Rapid Hepatitis C Elimination Trial- A Pilot Study of Daclatasvir/Asunaprevir/BMS-791325 With or Without Ribavirin To Treat Hepatitis C Virus
- Conditions
- Hepatitis C
- Interventions
- Drug: DCV/ASV/BMS-791325
- Registration Number
- NCT02098616
- Lead Sponsor
- Timothy Morgan, MD
- Brief Summary
The purpose of this study is to determine whether treatment with Daclatasvir/Asunaprevir/BMS-791325, with or without ribavirin, for 8, 6, or 4 weeks is feasible for the treatment of genotype 1a chronic hepatitis C in patients without cirrhosis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 25
- Subjects chronically infected with HCV genotype 1a
- HCV RNA ≥ 10,000 IU/mL at screening
- Treatment-naïve subjects with no previous exposure to an interferon formulation (ie, IFNα, pegIFNα), ribavirin (RBV), or HCV direct acting antiviral (DAA; protease, polymerase inhibitor, etc.)
- Evidence of cirrhosis
- Liver or any other organ transplant
- Current or known history of cancer within 5 years prior to enrollment
- Documented or suspected hepatocellular carcinoma (HCC)
- Not eligible for sofosbuvir + pegylated interferon + ribavirin therapy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 1 DCV/ASV/BMS-791325 Fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg and BMS-791325 75 mg) tablet orally twice a day for 8 weeks Arm 3 DCV/ASV/BMS-791325 Fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg and BMS-791325 75 mg) tablet orally twice a day for 4 weeks Arm A DCV/ASV/BMS-791325 + RBV Fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg and BMS-791325 75 mg) tablet orally twice a day plus weight based ribavirin orally twice a day for 8 weeks Arm 2 DCV/ASV/BMS-791325 Fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg and BMS-791325 75 mg) tablet orally twice a day for 6, 8 or 12 weeks Arm B DCV/ASV/BMS-791325 + RBV Fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg and BMS-791325 75 mg) tablet orally twice a day plus weight based ribavirin orally twice a day for 6, 8 or 12 weeks Arm C DCV/ASV/BMS-791325 + RBV Fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg and BMS-791325 75 mg) tablet orally twice a day plus weight based ribavirin orally twice a day for 4 weeks
- Primary Outcome Measures
Name Time Method Sustained Virologic Response Post treatment week 12 Proportion of treated subjects in each enrolled arm with sustained virologic response (SVR)12. SVR12 is defined as HCV RNA \< lower limit of quantification (LLOQ) target detected or target not detected (TD/TND) at post treatment Week 12
- Secondary Outcome Measures
Name Time Method Sustained virologic response 2, 4 and 24 weeks post-treatment Proportion of treated subjects in each arm with SVR2, SVR4 and SVR 24, defined as HCV RNA \< lower limit of quantification (LLOQ) target detected or target not detected (TD/TND) at post treatment Weeks, 2, 4, and 24 respectively
Post treatment virologic response post treatment Weeks 2 (SVR2), 4 (SVR4), and 24 (SVR24) To assess the proportion of subjects who achieve sustained virologic response (SVR) 2, SVR4 and SVR24.
Virologic failure On-treatment Day 2 and Weeks 1, 2, 4, 6, 8 and 12 and Post Treatment Weeks 2, 4, 12 and 24 To assess the proportion of subjects with virologic failure (including on treatment virologic breakthrough and relapse) and evaluate the emergence of viral resistant mutations.
On treatment virologic response On-treatment Day 2 and Weeks 1, 2, 4, 6, 8 and 12 To assess antiviral activity, as measured by the proportion of subjects who achieve HCV RNA \<lower limit of detection (LLOD) and/or \< lower limit of quantification (LLOQ) at each on treatment visit.
Safety Up to end of treatment (+7 days) On treatment safety, as measured by frequency of serious adverse events (SAEs) and adverse events (AEs), discontinuations due to AEs, and rates and grades of select laboratory abnormalities including liver function tests and hematology laboratory abnormalities in each arm
Day 2 positive predictive value Post treatment Week 12 To assess the predictive value of Day 2 virologic response on sustained virologic response (SVR) 12
Interferon lambda genotype and virologic response On-treatment Day 2 and Weeks 1, 2, 4, 6, 8 and 12 and Post Treatment Weeks 2, 4, 12 and 24 To compare the virologic response of subjects by genotype for interferon (IFN) lambda variants \[' IL28B' and IFNL4-ΔG\]
Trial Locations
- Locations (1)
VA Long Beach Healthcare System
🇺🇸Long Beach, California, United States
VA Long Beach Healthcare System🇺🇸Long Beach, California, United States