Telaprevir, Peg-IFN-alfa-2a, and RBV in Treatment-Experienced Black/African American and Non-Black/African American Subjects With Genotype 1 Chronic Hepatitis C

Vertex Pharmaceuticals

Status and phase: Terminated; Phase 4

Conditions: Hepatitis C

Treatments: Biological: Pegylated Interferon Alfa-2a; Drug: Ribavirin; Drug: Telaprevir

Study type: Interventional

Funder types: Industry

Identifiers

NCT01467492

VX11-950-116

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy and safety of telaprevir in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) and ribavirin (RBV) in treatment-experienced Black/African American and non-Black/African American participants with Genotype 1 Chronic Hepatitis C (CHC), who have not achieved a sustained viral response with a prior course of interferon-based therapy.

Full description

This is a single-arm, open-label, multicenter study of treatment-experienced participants with Genotype 1 CHC, who self-identified as Black/African American (Group A) or who did not self-identify as Black/African American (Group B). Participants did not achieve a sustained virologic response 24 weeks after at least 1 prior course of Peg-IFN-alfa-2a/RBV therapy of standard duration, and have 1 of the following viral responses:

• Prior relapse: Participant had a documented undetectable hepatitis C virus ribonucleic acid (HCV RNA) level at the planned end of treatment of at least 42 weeks duration (HCV RNA evaluated anytime between 3 weeks before and 6 weeks after the last dose of Peg IFN-alfa-2a or RBV).
• Prior null response: Participant had a <2-log10 decrease in HCV RNA at 12 weeks, during prior Peg IFN-alfa-2a/RBV treatment, but never achieved undetectable HCV RNA while on treatment.
• Prior partial response: Participant had a >=2-log10 decrease in HCV RNA at 12 weeks, during prior Peg IFN-alfa-2a/RBV treatment, but never achieved undetectable HCV RNA while on treatment.

Enrollment: 121 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants self-identify as Black/African American (Group A) or did not self-identify as Black/African American (Group B)
• Participants have Genotype 1 CHC and laboratory evidence of hepatitis C virus (HCV) infection for at least 6 months
• Participants did not achieve sustained viral response 24 weeks after last dose of study drug (SVR24), after at least 1 prior course of Peg-IFN-alfa-2a/RBV therapy of standard duration

Exclusion criteria

• Participants have received previous treatment with telaprevir or any other protease inhibitor(s) for CHC
• Participants who have evidence of hepatic decompensation
• Participants have diagnosed or suspected hepatocellular carcinoma
• Participants have any other cause of significant liver disease in addition to HCV
• Participants are currently abusing illicit drugs or alcohol, or have history of illicit substance or alcohol abuse within 2 years before the screening visit
• Participants who participated in any investigational drug study within 90 days before dosing

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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121 participants in 2 patient groups

Black

Experimental group

Description:

Telaprevir 750 milligram (mg) tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 microgram per week (mcg/week) subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 milligram per day (mg/day) (for participants weighing \<75 kilograms \[kg\]) or 1200 mg/day (for participants weighing \>=75 kg) for 24 or 48 weeks.

Treatment:

Drug: Telaprevir

Drug: Ribavirin

Biological: Pegylated Interferon Alfa-2a

Non-Black

Experimental group

Description:

Telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing \<75 kg) or 1200 mg/day (for participants weighing \>=75 kg) for 24 or 48 weeks.

Treatment:

Drug: Telaprevir

Drug: Ribavirin

Biological: Pegylated Interferon Alfa-2a