Hepatitis C Development

 

  • Target disease: Hepatitis C
  • Main partners (since project start): Clinical Research Malaysia, Ministry of Health, Malaysia; Ministry of Health and Ministry of Industry, Science and Technology, Thailand; Pharco Pharmaceuticals, Inc, Egypt; Presidio Pharmaceuticals, Inc, USA.
  • 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.

 

 

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.

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 2017