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ABSTRACT: Background and objectives
Hepatitis C virus infection is common in patients with CKD and leads to accelerated progression to ESRD. Sofosbuvir is a potent direct-acting antiviral therapy against hepatitis C virus; however, there are concerns about its safety in patients with CKD. The objective of our study was to determine the safety and efficacy of sofosbuvir in patients with CKD.Design, setting, participants, & measurements
We studied a retrospective observational cohort of patients with CKD defined by eGFR<60 ml/min per 1.73 m2, ?30 mg albuminuria per 1 g creatinine, or ?200 mg proteinuria per 1 g creatinine who received sofosbuvir-based therapy in a large health care system. Regression models were constructed to predict likelihood of sustained virologic response, detect adverse events, and examine changes in eGFR from baseline to follow-up.Results
Ninety-eight patients with CKD (42% stage 1 or 2 CKD and 58% stage 3 CKD) were included. Mean age was 62 years old, 78% were men, and 65% were white. Additionally, 49% of patients had diabetes, 38% of patients had cirrhosis, and 33% of patients had prior solid organ transplant. Overall sustained virologic response was 81% and varied by regimen used and viral genotype. Average baseline eGFR was equivalent to average on-treatment eGFR, but seven patients experienced a rise in creatinine ?1.5 times baseline while taking sofosbuvir; all but one recovered. In patients with eGFR<60 ml/min per 1.73 m2 at baseline (stage 3 CKD), regression models showed that hepatitis C cure was associated with a 9.3 (95% confidence interval, 0.44 to 18) ml/min per 1.73 m2 improvement in eGFR during the 6-month post-treatment follow-up period. Adverse events were common (81%), but serious adverse events (17%) and treatment discontinuations (8%) were uncommon.Conclusions
Sofosbuvir-based direct-acting antiviral therapy is safe and effective in a cohort of patients with CKD infected with hepatitis C.
SUBMITTER: Sise ME
PROVIDER: S-EPMC5628711 | biostudies-literature | 2017 Oct
REPOSITORIES: biostudies-literature
Sise Meghan E ME Backman Elke E Ortiz Guillermo A GA Hundemer Gregory L GL Ufere Nneka N NN Chute Donald F DF Brancale Joseph J Xu Dihua D Wisocky Jessica J Lin Ming V MV Kim Arthur Y AY Thadhani Ravi R Chung Raymond T RT
Clinical journal of the American Society of Nephrology : CJASN 20170907 10
<h4>Background and objectives</h4>Hepatitis C virus infection is common in patients with CKD and leads to accelerated progression to ESRD. Sofosbuvir is a potent direct-acting antiviral therapy against hepatitis C virus; however, there are concerns about its safety in patients with CKD. The objective of our study was to determine the safety and efficacy of sofosbuvir in patients with CKD.<h4>Design, setting, participants, & measurements</h4>We studied a retrospective observational cohort of pati ...[more]