The study is designed to test the hypothesis that the addition of a protease inhibitor to dual NS5a-NS5B nucleoside prodrug analog will enhance antiviral efficacy and hence shorten the treatment duration to 3 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
18
Ledipasvir/sofosbuvir (LDV/SOF) 90 mg/400 mg fixed-dose combination (FDC) tablet; administered orally once daily; Asunaprevir (ASV) 200mg, administered orally twice daily.
Sofosbuvir (SOF) 400 mg tablet administered orally once daily; Daclatasvir (DCV) 60 mg tablet administered orally once daily; Simeprevir (SMV) 150 mg tablet orally once daily.
Sofosbuvir (SOF) 400 mg tablet administered orally once daily; Daclatasvir (DCV) 60 mg tablet administered orally once daily; Asunaprevir (ASV) 200mg, administered orally twice daily.
Humanity and Health GI and Liver Centre
Hong Kong, Hong Kong, China
Proportion of participants with sustained virologic response 12 weeks after discontinuation of therapy (SVR12)
SVR12 is defined as HCV RNA \< lower limit of quantification (LLOQ) 12 weeks after last dose of study drug.
Time frame: Post treatment Week 12
Proportion of participants with adverse events leading to permanent discontinuation of study drug(s)
Time frame: Baseline up to Week 24
Proportion of participants with unquantifiable HCV viral load at specified time points during and after treatment.
Time frame: Baseline up to Week 24
HCV RNA levels and change during and after treatment.
Time frame: Baseline up to Week 24
Proportion of participants with on-treatment virologic breakthrough and relapse
Viral breakthrough is defined as having achieved undetectable HCV RNA levels (HCV RNA \< LLOQ) during treatment, but did not achieve a sustained virologic response (SVR). Viral relapse is defined as having achieved undetectable HCV RNA levels (HCV RNA \< LLOQ) within 4 weeks of end of treatment, but did not achieve an SVR.
Time frame: Baseline up to Week 24
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