A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Co-Administration of ABT-493 and ABT-530 With and Without RBV in Subjects With Chronic Hepatitis C Virus (HCV) Genotypes 2, 3, 4, 5 or 6 Infection
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Co-Administration of ABT-493 and ABT-530 With and Without RBV in Subjects With Chronic Hepatitis C Virus (HCV) Genotypes 2, 3, 4, 5 or 6 Infection
The purpose of this phase 2/3, open-label, multipart, multicenter study was to evaluate the
 efficacy, and safety of co-administration of ABT-493 and ABT-530 with and without ribavirin
 (RBV) in chronic HCV genotype 2 (GT2-), genotype 3 (GT3-), genotype 4 (GT4), genotype 5
 (GT5-), or genotype 6 (GT6-) infected participants with or without cirrhosis.
The study consisted of four independent parts with treatment and post-treatment periods of
 enrollment. Parts 1 and 2 were the supportive/ exploratory parts (phase 2) of the study and
 part 3 and 4 were the confirmatory/ registrational parts (phase 3) of the study. In parts 1
 and 2 of the study, ABT-493 and ABT-530 were co-administered as separate tablets. However, in
 parts 3 and 4 of the study, the ABT-493/ABT-530 co-formulated tablets were administered.
Inclusion Criteria:

 -  Screening laboratory result indicating HCV Genotype 2, 3, 4, 5, or 6 infection.

 -  Chronic HCV infection.

 -  Participant had to be either HCV treatment-naïve or treatment-experienced.

 -  Participant had to be documented as non-cirrhotic or as having compensated cirrhosis
 (GT3 only).

 Exclusion Criteria:

 -  History of severe, life-threatening or other significant sensitivity to any drug.

 -  Female who was pregnant, planning to become pregnant during the study, or
 breastfeeding; or male whose partner was 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) or
 anti-human immunodeficiency virus antibody (HIV Ab).

 -  HCV genotype performed during screening indicating co-infection with more than one HCV
 genotype.