Study of ABT-267 in Treatment Naive Hepatitis C Virus (HCV) Genotype 1 Infected Subjects
Study of ABT-267 in Treatment Naive Hepatitis C Virus (HCV) Genotype 1 Infected Subjects
The purpose of this study was to assess the safety, pharmacokinetics, and 4-week rapid
 virologic response (RVR) of 3 different doses of ABT-267 (also known as ombitasvir) in
 combination with pegylated interferon/ribavirin (pegIFN/RBV) compared with pegIFN/RBV alone
 (ABT-267 placebo) in treatment naïve, hepatitis C virus (HCV), genotype 1-infected
 participants.
The study was a randomized, double blind, placebo controlled study consisting of 2
 substudies. In substudy 1, participants received 1 of 3 doses of ABT-267 or placebo +
 pegIFN/RBV for 12 weeks. In substudy 2, participants received pegIFN/RBV for 36 weeks.
 Participants were followed for 48 weeks post ABT-267 treatment for evaluation of efficacy and
 safety.
Inclusion Criteria:

 -  Treatment naïve participants

 -  Females must be either postmenopausal for at least 2 years or surgically sterile

 -  Males must be surgically sterile or practicing specific forms of birth control

 -  Chronic hepatitis C virus (HCV), genotype-1 infected participants

 -  Documented FibroTest score in combination with an Aspartate Aminotransferase to
 Platelet Ratio Index (APRI), or a liver biopsy within the last 12 months to document
 absence of cirrhosis

 Exclusion Criteria:

 -  Pregnant or breastfeeding female

 -  Use of any medications contraindicated for use with pegylated interferon(pegIFN) or
 ribavirin (RBV) 2 weeks prior to study drug administration or 10 half-lives, whichever
 is longer

 -  Clinically significant cardiac, respiratory (except mild asthma), renal,
 gastrointestinal, hematologic, neurologic disease, or any uncontrolled medical illness
 or psychiatric disease or disorder

 -  Current or past clinical evidence of cirrhosis or bridging fibrosis

 -  Abnormal screening laboratory results