a study to evaluate the efficacy and safety of abt-493/abt-530 in japanese adults with genotype 2 chronic hepatitis c virus infection

Conditions: Chronic Hepatitis C Virus; Hepatitis C Virus

Summary: the purpose of this phase 3 study is to evaluate the efficacy and safety of abt-493/abt-530 in comparison to sofosbuvir plus ribavirin for 12 weeks in hepatitis c virus (hcv) genotype 2 (gt2) infected participants.

this was a randomized, open-label, active-control, multicenter study to evaluate efficacy, safety, and pharmacokinetics of abt-493/abt-530 in chronic hcv gt2-infected direct-acting antiviral agent (daa) treatment-naïve japanese adult participants without cirrhosis. the participants were randomized in a 2:1 ratio to abt-493/abt-530 for 8 weeks (arm a) and sofosbuvir plus ribavirin for 12 weeks (arm b).

Eligibility criteria:
inclusion criteria: * females were postmenopausal for at least 2 years prior to screening; 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 indicating hcv gt-2 infection without co-infection of any other genotype. * participant has positive anti-hcv antibody (ab) and plasma hcv rna viral load greater than or equal to 1000 iu/ml at screening visit. * chronic hcv infection defined as one of the following: * positive for anti-hcv ab and/or hcv rna at least 6 months before screening; or * a liver biopsy consistent with chronic hcv infection. * participant must be hcv treatment-naïve (i.e., patient has not received a single dose of any approved or investigational daa) and non-cirrhotic. prior hcv treatment using ifns with or without ribavirin is acceptable. previous hcv interferon (ifn) based treatment must have been completed greater than or equal to 2 months prior to screening. 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. * 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). * requirement for and inability to safely discontinue contraindicated medications or supplements at least 2 weeks or 10 half-lives (whichever is longer) prior to the first dose of any study drug. * clinically significant abnormalities, other than hcv-infection, based upon the results of a medical history, physical examination, vital signs, laboratory profile, and a 12-lead electrocardiogram (ecg) that make the participant an unsuitable candidate for this study in the opinion of the investigator, including, but not limited to: * uncontrolled diabetes as defined by a glycated hemoglobin (hemoglobin a1c) level \> 8.5% at the screening visit. * active or suspected malignancy or history of malignancy (other than basal cell skin cancer or cervical carcinoma in situ) in the past 5 years, or any history of hepatocellular carcinoma (hcc). * uncontrolled cardiac, respiratory, gastrointestinal, hematologic, neurologic, psychiatric, or other medical disease or disorder, which is unrelated to the existing hcv infection. * any cause of liver disease other than chronic hcv-infection, including but not limited to the following: * hemochromatosis, alpha-1 antitrypsin deficiency, wilson's disease, autoimmune hepatitis, alcoholic liver disease, or steatohepatitis considered to be the primary cause of the liver disease rather than concomitant/incidental with hcv infection.

Keywords: hepatitis c virus non-cirrhotic hepatitis c genotype 2 chronic hepatitis c virus hepatitis c