Evaluate the efficacy of 12 or 8 weeks treatment with Grazoprevir/Elbasvir in Early Chronic Hepatitis C GT1,4 in HIV co-infected patients and evaluate the safety and tolerability of Grazoprevir + Elbasvir in HIV-HCV co-infected patients.
Genotype 1b: 8 weeks treatment with Grazoprevir/Elbasvir Genotype 1a and 4: 12 weeks treatment with Grazoprevir/Elbasvir
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
62
Patients with 1b HCV genotype will be received treatment with Grazoprevir (100 mg) during 8 weeks.
Patients with 1b HCV genotype will be received treatment with Elbasvir (50mg) during 8 weeks.
Patients with 1a or 4 HCV genotype will be received treatment with Grazoprevir (100 mg) during 12 weeks.
Hospital Clínico y provincial de Barcelona
Barcelona, Spain
Sustained virological response.
Sustained virological response 12 (SVR12) defined as HCV-RNA undetectable at post-treatment.
Time frame: 24 weeks
Reinfection rate
Evaluate the reinfection rate during 1 year of follow-up Sustained virological response defined as HCV-RNA undetectable at post-treatment.
Time frame: 1 year
Evaluate the safety and tolerability by means of number of participants with treatment-related adverse events.
number of adverse events treatment-related assess in 62 patients.
Time frame: 2 years
Evaluate the emergence of of viral resistance-associated variants (RAV) resistant to MK-5172 and MK-8742. during the follow up.
In case of viral failure confirmation during the follow up, viral resistence-associated variants will be assess by samples genotyping HCV protease and NS5A gene at baseline and after the viral failure.
Time frame: 2 years
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Patients with 1a or 4 HCV genotype will be received treatment with Elbasvir (50mg) during 12 weeks.