Efficacy and safety of adefovir dipivoxil in kidney recipients, hemodialysis patients, and patients with renal insufficiency

This study analyzes the biochemical, serological, and virological efficacy and the safety of adefovir dipivoxil in patients with renal disturbances. Twelve patients with lamivudine-resistant hepatitis B virus (HBV) chronic infection were treated for a median time of 15 (3-19) months. The daily dosag...

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Veröffentlicht in:Transplantation 2005-10, Vol.80 (8), p.1086-1092
Hauptverfasser: FONTAINE, Hélène, VALLET-PICHARD, Anaïs, POL, Stanislas, CHAIX, Marie-Laure, CURRIE, Graham, SERPAGGI, Jeanne, VERKARRE, Virginie, VARAUT, Anne, MORALES, Eugenia, NALPAS, Bertrand, BROSGART, Carol
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container_end_page 1092
container_issue 8
container_start_page 1086
container_title Transplantation
container_volume 80
creator FONTAINE, Hélène
VALLET-PICHARD, Anaïs
POL, Stanislas
CHAIX, Marie-Laure
CURRIE, Graham
SERPAGGI, Jeanne
VERKARRE, Virginie
VARAUT, Anne
MORALES, Eugenia
NALPAS, Bertrand
BROSGART, Carol
description This study analyzes the biochemical, serological, and virological efficacy and the safety of adefovir dipivoxil in patients with renal disturbances. 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. 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). 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.
doi_str_mv 10.1097/01.tp.0000178305.39231.a2
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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. 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. 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Psychology</topic><topic>Fundamental immunology</topic><topic>Hepatitis B virus</topic><topic>Hepatitis B, Chronic - blood</topic><topic>Hepatitis B, Chronic - complications</topic><topic>Hepatitis B, Chronic - drug therapy</topic><topic>Humans</topic><topic>Intensive care medicine</topic><topic>Kidney Transplantation</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Organophosphonates - adverse effects</topic><topic>Organophosphonates - pharmacokinetics</topic><topic>Organophosphonates - therapeutic use</topic><topic>Renal Dialysis</topic><topic>Renal Insufficiency - complications</topic><topic>Surgery (general aspects). Transplantations, organ and tissue grafts. 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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. 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). 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.</abstract><cop>Hagerstown, MD</cop><pub>Lippincott</pub><pmid>16278590</pmid><doi>10.1097/01.tp.0000178305.39231.a2</doi><tpages>7</tpages><oa>free_for_read</oa></addata></record>
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subjects Adenine - adverse effects
Adenine - analogs & derivatives
Adenine - pharmacokinetics
Adenine - therapeutic use
Adult
Aged
Anesthesia. Intensive care medicine. Transfusions. Cell therapy and gene therapy
Antiviral Agents - adverse effects
Antiviral Agents - pharmacokinetics
Antiviral Agents - therapeutic use
Biological and medical sciences
Drug Resistance, Viral
Emergency and intensive care: renal failure. Dialysis management
Female
Fundamental and applied biological sciences. Psychology
Fundamental immunology
Hepatitis B virus
Hepatitis B, Chronic - blood
Hepatitis B, Chronic - complications
Hepatitis B, Chronic - drug therapy
Humans
Intensive care medicine
Kidney Transplantation
Male
Medical sciences
Middle Aged
Organophosphonates - adverse effects
Organophosphonates - pharmacokinetics
Organophosphonates - therapeutic use
Renal Dialysis
Renal Insufficiency - complications
Surgery (general aspects). Transplantations, organ and tissue grafts. Graft diseases
Tissue, organ and graft immunology
Viremia - drug therapy
title Efficacy and safety of adefovir dipivoxil in kidney recipients, hemodialysis patients, and patients with renal insufficiency
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