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

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

Research output: Contribution to journalArticle

17 Citations (Scopus)

Abstract

Aim: Treatment options have been limited for patients with hepatitis C virus (HCV) infection and chronic kidney disease stage 4/5 (CKD 4/5). The aim of this analysis was to evaluate the impact of elbasvir/grazoprevir (EBR/GZR) on estimated glomerular filtration rate (eGFR) in patients with CKD stage 3 enrolled in phase II/III clinical trials. Methods: We undertook a retrospective integrated analysis of patients with CKD 3 enrolled in the EBR/GZR phase II/III clinical trials. All patients were required to have chronic HCV infection and have received EBR 50 mg/GZR 100 mg, with or without ribavirin, for 8-18 weeks. Patients with CKD 3 (eGFR <60 to ≥30 mL/min/1.73 m2) at baseline plus ≥1 eGFR assessment postbaseline were included. In all studies, the primary endpoint was sustained virologic response 12 weeks after completion of therapy. Results: Thirty-two patients with CKD 3 were identified from a pooled dataset of 1689 patients enrolled in the EBR/GZR clinical trial program. Thirty-one (97%) patients achieved SVR12 and one patient relapsed. In these 32 patients, there was no decline in median eGFR at the end of treatment or at follow-up week 12 compared with baseline. Median eGFR values were 56 mL/min/1.73 m2 (range, 45-59) at baseline, 58 mL/min/1.73 m2 (range, 41-78) at the end of treatment and 59 mL/min/1.73 m2 (range, 38-78) 12 weeks after completing treatment. Discussion: Elbasvir/grazoprevir is a safe and effective treatment option for patients with compromised renal function, irrespective of baseline eGFR.

Original languageEnglish (US)
JournalHepatology Research
DOIs
StateAccepted/In press - 2017

Fingerprint

Preexisting Condition Coverage
Virus Diseases
Hepacivirus
Kidney
Glomerular Filtration Rate
Phase III Clinical Trials
Phase II Clinical Trials
MK-5172
2-(pyrrolidin-2-yl)-5-(2-(4-(5-(pyrrolidin-2-yl)-1H-imidazol-2-yl)phenyl)benzofuran-5-yl)-1H-imidazole
Therapeutics
Ribavirin
Chronic Hepatitis C
Chronic Renal Insufficiency
Clinical Trials

Keywords

  • Chronic kidney disease
  • Hepatitis C
  • Retrospective
  • Therapy

ASJC Scopus subject areas

  • Hepatology
  • Infectious Diseases

Cite this

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 N.; Barr, Eliav; Greaves, Wayne.

In: Hepatology Research, 2017.

Research output: Contribution to journalArticle

Reddy, K. Rajender ; Roth, David ; Bruchfeld, Annette ; Hwang, Peggy ; Haber, Barbara ; Robertson, Michael N. ; Barr, Eliav ; Greaves, Wayne. / Elbasvir/grazoprevir does not worsen renal function in patients with hepatitis C virus infection and pre-existing renal disease. In: Hepatology Research. 2017.
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abstract = "Aim: Treatment options have been limited for patients with hepatitis C virus (HCV) infection and chronic kidney disease stage 4/5 (CKD 4/5). The aim of this analysis was to evaluate the impact of elbasvir/grazoprevir (EBR/GZR) on estimated glomerular filtration rate (eGFR) in patients with CKD stage 3 enrolled in phase II/III clinical trials. Methods: We undertook a retrospective integrated analysis of patients with CKD 3 enrolled in the EBR/GZR phase II/III clinical trials. All patients were required to have chronic HCV infection and have received EBR 50 mg/GZR 100 mg, with or without ribavirin, for 8-18 weeks. Patients with CKD 3 (eGFR <60 to ≥30 mL/min/1.73 m2) at baseline plus ≥1 eGFR assessment postbaseline were included. In all studies, the primary endpoint was sustained virologic response 12 weeks after completion of therapy. Results: Thirty-two patients with CKD 3 were identified from a pooled dataset of 1689 patients enrolled in the EBR/GZR clinical trial program. Thirty-one (97{\%}) patients achieved SVR12 and one patient relapsed. In these 32 patients, there was no decline in median eGFR at the end of treatment or at follow-up week 12 compared with baseline. Median eGFR values were 56 mL/min/1.73 m2 (range, 45-59) at baseline, 58 mL/min/1.73 m2 (range, 41-78) at the end of treatment and 59 mL/min/1.73 m2 (range, 38-78) 12 weeks after completing treatment. Discussion: Elbasvir/grazoprevir is a safe and effective treatment option for patients with compromised renal function, irrespective of baseline eGFR.",
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AU - Reddy, K. Rajender

AU - Roth, David

AU - Bruchfeld, Annette

AU - Hwang, Peggy

AU - Haber, Barbara

AU - Robertson, Michael N.

AU - Barr, Eliav

AU - Greaves, Wayne

PY - 2017

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N2 - Aim: Treatment options have been limited for patients with hepatitis C virus (HCV) infection and chronic kidney disease stage 4/5 (CKD 4/5). The aim of this analysis was to evaluate the impact of elbasvir/grazoprevir (EBR/GZR) on estimated glomerular filtration rate (eGFR) in patients with CKD stage 3 enrolled in phase II/III clinical trials. Methods: We undertook a retrospective integrated analysis of patients with CKD 3 enrolled in the EBR/GZR phase II/III clinical trials. All patients were required to have chronic HCV infection and have received EBR 50 mg/GZR 100 mg, with or without ribavirin, for 8-18 weeks. Patients with CKD 3 (eGFR <60 to ≥30 mL/min/1.73 m2) at baseline plus ≥1 eGFR assessment postbaseline were included. In all studies, the primary endpoint was sustained virologic response 12 weeks after completion of therapy. Results: Thirty-two patients with CKD 3 were identified from a pooled dataset of 1689 patients enrolled in the EBR/GZR clinical trial program. Thirty-one (97%) patients achieved SVR12 and one patient relapsed. In these 32 patients, there was no decline in median eGFR at the end of treatment or at follow-up week 12 compared with baseline. Median eGFR values were 56 mL/min/1.73 m2 (range, 45-59) at baseline, 58 mL/min/1.73 m2 (range, 41-78) at the end of treatment and 59 mL/min/1.73 m2 (range, 38-78) 12 weeks after completing treatment. Discussion: Elbasvir/grazoprevir is a safe and effective treatment option for patients with compromised renal function, irrespective of baseline eGFR.

AB - Aim: Treatment options have been limited for patients with hepatitis C virus (HCV) infection and chronic kidney disease stage 4/5 (CKD 4/5). The aim of this analysis was to evaluate the impact of elbasvir/grazoprevir (EBR/GZR) on estimated glomerular filtration rate (eGFR) in patients with CKD stage 3 enrolled in phase II/III clinical trials. Methods: We undertook a retrospective integrated analysis of patients with CKD 3 enrolled in the EBR/GZR phase II/III clinical trials. All patients were required to have chronic HCV infection and have received EBR 50 mg/GZR 100 mg, with or without ribavirin, for 8-18 weeks. Patients with CKD 3 (eGFR <60 to ≥30 mL/min/1.73 m2) at baseline plus ≥1 eGFR assessment postbaseline were included. In all studies, the primary endpoint was sustained virologic response 12 weeks after completion of therapy. Results: Thirty-two patients with CKD 3 were identified from a pooled dataset of 1689 patients enrolled in the EBR/GZR clinical trial program. Thirty-one (97%) patients achieved SVR12 and one patient relapsed. In these 32 patients, there was no decline in median eGFR at the end of treatment or at follow-up week 12 compared with baseline. Median eGFR values were 56 mL/min/1.73 m2 (range, 45-59) at baseline, 58 mL/min/1.73 m2 (range, 41-78) at the end of treatment and 59 mL/min/1.73 m2 (range, 38-78) 12 weeks after completing treatment. Discussion: Elbasvir/grazoprevir is a safe and effective treatment option for patients with compromised renal function, irrespective of baseline eGFR.

KW - Chronic kidney disease

KW - Hepatitis C

KW - Retrospective

KW - Therapy

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