title: Use of sofosbuvir-based direct-acting antiviral therapy for hepatitis C viral infection in patients with severe renal insufficiency.
abstract: Sofosbuvir-based direct-acting antiviral therapy revolutionized the treatment of hepatitis C virus (HCV) infection. However, sofosbuvir use is not approved for patients with severe renal insufficiency (estimated glomerular filtration (eGFR) rate below 30 ml/min) or end-stage renal disease (ESRD) based on concerns raised during premarket animal testing over hepatobiliary and cardiovascular toxicity in this population. We report the first published data on use of sofosbuvir-based regimens in patients with severe renal insufficiency and ESRD, focusing on clinical efficacy and safety. Six patients were treated with full dose sofosbuvir; three received sofosbuvir and simeprevir, two received sofosbuvir and ribavirin, and one received sofosbuvir, ribavirin, and interferon. Three of the patients had cirrhosis. On-treatment viral suppression was 100% and sustained virological response (SVR) rate at 12 weeks was 67%. One patient had to discontinue antiviral therapy early due to side effects. No hepatobiliary or cardiovascular toxicity was reported.
authors.affiliation: a From the Department of Medicine , Massachusetts General Hospital , Boston , MA , USA.|e Harvard Medical School , Boston , MA , USA.
authors.forename: Gregory L
authors.initials: GL
authors.lastname: Hundemer
authors.affiliation: b Division of Nephrology, Massachusetts General Hospital , Boston , MA , USA.|e Harvard Medical School , Boston , MA , USA.
authors.forename: Meghan E
authors.initials: ME
authors.lastname: Sise
authors.affiliation: c Gastrointestinal Unit, Massachusetts General Hospital , Boston , MA , USA.|e Harvard Medical School , Boston , MA , USA.
authors.forename: Jessica
authors.initials: J
authors.lastname: Wisocky
authors.affiliation: a From the Department of Medicine , Massachusetts General Hospital , Boston , MA , USA.|e Harvard Medical School , Boston , MA , USA.
authors.forename: Nneka
authors.initials: N
authors.lastname: Ufere
authors.affiliation: d Department of Medicine , Newton-Wellesley Hospital , Newton , MA , USA.|e Harvard Medical School , Boston , MA , USA.|f Tufts University School of Medicine , Boston , MA , USA.
authors.forename: Lawrence S
authors.initials: LS
authors.lastname: Friedman
authors.affiliation: c Gastrointestinal Unit, Massachusetts General Hospital , Boston , MA , USA.|e Harvard Medical School , Boston , MA , USA.
authors.forename: Kathleen E
authors.initials: KE
authors.lastname: Corey
authors.affiliation: c Gastrointestinal Unit, Massachusetts General Hospital , Boston , MA , USA.|e Harvard Medical School , Boston , MA , USA.
authors.forename: Raymond T
authors.initials: RT
authors.lastname: Chung
mesh_terms: D000328:Adult; D000368:Aged; D000998:Antiviral Agents / Q000191:economics / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D005260:Female; D005838:Genotype; D016174:Hepacivirus / Q000187:drug effects / Q000472:pathogenicity; D006526:Hepatitis C / Q000150:complications / Q000188:drug therapy*; D019698:Hepatitis C, Chronic / Q000150:complications / Q000188:drug therapy*; D006801:Humans; D016898:Interferon-alpha / Q000627:therapeutic use; D007676:Kidney Failure, Chronic / Q000150:complications* / Q000821:virology; D008103:Liver Cirrhosis / Q000821:virology; D008297:Male; D008875:Middle Aged; D011092:Polyethylene Glycols / Q000627:therapeutic use; D012367:RNA, Viral / Q000097:blood; D012189:Retrospective Studies; D012254:Ribavirin / Q000627:therapeutic use; D000069474:Sofosbuvir / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome; D019562:Viral Load
chemical_list: D000998:Antiviral Agents; D016898:Interferon-alpha; C571406:PEG-IFN-SA; D012367:RNA, Viral; D011092:Polyethylene Glycols; D012254:Ribavirin; D000069474:Sofosbuvir
keywords: Hepatitis C; chronic kidney disease; end-stage renal disease; sofosbuvir