AustralieFrV1, Main, Exploration, bibRecord, 008C13

Long-Term Efficacy and Safety of Adefovir Dipivoxil for the Treatment of Hepatitis B e Antigen-Positive Chronic Hepatitis B

Identifieur interne : 008C13 ( Main/Exploration ); précédent : 008C12; suivant : 008C14

Long-Term Efficacy and Safety of Adefovir Dipivoxil for the Treatment of Hepatitis B e Antigen-Positive Chronic Hepatitis B

Auteurs : Patrick Marcellin [France] ; Ting-Tsung Chang [Taïwan] ; Seng G. Lee Lim [Singapour] ; William Sievert [Australie] ; Myron Tong [États-Unis] ; Sarah Arterburn [États-Unis] ; Katyna Borroto-Esoda [États-Unis] ; David Frederick [États-Unis] ; Franck Rousseau [États-Unis]

Source :

Hepatology : (Baltimore, Md.) [ 0270-9139 ] ; 2008.

RBID : Pascal:08-0418884

Descripteurs français

Pascal (Inist)
- Hépatite virale B, Adéfovir, Long terme, Toxicité, Traitement, Antigène HBe, Gastroentérologie, Antiviral.

English descriptors

KwdEn :
- Adefovir, Antiviral, Gastroenterology, Hepatitis B e antigen, Long term, Toxicity, Treatment, Viral hepatitis B.

Abstract

Treatment of 171 patients with hepatitis B e antigen (HBeAg)-positive chronic hepatitis B (CHB) with adefovir dipivoxil (ADV) 10 mg over 48 weeks resulted in significant histological, virological, serological, and biochemical improvement compared with placebo. The long-term efficacy and safety of ADV in a subset of these patients was investigated for up to 5 years. Sixty-five patients given ADV 10 mg in year 1 elected to continue in a long-term safety and efficacy study (LTSES). At enrollment, the 65 LTSES patients were a median 34 years old, 83% male, 74% Asian, 23% Caucasian, median baseline serum hepatitis B virus (HBV) DNA 8.45 log₁₀ copies/mL, and median baseline alanine aminotransferase (ALT) 2.0 X upper limit of normal. At 5 years on study, the median changes from baseline in serum HBV DNA and ALT for the 41 patients still on ADV were 4.05 log₁₀ copies/mL and -50 U/L, respectively. HBeAg loss and seroconversion were observed in 58% and 48% of patients by end of study, respectively. Fifteen patients had baseline and end of follow-up liver biopsies; improvements in necroinflammation and fibrosis were seen in 67% and 60% of these patients, respectively. Adefovir resistance mutations A181V or N236T developed in 13 LTSES patients; the first observation was at study week 195. There were no serious adverse events related to ADV. Conclusion: Treatment with ADV beyond 48 weeks was well tolerated and produced long-term virological, biochemical, serological, and histological improvement.

Affiliations:

Australie, France, Singapour, Taïwan, États-Unis
Victoria (État), Île-de-France
Melbourne, Paris

Links toward previous steps (curation, corpus...)

to stream PascalFrancis, to step Corpus: 003344
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Le document en format XML

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<series><title level="j" type="main">Hepatology : (Baltimore, Md.)</title>
<title level="j" type="abbreviated">Hepatology : (Baltim. Md.)</title>
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<profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adefovir</term>
<term>Antiviral</term>
<term>Gastroenterology</term>
<term>Hepatitis B e antigen</term>
<term>Long term</term>
<term>Toxicity</term>
<term>Treatment</term>
<term>Viral hepatitis B</term>
</keywords>
<keywords scheme="Pascal" xml:lang="fr"><term>Hépatite virale B</term>
<term>Adéfovir</term>
<term>Long terme</term>
<term>Toxicité</term>
<term>Traitement</term>
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<front><div type="abstract" xml:lang="en">Treatment of 171 patients with hepatitis B e antigen (HBeAg)-positive chronic hepatitis B (CHB) with adefovir dipivoxil (ADV) 10 mg over 48 weeks resulted in significant histological, virological, serological, and biochemical improvement compared with placebo. The long-term efficacy and safety of ADV in a subset of these patients was investigated for up to 5 years. Sixty-five patients given ADV 10 mg in year 1 elected to continue in a long-term safety and efficacy study (LTSES). At enrollment, the 65 LTSES patients were a median 34 years old, 83% male, 74% Asian, 23% Caucasian, median baseline serum hepatitis B virus (HBV) DNA 8.45 log<sub>10</sub>
 copies/mL, and median baseline alanine aminotransferase (ALT) 2.0 X upper limit of normal. At 5 years on study, the median changes from baseline in serum HBV DNA and ALT for the 41 patients still on ADV were 4.05 log<sub>10</sub>
 copies/mL and -50 U/L, respectively. HBeAg loss and seroconversion were observed in 58% and 48% of patients by end of study, respectively. Fifteen patients had baseline and end of follow-up liver biopsies; improvements in necroinflammation and fibrosis were seen in 67% and 60% of these patients, respectively. Adefovir resistance mutations A181V or N236T developed in 13 LTSES patients; the first observation was at study week 195. There were no serious adverse events related to ADV. Conclusion: Treatment with ADV beyond 48 weeks was well tolerated and produced long-term virological, biochemical, serological, and histological improvement.</div>
</front>
</TEI>
<affiliations><list><country><li>Australie</li>
<li>France</li>
<li>Singapour</li>
<li>Taïwan</li>
<li>États-Unis</li>
</country>
<region><li>Victoria (État)</li>
<li>Île-de-France</li>
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<settlement><li>Melbourne</li>
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</settlement>
</list>
<tree><country name="France"><region name="Île-de-France"><name sortKey="Marcellin, Patrick" sort="Marcellin, Patrick" uniqKey="Marcellin P" first="Patrick" last="Marcellin">Patrick Marcellin</name>
</region>
</country>
<country name="Taïwan"><noRegion><name sortKey="Chang, Ting Tsung" sort="Chang, Ting Tsung" uniqKey="Chang T" first="Ting-Tsung" last="Chang">Ting-Tsung Chang</name>
</noRegion>
</country>
<country name="Singapour"><noRegion><name sortKey="Lee Lim, Seng G" sort="Lee Lim, Seng G" uniqKey="Lee Lim S" first="Seng G." last="Lee Lim">Seng G. Lee Lim</name>
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</country>
<country name="Australie"><region name="Victoria (État)"><name sortKey="Sievert, William" sort="Sievert, William" uniqKey="Sievert W" first="William" last="Sievert">William Sievert</name>
</region>
</country>
<country name="États-Unis"><noRegion><name sortKey="Tong, Myron" sort="Tong, Myron" uniqKey="Tong M" first="Myron" last="Tong">Myron Tong</name>
</noRegion>
<name sortKey="Arterburn, Sarah" sort="Arterburn, Sarah" uniqKey="Arterburn S" first="Sarah" last="Arterburn">Sarah Arterburn</name>
<name sortKey="Borroto Esoda, Katyna" sort="Borroto Esoda, Katyna" uniqKey="Borroto Esoda K" first="Katyna" last="Borroto-Esoda">Katyna Borroto-Esoda</name>
<name sortKey="Frederick, David" sort="Frederick, David" uniqKey="Frederick D" first="David" last="Frederick">David Frederick</name>
<name sortKey="Rousseau, Franck" sort="Rousseau, Franck" uniqKey="Rousseau F" first="Franck" last="Rousseau">Franck Rousseau</name>
</country>
</tree>
</affiliations>
</record>

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Long-Term Efficacy and Safety of Adefovir Dipivoxil for the Treatment of Hepatitis B e Antigen-Positive Chronic Hepatitis B

Long-Term Efficacy and Safety of Adefovir Dipivoxil for the Treatment of Hepatitis B e Antigen-Positive Chronic Hepatitis B

Source :

Descripteurs français

English descriptors

Abstract

Links toward previous steps (curation, corpus...)

Le document en format XML

Pour manipuler ce document sous Unix (Dilib)

Pour mettre un lien sur cette page dans le réseau Wicri