Efficacy and Safety of 8-weeks of Glecaprevir/Pibrentasvir in Treatment-Naïve Adults With HCV Genotype 1-6 and Aspartate Aminotransferase to Platelet Ratio Index (APRI) ≤1

SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification (LLOQ; 15 IU/mL) 12 weeks after the last dose of study drug. The 95% confidence interval (95%CI) was calculated using the Wilson's score method. Efficacy was to be established if the lower bound of the 95%CI was greater than the threshold of 92.4%, based on the historical rate observed in glecaprevir/pibrentasvir registrational studies in treatment-naïve, non-cirrhotic patients (98.4%) minus a margin of 6%.

Time frame: 12 weeks after the last actual dose of study drug, Week 20

Population: The modified intention-to-treat (mITT) population includes all enrolled participants who received at least 1 dose of study drug, excluding participants who did not achieve SVR12 for reasons other than virologic failure, such as missing SVR12 data (5 participants) or premature study drug discontinuation (3 participants).

SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the LLOQ (15 IU/mL) 12 weeks after the last dose of study drug. The 95% confidence interval was calculated using the normal approximation to the binomial distribution. Efficacy was to be established if the lower bound of the 95%CI was greater than the threshold of 91.4%, based on the mITT threshold minus an expected 1% rate of non-virological SVR failures.

Time frame: 12 weeks after the last actual dose of study drug, Week 20

Population: The intention-to-treat (ITT) population included all enrolled participants who received at least 1 dose of study drug.

On-treatment virologic failure was defined as one of the following conditions: * confirmed HCV RNA ≥ 100 IU/mL after HCV RNA \< 15 IU/mL during the Treatment Period; or * confirmed increase from nadir in HCV RNA (two consecutive HCV RNA measurements \> 1 log₁₀ IU/mL above nadir) at any time point during the Treatment Period; or * HCV RNA ≥ 15 IU/mL at end of treatment with at least 6 weeks of treatment, where the HCV RNA value must be collected on or after Study Drug Day 36 and study drug duration ≥ 36 days.

Time frame: Up to 8 weeks

Population: Intention-to-treat population

Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels \< LLOQ at the end of treatment.

Time frame: From the end of treatment (Week 8) through 12 weeks after the last dose of study drug (Week 20)

Population: Intention-to-treat population with HCV RNA \< 15 IU/mL at the end of treatment, at least one post-treatment HCV RNA value, and who completed the assigned treatment.