Hepatitis C Cure in 8 Weeks: Trial Backs Shorter Therapy
Clinicians in India may soon optimize hepatitis C treatment duration by shifting suitable patients from twelve weeks to eight weeks of therapy. Recently, researchers evaluated an eight-week regimen of sofosbuvir-velpatasvir in treatment-naive individuals without cirrhosis. The Indian Council of Medical Research funded this landmark trial, known as the RESOLVE study. In addition, Sanjay Gandhi Post Graduate Institute of Medical Sciences led the multicentric investigation across five major tertiary institutions. The Lancet published the comprehensive results, demonstrating non-inferiority compared to standard twelve-week treatment.
Key Findings from the RESOLVE Clinical Trial
The multicentric study enrolled 880 treatment-naive adult participants across five premier medical centres in India. Specifically, investigators randomized 443 patients to receive sofosbuvir-velpatasvir for eight weeks. Meanwhile, the remaining participants received the standard twelve-week course. Ultimately, 816 participants completed post-therapy evaluation for sustained virological response twelve weeks after finishing medication. Consequently, the eight-week arm demonstrated an impressive 98.8% viral clearance rate. In comparison, the standard twelve-week arm achieved a 99% cure rate. Furthermore, no participants reported drug-related serious adverse events or discontinued therapy due to toxicity.
Evidence for Reducing Hepatitis C Treatment Duration
Reducing the hepatitis C treatment duration offers immense clinical and economic advantages. Currently, a standard twelve-week regimen of direct-acting antivirals costs approximately Rs 15,000 using Indian generic formulations. Therefore, an eight-week course reduces out-of-pocket expenditure by Rs 5,000 per patient. Because approximately 60 lakh individuals in India require antiviral therapy, national savings could reach Rs 3,000 crore. Moreover, lower financial barriers enable public health programs to treat substantially more individuals with existing budgets. Shorter regimens also improve patient adherence and lower clinic follow-up burdens.
Clinical Patient Selection and Future Research
However, physicians must exercise caution and adhere to precise patient selection criteria. Specifically, the trial findings apply solely to treatment-naive individuals without evidence of cirrhosis. Thus, clinicians cannot extrapolate these findings to patients with cirrhosis or those who previously failed therapy. Instead, individual pre-treatment assessment remains essential to determine appropriate therapeutic duration. Meanwhile, investigators have secured funding to study shortened regimens in patients with cirrhosis, which forms a vital part of advanced learning through gastroenterology speciality courses.
Frequently Asked Questions
Q1: Which patients are eligible for the shortened 8-week regimen?
The eight-week sofosbuvir-velpatasvir regimen currently applies only to treatment-naive patients with chronic hepatitis C who do not have cirrhosis. Therefore, patients with cirrhosis or prior treatment failure require standard guideline-directed courses.
Q2: How effective was the 8-week course compared to standard therapy?
In the RESOLVE trial, the eight-week regimen achieved a 98.8% viral clearance rate. In comparison, the standard twelve-week regimen achieved a 99% rate, confirming non-inferiority with zero drug-related discontinuations.
Q3: What are the economic benefits of shortening the regimen?
The shorter regimen cuts medication costs by one-third, saving approximately Rs 5,000 per patient. Consequently, this change could yield national savings of roughly Rs 3,000 crore across India.
References
- Hepatitis C treatment duration may be cut from 12 to 8 weeks - ETHealthworld
- Aggarwal R, et al. 8 weeks versus 12 weeks of sofosbuvir–velpatasvir for treatment-naive, non-cirrhotic, chronic hepatitis C (RESOLVE): a multicentre, open-label, non-inferiority, randomised controlled trial in India. The Lancet, 2026.
- Goel A, et al. Eight versus twelve weeks of sofosbuvir-velpatasvir in treatment-naïve non-cirrhotic patients with chronic hepatitis C virus infection: Study protocol for a multicentric, open labelled, randomized, non-inferiority trial (RESOLVE trial). PLOS ONE, 2023.
