Baseline Creatinine Clearance is a Predictor of Worsening Renal Function whileon HCV Treatment with Sofosbuvir-Ledipasvir

Rosenblatt, Ruth; Mehta, A.; Wagner, Michaela; Kumar, Surachit

doi:10.1016/s0168-8278(16)01602-0

Cited by 13 publications

(14 citation statements)

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“…Patients with HCV infection and eGFR >30 mL/min/1.73 m 2 have unrestricted access to direct‐acting antiviral treatments based on renal function, and in particular no dosage adjustment is required for sofosbuvir‐containing regimens. However, retrospective data indicate that an eGFR <60 mL/min/1.73 m 2 at the initiation of sofosbuvir/ledipasvir therapy is an independent predictor for worsening kidney function while on treatment . In contrast, data from the present analysis indicate that eGFR remained stable or improved in patients with HCV infection and CKD 3 receiving EBR/GZR for 8–18 weeks.…”

Section: Discussioncontrasting

confidence: 73%

“…In this study group, HIV co‐infection was higher among those with CKD 3 compared with all patients in the clinical database, regardless of renal function (41% vs. 17%). Unfortunately, patients with HIV/HCV co‐infection were excluded from the study of EBR/GZR in patients with CKD 4/5 kidney disease, and we are therefore unable to comment on whether the same disparity exists in patients with more advanced renal disease.…”

Section: Discussionmentioning

confidence: 99%

“…Appropriate dosing and safety of commonly used sofosbuvir‐containing regimens have not been established in patients with CKD 4/5 due to the impaired renal excretion of this agent and subsequent accumulation of metabolites in patients with severe renal impairment. Recently, focus has shifted to patients with moderate kidney dysfunction, with recent data suggesting that patients with CKD 3 (estimated glomerular filtration rate [eGFR] <60 to ≥30 mL/min/1.73 m 2 ) are more likely to experience worsening kidney dysfunction when receiving sofosbuvir/ledipasvir compared with patients with normal eGFR …”

Section: Introductionmentioning

confidence: 99%

“…Recently, focus has shifted to patients with moderate kidney dysfunction, with recent data suggesting that patients with CKD 3 (estimated glomerular filtration rate [eGFR] <60 to ≥30 mL/min/ 1.73 m 2 ) are more likely to experience worsening kidney dysfunction when receiving sofosbuvir/ledipasvir compared with patients with normal eGFR. 5 Elbasvir plus grazoprevir (EBR/GZR) is a fixed-dose combination treatment for patients with HCV genotype (GT)1 or 4 infection that showed high rates of efficacy in patients with CKD 4/5 in the phase III, placebo-controlled C-SURFER study. 6 In this study, sustained virologic response (SVR) rates of 99% (115/116) were achieved, with only one patient experiencing virologic failure.…”

Section: Introductionmentioning

confidence: 99%

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

Reddy

Roth

Bruchfeld

et al. 2017

Hepatology Research

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Section: Discussioncontrasting

confidence: 73%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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

Reddy

Roth

Bruchfeld

et al. 2017

Hepatology Research

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“…As shown by Rosenblatt et al . patients with pre‐existing moderate renal impairment are at a higher risk of having their kidney disease worsen during LDV/SOF treatment and creatinine clearance worsened during treatment in 42% of those with abnormal baseline renal function.…”

Section: Kidney Function Is a Safety Issuementioning

confidence: 96%

Hepatitis C: efficacy and safety in real life

Flisiak

Pogorzelska

Flisiak-Jackiewicz

2017

Liver International

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Interferon-free combinations were registered in 2014 and 2015 for the treatment of chronic HCV infection. As a result, real-world experience has been gathered in the last year and this paper presents data available in September 2016. Real-world studies on the efficacy of the ledipasvir/sofosbuvir (LDV/SOF)±ribavirin (RBV) regimen showed a sustained virologic response (SVR) rate of between 91% and 98%. The SVR rate in the 13858 patients included in this paper was 94%, and 92% in the 3506 patients with cirrhosis. In a number of recently published real-world studies evaluating ombitasvir/paritaprevir/ritonavir (OBV/PTV/r)±dasabuvir (DSV)±RBV, the SVR rate was between 92% and 100%. The SVR rate of the 4260 patients included in the studies in this paper was 97% and the rate was the same in the 1647 patients with cirrhosis. Recently, data evaluating SOF/simeprevir±RBV showed an SVR rate >90%, while in combination with daclatasvir this rate reached approximately 95%. The safety data available for LDV/SOF±RBV and OBV/PTV/r±DSV±RBV show that discontinuation due to adverse events was necessary in no more than 3% of patients and the frequency of serious adverse events was between 0 and 11%, in particular in real-world studies. Because of the similar efficacy and safety, real-world data support the use of either the LDV/SOF±RBV or OBV/PTV/r±DSV±RBV regimen in patients with genotypes 1 or 4. There is still not enough real-world data in patients with genotype 3 and other genotypes.

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Pan-Genotypic Hepatitis C Treatment with Glecaprevir and Pibrentasvir for 8 Weeks Resulted in Improved Cardiovascular and Metabolic Outcomes and Stable Renal Function: A Post-Hoc Analysis of Phase 3 Clinical Trials

et al. 2018

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IntroductionChronic hepatitis C (CHC) infection is associated with extrahepatic manifestations (EHMs) which can affect renal, cardiovascular and other comorbidities. The effect of CHC treatment with short-duration regimens on these EHMs is not well defined. Hence, we examined longitudinal estimated glomerular filtration rate (eGFR), triglycerides and glucose values to assess the impact of short-duration CHC therapy on renal, cardiovascular and metabolic diseases, respectively.MethodsWe conducted analyses of all patients without cirrhosis treated with glecaprevir and pibrentasvir (G/P) for 8 weeks in two phase 3 clinical trials. In addition, one phase 3 trial was carried out to explore the effects of treatment on renal EHMs in patients with advanced renal impairment at baseline. As a sensitivity analysis, we included all CHC patients treated with G/P for 8 or 12 weeks enrolled across five phase 3 trials. Adjusting for baseline demographics and clinical properties via mixed regression models enabled evaluation of changes in EHMs through end of treatment.ResultsG/P treatment for 8 weeks resulted in statistically significant declines in triglycerides (− 28.6 mg/dl) and glucose (− 11.2 mg/dl), while there was no statistically significant decline in eGFR. Biomarker improvements were greatest among patients with elevated triglycerides and elevated glucose at baseline. Similar effects were observed across all patients treated with G/P for 8 or 12 weeks.ConclusionShort-duration treatment with G/P resulted in stable renal function and improvements in cardiovascular and metabolic EHM markers, especially in patients with severe EHMs at baseline.FundingAbbVie Inc.Electronic supplementary materialThe online version of this article (10.1007/s40121-018-0218-x) contains supplementary material, which is available to authorized users.

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Baseline Creatinine Clearance is a Predictor of Worsening Renal Function whileon HCV Treatment with Sofosbuvir-Ledipasvir

Cited by 13 publications

References 0 publications

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

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

Hepatitis C: efficacy and safety in real life

Pan-Genotypic Hepatitis C Treatment with Glecaprevir and Pibrentasvir for 8 Weeks Resulted in Improved Cardiovascular and Metabolic Outcomes and Stable Renal Function: A Post-Hoc Analysis of Phase 3 Clinical Trials

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