The purpose of the study is to determine the safety, pharmacokinetics and efficacy of orally administered VX-135 with ribavirin in treatment naive subjects with chronic hepatitis C infection.
Up to twenty (20) subjects with CHC GT1 infection will be randomized in a 1:1 ratio (with stratification by IL-28B genotype (CC versus non-CC)) to evaluate VX-135 low dose or high dose both given in combination with RBV for 12 weeks. Safety and tolerability will be evaluated on an ongoing basis through assessment of adverse events (AEs), lab evaluations and physical examinations. Subjects will be monitored from Day 1 through end of follow-up for virologic breakthrough or relapse.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
20
Arensia, Republican Clinical Hospital
Chisinau, Moldova
Safety
The safety and tolerability as assessed by evaluating adverse events and laboratory testing.
Time frame: Week 12
evidence of HCV RNA viral load reduction
The proportion of subjects who have an SVR at 4 weeks after the last planned dose of treatment (SVR4)
Time frame: 16 weeks
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