NCT02405013

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 Central Africa

TAC (Treatment Africa Hepatitis C) : 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 Central Africa

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: ANRS, Emerging Infectious Diseases · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Hepatitis C
• HIV Infection

Interventions

Type	Name	Description
DRUG	Sofosbuvir	Sofosbuvir 400mg QD (Sovaldi®) in treatment-naïve patients infected with HCV genotype 2 (12-week course)
DRUG	Ribavirin	Ribavirin weight-adjusted dosing (1000mg BID in patients \< 75kg and 1200mg BID in patients ≥ 75kg) in treatment-naïve patients infected with HCV genotype 2 (12-week course)
DRUG	Sofosbuvir	Sofosbuvir/Ledipasvir 400mg/90mg (Harvoni®) in treatment-naïve patients infected with HCV genotype 1 or genotype 4 (12-week course)
DRUG	Ledipasvir	Sofosbuvir/Ledipasvir 400mg/90mg (Harvoni®) in treatment-naïve patients infected with HCV genotype 1 or genotype 4 (12-week course)

Timeline

• Start date: 2015-10-01
• Primary completion: 2017-07-01
• Completion: 2017-11-01
• First posted: 2015-04-01
• Last updated: 2017-12-13

Locations

4 sites across 3 countries: Cameroon, Côte d’Ivoire, Senegal