Ombitasvir/ABT-450/Ritonavir (Ombitasvir/ABT-450/r) With Dasabuvir and Ribavirin (RBV) in Treatment Naive and Treatment Experienced Genotype 1a Hepatitis C Virus Infected Adults

A study to evaluate the role of ombitasvir/ABT-450/ritonavir and dasabuvir coadministered
with RBV treatment leading to sustained virologic response 12 weeks post-dosing (SVR12) on
the changes from baseline in IFN-stimulated gene (ISG) expression in peripheral blood
mononucleated cells (PBMCs) in HCV GT1a-infected adult subjects.

Inclusion Criteria:

1. Screening laboratory result indicating HCV GT1a infection.

2. Chronic HCV infection.

3. Subjects must be non-cirrhotic.

4. Subjects must be treatment-naïve or have documentation that they were adherent to
prior pegIFN/RBV combination therapy and meet the criteria of prior pegIFN/RBV
treatment failure.

5. Subjects must meet specific human leukocyte antigen (HLA) allele requirements.

Exclusion Criteria:

1. Women who are pregnant or breastfeeding.

2. Positive test result for hepatitis B surface antigen (HBsAg) or anti-human
immunodeficiency virus antibody (HIV Ab) positive immunoassay.

3. Clinically significant abnormalities or co-morbidities, other than HCV infection,
that make the subject unsuitable for this study or treatment.

4. Current enrollment in another interventional clinical study, previous enrollment in
this study, prior or current use of any investigational or commercially available
anti-HCV agents other than pegIFN or RBV (including previous exposure to ABT-450,
ombitasvir, or dasabuvir), or receipt of any investigational product within 6 weeks
prior to study drug administration.

5. History or solid organ transplant.

6. Screening laboratory analysis that shows abnormal results.