An 8-week regimen cures most treatment-naïve hepatitis C

Design

Single-arm, phase 2 study (no comparator)

Population

275 treatment-naïve adults with chronic HCV, any genotype (13% cirrhosis)

Primary outcome

Sustained virologic response at 12 weeks (SVR12)

Effect

SVR12 90% intention-to-treat; 95–98% per protocol; 5 relapses

Direct-acting antivirals already cure most hepatitis C, and the direction of travel is shorter courses. This single-arm phase 2 study gave 275 treatment-naïve patients with chronic HCV of any genotype — 13% with compensated cirrhosis, 27% with baseline NS5A resistance substitutions — an 8-week regimen of the pan-genotypic agents bemnifosbuvir and ruzasvir.

Sustained virologic response at 12 weeks was 90% by intention-to-treat, and 95–98% in the per-protocol populations, with cure rates holding across genotypes and regardless of baseline resistance. Only five patients relapsed, and there were no drug-related serious adverse events or discontinuations.

An 8-week, resistance-robust, pan-genotypic option is a welcome addition, especially where adherence over a longer course is a challenge. The honest caveat is that this is single-arm phase 2, and India already has cheap generic pan-genotypic regimens of 8–12 weeks — so this adds an option and competition rather than filling an unmet need, pending phase 3 data and pricing.

• An 8-week bemnifosbuvir–ruzasvir regimen cured 90% by intention-to-treat and 95–98% per protocol.
• Cure held across genotypes and despite baseline NS5A resistance substitutions.
• Only five patients relapsed, with no drug-related serious adverse events.
• This is single-arm phase 2; cheap generic pan-genotypic regimens already exist in India.

Why it matters

It pushes hepatitis C treatment toward shorter, resistance-robust courses, which matters most where adherence is the barrier.

Don't overread it

A single-arm phase 2 study with no comparator cannot be ranked against established direct-acting antivirals; the intention-to-treat cure rate of 90% is lower than the per-protocol figure.

The statistics, in plain English

The gap between 90% intention-to-treat and 98% per-protocol reflects patients who did not complete or adhere; without a control arm, the regimen cannot yet be judged superior or non-inferior to current therapy.

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