Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02124044 | Safety, Tolerability, and Efficacy of Asunaprevir and Daclatasvir in Subjects Coinfected With HIV-HCV | PHASE2 | COMPLETED | 30 | — | — | Feb 1, 2014 | Nov 1, 2016 | May 16, 2017 | 1 | United States |
The primary outcome was the percentage of patients with sustained viral response measured 12 weeks after the stop of treatment. The viral response was assessed by serum HCV RNA concentrations lower than 43 IU/mL - the lower limit of quantification.
| Arm | Type | Description |
|---|---|---|
| HIV/HCV GT-1b, 24 wks ASV/DCV | EXPERIMENTAL | Oral treatment with Asunaprevir 100mg (ASV), twice daily, and Daclatasvir 60mg (DCV), once daily, for 24 weeks in HIV/HCV genotype 1b patients |
| HIV/HCV GT-1a/1b, 12 wks ASV/DCV with BMS-791325 | EXPERIMENTAL | Oral treatment with Asunaprevir 200mg (ASV), Daclatasvir 30 mg (DCV) and BMS-791325 75 mg in a fixed dose combination pill (FDC), twice daily, for 12 weeks in HIV/HCV genotype 1a or 1b patients |
| Name | Type | Description |
|---|---|---|
| Asunaprevir and Daclatasvir | DRUG | Oral treatment with Asunaprevir 100mg (ASV), twice daily, and Daclatasvir 60mg (DCV), once daily, for 24 weeks in HIV/HCV genotype 1b patients |
| Asunaprevir and Daclatasvir with BMS-791325 | DRUG | Oral treatment with Asunaprevir 200mg (ASV), Daclatasvir 30 mg (DCV) and BMS-791325 75 mg in a fixed dose combination pill (FDC), twice daily, for 12 weeks in HIV/HCV genotype 1a or 1b patients |
* INCLUSION CRITERIA Subjects who meet the following criteria are eligible to enter the study: 1. Eighteen years of age or older at screening 2. Naive to treatment for hepatitis C or treatment experienced on previous IFN-containing treatment for chronic HCV infection. Patients who have been re-inf...