A Study to Evaluate the Efficacy and Safety of Three Experimental Drugs Compared With Telaprevir (a Licensed Product) in People With Hepatitis C Virus Infection Who Have Not Had Treatment Before

AbbVie311 enrolled

Overview

This is a study to evaluate the efficacy and safety of three experimental drugs compared with telaprevir (a licensed product) in people with hepatitis C virus infection who have not had treatment before.

The primary purpose of this study is to demonstrate that treatment with ABT-450/ritonavir (r)/ABT-267 and ABT-333 administered with or without ribavirin (RBV) has non-inferior efficacy compared to treatment with telaprevir and pegylated interferon alpha-2a (pegIFN) and RBV and to compare the safety of these regimens in treatment-naive hepatitis C virus (HCV) genotype (GT) 1a- and 1b-infected adults.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

311

Conditions

Chronic Hepatitis C Infection

Interventions

ABT-450/r/ABT-267, ABT-333DRUG

Tablet; ABT-450 coformulated with ritonavir and ABT-267, ABT-333 tablet

RibavirinDRUG

Tablet

TelaprevirDRUG

Film-coated tablet

Pegylated Interferon alpha 2-a (PegIFN)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Males or females between 18 and 65 years, inclusive, at time of Screening * Females must be post-menopausal for more than 2 years or surgically sterile or practicing abstinence/specific forms of birth control * Subject has never received antiviral treatment for hepatitis C infection * Chronic HCV Genotype-1 infection prior to study enrollment Exclusion Criteria: * Positive test result for Hepatitis B surface antigen (HBsAg) or anti-Human Immunodeficiency virus antibody (HIV Ab) * Females who are pregnant or plan to become pregnant, or breastfeeding * Any current or past clinical evidence of cirrhosis * Screening laboratory analyses that showing abnormal laboratory results * Use of contraindicated medications within 2 weeks of dosing and subject with contraindication for telaprevir, pegIFN and RBV * Recent (within 6 months prior to study drug administration) history of drug or alcohol abuse that could preclude adherence to the protocol * Positive screen for drugs or alcohol

Outcomes

Primary Outcomes

Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment (SVR12) - Primary Efficacy Analyses

The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid \[HCV RNA\] level less than the lower limit of quantitation \[\< LLOQ\]) 12 weeks after the last dose of study drug.

Time frame: 12 weeks after the last actual dose of active study drug

Secondary Outcomes

Mean Change From Baseline to the Final Treatment Visit in Short-Form 36 Version 2 Health Status Survey (SF-36V2) Mental Component Summary (MCS)

SF-36V2 is a generic 36-item questionnaire measuring health-related quality of life (HRQoL) covering 2 summary measures: physical component summary (PCS) and MCS; it consists of 8 subscales. The MCS is represented by 4 subscales: vitality, social function, role limitations due to emotional problems, and mental health. Participants self-report on items in a subscale that have choices per item. Scoring is done for both MCS subscale scores and summary scores; for each, the range is 0 (worst HRQoL) to 100 (best HRQoL).

Time frame: From Day 1 of treatment up to 12 weeks for Arms A, C and D and up to 24 or 48 weeks for Arms B and E

Mean Change From Baseline to the Final Treatment Visit in SF-36V2 Physical Component Summary (PCS)

SF-36V2 is a generic 36-item questionnaire measuring HRQoL covering 2 summary measures: PCS and MCS; it consists of 8 subscales. The PCS is represented by 4 subscales: physical function, role limitations due to physical problems, bodily pain, and general health perception. Participants self-report on items in a subscale that have choices per item. Scoring is done for both PCS subscale scores and summary scores; for each, the range is 0 (worst HRQoL) to 100 (best HRQoL).

Time frame: From Day 1 of treatment up to 12 weeks for Arms A, C and D and up to 24 or 48 weeks for Arms B and E

Percentage of Participants With SVR12 - Secondary Efficacy Analyses

The percentage of participants with sustained virologic response (plasma HCV RNA level \< LLOQ) 12 weeks after the last dose of study drug.

Data from ClinicalTrials.gov

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Percentage of Participants With Virologic Failure During Treatment

Participants in Arms A, C or D demonstrating any of the following were considered virologic failures and discontinued therapy: * Confirmed increase from nadir in HCV RNA (defined as 2 consecutive HCV RNA measurements of \>1 log10 IU/mL above nadir) at any time point during treatment * Failure to achieve HCV RNA \< LLOQ by Week 6 or * Confirmed HCV RNA ≥ LLOQ (defined as 2 consecutive HCV RNA measurements ≥ LLOQ) at any point after HCV RNA \< LLOQ during treatment after HCV RNA \< LLOQ. Participants in Arms B and E followed virologic stopping criteria described in the TPV Summary of Product Characteristics; they were considered virologic failures and discontinued therapy as follows: * HCV RNA \> 1000 IU/mL at Week 4 to Week 12, discontinue TPV and pegIFN and RBV * HCV RNA \> 1000 IU/mL at Week 12, discontinue pegIFN and RBV * Confirmed HCV RNA \> lower limit of detection (LLOD) at Week 24, discontinue pegIFN and RBV * Confirmed HCV RNA \> LLOD at Week 36, discontinue pegIFN and RBV.

Time frame: 12 weeks for Arms A, C and D and 24 weeks or 48 weeks for Arms B and E