A new clinical trial conducted in Malaysia has found that an eight-week regimen of ravidasvir and sofosbuvir is just as safe and effective as the standard 12-week treatment for chronic hepatitis C.
This finding could accelerate efforts to scale up access to treatment in resource-limited settings by reducing treatment duration, costs and system burden.
The EASE study (Evaluating Accelerated Shortened treatment for hepatitis C in Asia through real-world Evidence) was led by the Health Ministry (MOH) and conducted across 26 sites nationwide between March 2021 and March 2023.
The randomised trial involved 322 patients diagnosed with chronic hepatitis C virus infection, including those with more complex medical profiles.
The primary objective was to determine whether an eight-week treatment course using the fixed-dose combination of ravidasvir and sofosbuvir would achieve similar sustained virological response (SVR), compared to the standard 12-week regimen.
An SVR refers to the continued absence of the hepatitis C virus in a patient's blood 12 weeks or more after they have completed treatment.
It is essentially considered a virological cure for the infection.
The study found no significant difference in efficacy between the two durations, with high SVR rates maintained in both arms.
Safety profiles were also comparable, with no new adverse effects identified.
The results were officially reported by the MOH in January (2025) and presented at the 2025 European Association for the Study of the Liver (EASL) Congress in early May in Amsterdam, the Netherlands.
Ravidasvir was co-developed through a public-health partnership involving the MOH, Drugs for Neglected Diseases initiative (DNDi), Pharco Pharmaceuticals (Egypt) and Pharmaniaga Berhad (Malaysia), with key clinical trials conducted in Malaysia and Thailand.
The treatment was first registered in Malaysia in 2021 and added to the World Health Organization (WHO) Essential Medicines List in 2023.
While hepatitis C continues to affect approximately 50 million people globally, with only about 20% receiving treatment, high drug prices remain a barrier in many countries.
A 2023 MOH study estimates 0.4% of the population in Malaysia to have hepatitis C.
In line with WHO targets, Malaysia aims to eliminate the disease as a public health threat by 2030.
