Aim of the study is to assess the efficacy and safety of 24 weeks of oral Sofosbuvir/Ledipasvir fixed-dose combination (FDC) in subjects with HCV genotype 1 infection and HIV co-infection, who have previously failed a NS3/4A protease inhibitor plus Pegylated interferon /ribavirin regimen or stopped prematurely their treatment for intolerance.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
68
SOF 400 mg/LDV 90 mg FDC tablet administered orally once daily
Centre de Méthodologie et de Gestion de Rennes
Rennes, France
Sustained virologic response 12 weeks after discontinuation of therapy (SVR12), i.e. at week 36.
Time frame: 12 weeks post-treatment
Adverse clinical and biological events that occur during the treatment and up to 24 weeks after the end of the treatment
Time frame: up to 24 weeks after the end of the treatment
Number and causes of poor adherence and treatment interruptions
Time frame: at 1,2,3,4,8,12,16, 20, 24 weeks during treatment, 4, 8,14,18,24 weeks after treatment discontinuationeeks after discontinuation of drugs
SVR rate 24 weeks (i.e. W48) after the end of treatment and according to the HCV sub-type
Time frame: Week 48
Number of patients with HCV resistance mutations to Sofosbuvir and/or Ledipasvir
Time frame: from Day(D)0 to Week (W)24
HCV viral load
Time frame: at Day 0, Week 1, 2, 4, 8, 12, 16, 20, week 24, and 4, 8, 12, 18 and 24 weeks after the end of the treatment
Plasma HIV RNA levels
Time frame: at Day 0, Week 4, 8, 12, 16, 20, 24, 36 and Week 48
Assess drug-drug interactions between HCV et HIV drugs
Describe pharmacokinetic parameters of HIV drugs at Day 0 and Week 4 Describe pharmacokinetic parameters of Sofosbuvir and Ledipasvir at Week 4
Time frame: Day 0 and Week 4
Patient's reported outcomes evaluation
Time frame: Day 0, Week 12, Week 24 and Week 36
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