Hepatology (Baltimore, Md.)
October 2, 2026 · via Europe PMC
Efficacy and safety of an 8-week bemnifosbuvir and ruzasvir regimen in chronic hepatitis C: Results from a Phase 2 study.
Jucov A, Conway B, Feld JJ, +8 more, Lawitz E.
AI summary — for doctors, generated from the abstract only
An 8-week bemnifosbuvir and ruzasvir regimen produced high SVR12 in treatment-naive HCV and was well tolerated.
What was studied
Single-arm Phase 2 study of 275 treatment-naive patients of any genotype (13% compensated cirrhosis) given the two drugs daily for 8 weeks.
Key findings
- SVR12 was 90% in ITT, 98% in PK/pill-compliant per-protocol and 95% in efficacy-evaluable
- Five per-protocol patients relapsed
- No drug-related serious adverse events or discontinuations
Clinical relevance
It is a potential short pan-genotypic regimen, including with baseline NS5A resistance variants.
Who should care
Limitations
Single-arm Phase 2 without comparator and the primary analysis excluded non-adherent patients (ITT SVR12 90%).
Not yet a practice change; monitor for further trials of this combination.
This is an AI-generated summary of the published abstract, not a clinical recommendation. It may not reflect the full text or subsequent updates — verify against the original source before acting on it.
Abstract
Background aims
Bemnifosbuvir and ruzasvir are potent pan-genotypic inhibitors of the hepatitis C virus (HCV) NS5B polymerase and NS5A protein, respectively. This single-arm, Phase 2 study evaluated the efficacy and safety of bemnifosbuvir and ruzasvir in treatment-naïve patients with chronic HCV infection of any genotype, with or without compensated cirrhosis.
Approach results
Patients received bemnifosbuvir 550 mg and ruzasvir 180 mg once daily for 8 weeks (intention-to-treat [ITT] population). The primary efficacy endpoint was the proportion of patients achieving sustained virologic response at 12 weeks post treatment (SVR12) in the Pharmacokinetic and Pill Compliant Per-Protocol (PK/PC-PP) population. Secondary efficacy endpoints included SVR12 in the Efficacy Evaluable Per-Protocol (EE-PP; those with outcomes regardless of study drug adherence) and safety (all dosed) populations, virologic failure, and SVR24. Of the 275 patients enrolled and who received treatment with bemnifosbuvir and ruzasvir, 13% had compensated cirrhosis and 27% had NS5A resistance-associated substitutions (RASs) at baseline. SVR12 was 90% (248/275; 95% CI: 86-93%) in the ITT population, 98% (210/215; 95% CI: 95-99%) in the PK/PC-PP population, and 95% (245/259; 95% CI: 91-97%) in the EE-PP population. Five patients in the PK/PC-PP population experienced virologic failure (post-treatment relapse). No drug-related serious adverse events or premature treatment discontinuations due to drug-related adverse events were reported.
Conclusions
An 8-week treatment with bemnifosbuvir and ruzasvir resulted in high rates of SVR12 across genotypes, regardless of the presence or absence of baseline RASs, and was well tolerated among treatment-naïve HCV patients.
DOI
10.1097/hep.0000000000001871
PMID
42826065
Research metadata (titles, abstracts, authors, publication dates) is sourced from Europe PMC, which aggregates content from PubMed/MEDLINE, PubMed Central, and other providers under the U.S. National Library of Medicine (NLM/NCBI). NLM does not claim copyright on abstracts; the original journal publishers or authors may hold rights to the full articles. AI-generated summaries are derived only from the abstract, never the full text, and are always labeled as AI-generated.
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