A Pilot Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of ABT-450 With Ritonavir (ABT-450/r) Dosed in Combination With ABT-072 and Ribavirin (RBV)

Analysis of the percentage of participants with hepatitis C virus ribonucleic acid less than the lower limit of quantitation (\< 25 IU/mL).

Time frame: Week 4 through Week 12

Population: For the percentage of subjects with HCV RNA suppressed below the LLOQ from Week 4 through Week 12 out of all subjects dosed, it was assumed that if 60% of subjects were successfully suppressed from Week 4 through Week 12 then 20 subjects would give a 95% two-sided confidence interval of (36.1%, 80.9%) using binomial exact methods.

Analysis of participants with HCV RNA levels below 1000 IU/mL at Week 2.

Time frame: Week 2

Population: Efficacy analyses included all participants who received at least 1 dose of study drug (ITT). Participants with missing data were imputed as failures.

Analysis of percentage of participants with hepatitis C virus ribonucleic acid less than the lower limit of quantitation (\< 25 IU/mL).

Time frame: Week 4

Population: Efficacy analyses included all participants who received at least 1 dose of study drug (ITT). Participants with missing data were imputed as failures.

Sustained Virologic Response 12 (SVR12) is defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (\< LLOQ; \< 25 IU/mL) 12 weeks after the last dose of study drug.

Time frame: Post-treatment Day 1 to Post-treatment Week 12

Population: Efficacy analyses included all participants who received at least 1 dose of study drug (ITT). Participants with missing data were imputed as failures.

Sustained Virologic Response 24 (SVR24) is defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (LLOQ; \< 25 IU/mL) 24 weeks after the last dose of study drug.

Time frame: Post-treatment Day 1 to Post-treatment Week 24

Population: Efficacy analyses included all participants who received at least 1 dose of study drug (ITT). Participants with missing data were imputed as failures.

The time to failure to suppress was defined as first day a participant met any virologic stopping criteria during treatment. The virologic stopping criteria also includes failure to achieve a 2 log10 IU/mL decrease in HCV RNA by Week 1, failure to achieve HCV RNA \<LLOQ by Week 6, or rebound, defined as first day of 2 consecutive increases of at least 0.5 log10 IU/mL above nadir (local minimum value) or confirmed HCV RNA \> lower limit of detection (LLOD) for participants who previously achieved HCV RNA \< LLOD.

Time frame: Day 1 through Week 12

Population: Efficacy analyses included all participants who received at least 1 dose of study drug (ITT).

Time to confirmed hepatitis C virus (HCV) ribonucleic acid (RNA) ≥ lower limit of quantitation (LLOQ) (2 consecutive measurements ≥ LLOQ) at any point in the post-treatment period among participants with HCV RNA \< LLOQ at the end of treatment.

Time frame: Post-treatment Day 1 to Post-treatment Week 24

Population: Efficacy analyses included all participants who received at least 1 dose of study drug (ITT) with hepatitis C virus (HCV) ribonucleic acid (RNA) \< lower limit of quantitation (LLOQ) at the final treatment visit who completed treatment.