Chronic Hepatitis C Virus (HCV)

The primary objectives of this study are to assess the efficacy and safety of ABT-493 and ABT-530 with or without RBV in subjects with chronic HCV genotype 2 (GT2) or genotype 3 (GT3) infection. Additional objectives are to assess the pharmacokinetics of ABT-493, ABT-530 and RBV and the emergence and persistence of viral variants with these treatment regimens

ABT-530, ABT-493

ABT-493 (A-1282576.0)
ABT-530 (A-1325912.0)

tablet

100
40

Efficacy:
Efficacy will be assessed by plasma HCV RNA levels throughout the study.
Primary and Secondary Efficacy Endpoints:
The primary efficacy endpoint is the percentage of subjects with SVR12 (HCV RNA < LLOQ 12 weeks
after the last actual dose of study drug) in each treatment arm.
The secondary efficacy endpoints are:
 The percentage of subjects with SVR4;
 The percentage of subjects with on-treatment virologic failure;
 The percentage of subjects with post-treatment relapse.
Virologic failure and safety data will be monitored throughout the study. These data enable assessment
of virologic stopping and futility criteria, treatment extension criteria, and the initiation of Part 2.
Patient Reported Outcomes (PROs):
Health state utility will be measured using the EuroQol-5 Dimensions-5 Level (EQ-5D-5L) instrument.
Treatment satisfaction will be assessed using the chronic HCV Treatment Satisfaction Instrument
(HCVTSat). The Work Productivity and Activity Impairment Questionnaire: Hepatitis C (WPAI:
Hepatitis C) will assess work and activity impairment due to HCV. The Fatigue Severity Scale (FSS)
will be used to measure the severity of fatigue and its effect on lifestyle and activities. The Short
Form 36 Version 2 Health Status Survey (SF-36v2) will be used to assess the functional health and
well-being of subjects.
Resistance:
The following information will be tabulated and summarized: 1) for all subjects, the variants at baseline
at signature resistance-associated amino acid positions relative to the appropriate prototypic reference
sequence, and 2) for subjects who do not achieve SVR12, all post-baseline variants relative to baseline.
Pharmacokinetic:
Individual plasma concentrations of ABT-493, ABT-530 and ribavirin, and possible metabolites of
ABT-493 and ABT-530 will be tabulated and summarized. Values for the pharmacokinetic parameters
of ABT-493, ABT-530 and ribavirin and possible metabolites of ABT-493 and ABT-530, including
apparent clearance (CL/F) and apparent volume of distribution (V/F), will be estimated using population
pharmacokinetic modeling procedures.
Safety:
Safety and tolerability will be assessed by monitoring adverse events, physical examinations, clinical
laboratory tests, 12-Lead ECGs and vital signs.

Main Inclusion:
1. Male or female between 18 and 70 years of age, inclusive, at time of Screening.
2. Screening laboratory result indicating HCV GT2 or GT3 infection.
3. Chronic HCV infection.
4. Subject must be either HCV treatment-naïve or treatment-experienced.
5. Per local standards, subjects are considered to be non-cirrhotic or to have compensated cirrhosis
(GT3 only).

Main Exclusion:
1. History of severe, life-threatening or other significant sensitivity to any drug.
2. Female who is pregnant, planning to become pregnant during the study, or breastfeeding; or male
whose partner is pregnant or planning to become pregnant during the study.
3. 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.
4. Positive test result at Screening for hepatitis B surface antigen (HBsAg) or anti-human
immunodeficiency virus antibody (HIV Ab).
5. HCV genotype performed during screening indicating co-infection with more than one HCV
genotype.