A Phase 2 interventional study of Sofosbuvir and Ribavirin in Hepatitis C and HIV Infection, sponsored by ANRS, Emerging Infectious Diseases. Completed at 4 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-12-13.
Sponsored by ANRS, Emerging Infectious Diseases · Phase 2, Interventional, and Treatment
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:
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:
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.
2,710 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.
This study's enrollment of 120 is above the median of 100 across 1,887 interventional studies indexed under Hepatitis A.
Browse Hepatitis A studies →ANRS, Emerging Infectious Diseases is the lead sponsor of 212 studies on the registry; 40 are open to participants now.
Counted across the registry records on this site, refreshed daily.
For patients infected with HIV :
Exclusion Criteria:
For each patient:
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:
Sofosbuvir 400mg QD (Sovaldi®) + 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 · Drug: Ribavirin
Sofosbuvir/Ledipasvir 400mg/90mg (Harvoni®) in treatment-naïve patients infected with HCV genotype 1 or genotype 4 (12-week course)
Drug: Sofosbuvir · Drug: Ledipasvir
Sofosbuvir 400mg QD (Sovaldi®) in treatment-naïve patients infected with HCV genotype 2 (12-week course)
Also known as: Sovaldi®
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)
Sofosbuvir/Ledipasvir 400mg/90mg (Harvoni®) in treatment-naïve patients infected with HCV genotype 1 or genotype 4 (12-week course)
Also known as: Harvoni®
Sofosbuvir/Ledipasvir 400mg/90mg (Harvoni®) in treatment-naïve patients infected with HCV genotype 1 or genotype 4 (12-week course)
Also known as: Harvoni®
Sustained Viral Load Response (SVR)
Time frame: Week 12
Tolerance
Grade 1, 2, 3 and 4 clinical or biological events (ACTG grading table), Adverse events-related HCV treatment discontinuation Adverse events-related ARV treatment modification
Time frame: 36 weeks
Viral kinetics as measured by SVR 24 and HCV-RNA
SVR 24 and HCV-RNA
Time frame: W0, W2, W4, W12, W24, W36
HIV treatment clinical parameters
Number, nature and incidence of severe morbid events related to HIV, and clinical and biological events of grade 3 or 4 (ANRS scale) related to the ARV treatment
Time frame: 36 weeks
Liver fibrosis
Elastometry score and only for cirrhotic patients : Child-Pugh score
Time frame: W0, W24 and W36
Adherence measured by number of remaining tablets at each visit based on the number of tablets should have been taken as a percentage of the total dose
Number of remaining tablets at each visit based on the number of tablets should have been taken as a percentage of the total dose
Time frame: W4, W8, W12
Quality of life
proportion of people reporting symptoms in the scale of symptoms experienced (scale of side effects perception SF12)
Time frame: 36 weeks
Performance of an unit of nanotechnology
calculation of sensitivity / specificity / positive predictive value and negative of each of the steps that will be performed (genotype, viral load) compared to the reference measurement (PCR for viral load and sequencing to genotype).
Time frame: 36 weeks
Setting up the network:
number of network meetings that have taken place before the end of the trial, the number of training sessions (on site or online) and the numbers enrolled in the network active partners. The ultimate goal is the establishment of an e-learning platform that will be an ancillary project.
Time frame: 36 weeks
Integration Access initiatives evaluated by the number of patients off protocol that will have access to new anti-HCV treatment due to "ACCESS" programs of pharmaceutical companies conducting such programs in Sub-Saharan Africa
It will be evaluated by the number of patients off protocol that will have access to new anti-HCV treatment due to "ACCESS" programs of pharmaceutical companies conducting such programs in Sub-Saharan Africa
Time frame: 36 weeks
Biological events
Plasma HIV-RNA and CD4 count
Time frame: W0, W24 and W36
This study is completed, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.
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ANRS, Emerging Infectious Diseases