An ICMR study of 880 patients showed an 8-week Hepatitis C treatment is as effective as the 12-week course. Dr Rakesh Aggarwal said, “the eight-week course was not less effective than the 12-week course.” This shorter regimen saves Rs 5,000 per patient and helps more people get treated across India.
The multicentre RESOLVE trial enrolled 880 patients without cirrhosis at five public hospitals: two each in Lucknow and New Delhi, and one in Varanasi. Half received sofosbuvir-velpatasvir for eight weeks and the other half for the standard 12 weeks. Among patients who completed treatment, cure rates were nearly identical: 98.8% in the eight-week group and 99% in the 12-week group.
“Statistical analysis confirmed that the shorter regimen was non-inferior to the standard treatment. In simple terms, this means the eight-week course was not less effective than the 12-week course, according to a pre-specified statistical margin. The trial was prompted by smaller observational studies suggesting that eight weeks of treatment might be sufficient. A randomised controlled trial was needed to establish this more definitively,” Dr Rakesh Aggarwal, lead study author and Chair for Disease Elimination, ICMR, told The Indian Express. Excerpts:
What could this mean for patients and public health?
Reducing treatment from 12 to eight weeks could cut drug costs by a third. At current market prices, this amounts to a saving of about Rs 5,000 per patient. The actual savings under the National Viral Hepatitis Control Programme may differ because government procurement prices are not publicly available to us.
A shorter course could also mean fewer hospital visits, less time away from work and better treatment completion. Experience with shorter treatment regimens for tuberculosis and leprosy suggests that reducing treatment duration can improve adherence, although this remains an expected benefit of the eight-week hepatitis C regimen rather than a finding established by this trial.
The findings are relevant to a large proportion of the more than 50 million people worldwide, including nearly six million in India, who need treatment for hepatitis C but have not yet developed cirrhosis. If adopted by public health programmes, the shorter regimen could allow more patients to be treated within existing budgets, helping India move closer to eliminating hepatitis C as a public health problem.
Who can receive the shorter treatment?
The findings apply to patients without cirrhosis. The trial excluded people with cirrhosis because their antiviral treatment is more challenging: they generally require longer treatment, and their reduced liver reserve makes treatment failure potentially more dangerous. Studying patients without cirrhosis first also ensured that those not cured by the shorter course could receive the standard 12-week treatment.
The trial population was broadly representative of patients treated in Indian hospitals, although people with certain conditions, including HIV co-infection and intravenous drug use, were excluded. Such groups account for a minority of India’s hepatitis C burden. In clinical practice, treatment decisions for people with additional conditions should be individualised. We see no clear reason why people who use drugs should not receive the shorter regimen, while a 12-week course may remain preferable for those with HIV co-infection.
What happens next?
The study’s main limitation is that it did not include patients with cirrhosis. National and international policymakers will need to review the evidence before deciding whether to recommend the shorter regimen more widely. Pharmaceutical companies would generally need to seek regulatory approval to change the authorised treatment duration, but may have limited commercial incentives to do so. Public health programmes and physicians sometimes adopt evidence-based regimens off-label, as has happened with single-dose HPV vaccination and fractional-dose injectable polio vaccination in India.
The team is now preparing to test a shorter regimen in patients with cirrhosis. With ICMR funding approved and the protocol ready, the study is awaiting completion of regulatory and logistical arrangements. Because these patients usually receive 24 weeks of treatment, the new trial will assess whether 12 weeks is as effective as the standard 24 weeks. An eight-week course may be too short for this group.
The eight-week regimen therefore offers a promising way to simplify hepatitis C treatment for patients without cirrhosis. Further research will determine whether treatment can also be shortened for those with more advanced liver disease.