Eight weeks of bemnifosbuvir plus ruzasvir: SVR12 of 98% per protocol in untreated hepatitis C

Design

Single-arm phase 2 study, 8 weeks of treatment

Population

275 treatment-naive adults with chronic HCV, any genotype; 13% compensated cirrhosis

Primary outcome

SVR12 in the pharmacokinetic and pill-compliant per-protocol population

Effect

98% (210/215; 95% CI 95 to 99) per protocol; 90% (248/275; 86 to 93) intention to treat

This single-arm phase 2 study treated 275 patients with chronic hepatitis C of any genotype, treatment-naive, 13% with compensated cirrhosis and 27% with baseline NS5A resistance-associated substitutions. They received bemnifosbuvir 550 mg and ruzasvir 180 mg once daily for 8 weeks. Both are investigational.

The primary end point, SVR12 in the pharmacokinetic and pill-compliant per-protocol population, was 98% (210 of 215; 95% CI 95 to 99). By intention to treat, SVR12 was 90% (248 of 275; 86 to 93), and 95% (245 of 259) in the efficacy-evaluable group. Five patients in the primary population relapsed. No drug-related serious adverse events or drug-related discontinuations were reported.

The primary population excludes people who missed doses or lacked adequate drug levels, so 98% overstates real-world results. The intention-to-treat figure of 90% includes people lost to follow-up, and a single-arm design has no direct comparator.

• This regimen is investigational and not available for prescribing from this study.
• Read the intention-to-treat result (90%) as the conservative figure.
• The study enrolled treatment-naive patients, including some with compensated cirrhosis.
• Existing pan-genotypic regimens remain the standard of care.

Why it matters

Shorter, simpler hepatitis C regimens help programmes reach people who struggle with long courses.

Don't overread it

A single-arm, industry-developed phase 2 study without a comparator; per-protocol results flatter the regimen.

The statistics, in plain English

The 98% and 90% describe the same trial under different rules about who counts. The per-protocol figure excludes poorly adherent patients; the intention-to-treat figure includes everyone who started, including those lost to follow-up.

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