Study to Assess the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of ABT-267 in HCV Infected Subjects
Study to Assess the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of ABT-267 in HCV Infected Subjects
The purpose of this study is to assess the safety, tolerability, pharmacokinetics, and
 antiviral activity of multiple, ascending doses of ABT-267 (also known as ombitasvir)
 administered as two-day monotherapy followed by ABT-267 in combination therapy with other
 direct-acting antiviral agents (DAAs) ABT-450 with ritonavir (ABT-450/r) and ABT-333 (also
 known as dasabuvir) plus ribavirin (RBV) in patients with chronic Hepatitis C virus (HCV)
 infection without cirrhosis.
An open-label, multicenter study to evaluate the safety, tolerability, pharmacokinetics, and
 antiviral activity of ABT-267 as monotherapy for 2 days, followed by ABT-267, ABT-450 with
 ritonavir (ABT-450/r) and ABT-333 plus ribavirin (RBV) combination therapy for 12 weeks in
 treatment-naïve, non-cirrhotic patients with chronic hepatitis C virus (HCV) infection. The
 study included post-treatment follow-up for 48 weeks.
Inclusion Criteria:

 -  Male or female between the age of 18 and 70 years, inclusive, at time of enrollment.

 -  Subject has never received antiviral treatment for hepatitis C virus (HCV) infection.

 -  Body mass index (BMI) is ≥ 18 to < 38 kg/m^2. BMI is calculated as weight measured in
 kilograms (kg) divided by the square of height measured in meters (m).

 -  Chronic HCV genotype 1-infection for at least 6 months prior to study enrollment.

 -  Subject has plasma HCV RNA level > 10,000 IU/mL at screening

 Exclusion Criteria:

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

 -  Females who are or plan to become pregnant or breastfeeding or males whose partner is
 pregnant or planning to become pregnant.

 -  Recent history of drug or alcohol abuse that could preclude adherence to the protocol.

 -  Positive test result for hepatitis B surface antigen or anti-human immunodeficiency
 virus (HIV) antibodies.

 -  Any current or past clinical evidence of cirrhosis (e.g., ascites, esophageal
 varices), or a liver biopsy or FibroTest/aspartate aminotransferase to platelet ratio
 (APRI) or FibroScan® showing cirrhosis or extensive bridging fibrosis.