title: Efficacy and safety of adefovir dipivoxil in kidney recipients, hemodialysis patients, and patients with renal insufficiency.
abstract: BACKGROUND
  This study analyzes the biochemical, serological, and virological efficacy and the safety of adefovir dipivoxil in patients with renal disturbances.
  
  
  METHODS
  Twelve patients with lamivudine-resistant hepatitis B virus (HBV) chronic infection were treated for a median time of 15 (3-19) months. The daily dosage was 10 mg initially and then adjusted according to renal function.
  
  
  RESULTS
  Median (range) ALT values remained stable: 55 (13-117) and 37 (17-266) UI/L. After the 12th month, the median decline in serum HBV DNA was from 8.76 (6.3-9.7) to 2.97 (1.15-5.65) log10 Eq/ml (median decline of -5.5 log10). No virologic breakthrough was observed. One of the six HBeAg-positive patients lost HBe Ag but without HBe seroconversion; none had HBs Ag loss. There were no significant clinical and biochemical adverse effects. In the 11 nonhemodialysed patients, the creatinine clearance significantly improved from 70 (30-100) to 88 (38-125) ml/mn (P=0.01) and the mean serum creatinine levels increased only slightly from 114 (91-839) to 130 (81-561) micromol/ml (NS). Serum phosphorus remained stable. The urinary level of protein decreased from 0.16 (0.08-8.63) to 0.12 (0.01-0.74) g/day (NS).
  
  
  CONCLUSIONS
  Adefovir dipivoxil is safe for the treatment of chronic hepatitis B in patients with varying degrees of renal dysfunction and lamivudine-resistant HBV and results in biochemical and virological efficacy similar to that reported in the general population.
authors.affiliation: Liver Unit, Necker Hospital, Paris, France.
authors.forename: Hélène
authors.initials: H
authors.lastname: Fontaine
authors.forename: Anaïs
authors.initials: A
authors.lastname: Vallet-Pichard
authors.forename: Marie-Laure
authors.initials: ML
authors.lastname: Chaix
authors.forename: Graham
authors.initials: G
authors.lastname: Currie
authors.forename: Jeanne
authors.initials: J
authors.lastname: Serpaggi
authors.forename: Virginie
authors.initials: V
authors.lastname: Verkarre
authors.forename: Anne
authors.initials: A
authors.lastname: Varaut
authors.forename: Eugenia
authors.initials: E
authors.lastname: Morales
authors.forename: Bertrand
authors.initials: B
authors.lastname: Nalpas
authors.forename: Carol
authors.initials: C
authors.lastname: Brosgart
authors.forename: Stanislas
authors.initials: S
authors.lastname: Pol
mesh_terms: D000225:Adenine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000493:pharmacokinetics / Q000627:therapeutic use; D000328:Adult; D000368:Aged; D000998:Antiviral Agents / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D024882:Drug Resistance, Viral; D005260:Female; D006515:Hepatitis B virus; D019694:Hepatitis B, Chronic / Q000097:blood / Q000150:complications / Q000188:drug therapy*; D006801:Humans; D016030:Kidney Transplantation; D008297:Male; D008875:Middle Aged; D063065:Organophosphonates / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D006435:Renal Dialysis; D051437:Renal Insufficiency / Q000150:complications*; D014766:Viremia / Q000188:drug therapy
chemical_list: D000998:Antiviral Agents; D063065:Organophosphonates; D000225:Adenine; C106812:adefovir dipivoxil