Feasibility, Tolerance and Efficacy of Interferon-free, Antiviral Treatment With Sofosbuvir + Ribavirin for the Treatment of Genotype 2 and Sofosbuvir/Ledipasvir for the Treatment of Genotype 1 and 4 Hepatitis C Virus-infected Patients in West and C

• Status: Completed
• Trial end date: 2017-11-01

Summary

Primary Objective:

To evaluate the efficacy (sustained virological response 12 weeks after end-of-treatment [SVR12]) of 12-week course of an interferon-free regimen combining sofosbuvir and weight-dosed ribavirin (genotype 2), or sofosbuvir and ledipasvir (genotype 1 or 4) in treatment-naïve patients infected with HCV genotype 1, 2 or 4 in West and Central Africa

Secondary Objectives:

1. To estimate the study treatment SVR24 rate

2. To evaluate the clinical and biological tolerance of study treatment

3. To describe HCV kinetics under HCV treatment, and identify associated factors

4. To describe the evolution of HIV disease under HCV treatment in HVC-HIV co-infected patients

5. To describe the changes of liver fibrosis based on non-invasive tests between treatment initiation, week 24, and week 36 after treatment, and estimate its association with SVR12 or SVR24

6. To identify factors associated with SVR12 and SVR24 (including HIV status)

7. To evaluate the performance of a nanodevice for rapid diagnosis of HCV viral load and genotypying and for assessing response to treatment (SVR12 and SVR24)

8. Facilitate the detection and treatment of those infected with HCV by supporting national initiatives for access to strategies without interferon

9. To set up a HCV clinical research network across French and English-speaking African countries, able to run large-scale comparative randomized clinical trials in a near future.

• Phase: Phase 2

Details

• Lead Sponsor: ANRS, Emerging Infectious Diseases; French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
• Treatments: Antiviral Agents; Interferons; Ledipasvir; Ledipasvir, sofosbuvir drug combination; Ribavirin; Sofosbuvir