- Target disease: Hepatitis C
- Main partners (since project start): Associated Medical Sciences/PHPT International Research Unit, Thailand; Clinical Research Malaysia, Ministry of Health, Malaysia; Doppel Pharma, Italy; Fundación Mundo Sano, Argentina; Hospital Kuala Lumpur, Malaysia; Hospitals of Geneva, Switzerland; Insud Pharma, Argentina; Laboratorio ELEA PHOENIX, Argentina; Médecins Sans Frontières, Ukraine; Ministry of Health and Ministry of Industry, Science and Technology, Thailand; Pharco Pharmaceuticals, Inc, Egypt; Pharmaniaga, Malaysia; Presidio Pharmaceuticals, Inc, USA.
- Project start: 2016
- Funding (since project start): Bill & Melinda Gates Foundation; Department for International Development (DFID), UK; Médecins Sans Frontières/Doctors without Borders, International; MSF Transformational Investment Capacity (MSF-TIC); The Starr International Foundation, Switzerland.
More than one million people in Thailand, and 400,000 in Malaysia are estimated to be infected with chronic HCV. The most prevalent genotypes are 1, 3, and 6. Yet, both countries are excluded from global voluntary licensing agreements that enable access to generic HCV treatments.
A Phase II/III study started in Malaysia and Thailand aims to assess, in real-world settings, the efficacy, safety, tolerability, pharmacokinetics, and acceptability of a 12-week regimen containing sofosbuvir in combination with the drug candidate ravidasvir, supplied by Egyptian manufacturer Pharco. Participants are included regardless of genotype, source of transmission (including intravenous drug use), or HIV co-infection. Patients with compensated liver disease with or without cirrhosis, will also be included (for participants with compensated liver cirrhosis, treatment duration will be 24 weeks). A total of 750 patients will be enrolled, including up to 30% with compensated cirrhosis and up to 20% who inject drugs, providing data on efficacy and safety of the combination, as well as on treatment compliance.
Initial results published in April 2018 showed that after 12 weeks of treatment, 97% of those enrolled were cured (95% CI: 94.4- 98.6). Cure rates were very high, even for the hardest-to-treat patients. Importantly, patients combining several risk factors were cured, and no unexpected safety signals were detected.
To further establish the pan-genotypic profile of ravidasvir, further data will be collected in Malaysia and Thailand, and other trials are envisioned in other parts of the world (for genotypes 2 and 5) and Ukraine (for vulnerable patient groups, including injecting drug users). Registration of ravidasvir will be pursued in Malaysia and other middle-income countries, including in Latin America.
All 301 patients in DNDi’s Phase II/III trial combining ravidasvir and sofosbuvir in Malaysia and Thailand have completed treatment. Top-line results are being analysed and will be published in April 2018.
At the end of 2016, six study sites in Malaysia had recruited 164 patients (out of a target of 300) and four sites in Thailand had been initiated, with the full cooperation of the Ministries of Health in these countries. Sites in additional countries including Vietnam should be initiated in the coming months.
Last update: August 2018