Real-World Efficacy and Safety of Pangenotypic Direct-Acting Antivirals Against Hepatitis C Virus Infection in Taiwan

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.

Comparison of 8- versus 12-weeks of glecaprevir/pibrentasvir for Taiwanese patients with hepatitis C and compensated cirrhosis in a real-world setting

“…The excellent broad-spectrum antiviral activity, negligible side effects, and simple once-daily dosage of pangenotypic DAA combination regimens simplify health care service delivery and can help accelerate the realization of the HCV elimination goals [ 16 ]. Large-scale real-world data from Taiwan also supported the excellent effectiveness and safety profiles of both first-line pangenotypic DAAs, namely GLE/PIB and sofosbuvir/velpatasvir (SOF/VEL) [ 7 , 17 – 20 ]. Shortening DAA treatment time regardless of cirrhosis status can further simplify HCV care, which may increase the number of health care professionals who can prescribe DAA regimens and increase the number of patients receiving treatment [ 10 , 11 ].…”

“…The excellent broad-spectrum antiviral activity, negligible side effects, and simple once-daily dosage of pangenotypic DAA combination regimens simplify health care service delivery and can help accelerate the realization of the HCV elimination goals [16]. Large-scale real-world data from Taiwan also supported the excellent effectiveness and safety profiles of both firstline pangenotypic DAAs, namely GLE/PIB and sofosbuvir/velpatasvir (SOF/VEL) [7,[17][18][19][20].…”

“…Shortening DAA treatment time regardless of cirrhosis status can further simplify HCV care, which may increase the number of health care professionals who can prescribe DAA regimens and increase the number of patients receiving treatment [10,11]. The fixed-dose combination of GLE/PIB has demonstrated suitable effectiveness and safety profiles in both clinical trials and real-world settings [7,14,17,19,[21][22][23][24][25][26][27][28][29]. GLE/PIB is also the only DAA regimen that has been granted NHI reimbursement for an 8-week short-term treatment, applicable to patients with all HCV genotypes and with or without compensated cirrhosis [11][12][13].…”

“…The emergence of all-oral DAAs in anti-HCV therapeutics with SVR rates reaching 95%–99% across all HCV genotypes has presented the prospect of eliminating HCV as a public health threat [ 6 ]. The introduction of pangenotypic regimens, characterized by simplified anti-HCV therapy and even higher SVR rates regardless of the genotype, offers new opportunities for the public health response to HCV infection [ 7 , 8 ]. Glecaprevir (GLE) is a NS3/4A protease inhibitor that targets the viral RNA replication.…”

Qualitative hepatitis C virus RNA assay identifies active infection with sufficient viral load for treatment among Phetchabun residents in Thailand

“…Most HCV infection remains persistent but asymptomatic throughout a person's lifetime, hindering early detection and treatment [4][5][6]. Direct-acting antiviral therapy is highly effective in eliminating infection in most patients regardless of viral genotype [7][8][9][10]. However, identifying active HCV infection and accessing treatment remain significant barriers in many underdeveloped regions.…”