Sofosbuvir and risk of estimated glomerular filtration rate decline or end‐stage renal disease in patients with renal impairment

Sulkowski, Mark S.; Telep, Laura; Colombo, Massimo; Durand, François; Reddy, K. Rajender; Lawitz, Eric; Bourlière, Marc; Cheinquer, Nelson; Scherbakovsky, Stacey; Ni, Liyun; Force, Lindsey; Ramroth, Heribert; Gaggar, Anuj; Chokkalingam, Anand P.; Sise, Meghan E.

doi:10.1111/apt.16830

Cited by 10 publications

(4 citation statements)

References 33 publications

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“…Since on-treatment raw creatinine values were not collected for the purpose of this analysis, we could not exclude eGFR fluctuations. This finding is supported by a recent analysis by Sulkowski et al, who demonstrated that even sofosbuvir-based AVT, which was considered nephrotoxic until recently, did not have an adverse impact on kidney function [54].…”

Section: Discussionsupporting

confidence: 59%

Evaluation of Long-Term Outcomes of Direct Acting Antiviral Agents in Chronic Kidney Disease Subjects: A Single Center Cohort Study

Czarnecka

Tronina

et al. 2023

JCM

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Background: The chronic kidney disease (CKD) population, including kidney transplant recipients (KTRs) and subjects on renal replacement therapy, is particularly vulnerable to unfavorable outcomes from chronic hepatitis C (CHC). Currently, there are oral direct-acting antiviral agents (DAAs) available to eradicate the virus with favorable short-term outcomes; however, their long-term effects are lacking. The aim of the study is to assess the long-term efficacy and safety of DAA therapy in the CKD population. Methods: An observational, cohort single-center study was performed. Fifty-nine CHC subjects with CKD, treated with DAAs between 2016 and 2018, were enrolled in the study. Safety and efficacy profiles were assessed, including sustained virologic response (SVR), occult hepatitis C infection (OCI) incidence, and liver fibrosis. Results: SVR was achieved in 96% of cases (n = 57). OCI was diagnosed only in one subject following SVR. Significant liver stiffness regression was observed 4 years after SVR compared to baseline values (Mdn = 6.1 kPa, IQR = 3.75 kPa; 4.9 kPa, IQR = 2.9 kPa), p < 0.001. The most common adverse events were anemia, weakness, and urinary tract infection. Conclusion: DAAs provide a safe and effective cure for CHC in both CKD patients and KTRs with a favorable safety profile in the long-term follow-up.

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Section: Discussionsupporting

confidence: 59%

Evaluation of Long-Term Outcomes of Direct Acting Antiviral Agents in Chronic Kidney Disease Subjects: A Single Center Cohort Study

Czarnecka

Tronina

et al. 2023

JCM

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“…In November 2019, the FDA changed the label for sofosbuvir-based regimens to allow their use in patients with kidney disease, even those with low eGFR (eGFR d"30 mL/min) or undergoing dialysis. Studies have shown that sofosbuvir does not worsen eGFR in CKD patients, nor linked to an increased risk of ESRD [18]; also there is no association between sofosbuvir and changes in eGFR levels during and after treatment [19] In the present study, we evaluated the efficacy of using half-dose sofosbuvir (200 mg/day) in treatment of hepatitis C infection in patients with ESRD on MHD.…”

Section: Introductionmentioning

confidence: 90%

Efficacy of Daclatasvir and Half Dose Sofosbuvir in the Treatment of Hepatitis –C Virus Infection in Patients of Maintanance Hemodialysis-3 Years Trial in A Tertiary Renal Center

Jabin¹,

Mostafi²,

Kaiser³

et al. 2023

J. Bangladesh Coll. Phys.

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Background: Hepatitis C virus (HCV) infection in end-stage renal disease (ESRD) heralds a bad outcome. Directly acting antiviral (DAA) drugs sofosbuvir along with daclatasvir are very effective in the management of HCV infection. Sofosbuvir is excreted mainly through the kidneys. There is sparse data worldwide on the use of sofosbuvir based drug regimens in ESRD patients having chronic hepatitis C (CHC) virus infection.This study was designed to evaluate the efficacy of half dose sofosbuvir in the management of HCV infection in ESRD patients on maintenance hemodialysis (MHD). Methods: This clinical trial was conducted among 125 ESRD patients on MHD at Gonoshasthaya dialysis center, Dhanmondi, Dhaka from July 2019 to June 2022. Total 125 HCV positive patient with ESRD on MHD were included in this study; all the patients underwent HCV-RNA PCR test. Patients with detectable HCV RNA were observed for six months without antiviral drugs to identify the occurrence of spontaneous clearance of virus. Patients who had detectable HCV-RNA after six months were treated with sofosbuvir(200 mg) and daclatasvir (60 mg), irrespective of genotype. The drugs were given daily for 12 weeks. All the patients were on regular follow up at two weeks interval. Blood counts, liver function, creatinine phosphokinase and serum amylase values were evaluated periodically; virological response was assessed by HCV-RNA after 12 weeks of antiviral treatment. Results: During the observation period, 29 (23.2%) patients had spontaneous virus clearance with an undetectable HCV-RNA. In the remaining 96 patients, the median HCV-RNA level was 2.76×104 (1.56 ×103– 1.89×106)I IU. Twelve weeks after the treatment, 91 (94.8%) patients achieved sustained virological response (SVR) with undetectable HCV-RNA. All patients tolerated the DAAs well and none of the patients reported any serious adverse events. No patient discontinued antiviral therapy due to side effects. Patients who attained SVR with DAA, after 6 months we repeated HCV-RNA in 30 patients, in majority of them (28, 93.3%), HCV-RNA were undetected but in 2 (6.7%) patients,HCV-RNA were detected again. Conclusion: Daclatasvir along with half-dose sofosbuvir are safe and effective in the treatment of CHC patients with ESRD on MHD. Half dose sofosbuvir regimen can reduce the cost of treatment of HCV in ESRD patients in developing countries like Bangladesh, where cost is a significant barrier to HCV treatment. J Bangladesh Coll Phys Surg 2023; 41: 102-107

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“…The condition can be reversed to normal on discontinuation of sofosbuvir therapy ( Carrier et al, 2021 ). However, a retrospective analysis showed no change in the eGFR of CKD patients taking a sofosbuvir-based regimen ( Sulkowski et al, 2022 ).…”

Section: Antivirals For the Treatment Of Covid-19mentioning

confidence: 99%

How to use COVID-19 antiviral drugs in patients with chronic kidney disease

et al. 2023

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Antiviral drugs such as Remdesivir (Veklury), Nirmatrelvir with Ritonavir (Paxlovid), Azvudine, and Molnupiravir (Lagevrio) can reduce the risk for severe and fatal Coronavirus Disease (COVID)-19. Although chronic kidney disease is a highly prevalent risk factor for severe and fatal COVID-19, most clinical trials with these drugs excluded patients with impaired kidney function. Advanced CKD is associated with a state of secondary immunodeficiency (SIDKD), which increases the susceptibility to severe COVID-19, COVID-19 complications, and the risk of hospitalization and mortality among COVID-19 patients. The risk to develop COVID-19 related acute kidney injury is higher in patients with precedent CKD. Selecting appropriate therapies for COVID-19 patients with impaired kidney function is a challenge for healthcare professionals. Here, we discuss the pharmacokinetics and pharmacodynamics of COVID-19-related antiviral drugs with a focus on their potential use and dosing in COVID-19 patients with different stages of CKD. Additionally, we describe the adverse effects and precautions to be taken into account when using these antivirals in COVID-19 patients with CKD. Lastly, we also discuss about the use of monoclonal antibodies in COVID-19 patients with kidney disease and related complications.

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Sofosbuvir and risk of estimated glomerular filtration rate decline or end‐stage renal disease in patients with renal impairment

Cited by 10 publications

References 33 publications

Evaluation of Long-Term Outcomes of Direct Acting Antiviral Agents in Chronic Kidney Disease Subjects: A Single Center Cohort Study

Evaluation of Long-Term Outcomes of Direct Acting Antiviral Agents in Chronic Kidney Disease Subjects: A Single Center Cohort Study

Efficacy of Daclatasvir and Half Dose Sofosbuvir in the Treatment of Hepatitis –C Virus Infection in Patients of Maintanance Hemodialysis-3 Years Trial in A Tertiary Renal Center

How to use COVID-19 antiviral drugs in patients with chronic kidney disease

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