Pilot, single center, open-label study to evaluate the efficacy and tolerability of Grazoprevir and Elbasvir in HCV GT1 and 4 liver transplant recipients.30 liver transplant recipients with hepatitis C recurrence.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Grazoprevir 100 mg/ day 12 weeks
Elbasvir 50 mg/day 12 weeks
Grazoprevir 100 mg/day 16 weeks
Sustained virological response
Sustained virological response 12 w (SVR24) defined as HCV-RNA undetectable at post-treatment week 12.
Time frame: 12 weeks post-treatment
Sustained virological response
Sustained virological response 12 ( SVR12) defined as HCV-RNA undetectable at post-treatment weeks 4 and , 24 respectively.
Time frame: 4 weeks and 24 weeks post-treatment
To evaluate the beneficial effects of antiviral therapy on renal function.
creatinine sample analyses blood analyses in all visits
Time frame: 24 weeks post-treatment
To assess the impact of therapy in kidney function.
Elevation Transaminases blood analyses in all visits
Time frame: 24 weeks post-treatment
Tolerability of this combination in liver transplant recipients.
Serious advers events evaluation
Time frame: Every visit
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Elbasvir 50 mg/d 16 weeks
Ribavirin 1200 mg/day 16 weeks