Abstract
Background/Purpose of StudyClinical trials have demonstrated excellent efficacy and safety of pangenotypic direct-acting antivirals (DAAs) for the treatment of hepatitis C virus (HCV). However, there are limited large-scale real-world data on these pangenotypic DAAs. This study examined the results of two pangenotypic regimens, glecaprevir/pibrentasvir (GLE/PIB) and sofosbuvir/velpatasvir (SOF/VEL), in a real-world setting in Taiwan.MethodsAll HCV patients treated with GLE/PIB or SOF/VEL from August 2018 to April 2020 at the Chiayi Chang Gung Memorial Hospital were included. The primary end point was sustained virologic response 12 weeks after treatment cessation (SVR12). Adverse events (AEs) were also reported.ResultsA total of 1 356 HCV patients received pangenotypic DAA treatment during the study period: 742 patients received GLE/PIB and 614 received SOF/VEL. The rates of SVR12 for GLE/PIB and SOF/VEL were 710/718 (98.9%) and 581/584 (99.5%), respectively, by per-protocol analysis, and 710/742 (95.7%) and 581/614 (94.6%), respectively, by evaluable population analysis. Eleven patients (GLE/PIB: 8, SOF/VEL: 3) did not achieve SVR12. The most common AEs for GLE/PIB and SOF/VEL were pruritus (17.4% vs. 2.9%), abdominal discomfort (5.8% vs. 4.4 %), dizziness (4.2% vs. 2%), and malaise (3.1% vs. 2.9%). Laboratory abnormalities were uncommon, with <1% of patients exhibiting elevated total bilirubin or aminotransferase levels with both regimens. There were five drug discontinuations owing to AEs (bilirubin elevation: 3, dermatological issues: 2).ConclusionIn real-world practice, the pangenotypic DAAs GLE/PIB and SOF/VEL are effective and well tolerated, achieving high SVR12 rates for patients with all HCV genotypes.
The Impact Of Direct‐Acting Antivirals On Hepatitis C Viraemia Among People Who Inject Drugs In England; Real‐World Data 2011‐2018
