Chronic Hepatitis C Virus
Conditions
Brief summary
The purpose of this study is to evaluate the efficacy and safety of two all oral regimens in subjects who have chronic hepatitis C and have not received treatment yet.
Interventions
DRUGVX-222
400 mg tablets twice daily for oral administration
DRUGtelaprevir
1125 mg tablets twice daily for oral administration
DRUGribavirin
1000 mg per day for subjects weighing \<75 kg and 1200 mg per day for subjects weighing ≥75 kg, dosed twice daily
Sponsors
Vertex Pharmaceuticals Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Subjects must have genotype 1 chronic hepatitis C (CHC) and laboratory evidence of HCV infection for at least 6 months before the Screening Visit * Subjects will be treatment naïve * Subjects must have documentation of the presence or absence of cirrhosis
Exclusion criteria
* History or other clinical evidence of significant or unstable cardiac disease * Evidence of hepatic decompensation * Diagnosed or suspected hepatocellular carcinoma * Any other cause of significant liver disease in addition to hepatitis C, which may include but is not limited to malignancy with hepatic involvement, hepatitis B, drug-or alcohol-related cirrhosis, autoimmune hepatitis, hemochromatosis, Wilson's disease, nonalcoholic steatohepatitis, or primary biliary cirrhosis * History of organ transplant, with the exception of corneal transplants and skin grafts
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of subjects who have a sustained viral response (SVR) at 12 weeks after the last planned dose of treatment | 12 weeks after the last planned dose of treatment |
Secondary
| Measure | Time frame |
|---|---|
| The proportion of subjects who have an SVR 24 weeks after the last planned dose of the study drug | 24 weeks after the last planned dose of the study drug |
| The proportion of subjects who have an SVR 4 weeks after the last planned dose of the study drug | 4 weeks after the last planned dose of the study drug |
| The proportion of subjects who relapse (i.e., who had <lower limit of quantitation LLOQ hepatitis C virus (HCV) RNA at the end of planned study drug treatment (planned EOT) followed by ≥LLOQ HCV RNA after planned EOT) | 48 weeks either after the last planned dose of study drug or after time of failure |
| The proportion of subjects who achieve undetectable HCV RNA (below the lower limit of detection (< (LLOQ) undetectable) at Weeks 2, 4, 8, 12, and 16 after the first dose of study drug, and <LLOQ at the end of planned study drug treatment (planned EOT) | up to 16 weeks |
| The safety and tolerability as assessed by adverse events (AEs), vital signs, 12-lead electrocardiograms (ECGs), and laboratory assessments (serum chemistry, hematology, and urinalysis) | up to 20 weeks |
| The proportion of subjects who have on-treatment virologic failure defined as subjects who either have viral breakthrough or who complete the assigned treatment and have ≥LLOQ HCV RNA at the end of study drug treatment (EOT) | up to 16 weeks |
| The association of the interleukin-28B (IL-28B) genotype (CC versus CT versus TT) with SVR12 | 12 weeks after the last planned dose of treatment |
| The amino acid sequence of the nonstructural (NS)3/4A and NS5B proteins in subjects who have treatment failure | 48 weeks either after the last planned dose of study drug or after time of failure |
| Time to achieve <LLOQ undetectable HCV RNA | up to 16 weeks |
Countries
United States
Outcome results
None listed