Elbasvir/grazoprevir does not worsen renal function in patients with hepatitis C virus infection and pre‐existing renal disease

Reddy, K. Rajender; Roth, David; Bruchfeld, Annette; Hwang, Peggy; Haber, Barbara; Robertson, Michael; Barr, Eliav; Greaves, Wayne

doi:10.1111/hepr.12899

Cited by 24 publications

(17 citation statements)

References 14 publications

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“…17 In a Japanese phase III trial, its SVR rate was 96.5% in chronic hepatitis C patients and 97.1% in cirrhosis patients. 18 Moreover, EBR/GZR could be safely given to patients with comorbid chronic kidney disease, as in the reports by Takeuchi et al and Reddy et al 19,20 The current study, carried out by the Japanese Red Cross Liver Study Group, investigated the outcomes and safety of EBR/GZR treatment, along with its efficacy, in patients with treatment failure with existing DAAs.…”

Section: Introductionmentioning

confidence: 78%

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Real‐world efficacy of elbasvir and grazoprevir for hepatitis C virus (genotype 1): A nationwide, multicenter study by the Japanese Red Cross Hospital Liver Study Group

Mashiba

Joko

Kurosaki

et al. 2019

Hepatology Research

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Aim The present study aimed to determine the real‐world efficacy and safety of the non‐structural protein (NS)5A inhibitor elbasvir (EBR) combined with the NS3/4A protease inhibitor grazoprevir (GZR) in patients with hepatitis C virus (HCV) genotype 1 (GT1) infection. Methods This study retrospectively evaluated the rate of sustained virologic response at 12 weeks post‐treatment (SVR12) and the safety of EBR/GZR treatment in 159 men and 194 women with a median age of 72 years, and it assessed factors associated with the SVR12 rate. The attending physicians were responsible for selecting candidate patients for EBR/GZR in this retrospective study. Results Treatment outcomes for EBR/GZR were good in direct‐acting antiviral (DAA)‐naïve patients, of whom 99.4% achieved SVR. Of 353 patients, 10 (2.9%) had treatment failure. Of these patients, eight previously underwent DAA therapy, and the remaining two had NS5A‐L31/Y93 double mutation. The SVR rate was 50% (8/16 patients) in patients who previously underwent DAA therapy, and 18.2% (2/11 patients) in patients with NS5A‐L31/Y93 double mutation. On multivariate logistic regression analysis, NS5A‐Y31/Y93 double mutation (odds ratio 356.3; 95% confidence interval, 23.91–16 940; P < 0.0001) was identified as an independent predictor of treatment failure. No serious adverse events were observed with EBR/GZR therapy. Conclusions The SVR rate of EBR/GZR would have been 100% in patients without either a history of DAA therapy or double mutation. This combination of drugs could be safely given and is, thus, considered a highly useful first‐line treatment for DAA‐naïve patients with HCV.

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Section: Introductionmentioning

confidence: 78%

“…Moreover, EBR/GZR could be safely given to patients with comorbid chronic kidney disease, as in the reports by Takeuchi et al . and Reddy et al …”

Section: Introductionmentioning

confidence: 91%

Real‐world efficacy of elbasvir and grazoprevir for hepatitis C virus (genotype 1): A nationwide, multicenter study by the Japanese Red Cross Hospital Liver Study Group

Mashiba

Joko

Kurosaki

et al. 2019

Hepatology Research

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“…Overall, tolerability was favorable given the broad spectrum of Asian participants with significant comorbidities included in this analysis, including those with end‐stage renal disease, HIV co‐infection, inherited blood disorders, and people who inject drugs . Renal function was not evaluated post‐baseline for the majority of participants in this analysis; however, previous studies have confirmed that treatment with EBR/GZR has no impact on renal function …”

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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“…The label explicitly states that no drug adjustment is required for any degree of renal impairment, including hemodialysis. A retrospective, integrated analysis of phase II/III clinical trials for this drug combination found that, among patients with CKD3 (eGFR 30 to <60 mL/min/1.7 m 2 ), 97% of patients achieved SVR without a decline in eGFR either at the end of treatment or 12 weeks after treatment, indicating that this drug combination was both safe and effective …”

Section: Treatmentmentioning

confidence: 99%

“…A retrospective, integrated analysis of phase II/III clinical trials for this drug combination found that, among patients with CKD3 (eGFR 30 to <60 mL/min/1.7 m 2 ), 97% of patients achieved SVR without a decline in eGFR either at the end of treatment or 12 weeks after treatment, indicating that this drug combination was both safe and effective. 52 Based on this clinical evidence, grazoprevir/elbasvir treatment is now a recommended option for patients with CKD or ESRD and HCV genotypes 1 or 4 ( Table 1). Prior to treatment initiation, it is recommended to test for HCV genotype 1 NS5A resistance-associated variants.…”

Section: Treatmentmentioning

confidence: 99%

Hepatitis C virus infection in patients with end‐stage renal disease

Wigneswaran¹,

Wyck

Pegues

et al. 2018

Hemodialysis International

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Chronic hepatitis C virus (HCV) infection is a major global health problem affecting 3-5 million people in the United States and over 100 million worldwide. Chronic HCV infection, which can lead to cirrhosis and hepatocellular carcinoma, also results in numerous other complications, including impairment of renal function. Because HCV is most often transmitted via parenteral exposure to blood or blood products, patients with end-stage renal disease (ESRD) treated with hemodialysis are at particular risk for infection. Historically, the medications available to treat HCV infection in these patients had significant side effects and were not particularly effective in generating a sustained virologic response. Since 2011, a number of direct-acting antiviral therapies have emerged that can lead to virological cure in the vast majority of patients, with low pill burden and few side effects. Here, we describe the biology and pathophysiology of HCV infection, and summarize current information on new therapies, with a particular focus on their application in patients with chronic kidney disease including ESRD.

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Elbasvir/grazoprevir does not worsen renal function in patients with hepatitis C virus infection and pre‐existing renal disease

Abstract: Elbasvir/grazoprevir is a safe and effective treatment option for patients with compromised renal function, irrespective of baseline eGFR.

Cited by 24 publications

References 14 publications

Real‐world efficacy of elbasvir and grazoprevir for hepatitis C virus (genotype 1): A nationwide, multicenter study by the Japanese Red Cross Hospital Liver Study Group

Real‐world efficacy of elbasvir and grazoprevir for hepatitis C virus (genotype 1): A nationwide, multicenter study by the Japanese Red Cross Hospital Liver Study Group

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

Hepatitis C virus infection in patients with end‐stage renal disease

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