Real-world efficacy and safety of pangenotypic direct-acting antivirals against hepatitis C virus infection in Taiwan

Chi-Wei Yen,Wei-Lin Tung,Chao-Hung Hung,Yi-Hsing Chen,Shui-Yi Tung,Chun-Hsien Chen,Sheng-Nan Lu,Wei-Ming Chen,Huang-Wei Xu,Kuo-Liang Wei,Chen-Heng Shen,Yung-Yu Hsieh,Te-Sheng Chang,Kao-Chi Chang

doi:10.1038/s41598-021-93095-x

Chi-Wei Yen, Wei-Lin Tung + Show 12 more

Open Access

https://doi.org/10.1038/s41598-021-93095-x

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Abstract

Clinical trials showed pangenotypic direct-acting antivirals’ (DAAs) excellent efficacy and safety when treating hepatitis C virus (HCV). Two pangenotypic regimens were examined, glecaprevir/pibrentasvir (GLE/PIB) and sofosbuvir/velpatasvir (SOF/VEL), in a real-world Taiwanese setting, including all HCV patients treated with GLE/PIB or SOF/VEL from August 2018 to April 2020. The primary endpoint was sustained virologic response 12 weeks after treatment cessation (SVR12), including adverse events (AEs). A total of 1,356 HCV patients received pangenotypic DAA treatment during the study: 742 and 614 received GLE/PIB and SOF/VEL, respectively. 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 (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; only < 1% exhibited elevated total bilirubin or aminotransferase levels with both regimens. Five drug discontinuations occurred due to AEs (bilirubin elevation: 3; dermatological issues: 2). Pangenotypic DAAs GLE/PIB and SOF/VEL are effective and well tolerated, achieving high SVR12 rates for patients with all HCV genotypes.

Highlights

Clinical trials showed pangenotypic direct-acting antivirals’ (DAAs) excellent efficacy and safety when treating hepatitis C virus (HCV)
The number of treatment-experienced patients in the GLE/PIB group (n = 96, 12.9%) was higher than that in the SOF/VEL group (n = 28, 4.5%). This is because GLE/PIB was approved by the Taiwan’s Food and Drug Administration (TFDA) and reimbursed by Taiwan’s National Health Insurance (NHI) earlier than SOF/VEL
Pangenotypic DAAs may prevent physician errors associated with unfamiliarity with genotype-specific DAAs and broaden the number of eligible patients by reducing the need for genotyping

Summary

Introduction

Clinical trials showed pangenotypic direct-acting antivirals’ (DAAs) excellent efficacy and safety when treating hepatitis C virus (HCV). A total of 1,356 HCV patients received pangenotypic DAA treatment during the study: 742 and 614 received GLE/PIB and SOF/VEL, respectively. Pangenotypic DAAs GLE/PIB and SOF/VEL are effective and well tolerated, achieving high SVR12 rates for patients with all HCV genotypes. SOF/VEL is approved for chronic HCV genotypes 1 through 6, without ribavirin, in patients aged ≥ 6 years with or without compensated c irrhosis[15,16,17,18,19]. It is administered using a weight-based dosing regimen of ribavirin in patients with decompensated cirrhosis. The recommended dose is one tablet (SOF 400 mg/VEL 100 mg) once daily for 12 weeks[9]

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