A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of ABT-450 With Ritonavir (ABT-450/r) When Given Together With ABT-333 and Ribavirin (RBV) in Treatment-Naïve and Non-responder Subjects With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection

AbbVie

Status and phase: Completed; Phase 2

Conditions: Hepatitis C; Hepatitis C Virus; Chronic Hepatitis C Infection

Treatments: Drug: ribavirin; Drug: ritonavir; Drug: ABT-333; Drug: ABT-450

Study type: Interventional

Funder types: Industry

Identifiers

NCT01306617

M12-746

Details and patient eligibility

About

The purpose of this study is to evaluate the antiviral activity, safety, and pharmacokinetics of ABT-450 with ritonavir (ABT-450/r) dosed in combination with ABT-333 (also known as dasabuvir) and ribavirin (RBV) in treatment-naïve and non responder participants with genotype 1 chronic hepatitis C virus (HCV) infection.

Full description

This was a phase 2a multicenter, open-label, sequential, 3-arm, combination treatment study of a regimen of ABT-450/r/ABT-333, and ribavirin (RBV) in hepatitis C virus (HCV) genotype 1-infected treatment-naïve participants and previous non-responders to pegylated interferon (pegIFN)/RBV treatment.

Enrollment: 50 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Chronic hepatitis C virus (HCV)
• Treatment naive, null or partial responders to previous treatment with peginterferon and ribavirin
• Males and females 18-65 years old
• Body mass index 18 to < 35 kg/m^2
• Females must be postmenopausal for at least 2 years or surgically sterile

Exclusion criteria

• Cirrhosis or extensive bridging fibrosis
• History of cardiac disease
• Positive screen for certain drugs or alcohol
• Abnormal laboratory results
• Significant sensitivity to any drug
• Positive hepatitis B surface antigen or anti-human immunodeficiency virus antibody
• Use of strong cytochrome P450 3A (CYP3A), cytochrome P450 2C8 (CYP2C8), and organic anion transporting polypeptide 1B1 (OATP1B1) enzyme inducers or inhibitors within 1 month of dosing

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 3 patient groups

ABT-450/r (250/100 mg) and ABT-333 plus RBV in treatment-naïve

Experimental group

Description:

ABT-450/r (250/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.

Treatment:

Drug: ribavirin

Drug: ABT-333

Drug: ritonavir

Drug: ABT-450

ABT-450/r (150/100 mg) and ABT-333 plus RBV in treatment-naïve

Experimental group

Description:

ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.

Treatment:

Drug: ribavirin

Drug: ABT-333

Drug: ritonavir

Drug: ABT-450

ABT-450/r (150/100 mg) and ABT-333 plus RBV in non-responders

Experimental group

Description:

ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID in previous non-responders to pegylated interferon (pegIFN) and RBV.

Treatment:

Drug: ribavirin

Drug: ABT-333

Drug: ritonavir

Drug: ABT-450