Efficacy and safety of adefovir dipivoxil in kidney recipients, hemodialysis patients, and patients with renal insufficiency.
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.
Fontaine
Hélène
H
Liver Unit, Necker Hospital, Paris, France.
Vallet-Pichard
Anaïs
A
Chaix
Marie-Laure
ML
Currie
Graham
G
Serpaggi
Jeanne
J
Verkarre
Virginie
V
Varaut
Anne
A
Morales
Eugenia
E
Nalpas
Bertrand
B
Brosgart
Carol
C
Pol
Stanislas
S
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
D000998:Antiviral Agents; D063065:Organophosphonates; D000225:Adenine; C106812:adefovir dipivoxil