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
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

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

Criteria

Inclusion Criteria:

• Age≥18 years

• Confirmed G1, G2 or G4 HCV infection

• Plasma HCV-RNA ≥1000 IU/mL

• No history of HCV treatment of any kind

• Willingness to use a birth control method (hormonal or intrauterine device for women, condoms for men), starting before HCV treatment initiation and continued until 4months (women) and 7 months (men) after end of treatment.

• Weight ≥40 kg and ≤125 kg

For patients infected with HIV :

• Confirmed HIV-1 infection

• Stable HIV treatment for at least 8 weeks with two NRTIs (tenofovir or abacavir, and lamivudine or emtricitabine) and a third agent (raltegravir, lopinavir/ritonavir, atazanavir/ritonavir, darunavir/ritonavir, efavirenz, nevirapine)

• Current CD4+ lymphocytes count ≥100/mm3

• Current plasma HIV-1 RNA <200 copies/mL

Exclusion Criteria:

For each patient:

• Cirrhosis classified Child-Pugh B or C

• Co-infection by the Hepatitis B virus

• Pregnant or breastfeeding ongoing

• History of transplantation of organs or tissues

• Progressive Cancer, including hepatocellular carcinoma

• Epilepsy

• Sickle Cell Disease

• A history of myocardial infarction or other severe heart disease

• Excessive consumption of alcohol or drug users, in the absence of substitution by methadone, a stable weaning for more than three months should be required

• Ongoing Participation in another clinical trial

• Contraindications to the Sofosbuvir as defined in the Summary of Product Characteristics

• At least one of the following laboratory abnormalities:

Haemoglobin <10 g / 100 ml (woman) <11 g / 100 ml (man) Platelet count <50,000 / mm3 polymorphonuclear neutrophils rate <750 / mm3 Creatinine clearance <50ml / min

For patients infected with HIV:

• Severe opportunistic infections in the last 6 months

• Poor adherence to antiretroviral treatment history

• Use of antiretroviral drugs other than those permitted in the test