Hepatitis C
Conditions
Keywords
Hepatitis, Hepatitis, Chronic, Hepatitis C, Hepatitis C, Chronic, Liver Diseases, Digestive System Diseases, Hepatitis, Viral, Human, RNA Virus Infections, Antiviral Agents, Drug Resistance, Viral
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.
Interventions
Fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg and BMS-791325 75 mg) orally twice a day
DRUGDCV/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
Sponsors
VA Long Beach Healthcare System
National Cancer Institute (NCI)
Bristol-Myers Squibb
Timothy Morgan, MD
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.)
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 \[' IL28B' and IFNL4-ΔG\] |
| 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. |
Countries
United States
Outcome results
None listed