEs (TEAEs) were Grade 1. In Part C, two patients had Grade 3 TEAEs unrelated to ABI‐H2158; there were no deaths, SAEs or Grade 4 TEAEs. In Part A, median time to maximum ABI‐H2158 plasma concentration (Tmax) and mean terminal elimination half‐life (t½) were 1–4 and 9.8–20.7 h, and area under the plasma concentration‐time curve increased dose proportionally. In Part B, Day 10 Tmax was 2 h, mean t½ was 15.5–18.4 h, and exposure accumulated 1.7‐ to 3.1‐fold. In Part C, Day 14 Tmax was 1 h, exposure accumulated 1.4‐ to 1.8‐fold, and ABI‐H2158 was associated with >2 log10 declines in HBV nucleic acids. In conclusion, ABI‐H2158 in cHBV patients following 14 days of dosing was well tolerated and demonstrated potent antiviral activity. Safety and pharmacokinetics supported future QD dosing.
3 citations
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TL;DR: ABI-H2158 is an HBV core inhibitor that advanced into Phase 2 clinical trials for the treatment of chronic hepatitis B virus infection (cHBV) but was discontinued due to hepatotoxicity as mentioned in this paper .
1 citations
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TL;DR: In this article , a multi-assay panel of highly sensitive nucleic acid assays designed to monitor levels of hepatitis B virus (HBV) DNA, pgRNA and total nucleic acids (TNA, composite DNA + pgRNA) in clinical specimens and to monitor changes during treatment with new antiviral combination regimens.