Chronic Hepatitis C Infection
Conditions
Brief summary
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.
Interventions
DRUGLDV/SOF+ASV
Ledipasvir/sofosbuvir (LDV/SOF) 90 mg/400 mg fixed-dose combination (FDC) tablet; administered orally once daily; Asunaprevir (ASV) 200mg, administered orally twice daily.
DRUGSOF+DCV+SMV
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.
DRUGSOF+DCV+ASV
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.
Sponsors
Beijing 302 Hospital
Emory University
Humanity and Health Research Centre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age equal to or greater than 18 years, with chronic genotype 1b HCV infection; * HCV RNA level \> 10,000 and \< 10,000,000 IU/ml at Screening; * Rapid response to triple DAAs therapy with less than 500 IU/ml plasma HCV RNA level at Day 2; * No evidence of cirrhosis. Cirrhosis defined as any 1 of the following, within 6 months of study entry: 1. Liver biopsy showing cirrhosis; 2. Fibroscan showing cirrhosis or results\>12.5 kPa ; 3. FibroTest® score \>0.75 and an aspartate aminotransferase (AST): platelet ratio index (APRI) \>2 during screening.
Exclusion criteria
* Pregnant or nursing female or male with pregnant female partner; * HIV or chronic hepatitis B virus (HBV) infection; * Hematologic or biochemical parameters at Screening outside the protocol-specified requirements; * Active or recent history (≤ 1 year) of drug or alcohol abuse; * Hepatocellular carcinoma or other malignancy (with exception of certain resolved skin cancers); * History or current evidence of any condition, therapy, laboratory abnormality or other circumstance that might confound the results of the study, or interfere with the subject's participation for the full duration of the study, such that it is not in the best interest of the subject to participate.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants with sustained virologic response 12 weeks after discontinuation of therapy (SVR12) | Post treatment Week 12 | SVR12 is defined as HCV RNA \< lower limit of quantification (LLOQ) 12 weeks after last dose of study drug. |
| Proportion of participants with adverse events leading to permanent discontinuation of study drug(s) | Baseline up to Week 24 | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants with unquantifiable HCV viral load at specified time points during and after treatment. | Baseline up to Week 24 | — |
| HCV RNA levels and change during and after treatment. | Baseline up to Week 24 | — |
| Proportion of participants with on-treatment virologic breakthrough and relapse | Baseline up to Week 24 | 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. |
Countries
China
Outcome results
None listed