A Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Subjects With Genotype 1 Infection

AbbVie

Status and phase: Completed; Phase 3

Conditions: HCV; Hepatitis C Virus; Chronic Hepatitis C

Treatments: Drug: ABT-493/ABT-530

Study type: Interventional

Funder types: Industry

Identifiers

NCT02604017

M13-590

2015-002087-17 (EudraCT Number)

Details and patient eligibility

About

This study seeks to evaluate the efficacy and safety of ABT-493/ABT-530 in participants with Genotype 1 hepatitis C virus infection without cirrhosis

Enrollment: 703 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female, at least 18 years of age at time of screening.
• Screening laboratory result indicating hepatitis C virus (HCV) genotype 1 (GT1) infection.
• Chronic HCV infection.
• Subject must be HCV treatment-naïve (i.e., patient has never received a single dose of any approved or investigational regimen) or treatment-experienced (has failed prior interferon [IFN] or pegylated IFN (pegIFN) with or without ribivarin (RBV), or sofosbuvir (SOF) plus RBV with or without pegIFN therapy).
• Subjects must be non-cirrhotic.

Additional Inclusion Criteria for HCV GT1/human immununovirus type 1 (HIV-1) co-infected patients:

• HIV-1 antiretroviral treatment (ART) naïve with CD4 ≥ 500 cells/mm3 (or CD4+ % ≥ 29%) at Screening and plasma HIV-1 RNA <1,000 copies/mL at Screening and at least once during the 12 months prior to Screening.

OR

• On a stable, qualifying HIV-1 ART regimen for at least 8 weeks prior to screening, with CD4 ≥ 200 cells/mm3 (or CD4+ % ≥14%) at Screening and plasma HIV-1 RNA < LLOQ at Screening and at least once during the 12 months prior to Screening.

Exclusion criteria

• History of severe, life-threatening or other significant sensitivity to any excipients of the study drugs.
• 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.
• Recent (within 6 months prior to study drug administration) history of drug or alcohol abuse that could preclude adherence to the protocol in the opinion of the investigator.
• Positive test result at Screening for hepatitis B surface antigen (HBsAg).
• HCV genotype performed during screening indicating co-infection with more than one HCV genotype.
• Chronic HIV type 2 (HIV-2) infection.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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703 participants in 2 patient groups

ABT-493/ABT-530 for 12 weeks

Experimental group

Description:

ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.

Treatment:

Drug: ABT-493/ABT-530

ABT-493/ABT-530 for 8 weeks

Experimental group

Description:

ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 8 weeks.

Treatment:

Drug: ABT-493/ABT-530