AustralieFrV1, Main, Exploration, bibRecord, 004D11

Regression of cirrhosis during treatment with tenofovir disoproxil fumarate for chronic hepatitis B: a 5-year open-label follow-up study

Identifieur interne : 004D11 ( Main/Exploration ); précédent : 004D10; suivant : 004D12

Regression of cirrhosis during treatment with tenofovir disoproxil fumarate for chronic hepatitis B: a 5-year open-label follow-up study

Auteurs : Patrick Marcellin [France] ; Edward Gane [Nouvelle-Zélande] ; Maria Buti [Espagne] ; Nezam Afdhal [États-Unis] ; William Sievert [Australie] ; Ira M. Jacobson [États-Unis] ; Mary Kay Washington [États-Unis] ; George Germanidis [Grèce] ; John F. Flaherty [États-Unis] ; Raul Aguilar Schall [États-Unis] ; Jeffrey D. Bornstein [États-Unis] ; Kathryn M. Kitrinos [États-Unis] ; G. Mani Subramanian [États-Unis] ; John G. Mchutchison [États-Unis] ; E. Jenny Heathcote [Canada]

Source :

Lancet : (British edition) [ 0140-6736 ] ; 2013.

RBID : Pascal:13-0084668

Descripteurs français

Pascal (Inist)
- Cirrhose, Régression, Traitement, Ténofovir, Hépatite virale B, Santé publique, Essai clinique, Médicament, Etude longitudinale, Médecine, Antiviral, Antirétroviral, Fumarate oral, Essai thérapeutique, Essai ouvert.
Wicri :
- topic : Santé publique, Médicament, Médecine.

English descriptors

KwdEn :
- Antiretroviral agent, Antiviral, Cirrhosis, Clinical trial, Drug, Follow up study, Medicine, Public health, Regression, Tenofovir, Treatment, Viral hepatitis B.

Abstract

Background Whether long-term suppression of replication of hepatitis B virus (HBV) has any beneficial effect on regression of advanced liver fibrosis associated with chronic HBV infection remains unclear. We aimed to assess the effects on fibrosis and cirrhosis of at least 5 years' treatment with tenofovir disoproxil fumarate (DF) in chronic HBV infection. Methods After 48 weeks of randomised double-blind comparison (trials NCT00117676 and NCT00116805) of tenofovir DF with adefovir dipivoxil, participants (positive or negative for HBeAg) were eligible to enter a 7-year study of open-label tenofovir DF treatment, with a pre-specified repeat liver biopsy at week 240. We assessed histological improvement (≥2 point reduction in Knodell necroinflammatory score with no worsening of fibrosis) and regression of fibrosis (≥1 unit decrease by Ishak scoring system). Findings Of 641 patients who received randomised treatment, 585 (91%) entered the open-label phase, and 489 (76%) completed 240 weeks. 348 patients (54%) had biopsy results at both baseline and week 240. 304 (87%) of the 348 had histological improvement, and 176 (51%) had regression of fibrosis at week 240 (p<0.0001). Of the 96 (28%) patients with cirrhosis (Ishak score 5 or 6) at baseline, 71 (74%) no longer had cirrhosis (≥1 unit decrease in score), whereas three of 252 patients without cirrhosis at baseline progressed to cirrhosis at year 5 (p<0.0001). Virological breakthrough occurred infrequently and was not due to resistance to tenofovir DF. The safety profile was favourable: 91 (16%) patients had adverse events but only nine patients had serious events related to the study drug. Interpretation In patients with chronic HBV infection, up to 5 years of treatment with tenofovir DF was safe and effective. Long-term suppression of HBV can lead to regression of fibrosis and cirrhosis.

Affiliations:

Australie, Canada, Espagne, France, Grèce, Nouvelle-Zélande, États-Unis
Catalogne
Barcelone

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

to stream PascalFrancis, to step Corpus: 000C19
to stream PascalFrancis, to step Curation: 005246
to stream PascalFrancis, to step Checkpoint: 000684
to stream Main, to step Merge: 004E58
to stream Main, to step Curation: 004D11

Le document en format XML

<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en" level="a">Regression of cirrhosis during treatment with tenofovir disoproxil fumarate for chronic hepatitis B: a 5-year open-label follow-up study</title>
<author><name sortKey="Marcellin, Patrick" sort="Marcellin, Patrick" uniqKey="Marcellin P" first="Patrick" last="Marcellin">Patrick Marcellin</name>
<affiliation wicri:level="1"><inist:fA14 i1="01"><s1>Service d'Hépatologie, Hôpital Beaujon, and INSERM Unit CRB3</s1>
<s2>Clichy</s2>
<s3>FRA</s3>
<sZ>1 aut.</sZ>
</inist:fA14>
<country>France</country>
<wicri:noRegion>Clichy</wicri:noRegion>
<wicri:noRegion>and INSERM Unit CRB3</wicri:noRegion>
<wicri:noRegion>Clichy</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Gane, Edward" sort="Gane, Edward" uniqKey="Gane E" first="Edward" last="Gane">Edward Gane</name>
<affiliation wicri:level="1"><inist:fA14 i1="02"><s1>Auckland City Hospital</s1>
<s2>Auckland</s2>
<s3>NZL</s3>
<sZ>2 aut.</sZ>
</inist:fA14>
<country>Nouvelle-Zélande</country>
<wicri:noRegion>Auckland City Hospital</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Buti, Maria" sort="Buti, Maria" uniqKey="Buti M" first="Maria" last="Buti">Maria Buti</name>
<affiliation wicri:level="3"><inist:fA14 i1="03"><s1>Liver Unit, Hospital General Universitari Vall d'Hebron and CIBERehd</s1>
<s2>Barcelona</s2>
<s3>ESP</s3>
<sZ>3 aut.</sZ>
</inist:fA14>
<country>Espagne</country>
<placeName><settlement type="city">Barcelone</settlement>
<region nuts="2" type="region">Catalogne</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Afdhal, Nezam" sort="Afdhal, Nezam" uniqKey="Afdhal N" first="Nezam" last="Afdhal">Nezam Afdhal</name>
<affiliation wicri:level="1"><inist:fA14 i1="04"><s1>Division of Gastroenterology, Beth Israel Deaconess Medical Center</s1>
<s2>Boston, MA</s2>
<s3>USA</s3>
<sZ>4 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<wicri:noRegion>Boston, MA</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Sievert, William" sort="Sievert, William" uniqKey="Sievert W" first="William" last="Sievert">William Sievert</name>
<affiliation wicri:level="1"><inist:fA14 i1="05"><s1>Monash University and Monash Medical Centre</s1>
<s2>Melbourne, VIC</s2>
<s3>AUS</s3>
<sZ>5 aut.</sZ>
</inist:fA14>
<country>Australie</country>
<wicri:noRegion>Monash University and Monash Medical Centre</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Jacobson, Ira M" sort="Jacobson, Ira M" uniqKey="Jacobson I" first="Ira M." last="Jacobson">Ira M. Jacobson</name>
<affiliation wicri:level="1"><inist:fA14 i1="06"><s1>Weill Cornell Medical College</s1>
<s2>New York, NY</s2>
<s3>USA</s3>
<sZ>6 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<wicri:noRegion>Weill Cornell Medical College</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Kay Washington, Mary" sort="Kay Washington, Mary" uniqKey="Kay Washington M" first="Mary" last="Kay Washington">Mary Kay Washington</name>
<affiliation wicri:level="1"><inist:fA14 i1="07"><s1>Vanderbilt University</s1>
<s2>Nashville,TN</s2>
<s3>USA</s3>
<sZ>7 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<wicri:noRegion>Vanderbilt University</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Germanidis, George" sort="Germanidis, George" uniqKey="Germanidis G" first="George" last="Germanidis">George Germanidis</name>
<affiliation wicri:level="1"><inist:fA14 i1="08"><s1>AHEPA University Hospital, Aristotle University Medical School</s1>
<s2>Thessaloniki</s2>
<s3>GRC</s3>
<sZ>8 aut.</sZ>
</inist:fA14>
<country>Grèce</country>
<wicri:noRegion>Thessaloniki</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Flaherty, John F" sort="Flaherty, John F" uniqKey="Flaherty J" first="John F." last="Flaherty">John F. Flaherty</name>
<affiliation wicri:level="1"><inist:fA14 i1="09"><s1>Gilead Sciences</s1>
<s2>Foster City, CA</s2>
<s3>USA</s3>
<sZ>9 aut.</sZ>
<sZ>10 aut.</sZ>
<sZ>11 aut.</sZ>
<sZ>12 aut.</sZ>
<sZ>13 aut.</sZ>
<sZ>14 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<wicri:noRegion>Gilead Sciences</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Aguilar Schall, Raul" sort="Aguilar Schall, Raul" uniqKey="Aguilar Schall R" first="Raul" last="Aguilar Schall">Raul Aguilar Schall</name>
<affiliation wicri:level="1"><inist:fA14 i1="09"><s1>Gilead Sciences</s1>
<s2>Foster City, CA</s2>
<s3>USA</s3>
<sZ>9 aut.</sZ>
<sZ>10 aut.</sZ>
<sZ>11 aut.</sZ>
<sZ>12 aut.</sZ>
<sZ>13 aut.</sZ>
<sZ>14 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<wicri:noRegion>Gilead Sciences</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Bornstein, Jeffrey D" sort="Bornstein, Jeffrey D" uniqKey="Bornstein J" first="Jeffrey D." last="Bornstein">Jeffrey D. Bornstein</name>
<affiliation wicri:level="1"><inist:fA14 i1="09"><s1>Gilead Sciences</s1>
<s2>Foster City, CA</s2>
<s3>USA</s3>
<sZ>9 aut.</sZ>
<sZ>10 aut.</sZ>
<sZ>11 aut.</sZ>
<sZ>12 aut.</sZ>
<sZ>13 aut.</sZ>
<sZ>14 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<wicri:noRegion>Gilead Sciences</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Kitrinos, Kathryn M" sort="Kitrinos, Kathryn M" uniqKey="Kitrinos K" first="Kathryn M." last="Kitrinos">Kathryn M. Kitrinos</name>
<affiliation wicri:level="1"><inist:fA14 i1="09"><s1>Gilead Sciences</s1>
<s2>Foster City, CA</s2>
<s3>USA</s3>
<sZ>9 aut.</sZ>
<sZ>10 aut.</sZ>
<sZ>11 aut.</sZ>
<sZ>12 aut.</sZ>
<sZ>13 aut.</sZ>
<sZ>14 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<wicri:noRegion>Gilead Sciences</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Mani Subramanian, G" sort="Mani Subramanian, G" uniqKey="Mani Subramanian G" first="G." last="Mani Subramanian">G. Mani Subramanian</name>
<affiliation wicri:level="1"><inist:fA14 i1="09"><s1>Gilead Sciences</s1>
<s2>Foster City, CA</s2>
<s3>USA</s3>
<sZ>9 aut.</sZ>
<sZ>10 aut.</sZ>
<sZ>11 aut.</sZ>
<sZ>12 aut.</sZ>
<sZ>13 aut.</sZ>
<sZ>14 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<wicri:noRegion>Gilead Sciences</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Mchutchison, John G" sort="Mchutchison, John G" uniqKey="Mchutchison J" first="John G." last="Mchutchison">John G. Mchutchison</name>
<affiliation wicri:level="1"><inist:fA14 i1="09"><s1>Gilead Sciences</s1>
<s2>Foster City, CA</s2>
<s3>USA</s3>
<sZ>9 aut.</sZ>
<sZ>10 aut.</sZ>
<sZ>11 aut.</sZ>
<sZ>12 aut.</sZ>
<sZ>13 aut.</sZ>
<sZ>14 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<wicri:noRegion>Gilead Sciences</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Jenny Heathcote, E" sort="Jenny Heathcote, E" uniqKey="Jenny Heathcote E" first="E." last="Jenny Heathcote">E. Jenny Heathcote</name>
<affiliation wicri:level="1"><inist:fA14 i1="10"><s1>University ofToronto</s1>
<s2>Toronto, ON</s2>
<s3>CAN</s3>
<sZ>15 aut.</sZ>
</inist:fA14>
<country>Canada</country>
<wicri:noRegion>University ofToronto</wicri:noRegion>
</affiliation>
</author>
</titleStmt>
<publicationStmt><idno type="wicri:source">INIST</idno>
<idno type="inist">13-0084668</idno>
<date when="2013">2013</date>
<idno type="stanalyst">PASCAL 13-0084668 INIST</idno>
<idno type="RBID">Pascal:13-0084668</idno>
<idno type="wicri:Area/PascalFrancis/Corpus">000C19</idno>
<idno type="wicri:Area/PascalFrancis/Curation">005246</idno>
<idno type="wicri:Area/PascalFrancis/Checkpoint">000684</idno>
<idno type="wicri:explorRef" wicri:stream="PascalFrancis" wicri:step="Checkpoint">000684</idno>
<idno type="wicri:doubleKey">0140-6736:2013:Marcellin P:regression:of:cirrhosis</idno>
<idno type="wicri:Area/Main/Merge">004E58</idno>
<idno type="wicri:Area/Main/Curation">004D11</idno>
<idno type="wicri:Area/Main/Exploration">004D11</idno>
</publicationStmt>
<sourceDesc><biblStruct><analytic><title xml:lang="en" level="a">Regression of cirrhosis during treatment with tenofovir disoproxil fumarate for chronic hepatitis B: a 5-year open-label follow-up study</title>
<author><name sortKey="Marcellin, Patrick" sort="Marcellin, Patrick" uniqKey="Marcellin P" first="Patrick" last="Marcellin">Patrick Marcellin</name>
<affiliation wicri:level="1"><inist:fA14 i1="01"><s1>Service d'Hépatologie, Hôpital Beaujon, and INSERM Unit CRB3</s1>
<s2>Clichy</s2>
<s3>FRA</s3>
<sZ>1 aut.</sZ>
</inist:fA14>
<country>France</country>
<wicri:noRegion>Clichy</wicri:noRegion>
<wicri:noRegion>and INSERM Unit CRB3</wicri:noRegion>
<wicri:noRegion>Clichy</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Gane, Edward" sort="Gane, Edward" uniqKey="Gane E" first="Edward" last="Gane">Edward Gane</name>
<affiliation wicri:level="1"><inist:fA14 i1="02"><s1>Auckland City Hospital</s1>
<s2>Auckland</s2>
<s3>NZL</s3>
<sZ>2 aut.</sZ>
</inist:fA14>
<country>Nouvelle-Zélande</country>
<wicri:noRegion>Auckland City Hospital</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Buti, Maria" sort="Buti, Maria" uniqKey="Buti M" first="Maria" last="Buti">Maria Buti</name>
<affiliation wicri:level="3"><inist:fA14 i1="03"><s1>Liver Unit, Hospital General Universitari Vall d'Hebron and CIBERehd</s1>
<s2>Barcelona</s2>
<s3>ESP</s3>
<sZ>3 aut.</sZ>
</inist:fA14>
<country>Espagne</country>
<placeName><settlement type="city">Barcelone</settlement>
<region nuts="2" type="region">Catalogne</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Afdhal, Nezam" sort="Afdhal, Nezam" uniqKey="Afdhal N" first="Nezam" last="Afdhal">Nezam Afdhal</name>
<affiliation wicri:level="1"><inist:fA14 i1="04"><s1>Division of Gastroenterology, Beth Israel Deaconess Medical Center</s1>
<s2>Boston, MA</s2>
<s3>USA</s3>
<sZ>4 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<wicri:noRegion>Boston, MA</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Sievert, William" sort="Sievert, William" uniqKey="Sievert W" first="William" last="Sievert">William Sievert</name>
<affiliation wicri:level="1"><inist:fA14 i1="05"><s1>Monash University and Monash Medical Centre</s1>
<s2>Melbourne, VIC</s2>
<s3>AUS</s3>
<sZ>5 aut.</sZ>
</inist:fA14>
<country>Australie</country>
<wicri:noRegion>Monash University and Monash Medical Centre</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Jacobson, Ira M" sort="Jacobson, Ira M" uniqKey="Jacobson I" first="Ira M." last="Jacobson">Ira M. Jacobson</name>
<affiliation wicri:level="1"><inist:fA14 i1="06"><s1>Weill Cornell Medical College</s1>
<s2>New York, NY</s2>
<s3>USA</s3>
<sZ>6 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<wicri:noRegion>Weill Cornell Medical College</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Kay Washington, Mary" sort="Kay Washington, Mary" uniqKey="Kay Washington M" first="Mary" last="Kay Washington">Mary Kay Washington</name>
<affiliation wicri:level="1"><inist:fA14 i1="07"><s1>Vanderbilt University</s1>
<s2>Nashville,TN</s2>
<s3>USA</s3>
<sZ>7 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<wicri:noRegion>Vanderbilt University</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Germanidis, George" sort="Germanidis, George" uniqKey="Germanidis G" first="George" last="Germanidis">George Germanidis</name>
<affiliation wicri:level="1"><inist:fA14 i1="08"><s1>AHEPA University Hospital, Aristotle University Medical School</s1>
<s2>Thessaloniki</s2>
<s3>GRC</s3>
<sZ>8 aut.</sZ>
</inist:fA14>
<country>Grèce</country>
<wicri:noRegion>Thessaloniki</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Flaherty, John F" sort="Flaherty, John F" uniqKey="Flaherty J" first="John F." last="Flaherty">John F. Flaherty</name>
<affiliation wicri:level="1"><inist:fA14 i1="09"><s1>Gilead Sciences</s1>
<s2>Foster City, CA</s2>
<s3>USA</s3>
<sZ>9 aut.</sZ>
<sZ>10 aut.</sZ>
<sZ>11 aut.</sZ>
<sZ>12 aut.</sZ>
<sZ>13 aut.</sZ>
<sZ>14 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<wicri:noRegion>Gilead Sciences</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Aguilar Schall, Raul" sort="Aguilar Schall, Raul" uniqKey="Aguilar Schall R" first="Raul" last="Aguilar Schall">Raul Aguilar Schall</name>
<affiliation wicri:level="1"><inist:fA14 i1="09"><s1>Gilead Sciences</s1>
<s2>Foster City, CA</s2>
<s3>USA</s3>
<sZ>9 aut.</sZ>
<sZ>10 aut.</sZ>
<sZ>11 aut.</sZ>
<sZ>12 aut.</sZ>
<sZ>13 aut.</sZ>
<sZ>14 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<wicri:noRegion>Gilead Sciences</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Bornstein, Jeffrey D" sort="Bornstein, Jeffrey D" uniqKey="Bornstein J" first="Jeffrey D." last="Bornstein">Jeffrey D. Bornstein</name>
<affiliation wicri:level="1"><inist:fA14 i1="09"><s1>Gilead Sciences</s1>
<s2>Foster City, CA</s2>
<s3>USA</s3>
<sZ>9 aut.</sZ>
<sZ>10 aut.</sZ>
<sZ>11 aut.</sZ>
<sZ>12 aut.</sZ>
<sZ>13 aut.</sZ>
<sZ>14 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<wicri:noRegion>Gilead Sciences</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Kitrinos, Kathryn M" sort="Kitrinos, Kathryn M" uniqKey="Kitrinos K" first="Kathryn M." last="Kitrinos">Kathryn M. Kitrinos</name>
<affiliation wicri:level="1"><inist:fA14 i1="09"><s1>Gilead Sciences</s1>
<s2>Foster City, CA</s2>
<s3>USA</s3>
<sZ>9 aut.</sZ>
<sZ>10 aut.</sZ>
<sZ>11 aut.</sZ>
<sZ>12 aut.</sZ>
<sZ>13 aut.</sZ>
<sZ>14 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<wicri:noRegion>Gilead Sciences</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Mani Subramanian, G" sort="Mani Subramanian, G" uniqKey="Mani Subramanian G" first="G." last="Mani Subramanian">G. Mani Subramanian</name>
<affiliation wicri:level="1"><inist:fA14 i1="09"><s1>Gilead Sciences</s1>
<s2>Foster City, CA</s2>
<s3>USA</s3>
<sZ>9 aut.</sZ>
<sZ>10 aut.</sZ>
<sZ>11 aut.</sZ>
<sZ>12 aut.</sZ>
<sZ>13 aut.</sZ>
<sZ>14 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<wicri:noRegion>Gilead Sciences</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Mchutchison, John G" sort="Mchutchison, John G" uniqKey="Mchutchison J" first="John G." last="Mchutchison">John G. Mchutchison</name>
<affiliation wicri:level="1"><inist:fA14 i1="09"><s1>Gilead Sciences</s1>
<s2>Foster City, CA</s2>
<s3>USA</s3>
<sZ>9 aut.</sZ>
<sZ>10 aut.</sZ>
<sZ>11 aut.</sZ>
<sZ>12 aut.</sZ>
<sZ>13 aut.</sZ>
<sZ>14 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<wicri:noRegion>Gilead Sciences</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Jenny Heathcote, E" sort="Jenny Heathcote, E" uniqKey="Jenny Heathcote E" first="E." last="Jenny Heathcote">E. Jenny Heathcote</name>
<affiliation wicri:level="1"><inist:fA14 i1="10"><s1>University ofToronto</s1>
<s2>Toronto, ON</s2>
<s3>CAN</s3>
<sZ>15 aut.</sZ>
</inist:fA14>
<country>Canada</country>
<wicri:noRegion>University ofToronto</wicri:noRegion>
</affiliation>
</author>
</analytic>
<series><title level="j" type="main">Lancet : (British edition)</title>
<title level="j" type="abbreviated">Lancet : (Br. ed.)</title>
<idno type="ISSN">0140-6736</idno>
<imprint><date when="2013">2013</date>
</imprint>
</series>
</biblStruct>
</sourceDesc>
<seriesStmt><title level="j" type="main">Lancet : (British edition)</title>
<title level="j" type="abbreviated">Lancet : (Br. ed.)</title>
<idno type="ISSN">0140-6736</idno>
</seriesStmt>
</fileDesc>
<profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Antiretroviral agent</term>
<term>Antiviral</term>
<term>Cirrhosis</term>
<term>Clinical trial</term>
<term>Drug</term>
<term>Follow up study</term>
<term>Medicine</term>
<term>Public health</term>
<term>Regression</term>
<term>Tenofovir</term>
<term>Treatment</term>
<term>Viral hepatitis B</term>
</keywords>
<keywords scheme="Pascal" xml:lang="fr"><term>Cirrhose</term>
<term>Régression</term>
<term>Traitement</term>
<term>Ténofovir</term>
<term>Hépatite virale B</term>
<term>Santé publique</term>
<term>Essai clinique</term>
<term>Médicament</term>
<term>Etude longitudinale</term>
<term>Médecine</term>
<term>Antiviral</term>
<term>Antirétroviral</term>
<term>Fumarate oral</term>
<term>Essai thérapeutique</term>
<term>Essai ouvert</term>
</keywords>
<keywords scheme="Wicri" type="topic" xml:lang="fr"><term>Santé publique</term>
<term>Médicament</term>
<term>Médecine</term>
</keywords>
</textClass>
</profileDesc>
</teiHeader>
<front><div type="abstract" xml:lang="en">Background Whether long-term suppression of replication of hepatitis B virus (HBV) has any beneficial effect on regression of advanced liver fibrosis associated with chronic HBV infection remains unclear. We aimed to assess the effects on fibrosis and cirrhosis of at least 5 years' treatment with tenofovir disoproxil fumarate (DF) in chronic HBV infection. Methods After 48 weeks of randomised double-blind comparison (trials NCT00117676 and NCT00116805) of tenofovir DF with adefovir dipivoxil, participants (positive or negative for HBeAg) were eligible to enter a 7-year study of open-label tenofovir DF treatment, with a pre-specified repeat liver biopsy at week 240. We assessed histological improvement (≥2 point reduction in Knodell necroinflammatory score with no worsening of fibrosis) and regression of fibrosis (≥1 unit decrease by Ishak scoring system). Findings Of 641 patients who received randomised treatment, 585 (91%) entered the open-label phase, and 489 (76%) completed 240 weeks. 348 patients (54%) had biopsy results at both baseline and week 240. 304 (87%) of the 348 had histological improvement, and 176 (51%) had regression of fibrosis at week 240 (p<0.0001). Of the 96 (28%) patients with cirrhosis (Ishak score 5 or 6) at baseline, 71 (74%) no longer had cirrhosis (≥1 unit decrease in score), whereas three of 252 patients without cirrhosis at baseline progressed to cirrhosis at year 5 (p<0.0001). Virological breakthrough occurred infrequently and was not due to resistance to tenofovir DF. The safety profile was favourable: 91 (16%) patients had adverse events but only nine patients had serious events related to the study drug. Interpretation In patients with chronic HBV infection, up to 5 years of treatment with tenofovir DF was safe and effective. Long-term suppression of HBV can lead to regression of fibrosis and cirrhosis.</div>
</front>
</TEI>
<affiliations><list><country><li>Australie</li>
<li>Canada</li>
<li>Espagne</li>
<li>France</li>
<li>Grèce</li>
<li>Nouvelle-Zélande</li>
<li>États-Unis</li>
</country>
<region><li>Catalogne</li>
</region>
<settlement><li>Barcelone</li>
</settlement>
</list>
<tree><country name="France"><noRegion><name sortKey="Marcellin, Patrick" sort="Marcellin, Patrick" uniqKey="Marcellin P" first="Patrick" last="Marcellin">Patrick Marcellin</name>
</noRegion>
</country>
<country name="Nouvelle-Zélande"><noRegion><name sortKey="Gane, Edward" sort="Gane, Edward" uniqKey="Gane E" first="Edward" last="Gane">Edward Gane</name>
</noRegion>
</country>
<country name="Espagne"><region name="Catalogne"><name sortKey="Buti, Maria" sort="Buti, Maria" uniqKey="Buti M" first="Maria" last="Buti">Maria Buti</name>
</region>
</country>
<country name="États-Unis"><noRegion><name sortKey="Afdhal, Nezam" sort="Afdhal, Nezam" uniqKey="Afdhal N" first="Nezam" last="Afdhal">Nezam Afdhal</name>
</noRegion>
<name sortKey="Aguilar Schall, Raul" sort="Aguilar Schall, Raul" uniqKey="Aguilar Schall R" first="Raul" last="Aguilar Schall">Raul Aguilar Schall</name>
<name sortKey="Bornstein, Jeffrey D" sort="Bornstein, Jeffrey D" uniqKey="Bornstein J" first="Jeffrey D." last="Bornstein">Jeffrey D. Bornstein</name>
<name sortKey="Flaherty, John F" sort="Flaherty, John F" uniqKey="Flaherty J" first="John F." last="Flaherty">John F. Flaherty</name>
<name sortKey="Jacobson, Ira M" sort="Jacobson, Ira M" uniqKey="Jacobson I" first="Ira M." last="Jacobson">Ira M. Jacobson</name>
<name sortKey="Kay Washington, Mary" sort="Kay Washington, Mary" uniqKey="Kay Washington M" first="Mary" last="Kay Washington">Mary Kay Washington</name>
<name sortKey="Kitrinos, Kathryn M" sort="Kitrinos, Kathryn M" uniqKey="Kitrinos K" first="Kathryn M." last="Kitrinos">Kathryn M. Kitrinos</name>
<name sortKey="Mani Subramanian, G" sort="Mani Subramanian, G" uniqKey="Mani Subramanian G" first="G." last="Mani Subramanian">G. Mani Subramanian</name>
<name sortKey="Mchutchison, John G" sort="Mchutchison, John G" uniqKey="Mchutchison J" first="John G." last="Mchutchison">John G. Mchutchison</name>
</country>
<country name="Australie"><noRegion><name sortKey="Sievert, William" sort="Sievert, William" uniqKey="Sievert W" first="William" last="Sievert">William Sievert</name>
</noRegion>
</country>
<country name="Grèce"><noRegion><name sortKey="Germanidis, George" sort="Germanidis, George" uniqKey="Germanidis G" first="George" last="Germanidis">George Germanidis</name>
</noRegion>
</country>
<country name="Canada"><noRegion><name sortKey="Jenny Heathcote, E" sort="Jenny Heathcote, E" uniqKey="Jenny Heathcote E" first="E." last="Jenny Heathcote">E. Jenny Heathcote</name>
</noRegion>
</country>
</tree>
</affiliations>
</record>

Pour manipuler ce document sous Unix (Dilib)

EXPLOR_STEP=$WICRI_ROOT/Wicri/Asie/explor/AustralieFrV1/Data/Main/Exploration

HfdSelect -h $EXPLOR_STEP/biblio.hfd -nk 004D11 | SxmlIndent | more

HfdSelect -h $EXPLOR_AREA/Data/Main/Exploration/biblio.hfd -nk 004D11 | SxmlIndent | more

Pour mettre un lien sur cette page dans le réseau Wicri

{{Explor lien
   |wiki=    Wicri/Asie
   |area=    AustralieFrV1
   |flux=    Main
   |étape=   Exploration
   |type=    RBID
   |clé=     Pascal:13-0084668
   |texte=   Regression of cirrhosis during treatment with tenofovir disoproxil fumarate for chronic hepatitis B: a 5-year open-label follow-up study
}}

This area was generated with Dilib version V0.6.33.
Data generation: Tue Dec 5 10:43:12 2017. Site generation: Tue Mar 5 14:07:20 2024

	Serveur d'exploration sur les relations entre la France et l'Australie
	Attention, ce site est en cours de développement ! Attention, site généré par des moyens informatiques à partir de corpus bruts. Les informations ne sont donc pas validées.

Serveur d'exploration sur les relations entre la France et l'Australie

Regression of cirrhosis during treatment with tenofovir disoproxil fumarate for chronic hepatitis B: a 5-year open-label follow-up study

Regression of cirrhosis during treatment with tenofovir disoproxil fumarate for chronic hepatitis B: a 5-year open-label follow-up study

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