- Target disease: Hepatitis C
- Main partners (since project start): Pharco Pharmaceuticals, Inc., Egypt; Presidio Pharmaceuticals, Inc., USA; Clinical Research Malaysia, Ministry of Health, Malaysia.
- Project start: Clinical trials to start 2016
- Funding (since project start): Bill & Melinda Gates Foundation; Médecins Sans Frontières/Doctors without Borders, International.
DNDi began its HCV programme with a Phase II/III study in Malaysia and Thailand (other countries will be added in a second stage) that will 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 in participants infected with HCV, 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.
Last update: February 2017