All India Institute of Medical Sciences, Delhi reported that a single-dose regimen of sofosbuvir-velpatasvir achieved sustained virologic response in 94 percent of genotype-three hepatitis C patients who met strict trial criteria, matching outcomes from the standard 12-week course in a parallel arm. Principal investigators presented the interim analysis Wednesday to the hospital ethics committee ahead of wider publication.
Trial design
The study enrolled 210 treatment-naive adults with low fibrosis scores and no HIV co-infection. Participants received either one observed dose with four weeks of monitoring or the conventional 12-week therapy. Viral load tests at 12 weeks post-treatment showed comparable clearance rates, though the single-dose arm recorded more mild fatigue reports in the first week.
Researchers stressed that the protocol is not yet policy. Patients with cirrhosis, prior treatment failure or extrahepatic manifestations were excluded, limiting generalisability to the roughly six million Indians estimated to carry hepatitis C antibodies.
Programme implications
National Health Mission officials have pushed to decentralise direct-acting antiviral delivery to district hospitals. A shorter course could cut pill burden and supervision costs in outreach camps, especially in northeastern states where genotype-three prevalence is high.
Cautions
Indian Pharmaceutical Alliance members warned that wholesale switching without phase-four surveillance could fuel resistance if adherence monitoring slips. AIIMS plans a six-month extension study tracking reinfection among high-risk cohorts.
For patients, the message is narrower: ask hepatologists whether trial criteria apply, do not self-shorten prescribed courses, and continue harm-reduction counselling for injection drug users. A one-day cure headline is alluring; hepatitis elimination still depends on screening scale, not dosing convenience alone.
Funding and access
Union health budget lines for hepatitis elimination already strain under screening costs in Punjab and Haryana, where genotype-three clusters persist among older cohorts. A shorter regimen could free pharmacy budgets if prices fall, but only if manufacturers agree to volume tenders tied to district hospital uptake.
Patient advocacy groups welcomed the trial yet asked AIIMS to publish inclusion criteria in regional languages before media headlines encourage self-medication. Harm-reduction NGOs want parallel counselling slots at trial sites so high-risk groups do not drop out after the first visit.
State programmes
Punjab health officials asked whether single-dose protocols could accelerate clearance of backlog patients identified in prison screening drives. AIIMS investigators said prison populations were excluded from the current trial because follow-up testing schedules are harder to enforce behind bars.
Generic manufacturers already supply sofosbuvir-velpatasvir at steep discounts to the national programme; any regimen change would require National Pharmaceutical Pricing Authority review of per-patient costs even if pill counts fall.