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 (MALACHITE 1)

AbbVie

Status and phase: Completed; Phase 3

Conditions: Chronic Hepatitis C Infection

Treatments: Drug: Telaprevir; Drug: Pegylated Interferon alpha 2-a (PegIFN); Drug: ABT-450/r/ABT-267, ABT-333; Drug: Ribavirin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01854697

2012-003754-84 (EudraCT Number)

M13-774

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 311 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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311 participants in 5 patient groups

Arm A: 3-DAA + RBV in GT1a

Experimental group

Description:

ABT-450/r/ABT-267 150 mg/100 mg/25 mg once daily (QD) and ABT-333 250 mg twice daily (BID) and weight-based RBV for 12 weeks (3 direct-acting antivirals \[DAAs\] with RBV in GT1a)

Treatment:

Drug: Ribavirin

Drug: ABT-450/r/ABT-267, ABT-333

Arm B: TPV/PR in GT1a

Active Comparator group

Description:

Telaprevir (TPV) 750 mg every 8 hours (q8h) and pegIFN 180 µg/week and weight-based RBV (PR) for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight-based RBV according to response guided therapy per the prescribing information for telaprevir (telaprevir with pegIFN/RBV in GT1a)

Treatment:

Drug: Telaprevir

Drug: Pegylated Interferon alpha 2-a (PegIFN)

Drug: Ribavirin

Arm C: 3-DAA + RBV in GT1b

Experimental group

Description:

ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID and weight-based RBV for 12 weeks (3 DAAs with RBV in GT1b)

Treatment:

Drug: Ribavirin

Drug: ABT-450/r/ABT-267, ABT-333

Arm D: 3-DAA in GT1b

Experimental group

Description:

ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID for 12 weeks (3 DAAs without RBV in GT1b)

Treatment:

Drug: ABT-450/r/ABT-267, ABT-333

Arm E: TPV/PR in GT1b

Active Comparator group

Description:

Telaprevir 750 mg q8h and pegIFN 180 µg/week and weight-based RBV for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight-based RBV according to response guided therapy per the prescribing information for telaprevir (telaprevir with pegIFN/RBV in GT1b)

Treatment:

Drug: Telaprevir

Drug: Pegylated Interferon alpha 2-a (PegIFN)

Drug: Ribavirin