a study to evaluate the efficacy and safety of abt-493/abt-530 in japanese adults with chronic hepatitis c virus infection

Conditions: Chronic Hepatitis C Virus; Hepatitis C Virus

Summary: 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 \[gt1- or gt2-infected subjects with compensated cirrhosis, hcv gt3-, 4-, 5- and 6-infected subjects (with compensated cirrhosis or without cirrhosis), hcv gt1- and gt2-infected subjects who had failed prior daa treatments (with compensated cirrhosis or without cirrhosis), hcv gt1- or gt2-infected subjects with severe renal impairment (with compensated cirrhosis or without cirrhosis)\].

Eligibility criteria:
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.

Keywords: compensated cirrhosis non-cirrhotic renal impairment hepatitis c virus (hcv) hepatitis c chronic hepatitis c hepatitis c genotype 1 hepatitis c genotype 2 hepatitis c genotype 3 hepatitis c genotype 4 hepatitis c genotype 5 hepatitis c genotype 6 daa-experienced