Peginterferon alfa-2a alone, lamivudine alone, and the two in combination in patients with hbeag-negative chronic hepatitis B
Identifieur interne : 00AB55 ( Main/Exploration ); précédent : 00AB54; suivant : 00AB56Peginterferon alfa-2a alone, lamivudine alone, and the two in combination in patients with hbeag-negative chronic hepatitis B
Auteurs : Patrick Marcellin [France] ; George K. K. Lau [Hong Kong] ; Ferruccio Bonino [Italie] ; Patrizia Farci [Italie] ; Stephanos Hadziyannis [Grèce] ; RUI JIN [République populaire de Chine] ; Zhi-Meng Lu [République populaire de Chine] ; Teerha Piratvisuth [Thaïlande] ; Georgios Germanidis [Grèce] ; Cihan Yurdaydin [Turquie] ; Moises Diago [Espagne] ; Selim Gurel [Turquie] ; Ming-Yang Lai [Taïwan] ; Peter Button [Australie] ; Nigel Pluck [Royaume-Uni]Source :
- The New England journal of medicine [ 0028-4793 ] ; 2004.
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Abstract
BACKGROUND Available treatments for hepatitis B e antigen (HBeAg)-negative chronic hepatitis B are associated with poor sustained responses. As a result, nucleoside and nucleotide analogues are typically continued indefinitely, a strategy associated with the risk of resistance and unknown long-term safety implications. METHODS We compared the efficacy and safety ofpeginterferon alfa-2a (180 μg once weekly) plus placebo, peginterferon alfa-2a plus lamivudine (100 mg daily), and lamivudine alone in 177, 179, and 181 patients with HBeAg-negative chronic hepatitis B, respectively. Patients were treated for 48 weeks and followed for an additional 24 weeks. RESULTS After 24 weeks offollow-up, the percentage of patients with normalization ofalanine aminotransferase levels or hepatitis B virus (HBV) DNA levels below 20,000 copies per milliliter was significantly higher with peginterferon alfa-2a monotherapy (59 percent and 43 percent, respectively) and peginterferon alfa-2a plus lamivudine (60 percent and 44 percent) than with lamivudine monotherapy (44 percent, P=0.004 and P=0.003, respectively; and 29 percent, P=0.007 and P=0.003, respectively). Rates of sustained suppression of HBV DNA to below 400 copies per milliliter were 19 percent with peginterferon alfa-2a monotherapy, 20 percentwith combination therapy, and 7 percent with lamivudine alone (P<0.001 for both comparisons with lamivudine alone). Loss of hepatitis B surface antigen occurred in 12 patients in the peginterferon groups, as compared with 0 patients in the group given lamivudine alone. Adverse events, including pyrexia, fatigue, myalgia, and headache, were less frequent with lamivudine monotherapy than with peginterferon alfa-2a monotherapy or combination therapy. CONCLUSIONS Patients with HBeAg-negative chronic hepatitis B had significantly higher rates of response, sustained for 24 weeks after the cessation oftherapy, with peginterferon alfa-2a than with lamivudine. The addition of lamivudine to peginterferon alfa-2a did not improve post-therapy response rates.
Affiliations:
- Australie, Espagne, France, Grèce, Hong Kong, Italie, Royaume-Uni, République populaire de Chine, Taïwan, Thaïlande, Turquie
- Attique (région), Lombardie
- Athènes, Milan, Pékin
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first="Georgios" last="Germanidis">Georgios Germanidis</name><affiliation wicri:level="1"><inist:fA14 i1="09"><s1>Papageorgiou General Hospital, Pathology Clinic</s1><s2>Thessalonika</s2><s3>GRC</s3><sZ>9 aut.</sZ></inist:fA14><country>Grèce</country><wicri:noRegion>Thessalonika</wicri:noRegion></affiliation></author><author><name sortKey="Yurdaydin, Cihan" sort="Yurdaydin, Cihan" uniqKey="Yurdaydin C" first="Cihan" last="Yurdaydin">Cihan Yurdaydin</name><affiliation wicri:level="1"><inist:fA14 i1="10"><s1>University of Ankara, Faculty of Medicine</s1><s2>Ankara</s2><s3>TUR</s3><sZ>10 aut.</sZ></inist:fA14><country>Turquie</country><wicri:noRegion>Ankara</wicri:noRegion></affiliation></author><author><name sortKey="Diago, Moises" sort="Diago, Moises" uniqKey="Diago M" first="Moises" last="Diago">Moises Diago</name><affiliation wicri:level="1"><inist:fA14 i1="11"><s1>Hospital General Universitario de Valencia</s1><s2>Valencia</s2><s3>ESP</s3><sZ>11 aut.</sZ></inist:fA14><country>Espagne</country><wicri:noRegion>Hospital General Universitario de Valencia</wicri:noRegion></affiliation></author><author><name sortKey="Gurel, Selim" sort="Gurel, Selim" uniqKey="Gurel S" first="Selim" last="Gurel">Selim Gurel</name><affiliation wicri:level="1"><inist:fA14 i1="12"><s1>University of Uludag, Faculty of Medicine</s1><s2>Bursa</s2><s3>TUR</s3><sZ>12 aut.</sZ></inist:fA14><country>Turquie</country><wicri:noRegion>Bursa</wicri:noRegion></affiliation></author><author><name sortKey="Lai, Ming Yang" sort="Lai, Ming Yang" uniqKey="Lai M" first="Ming-Yang" last="Lai">Ming-Yang Lai</name><affiliation wicri:level="1"><inist:fA14 i1="13"><s1>National Taiwan University Hospital, Internal Medicine</s1><s2>Taipei</s2><s3>TWN</s3><sZ>13 aut.</sZ></inist:fA14><country>Taïwan</country><wicri:noRegion>Taipei</wicri:noRegion></affiliation></author><author><name sortKey="Button, Peter" sort="Button, Peter" uniqKey="Button P" first="Peter" last="Button">Peter Button</name><affiliation wicri:level="1"><inist:fA14 i1="14"><s1>Roche</s1><s2>Dee Why</s2><s3>AUS</s3><sZ>14 aut.</sZ></inist:fA14><country>Australie</country><wicri:noRegion>Roche</wicri:noRegion></affiliation></author><author><name sortKey="Pluck, Nigel" sort="Pluck, Nigel" uniqKey="Pluck N" first="Nigel" last="Pluck">Nigel Pluck</name><affiliation wicri:level="1"><inist:fA14 i1="15"><s1>Roche</s1><s2>Welwyn</s2><s3>GBR</s3><sZ>15 aut.</sZ></inist:fA14><country>Royaume-Uni</country><wicri:noRegion>Roche</wicri:noRegion></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">INIST</idno><idno type="inist">04-0502722</idno><date when="2004">2004</date><idno type="stanalyst">PASCAL 04-0502722 INIST</idno><idno type="RBID">Pascal:04-0502722</idno><idno type="wicri:Area/PascalFrancis/Corpus">004C95</idno><idno type="wicri:Area/PascalFrancis/Curation">001419</idno><idno type="wicri:Area/PascalFrancis/Checkpoint">004A13</idno><idno type="wicri:explorRef" 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Beaujon</wicri:noRegion><wicri:noRegion>Clichy</wicri:noRegion></affiliation></author><author><name sortKey="Lau, George K K" sort="Lau, George K K" uniqKey="Lau G" first="George K. K." last="Lau">George K. K. Lau</name><affiliation wicri:level="1"><inist:fA14 i1="02"><s1>Queen Mary Hospital, University of Hong Kong</s1><s3>HKG</s3><sZ>2 aut.</sZ></inist:fA14><country>Hong Kong</country><wicri:noRegion>Queen Mary Hospital, University of Hong Kong</wicri:noRegion></affiliation></author><author><name sortKey="Bonino, Ferruccio" sort="Bonino, Ferruccio" uniqKey="Bonino F" first="Ferruccio" last="Bonino">Ferruccio Bonino</name><affiliation wicri:level="3"><inist:fA14 i1="03"><s1>Istituto di Ricovero e Cura a Carratere Scientifico, Ospedale Maggiore di Milano Policlinico</s1><s2>Milan</s2><s3>ITA</s3><sZ>3 aut.</sZ></inist:fA14><country>Italie</country><placeName><settlement type="city">Milan</settlement><region nuts="2">Lombardie</region></placeName></affiliation></author><author><name sortKey="Farci, Patrizia" sort="Farci, Patrizia" uniqKey="Farci P" first="Patrizia" last="Farci">Patrizia Farci</name><affiliation wicri:level="1"><inist:fA14 i1="04"><s1>Division of Clinical Medicine I, University of Cagliari</s1><s2>Cagliari</s2><s3>ITA</s3><sZ>4 aut.</sZ></inist:fA14><country>Italie</country><wicri:noRegion>Cagliari</wicri:noRegion></affiliation></author><author><name sortKey="Hadziyannis, Stephanos" sort="Hadziyannis, Stephanos" uniqKey="Hadziyannis S" first="Stephanos" last="Hadziyannis">Stephanos Hadziyannis</name><affiliation wicri:level="3"><inist:fA14 i1="05"><s1>Department of Medicine and Hepatology, Henry Dunant Hospital</s1><s2>Athens</s2><s3>GRC</s3><sZ>5 aut.</sZ></inist:fA14><country>Grèce</country><placeName><settlement type="city">Athènes</settlement><region nuts="2" type="region">Attique (région)</region></placeName></affiliation></author><author><name sortKey="Rui Jin" sort="Rui Jin" uniqKey="Rui Jin" last="Rui Jin">RUI JIN</name><affiliation wicri:level="3"><inist:fA14 i1="06"><s1>Digestive Disease Department, BeijingYou An Hospital</s1><s2>Beijing</s2><s3>CHN</s3><sZ>6 aut.</sZ></inist:fA14><country>République populaire de Chine</country><placeName><settlement type="city">Pékin</settlement></placeName></affiliation></author><author><name sortKey="Lu, Zhi Meng" sort="Lu, Zhi Meng" uniqKey="Lu Z" first="Zhi-Meng" last="Lu">Zhi-Meng Lu</name><affiliation wicri:level="1"><inist:fA14 i1="07"><s1>Department of Infectious Diseases, Ruijin Hospital</s1><s2>Shanghai</s2><s3>CHN</s3><sZ>7 aut.</sZ></inist:fA14><country>République populaire de Chine</country><wicri:noRegion>Shanghai</wicri:noRegion></affiliation></author><author><name sortKey="Piratvisuth, Teerha" sort="Piratvisuth, Teerha" uniqKey="Piratvisuth T" first="Teerha" last="Piratvisuth">Teerha Piratvisuth</name><affiliation wicri:level="1"><inist:fA14 i1="08"><s1>Songklanakarin Hospital</s1><s2>Songkla</s2><s3>THA</s3><sZ>8 aut.</sZ></inist:fA14><country>Thaïlande</country><wicri:noRegion>Songklanakarin Hospital</wicri:noRegion></affiliation></author><author><name sortKey="Germanidis, Georgios" sort="Germanidis, Georgios" uniqKey="Germanidis G" first="Georgios" last="Germanidis">Georgios Germanidis</name><affiliation wicri:level="1"><inist:fA14 i1="09"><s1>Papageorgiou General Hospital, Pathology Clinic</s1><s2>Thessalonika</s2><s3>GRC</s3><sZ>9 aut.</sZ></inist:fA14><country>Grèce</country><wicri:noRegion>Thessalonika</wicri:noRegion></affiliation></author><author><name sortKey="Yurdaydin, Cihan" sort="Yurdaydin, Cihan" uniqKey="Yurdaydin C" first="Cihan" last="Yurdaydin">Cihan Yurdaydin</name><affiliation wicri:level="1"><inist:fA14 i1="10"><s1>University of Ankara, Faculty of Medicine</s1><s2>Ankara</s2><s3>TUR</s3><sZ>10 aut.</sZ></inist:fA14><country>Turquie</country><wicri:noRegion>Ankara</wicri:noRegion></affiliation></author><author><name sortKey="Diago, Moises" sort="Diago, Moises" uniqKey="Diago M" first="Moises" last="Diago">Moises Diago</name><affiliation wicri:level="1"><inist:fA14 i1="11"><s1>Hospital General Universitario de Valencia</s1><s2>Valencia</s2><s3>ESP</s3><sZ>11 aut.</sZ></inist:fA14><country>Espagne</country><wicri:noRegion>Hospital General Universitario de Valencia</wicri:noRegion></affiliation></author><author><name sortKey="Gurel, Selim" sort="Gurel, Selim" uniqKey="Gurel S" first="Selim" last="Gurel">Selim Gurel</name><affiliation wicri:level="1"><inist:fA14 i1="12"><s1>University of Uludag, Faculty of Medicine</s1><s2>Bursa</s2><s3>TUR</s3><sZ>12 aut.</sZ></inist:fA14><country>Turquie</country><wicri:noRegion>Bursa</wicri:noRegion></affiliation></author><author><name sortKey="Lai, Ming Yang" sort="Lai, Ming Yang" uniqKey="Lai M" first="Ming-Yang" last="Lai">Ming-Yang Lai</name><affiliation wicri:level="1"><inist:fA14 i1="13"><s1>National Taiwan University Hospital, Internal Medicine</s1><s2>Taipei</s2><s3>TWN</s3><sZ>13 aut.</sZ></inist:fA14><country>Taïwan</country><wicri:noRegion>Taipei</wicri:noRegion></affiliation></author><author><name sortKey="Button, Peter" sort="Button, Peter" uniqKey="Button P" first="Peter" last="Button">Peter Button</name><affiliation wicri:level="1"><inist:fA14 i1="14"><s1>Roche</s1><s2>Dee Why</s2><s3>AUS</s3><sZ>14 aut.</sZ></inist:fA14><country>Australie</country><wicri:noRegion>Roche</wicri:noRegion></affiliation></author><author><name sortKey="Pluck, Nigel" sort="Pluck, Nigel" uniqKey="Pluck N" first="Nigel" last="Pluck">Nigel Pluck</name><affiliation wicri:level="1"><inist:fA14 i1="15"><s1>Roche</s1><s2>Welwyn</s2><s3>GBR</s3><sZ>15 aut.</sZ></inist:fA14><country>Royaume-Uni</country><wicri:noRegion>Roche</wicri:noRegion></affiliation></author></analytic><series><title level="j" type="main">The New England journal of medicine</title><title level="j" type="abbreviated">N. Engl. j. med.</title><idno type="ISSN">0028-4793</idno><imprint><date when="2004">2004</date></imprint></series></biblStruct></sourceDesc><seriesStmt><title level="j" type="main">The New England journal of medicine</title><title level="j" type="abbreviated">N. Engl. j. med.</title><idno type="ISSN">0028-4793</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Antiviral</term><term>Human</term><term>Immunomodulator</term><term>Lamivudine</term><term>Medicine</term><term>Peginterferon alfa-2a</term><term>Viral hepatitis B</term></keywords><keywords scheme="Pascal" xml:lang="fr"><term>Peginterféron alfa-2a</term><term>Lamivudine</term><term>Homme</term><term>Hépatite virale B</term><term>Médecine</term><term>Immunomodulateur</term><term>Antiviral</term></keywords><keywords scheme="Wicri" type="topic" xml:lang="fr"><term>Homme</term><term>Médecine</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">BACKGROUND Available treatments for hepatitis B e antigen (HBeAg)-negative chronic hepatitis B are associated with poor sustained responses. As a result, nucleoside and nucleotide analogues are typically continued indefinitely, a strategy associated with the risk of resistance and unknown long-term safety implications. METHODS We compared the efficacy and safety ofpeginterferon alfa-2a (180 μg once weekly) plus placebo, peginterferon alfa-2a plus lamivudine (100 mg daily), and lamivudine alone in 177, 179, and 181 patients with HBeAg-negative chronic hepatitis B, respectively. Patients were treated for 48 weeks and followed for an additional 24 weeks. RESULTS After 24 weeks offollow-up, the percentage of patients with normalization ofalanine aminotransferase levels or hepatitis B virus (HBV) DNA levels below 20,000 copies per milliliter was significantly higher with peginterferon alfa-2a monotherapy (59 percent and 43 percent, respectively) and peginterferon alfa-2a plus lamivudine (60 percent and 44 percent) than with lamivudine monotherapy (44 percent, P=0.004 and P=0.003, respectively; and 29 percent, P=0.007 and P=0.003, respectively). Rates of sustained suppression of HBV DNA to below 400 copies per milliliter were 19 percent with peginterferon alfa-2a monotherapy, 20 percentwith combination therapy, and 7 percent with lamivudine alone (P<0.001 for both comparisons with lamivudine alone). Loss of hepatitis B surface antigen occurred in 12 patients in the peginterferon groups, as compared with 0 patients in the group given lamivudine alone. Adverse events, including pyrexia, fatigue, myalgia, and headache, were less frequent with lamivudine monotherapy than with peginterferon alfa-2a monotherapy or combination therapy. CONCLUSIONS Patients with HBeAg-negative chronic hepatitis B had significantly higher rates of response, sustained for 24 weeks after the cessation oftherapy, with peginterferon alfa-2a than with lamivudine. The addition of lamivudine to peginterferon alfa-2a did not improve post-therapy response rates.</div></front></TEI><affiliations><list><country><li>Australie</li><li>Espagne</li><li>France</li><li>Grèce</li><li>Hong Kong</li><li>Italie</li><li>Royaume-Uni</li><li>République populaire de Chine</li><li>Taïwan</li><li>Thaïlande</li><li>Turquie</li></country><region><li>Attique (région)</li><li>Lombardie</li></region><settlement><li>Athènes</li><li>Milan</li><li>Pékin</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="Hong Kong"><noRegion><name sortKey="Lau, George K K" sort="Lau, George K K" uniqKey="Lau G" first="George K. K." last="Lau">George K. K. Lau</name></noRegion></country><country name="Italie"><region name="Lombardie"><name sortKey="Bonino, Ferruccio" sort="Bonino, Ferruccio" uniqKey="Bonino F" first="Ferruccio" last="Bonino">Ferruccio Bonino</name></region><name sortKey="Farci, Patrizia" sort="Farci, Patrizia" uniqKey="Farci P" first="Patrizia" last="Farci">Patrizia Farci</name></country><country name="Grèce"><region name="Attique (région)"><name sortKey="Hadziyannis, Stephanos" sort="Hadziyannis, Stephanos" uniqKey="Hadziyannis S" first="Stephanos" last="Hadziyannis">Stephanos Hadziyannis</name></region><name sortKey="Germanidis, Georgios" sort="Germanidis, Georgios" uniqKey="Germanidis G" first="Georgios" last="Germanidis">Georgios Germanidis</name></country><country name="République populaire de Chine"><noRegion><name sortKey="Rui Jin" sort="Rui Jin" uniqKey="Rui Jin" last="Rui Jin">RUI JIN</name></noRegion><name sortKey="Lu, Zhi Meng" sort="Lu, Zhi Meng" uniqKey="Lu Z" first="Zhi-Meng" last="Lu">Zhi-Meng Lu</name></country><country name="Thaïlande"><noRegion><name sortKey="Piratvisuth, Teerha" sort="Piratvisuth, Teerha" uniqKey="Piratvisuth T" first="Teerha" last="Piratvisuth">Teerha Piratvisuth</name></noRegion></country><country name="Turquie"><noRegion><name sortKey="Yurdaydin, Cihan" sort="Yurdaydin, Cihan" uniqKey="Yurdaydin C" first="Cihan" last="Yurdaydin">Cihan Yurdaydin</name></noRegion><name sortKey="Gurel, Selim" sort="Gurel, Selim" uniqKey="Gurel S" first="Selim" last="Gurel">Selim Gurel</name></country><country name="Espagne"><noRegion><name sortKey="Diago, Moises" sort="Diago, Moises" uniqKey="Diago M" first="Moises" last="Diago">Moises Diago</name></noRegion></country><country name="Taïwan"><noRegion><name sortKey="Lai, Ming Yang" sort="Lai, Ming Yang" uniqKey="Lai M" first="Ming-Yang" last="Lai">Ming-Yang Lai</name></noRegion></country><country name="Australie"><noRegion><name sortKey="Button, Peter" sort="Button, Peter" uniqKey="Button P" first="Peter" last="Button">Peter Button</name></noRegion></country><country name="Royaume-Uni"><noRegion><name sortKey="Pluck, Nigel" sort="Pluck, Nigel" uniqKey="Pluck N" first="Nigel" last="Pluck">Nigel Pluck</name></noRegion></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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|texte= Peginterferon alfa-2a alone, lamivudine alone, and the two in combination in patients with hbeag-negative chronic hepatitis B
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