This study will evaluate the efficacy and safety of NEUTRINO regimen in Chinese chronic HCV genotype 1b treatment-experienced patients.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
32
Sofosbuvir (SOF) 400 mg tablet is administered orally once daily; Pegylated interferon alfa-2a (PEG) 180 μg was administered once weekly by subcutaneous injection; Ribavirin (RBV) was administered as a tablet orally according to body weight (\< 75kg = 1000 mg and ≥ 75 kg = 1200 mg).
Liver Fibrosis Diagnosis and Treatment Centre, 302 Hospital
Beijing, Beijing Municipality, China
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)
Adverse events leading to permanent discontinuation of study drug(s)
Time frame: Baseline up to Week 24
Change in HCV RNA From Baseline to Week 12
Time frame: Baseline up to Week 24
Proportion of participants with on-treatment virologic breakthrough and relapse
Time frame: Baseline up to Week 24
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