Effectiveness and safety of elbasvir/grazoprevir in Korean patients with hepatitis C virus infection: a nationwide real-world study

Abstract

Background/Aim: This study aimed to establish the real-world effectiveness and safety of grazoprevir/elbasvir (EBR/GZR) therapy in South Korea. Methods: A total of 242 patients with chronic hepatitis C virus (HCV) genotype 1 or 4 infection who started EBR/GZR were consecutively enrolled from seven tertiary hospitals. Retrospective analysis of the fractions of patients that achieved sustained virological response (SVR) was performed, and the incidence of adverse events was noted. Results:The mean age of enrolled patients was 59.0 ± 12.6 years and 47.5% were males. Patients with HCV genotype 1b accounted for 93.8% (n = 227), and patients with HCV of unspecified genotype 1 accounted for 5.8% (n = 14). Hypertension was the most common comorbid disease (29.8%) followed by diabetes (22.7%) and chronic kidney disease (CKD, 12.4%). SVR rates of treatment-naïve and treatment-experienced patients were 85.5% (182/213) and 93.1% (27/29), respectively, in the intention-to-treat analyses, whereas in the per-protocol analyses, those were 97.8% (179/183) and 100% (28/28), respectively. Fewer patients with HCV genotype 1 of unspecified subtype achieved SVR (81.8%, n = 11) compared to the patients with SVR infected with genotype 1b (99%, n = 198, p < 0.001). All patients with CKD showed SVR. Itching (12%) and dyspepsia (4.1%) were common adverse events. Of the four patients who discontinued the antiviral therapy, one experienced mild fatigue but neither treatment withdrawal was because of an adverse event. Conclusions: EBR/GZR showed high real-world effectiveness and safety in Korean patients with chronic HCV infection regardless of the previous antiviral treatment, liver cirrhosis, or CKD status.

Effectiveness of Elbasvir and Grazoprevir Combination and 1-year Follow-up Hepatic Function for HCV Genotype 1b Infection: Results From a Chinese Real-world Cohort.

“…Through the inclusion of compensatory cirrhosis patients, our study showed that the overall SVR12 rate in patients receiving EBR /GZR was excellent (99.5%) and was slightly higher than the response rates(98.2%)in the clinical trials from the Asia-Paci c region and Russia [6]. Of the 47compensated cirrhotic patients in our study, 100% of patients achieved a virological response at the end of treatment, and 46 patients (97.6%) achieved SVR12, which was similar to the previous real-world studies [14,17,18]. Although SVR12 was considered to be hepatitis C virus cure [19], in our study, one cirrhosis patient relapsed 48 weeks posttreatment after receiving SVR12.…”

A Systematic Review of Direct-Acting Antivirals for Hepatitis C in Advanced CKD

“…We found 22 studies that reported on specific DAA regimens in patients with CKD G4–G5ND (eGFR <30 ml/min per 1.73 m 2 , not on dialysis). 9 , 21 , 22 , 23 , 24 , 25 , 26 , 27 , 28 , 29 , 30 , 31 , 32 , 33 , 34 , 35 , 36 , 37 , 38 , 39 , 40 , 41 The studies evaluated the following: DCV/ASV (1 study, N = 10), GLE/PIB (4 studies, N = 149), GZR/EBR (5 studies, N = 857), PrO±D (5 studies, N = 153), SOF (2 studies, N = 41), SOF/DCV (4 studies, N = 571), SOF/LDV (2 studies, N = 43), SOF/SIM (1 study, N = 41), and SOF/VEL (2 studies, N = 99). Conclusions pertaining to DAA treatment in patients in CKD G4–G5ND are summarized in Table 1 .…”

A cost-effectiveness study of universal screening for hepatitis C virus infection in South Korea: A societal perspective

“…The population structure by age was extracted from the 2019 population census [ 16 ]; the prevalence of anti-HCV by age group was estimated to be 0.38%, 0.63%, and 1.06% in 40s, 50s, and 60s, respectively [ 6 ]. The annual detection rate of HCV infection without screening was applied as 3.8–5.6% [ 17 , 18 ].…”

“…Specifically, glecaprevir/pibrentasvir for 8 weeks was the most commonly prescribed regimen (74.8%), followed by ledipasvir/sofosbuvir (11.2%), elbasvir/grazoprevir (10.5%), and sofosbuvir and ribavirin (3.5%) for 12 weeks each. The SVR rates of each regimen were obtained from the literature review [ 17 , 19 - 22 ].…”