Effect of Sofosbuvir-Based Hepatitis C Virus Therapy on Kidney Function in Patients with CKD

Clinical journal of the American Society of Nephrology: CJASN

Guillermo A. Ortiz²  Meghan E. Sise³ 

[1] and..‖Division of Gastroenterology, Brigham and Women’s Hospital, Boston, Massachusetts..¶Department of Medicine, Division of Infectious Diseases, Massachusetts General Hospital, Boston, Massachusetts;*Department of Medicine, Division of Nephrology,..*Department of Medicine, Division of Nephrology,..‡Department of Medicine, Gastrointestinal Unit, and..‡Department of Medicine, Gastrointestinal Unit, and..‡Department of Medicine, Gastrointestinal Unit, and..*Department of Medicine, Division of Nephrology,..§Division of Gastroenterology, University of Massachusetts Medical Center, Worcester, Massachusetts;*Department of Medicine, Division of Nephrology,..†Department of Pharmacy,..;*Department of Medicine, Division of Nephrology,..‡Department of Medicine, Gastrointestinal Unit, and..

关键词: diabetes;    virology;    chronic kidney disease;    drug nephrotoxicity;    progression of renal failure;    albuminuria;    Antiviral Agents;    creatinine;    diabetes mellitus;    Disease Progression;    Follow-Up Studies;    Genotype;    glomerular filtration rate;    Hepacivirus;    Hepatitis C;    Humans;    Kidney Failure, Chronic;    Liver;    Cirrhosis;    Male;    Middle Aged;    proteinuria;    Renal Insufficiency, Chronic;    Retrospective Studies;    Sofosbuvir;    Sustained Virologic Response;   

DOI  :  10.2215/CJN.02510317

学科分类：泌尿医学

来源: American Society of Nephrology

【 摘 要 】

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.

【 授权许可】

CC BY