This multi-center, post-marketing, observational study evaluates the real world safety and effectiveness of glecaprevir plus pibrentasvir use in participants infected with the hepatitis C virus genotype 1 - 6.
Study Type
OBSERVATIONAL
Enrollment
1,095
Abbvie Japan /ID# 161985
Tokyo, Japan
Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-treatment (SVR12)
SVR12 defined as the hepatitis C virus (HCV) ribonucleic acid (RNA) level \< the lower limit of quantification (LLOQ) 12 weeks after the last dose of Glecaprevir plus Pibrentasvir.
Time frame: 12 weeks after last dose of drug
Percentage of Participants with Post-treatment Relapse
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: Up to 24 weeks after last dose of drug
Percentage of Participants with On-treatment Virologic Failure
On-treatment virologic failure was defined as HCV RNA levels reach \< LLOQ during treatment then increase to \>= LLOQ during treatment, or confirmed increase of \> 1 log10 IU/mL above the lowest value post-baseline HCV RNA during treatment.
Time frame: Up to 12 weeks after first dose
Percentage of Participants Achieving SVR4
SVR4 defined as defined as the HCV RNA level \< LLOQ 4 weeks after the last dose of Glecaprevir plus Pibrentasvir.
Time frame: 4 weeks after last dose
Percentage of Participants Achieving SVR8
SVR8 defined as defined as the HCV RNA level \< LLOQ 8 weeks after the last dose of Glecaprevir plus Pibrentasvir.
Time frame: 8 weeks after last dose of drug
Percentage of Participants Achieving SVR24
SVR24 defined as the HCV RNA level \< LLOQ 24 weeks after the last dose of Glecaprevir plus Pibrentasvir.
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Time frame: 24 weeks after last dose of drug