- Design
- Phase 2, single-arm, open-label
- Population
- 275 treatment-naive adults with chronic HCV, any genotype; 13% compensated cirrhosis
- Primary outcome
- SVR12 in the adherent per-protocol population
- Effect
- 98% (95% CI 95–99) per-protocol; 90% (86–93) intention-to-treat
A single-arm phase 2 study treated 275 adults with chronic hepatitis C of any genotype, 13% with compensated cirrhosis and 27% with baseline NS5A resistance variants, with once-daily bemnifosbuvir and ruzasvir for eight weeks.
SVR12 was 90% in everyone treated, 95% in those with evaluable outcomes and 98% in patients who took the drugs as prescribed. Five adherent patients relapsed. There were no drug-related serious adverse events or discontinuations.
The gap between 90% and 98% shows how much depends on adherence and follow-up, which matters in programmes treating people who inject drugs. Existing pan-genotypic regimens already achieve similar results, so the case for this one will rest on cost, interactions and shorter treatment in cirrhosis. It is investigational.
- Continue using established pan-genotypic regimens; this combination is not approved.
- Plan adherence support from the start, as missed doses explained most of the gap in cure rates.
- Check SVR12 in every patient to confirm cure.
- Screen for reinfection risk and offer harm reduction after cure.
Why it matters
Another short pan-genotypic option could help price and access in high-burden countries.
Don't overread it
A single-arm phase 2 study cannot show superiority to existing regimens.
The statistics, in plain English
Intention-to-treat SVR of 90% counts everyone who started, including those lost to follow-up. The per-protocol 98% shows the drugs' potency when taken; the real-world figure usually sits between the two.
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