Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Other |
Percentage of Participants Who Achieve SVR12: mITT-GT Population |
SVR12 is defined as HCV RNA < LLOQ 12 weeks after the last dose of study drugs without any confirmed quantifiable (= LLOQ) post-treatment value before or during that SVR window. Confidence interval calculated using the normal approximation to the binomial distribution. |
12 weeks after the last actual dose of study drug |
|
Other |
Percentage of Participants With On-Treatment Virologic Failure During Treatment Period: mITT-GT Population |
On-treatment virologic failure is defined as breakthrough (confirmed HCV RNA = LLOQ after HCV RNA < LLOQ during treatment, or confirmed increase from nadir in HCV RNA (two consecutive HCV rna measurements > 1 log^10 IU/mL above nadir) at any time point during treatment) or failure to suppress during treatment (all on-treatment values of HCV RNA = LLOQ) with at least 6 weeks (defined as study drug duration = 36 days) of treatment. Confidence interval calculated using the Wilson score method. |
Up to 8 weeks while on treatment |
|
Other |
Percentage of Participants With Post-Treatment Relapse12: mITT-GT Population |
Relapse12 is defined as confirmed HCV RNA = LLOQ between end of treatment and 12 weeks after last actual dose of active study drug (up to and including the SVR12 window) excluding reinfection among participants with HCV RNA < LLOQ at final treatment visit who complete treatment and have post-treatment HCV RNA data. Completion of treatment is defined as a study drug duration = 51 days for participants who receive 8 weeks of treatment. HCV reinfection is defined as confirmed HCV RNA = LLOQ after the end of treatment in a participant 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 of the NS3 or NS5A, and/or NS5B gene sequences. Confidence interval calculated using the normal approximation to the binomial distribution. |
Up to 12 weeks after last dose of study drug |
|
Other |
Percentage of Female Participants Responding With SVR12: mITT-GT Population |
SVR12 is defined as HCV RNA < LLOQ 12 weeks after the last dose of study drugs without any confirmed quantifiable (= LLOQ) post-treatment value before or during that SVR window. Confidence interval calculated using the normal approximation to the binomial distribution. |
12 weeks after the last actual dose of study drug |
|
Other |
Percentage of Participants With Baseline HCV RNA < 6,000,000 IU/mL Responding With SVR12: mITT-GT Population |
SVR12 is defined as HCV RNA < LLOQ 12 weeks after the last dose of study drugs without any confirmed quantifiable (= LLOQ) post-treatment value before or during that SVR window. Confidence interval calculated using the normal approximation to the binomial distribution. |
Baseline and 12 weeks after the last actual dose of study drug |
|
Primary |
Percentage of Participants Who Achieve Sustained Virologic Response 12 Weeks Post-treatment (SVR12) |
SVR12 is defined as hepatitis C virus (HCV) ribonucleic acid (RNA) < lower limit of quantification (LLOQ) 12 weeks after the last dose of study drugs without any confirmed quantifiable (= LLOQ) post-treatment value before or during that SVR window. Confidence interval calculated using the normal approximation to the binomial distribution. |
12 weeks after the last actual dose of study drug |
|
Secondary |
Percentage of Participants With On-Treatment Virologic Failure During Treatment Period |
On-treatment virologic failure is defined as breakthrough (confirmed HCV RNA = LLOQ after HCV RNA < LLOQ during treatment, or confirmed increase from nadir in HCV RNA (two consecutive HCV rna measurements > 1 log^10 IU/mL above nadir) at any time point during treatment) or failure to suppress during treatment (all on-treatment values of HCV RNA = LLOQ) with at least 6 weeks (defined as study drug duration = 36 days) of treatment. Confidence interval calculated using the normal approximation to the binomial distribution. |
Up to 8 weeks while on treatment |
|
Secondary |
Percentage of Participants With Post-Treatment Relapse12 |
Relapse12 is defined as confirmed HCV RNA = LLOQ between end of treatment and 12 weeks after last actual dose of active study drug (up to and including the SVR12 window) excluding reinfection among participants with HCV RNA < LLOQ at final treatment visit who complete treatment and have post-treatment HCV RNA data. Completion of treatment is defined as a study drug duration = 51 days for participants who receive 8 weeks of treatment. HCV reinfection is defined as confirmed HCV RNA = LLOQ after the end of treatment in a participant 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 of the NS3 or NS5A, and/or NS5B gene sequences. Confidence interval calculated using the normal approximation to the binomial distribution. |
Up to 12 weeks after last dose of study drug |
|
Secondary |
Percentage of Female Participants Responding With SVR12 |
SVR12 is defined as HCV RNA < LLOQ 12 weeks after the last dose of study drugs without any confirmed quantifiable (= LLOQ) post-treatment value before or during that SVR window. Confidence interval calculated using the normal approximation to the binomial distribution. |
12 weeks after the last actual dose of study drug |
|
Secondary |
Percentage of Participants With Baseline HCV RNA < 6,000,000 IU/mL Responding With SVR12 |
SVR12 is defined as HCV RNA < LLOQ 12 weeks after the last dose of study drugs without any confirmed quantifiable (= LLOQ) post-treatment value before or during that SVR window. Confidence interval calculated using the normal approximation to the binomial distribution. |
Baseline and 12 weeks after the last actual dose of study drug |
|