A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of ABT-493 and ABT-530 With and Without Ribavirin in Adults With HCV Who Failed a Prior DAA Containing Therapy

AbbVie

Status and phase: Completed; Phase 3; Phase 2

Conditions: Direct-Acting Antiviral Agent (DAA)-Experienced; HCV; Hepatitis C Virus; Chronic Hepatitis C

Treatments: Drug: ribavirin (RBV); Drug: ABT-493, ABT-530; Drug: ABT-493/ABT-530

Study type: Interventional

Funder types: Industry

Identifiers

NCT02446717

2015-002350-13 (EudraCT Number)

M15-410

Details and patient eligibility

About

The purpose of this study is to assess the efficacy and safety of ABT-493 and ABT-530 with or without ribavirin (RBV) in participants with chronic hepatitis C virus, (HCV)-infection who previously failed treatment with a direct acting antiviral (DAA)-containing regimen.

Enrollment: 141 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients from 18 to 70 years in Arms A, B, and C; patients 18 years of age or older in Arms D and E.
2. Previous treatment with DAA-containing regimen for chronic hepatitis C virus (HCV) infection resulting in either on-treatment virologic failure or post-treatment relapse
3. Chronic HCV genotype (GT) 1, 4, 5, or 6-infection (GT4-6 in Arms D and E)

Exclusion criteria

1. History of severe, life-threatening or other significant sensitivity to any drug
2. Female who is pregnant, planning to become pregnant during the study or breastfeeding; or male whose partner is pregnant or planning to become pregnant during the study
3. Recent (within 6 months prior to study drug administration) history of drug or alcohol abuse that could preclude adherence to the protocol
4. Positive for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab)
5. Co-infection with more than one HCV genotype

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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141 participants in 5 patient groups

Arm A

Experimental group

Description:

ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (80 mg) QD for 12 weeks in chronic HCV genotype 1- infected participants without cirrhosis.

Treatment:

Drug: ABT-493, ABT-530

Arm B

Experimental group

Description:

ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD plus ribavirin (RBV) for 12 weeks in chronic HCV genotype 1- infected participants without cirrhosis.

Treatment:

Drug: ABT-493, ABT-530

Drug: ribavirin (RBV)

Arm C

Experimental group

Description:

ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in chronic HCV genotype 1- infected participants without cirrhosis.

Treatment:

Drug: ABT-493, ABT-530

Arm D

Experimental group

Description:

ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks in HCV genotypes 1- or 4-6- infected participants with or without cirrhosis.

Treatment:

Drug: ABT-493/ABT-530

Arm E

Experimental group

Description:

ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 16 weeks in HCV genotype 1- or 4-6- infected participants with or without cirrhosis.

Treatment:

Drug: ABT-493/ABT-530