Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Beijing 302 Hospital | OTHER |
| Emory University | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LDV/SOF+ASV | Experimental | Participants with genotype 1b HCV infection will receive LDV/SOF FDC + ASV 3 weeks. |
|
| SOF+DCV+SMV | Experimental | Participants with genotype 1b HCV infection will receive SOF + DCV + SMV for 3 weeks. |
|
| SOF+DCV+ASV | Experimental | Participants with genotype 1b HCV infection will receive SOF + DCV + ASV for 3 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LDV/SOF+ASV | Drug | Ledipasvir/sofosbuvir (LDV/SOF) 90 mg/400 mg fixed-dose combination (FDC) tablet; administered orally once daily; Asunaprevir (ASV) 200mg, administered orally twice daily. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Post treatment Week 12 |
| Proportion of participants with adverse events leading to permanent discontinuation of study drug(s) | Baseline up to Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
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:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| George Lau, MD | Humanity and Health GI and Liver Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Humanity and Health GI and Liver Centre | Hong Kong | Hong Kong | 00852 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27917405 | Derived | Lau G, Benhamou Y, Chen G, Li J, Shao Q, Ji D, Li F, Li B, Liu J, Hou J, Sun J, Wang C, Chen J, Wu V, Wong A, Wong CL, Tsang ST, Wang Y, Bassit L, Tao S, Jiang Y, Hsiao HM, Ke R, Perelson AS, Schinazi RF. Efficacy and safety of 3-week response-guided triple direct-acting antiviral therapy for chronic hepatitis C infection: a phase 2, open-label, proof-of-concept study. Lancet Gastroenterol Hepatol. 2016 Oct;1(2):97-104. doi: 10.1016/S2468-1253(16)30015-2. Epub 2016 Jul 25. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000069474 | Sofosbuvir |
| C586541 | ledipasvir |
| C000595958 | ledipasvir, sofosbuvir drug combination |
| C571889 | asunaprevir |
| C549273 | daclatasvir |
| D000069616 | Simeprevir |
| ID | Term |
|---|---|
| D014542 | Uridine Monophosphate |
| D014500 | Uracil Nucleotides |
| D011742 | Pyrimidine Nucleotides |
| D011743 | Pyrimidines |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| SOF+DCV+SMV | Drug | 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. |
|
|
| SOF+DCV+ASV | Drug | 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. |
|
|
| 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. | Baseline up to Week 24 |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009711 | Nucleotides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012265 | Ribonucleotides |
| D013449 | Sulfonamides |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |