title: Renal Function in Chronic Hepatitis B Patients Treated With Tenofovir Disoproxil Fumarate or Entecavir Monotherapy: A Matched Case-Cohort Study.
abstract: OBJECTIVE
  Tenofovir (TDF)-associated renal dysfunction has been described in various studies of human immunodeficiency virus-infected patients. Our goal is to examine the incidence and magnitude of decrease in renal function in chronic hepatitis B patients treated with TDF.
  
  
  METHODS
  We performed a case-cohort study of 103 patients on TDF 300 mg and 103 patients unexposed to TDF (Entecavir) at 4 centers, who were matched for age±10 years, sex, and baseline estimated glomerular filtration rate (eGFR) group. Calculation and evaluation of eGFR were performed with both the Cockcroft-Gault formula and the Modification of Diet in Renal Disease formula.
  
  
  RESULTS
  The exposed and unexposed populations were well matched with a similar mean age (44±10 y), proportion of male patients (63.1%), and baseline eGFR groups (86.4% unimpaired). There was no significant difference in the proportion of patients reclassified to a more severe renal classification (RMSRC) or in the proportion of patients with decrease in eGFR of ≥20% in those exposed to TDF versus control. The incidence density for RMSRC was 7.4 cases per 100 patient-years in the exposed group compared with 11.5 cases per 100 patient-years in the unexposed group (95% CI, 0.31-1.34). The relative risk of exposed to unexposed was 0.64 (95% CI, 0.31-1.34). On Cox proportional hazard analysis following adjustment for sex, age, baseline diagnosis hypertension, diabetes, impaired baseline renal function, and cirrhosis, TDF was not a predictor for RMSRC or decrease in eGFR≥20%.
  
  
  CONCLUSIONS
  TDF treatment was not an independent predictor for significant deterioration of renal function. Renal function of chronic hepatitis B patients on antiviral therapy should be monitored, especially in those who are older and/or with mildly impaired renal function.
authors: *School of Pharmacy, University of California, San Francisco, San Francisco †Pacific Health Foundation ∥San Jose Gastroenterology, San Jose ‡Department of Medicine, Santa Clara Valley Medical Center, Santa Clara §School of Medicine, University of California, Davis, Sacramento ¶Division of Gastroenterology and Hepatology, Stanford University Medical Center, Palo Alto, CA.
authors: Nghi B
authors: NB
authors: Ha
authors: Kevin
authors: K
authors: Ku
authors: Nghiem B
authors: NB
authors: Ha
authors: Kevin T
authors: KT
authors: Chaung
authors: Huy N
authors: HN
authors: Trinh
authors: Mindie H
authors: MH
authors: Nguyen
mesh_terms: D058186:Acute Kidney Injury / Q000139:chemically induced* / Q000453:epidemiology; D000328:Adult; D000998:Antiviral Agents / Q000009:adverse effects*; D016022:Case-Control Studies; D005260:Female; D005919:Glomerular Filtration Rate; D006147:Guanine / Q000009:adverse effects / Q000031:analogs & derivatives*; D019694:Hepatitis B, Chronic / Q000188:drug therapy*; D006801:Humans; D015994:Incidence; D007677:Kidney Function Tests; D008297:Male; D008875:Middle Aged; D016016:Proportional Hazards Models; D012307:Risk Factors; D000068698:Tenofovir / Q000009:adverse effects*
chemical_list: D000998:Antiviral Agents; C413685:entecavir; D006147:Guanine; D000068698:Tenofovir