Background and importance Pan-genotypic direct acting antiviral agents (ie, glecaprevir/pibrentasvir (GLE/PIB)), have been proven in clinical trials to be effective and safe in the treatment of chronic hepatitis C (CHC) infection. However, CHC genotypes may vary in different populations and limited evidence is available regarding the effects of GLE/PIB in patients with different genotypes.
Aim and objectives To compare the effectiveness and safety of GLE/PIB in CHC patients with different genotypes in Taiwan.
Material and methods We retrospectively identified a cohort of CHC patients newly initiating GLE/PIB between August 2018 and June 2019 from the Chang Gung Research Database, a multi-institutional electronic medical records database covering approximately 1.3 million individuals (6% of the Taiwan population). We classified patients by genotype who were followed up for 12 weeks from completion of GLE/PIB therapy. Sustained virological response at 12 weeks (SVR12) was observed as the primary outcome. The safety outcome included elevation of alanine aminotransferase (ALT) or total bilirubin by three times the upper limit of normal (ULN), which was taken as an indicator of liver related adverse events. We calculated the rate of study outcomes among CHC patients with different genotypes.
Results We identified 1589 CHC patients newly initiating GLE/PIB. Mean age was 61.7 (SD 12.6) years and 53% were women. The major CHC genotype was type 2 (60.2%), followed by type 1b (16.5%) and mixed type (5.7%). We found the rate of SVR12 was relatively lower among patients with genotype type 6 (91.1%), type 2 (91.4%) and type 3 (92.2%) compared with genotype type 1 (100%), type 5 (100%), mixed type (96.7%) and unknown type (93.8%). Furthermore, 14.7% of patients were found to have ALT elevation (>3 times the ULN). Most of these were genotype type 2 (8.7%), followed by type 1b (1.8%) and type 3 (1.2%). No patient had total bilirubin levels over three times the ULN.
Conclusion and relevance The effectiveness and safety of GLE/PIB in Taiwan may vary in CHC patients with different genotypes. The findings could be strong grounds for future large scale prospective studies to confirm the association between CHC genotypes and treatment outcome with GLE/PIB.
Conflict of interest No conflict of interest