title: Frequency and risk factors of renal impairment during long-term adefovir dipivoxil treatment in chronic hepatitis B patients.
abstract: OBJECTIVE
  There are insufficient data on renal safety during long-term adefovir dipivoxil (ADV) treatment. We aimed to elucidate the incidence and risk factors of renal impairment in chronic hepatitis B (CHB) patients treated with ADV.
  
  
  METHODS
  We retrospectively enrolled 687 CHB patients (51.4% with compensated cirrhosis) treated with ADV alone (18.2%) or in combination with lamivudine (81.8%) for more than 12 months. Renal function was measured using the estimated glomerular filtration rate (eGFR), and renal dysfunction was defined as mild (20-30% decrease), moderate (30-50%), or severe (more than 50%).
  
  
  RESULTS
  During the median treatment duration of 27 months, 72 patients (10.5%) developed renal impairment, which was mild in 77.8% of cases, moderate in 20.8% of cases, and severe in one patient. The cumulative incidence of renal impairment at 1, 3, and 5 years was 2.6%, 14.8%, and 34.7%, respectively. Modification of the dosing interval or discontinuation of ADV was required in seven and three patients, respectively, and none of them showed a further decline in the eGFR. Although a univariate analysis revealed age, the number of exposure to radio-contrast dye, liver cirrhosis, and hepatocellular carcinoma as risk factors of renal impairment, age was the only significant risk factor identified in the multivariate analysis (odds ratio = 1.048, 95% confidence interval = 1.019-1.076, P = 0.001).
  
  
  CONCLUSIONS
  Renal impairment in long-term ADV users was relatively frequent, but serious renal toxicity was rare, and all cases were safely managed. Careful monitoring of renal function is required, especially in older patients.
authors.affiliation: Department of Medicine, Sungkyunkwan University School of Medicine, Samsung Medical Center, Seoul, Korea.
authors.forename: Yu Jin
authors.initials: YJ
authors.lastname: Kim
authors.forename: Hyun Chin
authors.initials: HC
authors.lastname: Cho
authors.forename: Dong Hyun
authors.initials: DH
authors.lastname: Sinn
authors.forename: Geum-Youn
authors.initials: GY
authors.lastname: Gwak
authors.forename: Moon Seok
authors.initials: MS
authors.lastname: Choi
authors.forename: Kwang Cheol
authors.initials: KC
authors.lastname: Koh
authors.forename: Seung Woon
authors.initials: SW
authors.lastname: Paik
authors.forename: Byung Chul
authors.initials: BC
authors.lastname: Yoo
authors.forename: Joon Hyeok
authors.initials: JH
authors.lastname: Lee
mesh_terms: D000225:Adenine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D000293:Adolescent; D000328:Adult; D000368:Aged; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D005919:Glomerular Filtration Rate / Q000187:drug effects*; D019694:Hepatitis B, Chronic / Q000188:drug therapy*; D006801:Humans; D015994:Incidence; D053208:Kaplan-Meier Estimate; D007668:Kidney / Q000187:drug effects* / Q000503:physiopathology; D007674:Kidney Diseases / Q000139:chemically induced* / Q000453:epidemiology / Q000503:physiopathology; D019259:Lamivudine / Q000008:administration & dosage; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D016017:Odds Ratio; D063065:Organophosphonates / Q000008:administration & dosage / Q000009:adverse effects*; D016016:Proportional Hazards Models; D056910:Republic of Korea; D012189:Retrospective Studies; D018894:Reverse Transcriptase Inhibitors / Q000008:administration & dosage / Q000009:adverse effects*; D018570:Risk Assessment; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D063065:Organophosphonates; D018894:Reverse Transcriptase Inhibitors; D019259:Lamivudine; D000225:Adenine; C106812:adefovir dipivoxil