A Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Japanese Adults With Chronic Hepatitis C Virus Infection
A Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Japanese Adults With Chronic Hepatitis C Virus Infection
The purpose of this phase 3, multicenter study is to evaluate the efficacy and safety of
 ABT-493/ABT-530 in Japanese adults with chronic Hepatitis C Virus (HCV)-infected, HCV
 direct-acting antiviral agent (DAA) treatment-naïve, and DAA treatment-experienced Japanese
 adult subjects.
The study consisted of two sub-studies that enrolled in parallel. Substudy 1 was randomized,
 open-label, and active-controlled, wherein HCV treatment-naïve or interferon
 (IFN)-experienced (i.e., DAA treatment-naïve), genotype (GT)1-infected participants without
 cirrhosis were enrolled. Substudy 2 was non-randomized, open label, and enrolled special
 populations of HCV-infected participants [GT1- or GT2-infected subjects with compensated
 cirrhosis, HCV GT3-, 4-, 5- and 6-infected subjects (with compensated cirrhosis or without
 cirrhosis), HCV GT1- and GT2-infected subjects who had failed prior DAA treatments (with
 compensated cirrhosis or without cirrhosis), HCV GT1- or GT2-infected subjects with severe
 renal impairment (with compensated cirrhosis or without cirrhosis)].
Inclusion Criteria:

 -  Females were postmenopausal for at least 2 years; surgically sterile or had a
 vasectomized partner; or, if of childbearing potential and sexually active with a male
 partner, were currently using at least 1 effective method of birth control at the time
 of Screening and agreed to practice 1 effective method of birth control from Screening
 through 30 days after stopping study drug. Sexually active males were surgically
 sterile or, if sexually active with a female partner of childbearing potential, agreed
 to practice 1 effective form of birth control from Screening through 30 days after
 stopping study drug.

 -  Screening central laboratory result indicated HCV single genotype infection for the
 appropriate treatment arm, without co-infection of any other genotype.

 -  Chronic HCV infection is defined as one of the following:

 -  Positive for anti-HCV antibody (Ab) and/or HCV RNA at least 6 months before
 Screening.

 -  A liver biopsy consistent with chronic HCV infection.

 -  Agreed to voluntarily sign and date an informed consent form, approved by an
 Institutional Review Board (IRB)/Independent Ethics Committee (IEC) prior to the
 initiation of any screening or study specific procedures.

 -  Participants who were able to understand and adhere to the study visit schedule and
 all other protocol requirements.

 -  Absence of hepatocellular carcinoma (HCC) as indicated by an ultrasound, computed
 tomography (CT) scan or magnetic resonance imaging (MRI).

 Exclusion Criteria:

 -  Females who were pregnant or planned to become pregnant, or breastfeeding or males
 whose partner was pregnant or planning to become pregnant during the study.

 -  Participants co-infected with hepatitis B virus or human immunodeficiency virus.

 -  Use of contraindicated medications or supplements within 2 weeks or 10 half-lives (if
 known), whichever was longer, prior to the first dose of any study drug.

 -  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.

 -  Any cause of liver disease other than chronic HCV infection.

 -  Any current or past clinical evidence of Child-Pugh B or C classification or clinical
 history of decompensated liver disease.

 -  Consideration by the investigator, for any reason, that the participant is an
 unsuitable candidate to receive ABT-493/ABT-530.