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

• Status: Completed
• Trial end date: 2017-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AbbVie

Criteria

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.