A Study to Evaluate Chronic Hepatitis C Infection in Adults With Genotype 1a Infection

The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid \[HCV RNA\] level less than the lower limit of quantitation \[\< LLOQ\]) 12 weeks after the last dose of study drug. The LLOQ for the assay was 25 IU/mL. The primary efficacy endpoints were noninferiority of the percentage of participants who achieved sustained virologic response 12 weeks after treatment in each treatment arm (ABT-450/r/ABT-267 and ABT-333, plus either placebo RBV or RBV) compared with the historical control rate for noncirrhotic, treatment-naïve participants with HCV GT1a infection treated with telaprevir and peginterferon(pegIFN)/RBV.

Time frame: 12 weeks after last dose of study drug

Population: All randomized participants who received at least 1 dose of study drug (intent-to-treat \[ITT\] population); participants with missing data were counted as non-responders.

The percentage of participants with a decrease in hemoglobin from greater than or equal to the lower limit of normal (≥ LLN) at baseline to \< LLN at the end of treatment.

Time frame: Baseline (Day 1) and Week 12 (End of Treatment)

Population: All randomized participants who received at least 1 dose of study drug (ITT population) and had hemoglobin ≥ LLN reference range at baseline.

The percentage of participants with sustained virologic response (plasma HCV RNA less than the lower limit of quantitation \[\< LLOQ\]) 12 weeks after the last dose of study drug. The secondary efficacy endpoints were superiority of the percentage of participants who achieved sustained virologic response 12 weeks after treatment in each treatment arm (ABT-450/r/ABT-267 and ABT-333, plus either placebo RBV or RBV) compared with the historical control rate for noncirrhotic, treatment-naïve participants with HCV GT1a infection treated with telaprevir and pegIFN/RBV; and the noninferiority of the percentage of participants who achieved sustained virologic response 12 weeks after treatment who received ABT-450/r/ABT-267 and ABT-333, plus placebo RBV compared with those who received ABT-450/r/ABT-267 and ABT-333, plus RBV.

Time frame: 12 weeks after last dose of study drug

Population: All randomized participants who received at least 1 dose of study drug (ITT population); participants with missing data were counted as non-responders.

Virologic failure during treatment was defined as rebound (confirmed HCV RNA greater than or equal to the lower limit of quantitation \[≥ LLOQ\] after HCV RNA \< LLOQ during treatment, or confirmed increase from the lowest value post baseline in HCV RNA \[2 consecutive HCV RNA measurements \> 1 log10 IU/mL above the lowest value post baseline\] at any time point during treatment), or failure to suppress (HCV RNA ≥ LLOQ persistently during treatment with at least 6 weeks \[≥ 36 days\] of treatment).

Time frame: Baseline (Day 1), and Treatment Weeks 1, 2, 4, 6, 8, 10, and 12

Population: All randomized participants who received at least 1 dose of study drug (ITT population).

Participants who completed treatment with plasma HCV RNA less than the lower limit of quantification (\<LLOQ) at the end of treatment were considered to have virologic relapse if they had confirmed HCV RNA ≥ LLOQ during the post-treatment period. 95% CI calculated using the normal approximation to the binomial distribution.

Time frame: Between End of Treatment (Week 12) and Post-treatment (up to Week 12 Post-Treatment)

Population: All randomized participants who received at least 1 dose of study drug (ITT population) with HCV RNA \< LLOQ at the final treatment visit and completed treatment.