Effectiveness of Elbasvir/Grazoprevir in Patients with Hepatitis C Virus Genotype 1 Infection and Chronic Kidney Disease in the United States Veterans Population

Overview

Journal Antiviral Res

Publisher Elsevier

Date 2019 Dec 22

PMID 31862503

Citations 4

Authors

Debra T Choi

Amy Puenpatom

Xian Yu

Kevin F Erickson

Fasiha Kanwal

Hashem B El-Serag

Jennifer R Kramer

Affiliations

Soon will be listed here.

Abstract

Background & Aims: Randomized controlled trials of EBR/GZR have reported high treatment efficacy, safety and tolerability in patients undergoing dialysis. However, real world effectiveness data for EBR/GZR in this population is lacking. We evaluated the effectiveness of EBR/GZR in an HCV-infected population with all stages of CKD including dialysis compared with control patients with estimated glomerular filtration rate (eGFR) ≥60 in the US Department of Veterans Affairs (VA).

Methods: We conducted a retrospective cohort study of patients with chronic HCV genotype 1 infection with EBR/GZR prescriptions dispensed during February 1, 2016-August 31, 2017 in 128 VA Medical Centers. We collected patient information regarding history of dialysis, end stage renal disease (ESRD), and/or eGFR values. We measured SVR based on undetectable HCV RNA at least 4 weeks after the completion of treatment. We examined SVR rates by CKD stage compared to control patients and within patient subgroups using logistic regression models.

Results: We identified 5961 patients (42.5% genotype 1a, 55.0% genotype 1b) who met eligibility criteria and completed a EBR/GZR treatment course (≥11 weeks). Approximately 73.2% (n = 4361) had eGFR ≥60 who served as control patients, 14.4% (n = 860) had Stage 3 CKD, and 12.4% (n = 740) had Stage 4-5 CKD or ESRD. Of patients with Stage 4-5 CKD/ESRD, 76.1% underwent dialysis (n = 563). The overall SVR was 96.7% in all patients, 96.4% for eGFR≥60, 98.3% in Stage 3 CKD, and 96.5% in Stage 4-5 CKD/ESRD. No statistically significant differences were found in the SVR rates in patients with or without dialysis in the Stage 4-5 CKD/ESRD patients (adjusted OR 0.91; 95% CI 0.56-1.47 and OR 1.74; 95% CI 0.63-4.81) compared with those with eGFR≥60.

Conclusion: We found EBR/GZR was effective in patients with HCV GT1 infection regardless of CKD severity or receipt of dialysis in the US VA population.

Citing Articles

Hepatitis C Virus Infection in Hemodialysis Patients in the Era of Direct-Acting Antiviral Treatment: Observational Study and Narrative Review.

Ratiu I, Mihaescu A, Olariu N, Ratiu C, Cristian B, Ratiu A Medicina (Kaunas). 2025; 60(12.

PMID: 39768975 PMC: 11678887. DOI: 10.3390/medicina60122093.

The efficacy and safety of direct-acting antiviral regimens for end-stage renal disease patients with HCV infection: a systematic review and network meta-analysis.

Chen R, Xiong Y, Zeng Y, Wang X, Xiao Y, Zheng Y Front Public Health. 2023; 11:1179531.

PMID: 37841743 PMC: 10570741. DOI: 10.3389/fpubh.2023.1179531.

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

Balk E, Adam G, Jadoul M, Martin P, Gordon C Kidney Int Rep. 2023; 8(2):240-253.

PMID: 36815114 PMC: 9939364. DOI: 10.1016/j.ekir.2022.11.008.

Viral hepatitis: Milestones, unresolved issues, and future goals.

Torre P, Aglitti A, Masarone M, Persico M World J Gastroenterol. 2021; 27(28):4603-4638.

PMID: 34366625 PMC: 8326259. DOI: 10.3748/wjg.v27.i28.4603.

Elbasvir/grazoprevir treatment in an HCV-infected peritoneal dialysis patient.

Chen J, Li Y, Li G, Lei P Ren Fail. 2020; 42(1):377-380.

PMID: 32301365 PMC: 7178844. DOI: 10.1080/0886022X.2020.1753073.

References

Flamm S, Bacon B, Curry M, Milligan S, Nwankwo C, Tsai N . Real-world use of elbasvir-grazoprevir in patients with chronic hepatitis C: retrospective analyses from the TRIO network. Aliment Pharmacol Ther. 2018; 47(11):1511-1522. DOI: 10.1111/apt.14635. View

. EASL Recommendations on Treatment of Hepatitis C 2018. J Hepatol. 2018; 69(2):461-511. DOI: 10.1016/j.jhep.2018.03.026. View

Takeuchi Y, Akuta N, Sezaki H, Suzuki F, Fujiyama S, Kawamura Y . Efficacy and safety of elbasvir plus grazoprevir combination therapy in Japanese patients infected with hepatitis C virus genotype 1b. Hepatol Res. 2018; 49(3):256-263. DOI: 10.1111/hepr.13242. View

Gordon C, Nader C . Evolving therapies for hepatitis C virus in chronic kidney disease: the beginning of a new era. Curr Opin Nephrol Hypertens. 2016; 26(2):129-135. DOI: 10.1097/MNH.0000000000000298. View

Pereira B, Levey A . Hepatitis C virus infection in dialysis and renal transplantation. Kidney Int. 1997; 51(4):981-99. DOI: 10.1038/ki.1997.139. View

Kramer J, Davila J, Miller E, Richardson P, Giordano T, El-Serag H . The validity of viral hepatitis and chronic liver disease diagnoses in Veterans Affairs administrative databases. Aliment Pharmacol Ther. 2007; 27(3):274-82. DOI: 10.1111/j.1365-2036.2007.03572.x. View

Kramer J, Puenpatom A, Erickson K, Cao Y, Smith D, El-Serag H . Real-world effectiveness of elbasvir/grazoprevir In HCV-infected patients in the US veterans affairs healthcare system. J Viral Hepat. 2018; 25(11):1270-1279. PMC: 6202183. DOI: 10.1111/jvh.12937. View

Al-Salama Z, Deeks E . Elbasvir/Grazoprevir: A Review in Chronic HCV Genotypes 1 and 4. Drugs. 2017; 77(8):911-921. DOI: 10.1007/s40265-017-0739-8. View

Bruchfeld A, Roth D, Martin P, Nelson D, Pol S, Londono M . Elbasvir plus grazoprevir in patients with hepatitis C virus infection and stage 4-5 chronic kidney disease: clinical, virological, and health-related quality-of-life outcomes from a phase 3, multicentre, randomised, double-blind, placebo-controlled.... Lancet Gastroenterol Hepatol. 2017; 2(8):585-594. DOI: 10.1016/S2468-1253(17)30116-4. View

10.

Fihn S, Francis J, Clancy C, Nielson C, Nelson K, Rumsfeld J . Insights from advanced analytics at the Veterans Health Administration. Health Aff (Millwood). 2014; 33(7):1203-11. DOI: 10.1377/hlthaff.2014.0054. View

11.

Hezode C, Colombo M, Bourliere M, Spengler U, Ben-Ari Z, Strasser S . Elbasvir/Grazoprevir for Patients With Hepatitis C Virus Infection and Inherited Blood Disorders: A Phase III Study. Hepatology. 2017; 66(3):736-745. DOI: 10.1002/hep.29139. View

12.

Wong E, Wang V, Liu C, Hebert P, Maciejewski M . Do Veterans Health Administration Enrollees Generalize to Other Populations?. Med Care Res Rev. 2015; 73(4):493-507. DOI: 10.1177/1077558715617382. View

13.

Roth D, Nelson D, Bruchfeld A, Liapakis A, Silva M, Monsour Jr H . Grazoprevir plus elbasvir in treatment-naive and treatment-experienced patients with hepatitis C virus genotype 1 infection and stage 4-5 chronic kidney disease (the C-SURFER study): a combination phase 3 study. Lancet. 2015; 386(10003):1537-45. DOI: 10.1016/S0140-6736(15)00349-9. View

14.

Ioannou G, Beste L, Chang M, Green P, Lowy E, Tsui J . Effectiveness of Sofosbuvir, Ledipasvir/Sofosbuvir, or Paritaprevir/Ritonavir/Ombitasvir and Dasabuvir Regimens for Treatment of Patients With Hepatitis C in the Veterans Affairs National Health Care System. Gastroenterology. 2016; 151(3):457-471.e5. PMC: 5341745. DOI: 10.1053/j.gastro.2016.05.049. View

15.

Sakhuja A, Schold J, Kumar G, Dall A, Sood P, Navaneethan S . Outcomes of patients receiving maintenance dialysis admitted over weekends. Am J Kidney Dis. 2013; 62(4):763-70. PMC: 3783620. DOI: 10.1053/j.ajkd.2013.03.014. View

16.

Levey A, Coresh J, Greene T, Stevens L, Zhang Y, Hendriksen S . Using standardized serum creatinine values in the modification of diet in renal disease study equation for estimating glomerular filtration rate. Ann Intern Med. 2006; 145(4):247-54. DOI: 10.7326/0003-4819-145-4-200608150-00004. View

17.

Zeuzem S, Ghalib R, Reddy K, Pockros P, Ben Ari Z, Zhao Y . Grazoprevir-Elbasvir Combination Therapy for Treatment-Naive Cirrhotic and Noncirrhotic Patients With Chronic Hepatitis C Virus Genotype 1, 4, or 6 Infection: A Randomized Trial. Ann Intern Med. 2015; 163(1):1-13. DOI: 10.7326/M15-0785. View

18.

Goodkin D, Bieber B, Jadoul M, Martin P, Kanda E, Pisoni R . Mortality, Hospitalization, and Quality of Life among Patients with Hepatitis C Infection on Hemodialysis. Clin J Am Soc Nephrol. 2016; 12(2):287-297. PMC: 5293341. DOI: 10.2215/CJN.07940716. View

19.

Solberg L, Engebretson K, Sperl-Hillen J, Hroscikoski M, OConnor P . Are claims data accurate enough to identify patients for performance measures or quality improvement? The case of diabetes, heart disease, and depression. Am J Med Qual. 2006; 21(4):238-45. DOI: 10.1177/1062860606288243. View

20.

Su F, Green P, Berry K, Ioannou G . The association between race/ethnicity and the effectiveness of direct antiviral agents for hepatitis C virus infection. Hepatology. 2016; 65(2):426-438. PMC: 6535089. DOI: 10.1002/hep.28901. View