A Multipart, Open-label Study to Evaluate the Safety and Efficacy of ABT-450/r/ABT-267 With and Without ABT-333 Coadministered With and Without Ribavirin in Adult With Genotype 1 or 4 Hepatitis C Virus (HCV) Infection and Human Immunodeficiency Virus, Type 1 Coinfection

SVR12 is defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (\< LLOQ) 12 weeks after the last dose of study drug without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. The 95% confidence interval (CI) is calculated using the Wilson score method for binomial distribution. The primary efficacy endpoint was the non-inferiority of the percentage of participants in the GT1 Analysis Group in Part 2 achieving SVR12 compared to the historical SVR12 rate for sofosbuvir plus ribavirin (a non-inferiority threshold of the lower bound of the 95% CI of 74%).

Time frame: 12 weeks after the last actual dose of study drug

Population: Intent-to-treat population: Part 2 randomized or enrolled participants who received at least 1 dose of study drug. Imputation applied; participants with missing HCV RNA data after imputation were counted as failures. The primary efficacy endpoint analysis was based on subjects in the GT 1 Analysis Group in Part 2 containing Arms E, F, H, I, and J.

SVR12 is defined as plasma HCV RNA \< LLOQ 12 weeks after the last dose of study drug without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. The 95% CI is calculated using the Wilson score method for binomial distribution.

Time frame: 12 weeks after last dose of study drug

Population: Intent-to-treat population: Part 2 randomized or enrolled participants who received at least 1 dose of study drug. Imputation applied; participants with missing HCV RNA data after imputation were counted as failures.

SVR12 is defined as plasma HCV RNA \< LLOQ 12 weeks after the last dose of study drug without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. The 95% CI is calculated using the Wilson score method for binomial distribution.

Time frame: 12 weeks after last dose of study drug

Population: Intent-to-treat population: Part 1a randomized participants who received at least 1 dose of study drug. Imputation applied; participants with missing HCV RNA data after imputation were counted as failures.

Percentage of participants with on-treatment HCV virologic failure during the treatment period for each arm in Part 1a. Virologic failure is defined as confirmed quantifiable HCV RNA among participants with previously unquantifiable HCV RNA during treatment.

Time frame: up to 12 or 24 weeks, based on treatment duration

Population: Intent-to-treat population: Part 1a randomized participants who received at least 1 dose of study drug.

HIV virologic success was defined as HIV-1 RNA suppression (HIV-1 RNA value \< 40 copies/mL).

Time frame: End of treatment: HIV Week 12 window for 12-weeks of treatment (Treatment Day 71 - 98) or HIV Week 24 window (Treatment Day 155 - 182) for 24-weeks of treatment. Post-Treatment Week 12 (PTW12): HIV PTW12 window (Post-Treatment Day 57 - 126)

Population: Intent-to-treat population: Part 1a randomized participants who received at least 1 dose of study drug.

Percentage of participants who experienced Relapse12 among participants who completed treatment with HCV RNA \< LLOQ at final treatment visit and had at least one post-treatment HCV RNA value. Relapse12 is defined as confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after last actual dose of study drug (up to and including the SVR12 assessment time point) for a participant with HCV RNA \< LLOQ at final treatment visit who completed treatment and had post-treatment data. Completion of treatment is defined as study drug duration ≥ 77 days for Arm A and ≥ 154 days for Arm B. The 95% CI is calculated using Wilson score method for the binomial distribution.

Time frame: up to 12 or 24 weeks, based on treatment duration, after the last actual dose of study drug

Population: Intent-to-treat population: Part 1a randomized participants who received at least 1 dose of study drug and who completed treatment with HCV RNA \< LLOQ at final treatment visit and had at least one post-treatment HCV RNA value.

SVR12 is defined as plasma HCV RNA \< LLOQ 12 weeks after the last dose of study drug without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. The 95% CI is calculated using the Wilson score method for binomial distribution.

Time frame: 12 weeks after last dose of study drug

Population: Intent-to-treat population: Part 1b randomized participants who received at least 1 dose of study drug. Imputation applied; participants with missing HCV RNA data after imputation were counted as failures.

Percentage of participants with on-treatment HCV virologic failure during the treatment period for each arm and overall in Part 1b. Virologic failure is defined as confirmed quantifiable HCV RNA among participants with previously unquantifiable HCV RNA during treatment.

Time frame: up to 12 weeks

Population: Intent-to-treat population: Part 1b randomized participants who received at least 1 dose of study drug.

HIV virologic success was defined as HIV-1 RNA suppression (HIV-1 RNA value \< 40 copies/mL).

Time frame: End of treatment: HIV Week 12 window (Treatment Day 78 - 98). PTW12: HIV PTW12 window (Post-Treatment Day 57 - 126)

Population: Intent-to-treat population: Part 1b randomized participants who received at least 1 dose of study drug.

Percentage of participants who experienced Relapse12 among participants who completed treatment with HCV RNA \< LLOQ at final treatment visit and had at least one post-treatment HCV RNA value. Relapse12 is defined as confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after last actual dose of study drug (up to and including the SVR12 assessment time point) for a participant with HCV RNA \< LLOQ at final treatment visit who completed treatment and had post-treatment data. Completion of treatment is defined as study drug duration ≥ 77 days for Arm C and Arm D. The 95% CI is calculated using Wilson score method for the binomial distribution.

Time frame: up to 12 weeks after the last actual dose of study drug

Population: Intent-to-treat population: all Part 1b randomized participants who received at least 1 dose of study drug and who completed treatment with HCV RNA \< LLOQ at final treatment visit and had at least one post-treatment HCV RNA value.

Percentage of participants with on-treatment HCV virologic failure during the treatment period for arms in Part 2. Virologic failure is defined as confirmed quantifiable HCV RNA among participants with previously unquantifiable HCV RNA during treatment.

Time frame: up to 12 or 24 weeks, based on treatment duration

Population: Intent-to-treat population: Part 2 randomized or enrolled participants in the GT1 analysis group (and its composing arms) and GT4 analysis group who received at least 1 dose of study drug. Due to a label change after study start that no longer recommended the Arm G treatment regimen to GT1b cirrhotic subjects, Arm G data was not analyzed.

HIV virologic success was defined as HIV-1 RNA suppression (HIV-1 RNA value \< 40 copies/mL).

Time frame: End of treatment: HIV Week 12 window for 12-weeks of treatment (Treatment Day 71 - 98) or HIV Week 24 window (Treatment Day 155 - 182) for 24-weeks of treatment. PTW12: HIV PTW12 window (Post-Treatment Day 57 - 126)

Population: Intent-to-treat population: Part 2 randomized or enrolled participants in the GT1 analysis group (and its composing arms) and GT4 analysis group who received at least 1 dose of study drug. Due to a label change after study start that no longer recommended the Arm G treatment regimen to GT1b cirrhotic subjects, Arm G data was not analyzed.

Percentage of participants who experienced Relapse12 among those who completed treatment with HCV RNA \< LLOQ at final treatment visit and had ≥1 post-treatment HCV RNA value. Relapse12=confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after last actual dose of study drug (up to and including the SVR12 window) for a participant with HCV RNA \< LLOQ at final treatment visit who completed treatment and had post-treatment data, excluding reinfection. Completion of treatment=study drug duration ≥ 77 days for participants who received 12 weeks of treatment and ≥154 days for participants who received 24 weeks of treatment. HCV reinfection=confirmed HCV RNA ≥ LLOQ after the end of treatment in a subject who had HCV RNA \< LLOQ at final treatment visit, along with the post-treatment detection of a different HCV genotype, subtype, or clade compared with baseline, as determined by phylogenetic analysis. The 95% CI is calculated using Wilson score method for the binomial distribution.

Time frame: up to 12 or 24 weeks, based on treatment duration, after the last actual dose of study drug

Population: Intent-to-treat population: Part 2 randomized or enrolled participants in the GT1 analysis group (and its composing arms) and GT4 analysis group who received ≥1 dose of study drug, who completed treatment with HCV RNA \< LLOQ at final treatment visit, and had ≥1 post-treatment HCV RNA value. Arm G data was not analyzed (see Outcome Measure 8).

SVR12 is defined as plasma HCV RNA \< LLOQ 12 weeks after the last dose of study drug without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. The 95% CI is calculated using the Wilson score method for binomial distribution.

Time frame: 12 weeks after last dose of study drug

Population: Intent-to-treat population: Part 2 randomized or enrolled participants who received at least 1 dose of study drug. Imputation applied; participants with missing HCV RNA data after imputation were counted as failures.