Study design Multicenter, phase IIb, non randomized, open-label trial involving 3 groups of HCV-mono infected or HCV-HIV co-infected patients: group G1 (patients infected with HCV genotype 1), group G2 (patients infected with HCV genotype 2), and group G4 (patients infected with HCV genotype 4).
Number of Subjects A sample size of 40 patients per group will allow to demonstrate that the SVR12 is \>70% ("expected efficacy" in difficult-to-treat patients, according to SPARE interim results), with the lower bound of the confidence interval being \>50% ("unacceptable" efficacy). The overall sample size is 3x40=120 patients.
Participating Countries 3 countries from West Africa (Senegal, Côte d'Ivoire) and Central Africa (Cameroon) Number of Sites 5 clinical sites:
* Côte d'Ivoire: Hepatology Departementat the Yopougon University Teaching Hospital, , Abidjan; and Blood Donors clinic (CMSDS) at the National Blood Bank (CNTS), Abidjan
* Senegal: CRCF (Centre Régional de Recherche et de Formation), and Fann University Teaching Hospital
* Cameroon: Clinique de la Cathédrale
Duration of Recruitment : 6 months
Duration of Treatment : 12 weeks
Duration of follow-up : 36 weeks
Anticipated Start Date / Anticipated End Date: November 2015 - October 2016
Target Population /Demographics : Patients \>18 years, living with chronic hepatitis C genotype 1, 2 or 4, in West and Central Africa. In each genotype group approx. 50% of patients will be HCV-HIV co-infected, and 50% of patients will be mono-infected with HCV
This study will enable us to assess the feasibility, tolerance and efficacy of such a strategy in resource-constrained settings with considerable treatment needs.
