VX-222 + Telaprevir + Ribavirin for 12 or 16 Weeks in Treatment-Naive Subjects With Genotype 1a Hepatitis C

Study Overview
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Brief Summary
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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.

Official Title
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A Multicenter, Randomized, Open-label, Phase 2b Study to Evaluate the Efficacy and Safety of Two Regimens of All-oral Triple Therapy (VX-222 in Combination With Telaprevir [Incivek™] and Ribavirin [Copegus®]) in Treatment-Naïve Subjects With Genotype 1a Chronic Hepatitis C

Conditions
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Chronic Hepatitis C Virus

Intervention / Treatment
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* Drug: VX-222
* Drug: telaprevir
* Drug: ribavirin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 12 week treatment<br> | Drug: VX-222<br>* 400 mg tablets twice daily for oral administration<br>Drug: telaprevir<br>* 1125 mg tablets twice daily for oral administration<br>* Other names: VX-950, INCIVEK, INCIVO, TELAVIC;Drug: ribavirin<br>* 1000 mg per day for subjects weighing <75 kg and 1200 mg per day for subjects weighing ≥75 kg, dosed twice daily<br>* Other names: Copegus;|
| Experimental: 16 week treatment<br> | Drug: VX-222<br>* 400 mg tablets twice daily for oral administration<br>Drug: telaprevir<br>* 1125 mg tablets twice daily for oral administration<br>* Other names: VX-950, INCIVEK, INCIVO, TELAVIC;Drug: ribavirin<br>* 1000 mg per day for subjects weighing <75 kg and 1200 mg per day for subjects weighing ≥75 kg, dosed twice daily<br>* Other names: Copegus;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 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 | 
| Time to achieve <LLOQ undetectable HCV RNA |  | up to 16 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 |