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 |
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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. 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.</description><identifier>ISSN: 0041-1337</identifier><identifier>EISSN: 1534-6080</identifier><identifier>DOI: 10.1097/01.tp.0000178305.39231.a2</identifier><identifier>PMID: 16278590</identifier><identifier>CODEN: TRPLAU</identifier><language>eng</language><publisher>Hagerstown, MD: Lippincott</publisher><subject>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</subject><ispartof>Transplantation, 2005-10, Vol.80 (8), p.1086-1092</ispartof><rights>2006 INIST-CNRS</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c427t-ad44876fb1d674c2897c7405eef291b7203488c9d8ca018311711b037c86eb6d3</citedby><cites>FETCH-LOGICAL-c427t-ad44876fb1d674c2897c7405eef291b7203488c9d8ca018311711b037c86eb6d3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>315,781,785,27929,27930</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=17287985$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/16278590$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>FONTAINE, Hélène</creatorcontrib><creatorcontrib>VALLET-PICHARD, Anaïs</creatorcontrib><creatorcontrib>POL, Stanislas</creatorcontrib><creatorcontrib>CHAIX, Marie-Laure</creatorcontrib><creatorcontrib>CURRIE, Graham</creatorcontrib><creatorcontrib>SERPAGGI, Jeanne</creatorcontrib><creatorcontrib>VERKARRE, Virginie</creatorcontrib><creatorcontrib>VARAUT, Anne</creatorcontrib><creatorcontrib>MORALES, Eugenia</creatorcontrib><creatorcontrib>NALPAS, Bertrand</creatorcontrib><creatorcontrib>BROSGART, Carol</creatorcontrib><title>Efficacy and safety of adefovir dipivoxil in kidney recipients, hemodialysis patients, and patients with renal insufficiency</title><title>Transplantation</title><addtitle>Transplantation</addtitle><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.</description><subject>Adenine - adverse effects</subject><subject>Adenine - analogs & derivatives</subject><subject>Adenine - pharmacokinetics</subject><subject>Adenine - therapeutic use</subject><subject>Adult</subject><subject>Aged</subject><subject>Anesthesia. Intensive care medicine. Transfusions. Cell therapy and gene therapy</subject><subject>Antiviral Agents - adverse effects</subject><subject>Antiviral Agents - pharmacokinetics</subject><subject>Antiviral Agents - therapeutic use</subject><subject>Biological and medical sciences</subject><subject>Drug Resistance, Viral</subject><subject>Emergency and intensive care: renal failure. Dialysis management</subject><subject>Female</subject><subject>Fundamental and applied biological sciences. Psychology</subject><subject>Fundamental immunology</subject><subject>Hepatitis B virus</subject><subject>Hepatitis B, Chronic - blood</subject><subject>Hepatitis B, Chronic - complications</subject><subject>Hepatitis B, Chronic - drug therapy</subject><subject>Humans</subject><subject>Intensive care medicine</subject><subject>Kidney Transplantation</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Organophosphonates - adverse effects</subject><subject>Organophosphonates - pharmacokinetics</subject><subject>Organophosphonates - therapeutic use</subject><subject>Renal Dialysis</subject><subject>Renal Insufficiency - complications</subject><subject>Surgery (general aspects). Transplantations, organ and tissue grafts. Graft diseases</subject><subject>Tissue, organ and graft immunology</subject><subject>Viremia - drug therapy</subject><issn>0041-1337</issn><issn>1534-6080</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2005</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpFkE9v1DAQxS0EotvCV0DmQE8keOwkYx9R1QJSJS70bE38RzVkkxBnWyLx4ZulQTuX0cz83hvpMfYeRAnC4CcB5TyWYi1ArURdKiMVlCRfsB3UqioaocVLthOiggKUwjN2nvPPla8V4mt2Bo1EXRuxY3-vY0yO3MKp9zxTDPPCh8jJhzg8pIn7NKaH4U_qeOr5r-T7sPApuHUb-jl_5PdhP_hE3ZJT5iPN2_ro9n_ij2m-X0U9HU3y4fhxPbjlDXsVqcvh7dYv2N3N9Y-rr8Xt9y_frj7fFq6SOBfkq0pjE1vwDVZOaoMOK1GHEKWBFqVQldbOeO1IgFYACNAKhU43oW28umCXz77jNPw-hDzbfcoudB31YThkC0YrDQZX0DyDbhpynkK045T2NC0WhD1GbwXYebSn6O2_6C3JVftue3Jo98GflFvWK_BhAyg76uJEvUv5xKHUaHStngAruY8y</recordid><startdate>20051027</startdate><enddate>20051027</enddate><creator>FONTAINE, Hélène</creator><creator>VALLET-PICHARD, Anaïs</creator><creator>POL, Stanislas</creator><creator>CHAIX, Marie-Laure</creator><creator>CURRIE, Graham</creator><creator>SERPAGGI, Jeanne</creator><creator>VERKARRE, Virginie</creator><creator>VARAUT, Anne</creator><creator>MORALES, Eugenia</creator><creator>NALPAS, Bertrand</creator><creator>BROSGART, Carol</creator><general>Lippincott</general><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7T5</scope><scope>7U9</scope><scope>H94</scope></search><sort><creationdate>20051027</creationdate><title>Efficacy and safety of adefovir dipivoxil in kidney recipients, hemodialysis patients, and patients with renal insufficiency</title><author>FONTAINE, Hélène ; VALLET-PICHARD, Anaïs ; POL, Stanislas ; CHAIX, Marie-Laure ; CURRIE, Graham ; SERPAGGI, Jeanne ; VERKARRE, Virginie ; VARAUT, Anne ; MORALES, Eugenia ; NALPAS, Bertrand ; BROSGART, Carol</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c427t-ad44876fb1d674c2897c7405eef291b7203488c9d8ca018311711b037c86eb6d3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2005</creationdate><topic>Adenine - adverse effects</topic><topic>Adenine - analogs & derivatives</topic><topic>Adenine - pharmacokinetics</topic><topic>Adenine - therapeutic use</topic><topic>Adult</topic><topic>Aged</topic><topic>Anesthesia. Intensive care medicine. Transfusions. Cell therapy and gene therapy</topic><topic>Antiviral Agents - adverse effects</topic><topic>Antiviral Agents - pharmacokinetics</topic><topic>Antiviral Agents - therapeutic use</topic><topic>Biological and medical sciences</topic><topic>Drug Resistance, Viral</topic><topic>Emergency and intensive care: renal failure. Dialysis management</topic><topic>Female</topic><topic>Fundamental and applied biological sciences. 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. Graft diseases</topic><topic>Tissue, organ and graft immunology</topic><topic>Viremia - drug therapy</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>FONTAINE, Hélène</creatorcontrib><creatorcontrib>VALLET-PICHARD, Anaïs</creatorcontrib><creatorcontrib>POL, Stanislas</creatorcontrib><creatorcontrib>CHAIX, Marie-Laure</creatorcontrib><creatorcontrib>CURRIE, Graham</creatorcontrib><creatorcontrib>SERPAGGI, Jeanne</creatorcontrib><creatorcontrib>VERKARRE, Virginie</creatorcontrib><creatorcontrib>VARAUT, Anne</creatorcontrib><creatorcontrib>MORALES, Eugenia</creatorcontrib><creatorcontrib>NALPAS, Bertrand</creatorcontrib><creatorcontrib>BROSGART, Carol</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Immunology Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>AIDS and Cancer Research Abstracts</collection><jtitle>Transplantation</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>FONTAINE, Hélène</au><au>VALLET-PICHARD, Anaïs</au><au>POL, Stanislas</au><au>CHAIX, Marie-Laure</au><au>CURRIE, Graham</au><au>SERPAGGI, Jeanne</au><au>VERKARRE, Virginie</au><au>VARAUT, Anne</au><au>MORALES, Eugenia</au><au>NALPAS, Bertrand</au><au>BROSGART, Carol</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Efficacy and safety of adefovir dipivoxil in kidney recipients, hemodialysis patients, and patients with renal insufficiency</atitle><jtitle>Transplantation</jtitle><addtitle>Transplantation</addtitle><date>2005-10-27</date><risdate>2005</risdate><volume>80</volume><issue>8</issue><spage>1086</spage><epage>1092</epage><pages>1086-1092</pages><issn>0041-1337</issn><eissn>1534-6080</eissn><coden>TRPLAU</coden><abstract>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.</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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