- Design
- Single-arm, phase 2
- Population
- 275 treatment-naive adults with chronic hepatitis C, any genotype; 13% compensated cirrhosis
- Primary outcome
- SVR12 in adherent per-protocol population
- Effect
- SVR12 98% per-protocol (95–99%); 90% intention to treat (86–93%)
This single-arm phase 2 study, published in Hepatology on 2 October, treated 275 treatment-naive adults with chronic hepatitis C of any genotype with once-daily bemnifosbuvir (an NS5B inhibitor) and ruzasvir (an NS5A inhibitor) for eight weeks. Thirteen per cent had compensated cirrhosis and 27% had baseline NS5A resistance-associated variants.
Sustained virological response 12 weeks after treatment was 90% (95% CI 86–93%) by intention to treat, 95% among those with evaluable outcomes, and 98% among adherent patients with adequate drug levels. Five adherent patients relapsed. There were no drug-related serious adverse events or discontinuations.
The regimen offers no clear efficacy advantage over existing pan-genotypic eight- and twelve-week regimens; its interest is as another short, simple option. It has no comparator arm, is phase 2, and is not approved anywhere. The 90% intention-to-treat figure is the more realistic estimate for routine care. In India, generic sofosbuvir-based regimens remain the affordable standard.
- Bemnifosbuvir–ruzasvir is investigational and not approved by the FDA, EMA or CDSCO.
- Generic sofosbuvir–velpatasvir remains a pan-genotypic standard in India.
- Adherence drives cure: the gap between 90% and 98% here was largely missed doses or follow-up.
- Check for cirrhosis before treatment; it changes surveillance after cure, not just regimen choice.
Why it matters
Shorter, simpler regimens help elimination programmes, where completion is often the barrier.
Don't overread it
Single-arm phase 2 without a comparator; it does not show this regimen is better than existing ones.
The statistics, in plain English
Per-protocol cure rates (98%) count only adherent patients with adequate drug levels and flatter the regimen; the intention-to-treat rate (90%) includes everyone who started and better reflects real-world results.
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