Efficacy and safety of elbasvir/grazoprevir for Japanese patients with genotype 1b chronic hepatitis C complicated by chronic kidney disease, including those undergoing hemodialysis: A post hoc analysis of a multicenter study

BackgroundElbasvir/grazoprevir (EBR/GZR) is a new generation, fixed‐dose, combination antiviral drug used in chronic hepatitis C virus (HCV) genotype (GT) 1 or 4 infection. Our study evaluates the clinical efficacy and safety of EBR/GZR after its launch in Taiwan.MethodsThis is a retrospective observational study. Patients who had received EBR/GZR for chronic HCV GT 1 between June 2017 and April 2018 were recruited. Patients’ age, sex, HCV GT, changes in HCV RNA level before and after treatment, sustained virologic response 12 weeks (SVR12) after the cessation of drug administration, side effects, and interaction effects were used to evaluate the clinical efficacy and safety.ResultsA total of 149 patients were recruited. Of them, 145 (97.3%) had HCV GT 1b, and the rest had HCV GT 1a; most of the EBR/GZR‐related side effects in this study were mild. Three participants were discontinued because their alanine transaminase levels were elevated to over 10 times the upper limit of normal. The therapeutic effect analyses revealed a rapid virologic response rate of 95.3% and an SVR12 rate of 98%. Subgroup analyses performed using SVR12 as the outcome variable revealed three demographic factors HCV GT 1, hepatocellular carcinoma medical history, and noncirrhosis plus HCV RNA level.ConclusionsThis study confirmed that EBR/GZR is safe and effective for treating patients with HCV GT 1 and exhibited excellent overall clinical efficacy in Taiwan. The therapeutic effects are unrelated to factors such as sex, HCV RNA level before treatment, and history of liver cirrhosis.

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“…This finding was comparable with recent publication in Japan, 15 and an SVR12 rate of 100% was established in this subgroup.…”

Section: Discussionsupporting

confidence: 93%

“…There was no significant statistical difference between cirrhosis and noncirrhosis during the course of treatment or follow‐up period (Figure ). This finding was comparable with recent publication in Japan, and an SVR12 rate of 100% was established in this subgroup.…”

Section: Discussionmentioning

confidence: 99%

The efficacy and safety of elbasvir/grazoprevir treatment in HCV genotype 1 patients in Taiwan

Tsai

Deng

Hsu

2019

Journal of Medical Virology

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“…SVR12 rates remained high across other important participant subgroups, including those with compensated cirrhosis, with a baseline viral load > 2 000 000 IU/mL, and aged ≥ 65 years, but SVR12 was lower in participants with GT1a infection. These data support the findings from the EBR/GZR phase 3 clinical development program in both Asian and white individuals and are also consistent with several recent studies reporting SVR rates of 94–98% in Japanese individuals with HCV GT1 infection following treatment with EBR/GZR …”

Section: Discussionsupporting

confidence: 91%

“…These data support the findings from the EBR/GZR phase 3 clinical development program in both Asian and white individuals and are also consistent with several recent studies reporting SVR rates of 94-98% in Japanese individuals with HCV GT1 infection following treatment with EBR/GZR. [22][23][24] Non-structural protein 5A RASs at amino acid positions L31 and Y93 were common among the 12 participants with HCV GT1b infection who experienced relapse, and in most of these participants, the RASs remained detectable at the time of virologic failure. Among the small number of participants with relapse who had GT1b infection and wild-type virus at baseline, all had treatment-emergent Y93H at the time of failure.…”

Section: Discussionmentioning

confidence: 99%

Safety and efficacy of elbasvir/grazoprevir in Asian participants with hepatitis C virus genotypes 1 and 4 infection

Wei

Kumada

Perumalswami

et al. 2019

J of Gastro and Hepatol

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Background and Aim Estimates suggest that in Asia, more than 31 million individuals have hepatitis C virus infection. The present analysis was conducted to assess the efficacy and safety of elbasvir/grazoprevir in Asian participants enrolled in the elbasvir/grazoprevir phase 2/3 clinical trials. Methods This is an integrated analysis of data from 12 international phase 2/3 clinical trials. Asian participants with chronic hepatitis C virus genotype 1 or 4 infection who received elbasvir 50 mg/grazoprevir 100 mg once daily for 12 weeks or elbasvir/grazoprevir plus ribavirin for 16 weeks were included in this analysis. The primary end point was sustained virologic response at 12 weeks after completion of therapy (SVR12). Results Seven hundred eighty Asian participants from 15 countries were included in this analysis. SVR12 was achieved by 756/780 (96.9%) of all participants, including 748/772 (96.9%) of those who received elbasvir/grazoprevir for 12 weeks and 8/8 (100%) of those who received elbasvir/grazoprevir plus ribavirin for 16 weeks. In the genotype 1b‐infected population, the SVR12 rate was 691/709 (97.5%), and there was no impact of age, high baseline viral load, or presence of cirrhosis. The most frequently reported adverse events were nasopharyngitis (8.0%), upper respiratory tract infection (5.4%), and diarrhea (5.2%). Twenty participants receiving elbasvir/grazoprevir for 12 weeks reported a total of 25 serious adverse events, and 7 (0.9%) discontinued treatment because of an adverse event. Conclusion Elbasvir/grazoprevir administered for 12 weeks is an effective and generally well‐tolerated treatment option for Asian individuals with hepatitis C virus genotype 1b infection.

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“…Currently, interferon‐free, direct‐acting antiviral treatment is the standard of care for chronic hepatitis C, and yields a high sustained virologic response rate . Several phase 3 and real‐world studies have demonstrated that the following direct‐acting antiviral treatment regimens are effective and safe, even for chronic kidney disease patients with and without haemodialysis: daclatasvir/asunaprevir, ombitasvir/paritaprevir plus ritonavir, and grazoprevir/elbasvir . However, these regimens have some limitations.…”

Section: Introductionmentioning

confidence: 99%

The efficacy and safety of glecaprevir plus pibrentasvir in 141 patients with severe renal impairment: a prospective, multicenter study

Atsukawa¹,

Tsubota²,

Toyoda³

et al. 2019

Aliment Pharmacol Ther

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Background: Patients with chronic hepatitis C are often complicated by chronic kidney disease (CKD).Aim: To evaluate the efficacy, safety and pharmacokinetics of glecaprevir/pibrentasvir in patients with severe renal impairment. Methods:In a prospective, multicentre study involving 35 medical institutions, 832 genotype 1-3 patients were treated with glecaprevir/pibrentasvir. The efficacy and safety of glecaprevir/pibrentasvir were analysed for patients with CKD stage 4 or 5.Multivariate analysis was performed to identify the factors associated with the most frequently observed adverse event. In patients undergoing haemodialysis, a pharmacokinetic study was conducted to investigate the dialysability of the drugs: plasma samples were obtained from the arterial and venous sides of a dialyser to serially measure drug concentrations. Results:The subjects comprised 141 patients (32 with CKD stage 4 and 109 with CKD stage 5), of whom 100 were undergoing haemodialysis. All but one stage 5 CKD patients undergoing haemodialysis achieved sustained virologic response (99.3%). Adverse events were observed in 39.7% of subjects: pruritus was the most frequent (30.5%), and was significantly associated with haemodialysis. In the pharmacokinetic study, no arterial-venous differences in the plasma concentrations of glecaprevir/pibrentasvir were detected during the haemodialysis sessions.Masanori Atsukawa, Akihito Tsubota and Hidenori Toyoda contributed equally to the preparation of this manuscript. The complete list of affiliations is listed in Appendix 1.

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Efficacy and safety of elbasvir/grazoprevir for Japanese patients with genotype 1b chronic hepatitis C complicated by chronic kidney disease, including those undergoing hemodialysis: A post hoc analysis of a multicenter study

Abstract: The present study demonstrated that elbasvir and grazoprevir are highly effective and safe for genotype 1b chronic hepatitis C Japanese patients with CKD, including those undergoing hemodialysis.

Cited by 29 publications

References 45 publications

The efficacy and safety of elbasvir/grazoprevir treatment in HCV genotype 1 patients in Taiwan

The efficacy and safety of elbasvir/grazoprevir treatment in HCV genotype 1 patients in Taiwan

Safety and efficacy of elbasvir/grazoprevir in Asian participants with hepatitis C virus genotypes 1 and 4 infection

The efficacy and safety of glecaprevir plus pibrentasvir in 141 patients with severe renal impairment: a prospective, multicenter study

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