Hepatitis C Development

 

  • 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.

 

Overall Objective:

  • Conduct a Phase II/III clinical study assessing the efficacy of sofosbuvir + ravidasvir combination as an alternative regimen for the treatment of HCV.

 

 

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.

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. More than one million people are estimated to be chronically infected in Thailand and 400,000 in Malaysia, with the most prevalent genotypes being 1, 3, and 6. Yet both countries are excluded from global voluntary licensing agreements that enable access to generic HCV treatments. Additional sites in Vietnam (genotypes 2 and 6) and South Africa (genotype 5) are expected to be initiated in 2017.


Last update: February 2017