AustralieFrV1, Main, Exploration, bibRecord, 008E86

Albinterferon Alfa-2b Dosed Every Two or Four Weeks in Interferon-Naïve Patients With Genotype 1 Chronic Hepatitis C

Identifieur interne : 008E86 ( Main/Exploration ); précédent : 008E85; suivant : 008E87

Albinterferon Alfa-2b Dosed Every Two or Four Weeks in Interferon-Naïve Patients With Genotype 1 Chronic Hepatitis C

Auteurs : Stefan Zeuzem [Allemagne] ; Eric M. Yoshida [Canada] ; Yves Benhamou [France] ; Stephen Pianko [Australie] ; Vincent G. Bain [Canada] ; Daniel Shouval [Israël] ; Robert Flisiak [Pologne] ; Vratislav Rehak [Roumanie] ; Mircea Grigorescu [République tchèque] ; Kelly Kaita [Canada] ; Patrick W. Cronin [États-Unis] ; Erik Pulkstenis [États-Unis] ; G. Mani Subramanian [États-Unis] ; John G. Mchutchison [États-Unis]

Source :

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

RBID : Pascal:08-0384099

Descripteurs français

Pascal (Inist)
- Hépatite virale C, Albinterféron alfa-2b, Interféron, Homme, Génotype, Typage, Gastroentérologie.
Wicri :
- topic : Homme.

English descriptors

KwdEn :
- Albinterferon alfa-2b, Gastroenterology, Genotype, Human, Interferon, Typing, Viral hepatitis C.

Abstract

The efficacy and safety of albinterferon alfa-2b (alb-IFN), a novel recombinant protein consisting ofinterferon alfa-2b genetically fused to human albumin, was evaluated in a phase 2b, open-label study of patients with genotype 1, chronic hepatitis C. In all, 458 IFN-alfa treatment-naive patients were randomized to 48-week treatment with peginterferon alfa (PEG-IFNa)-2a 180 μg one time per week (qwk), or alb-IFN 900 or 1,200 μg once every two weeks (q2wk), or 1,200 μg once every four weeks (q4wk), administered subcutaneously, plus weight-based oral ribavirin 1,000 or 1,200 mg/day. Hepatitis C virus RNA was measured by real-time polymerase chain reaction (limit of detection: 10 IU/mL). The primary efficacy endpoint was sustained virologic response (hepatitis C virus RNA < 10 IU/mL 24 weeks after the end of treatment). By intention-to-treat analysis, sustained virologic response rates were 58.5% (69/118) with alb-IFN 900 μg q2wk, 55.5% (61/110) with 1,200 μg q2wk, and 50.9% (59/116) with 1,200 μg q4wk, and 57.9% (66/114) with PEG-IFNa-2a (P = 0.64 for overall test). Discontinuation rates due to adverse events were 9.3% with alb-IFN 900 μg q2wk, 18.2% with 1,200 μg q2wk and 12.1% with 1,200 μg q4wk, and 6.1% with PEG-IFNa-2a (P = 0.04). Hematologic reductions were lowest in the q4wk group and comparable across other groups. At week 12, mean treatment-associated missed workdays were significantly lower with alb-IFN 900 μg q2wk versus PEG-IFNa-2a (1.1 versus 4.3 days; P = 0.006). Conclusion: Alb-IFN administered q2wk or q4wk may offer comparable efficacy, with an improved dosing schedule, compared with PEG-IFNα-2a.

Affiliations:

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Le document en format XML

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<sourceDesc><biblStruct><analytic><title xml:lang="en" level="a">Albinterferon Alfa-2b Dosed Every Two or Four Weeks in Interferon-Naïve Patients With Genotype 1 Chronic Hepatitis C</title>
<author><name sortKey="Zeuzem, Stefan" sort="Zeuzem, Stefan" uniqKey="Zeuzem S" first="Stefan" last="Zeuzem">Stefan Zeuzem</name>
<affiliation wicri:level="3"><inist:fA14 i1="01"><s1>J.W. Goethe-University Hospital</s1>
<s2>Frankfurt</s2>
<s3>DEU</s3>
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<region type="district" nuts="2">District de Darmstadt</region>
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<author><name sortKey="Yoshida, Eric M" sort="Yoshida, Eric M" uniqKey="Yoshida E" first="Eric M." last="Yoshida">Eric M. Yoshida</name>
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<affiliation wicri:level="3"><inist:fA14 i1="03"><s1>Hôpital Pitié-Salpêtrière</s1>
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<author><name sortKey="Bain, Vincent G" sort="Bain, Vincent G" uniqKey="Bain V" first="Vincent G." last="Bain">Vincent G. Bain</name>
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</inist:fA14>
<country>Canada</country>
<wicri:noRegion>University of Alberta</wicri:noRegion>
</affiliation>
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<author><name sortKey="Shouval, Daniel" sort="Shouval, Daniel" uniqKey="Shouval D" first="Daniel" last="Shouval">Daniel Shouval</name>
<affiliation wicri:level="1"><inist:fA14 i1="06"><s1>Hadassah University</s1>
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<country>Israël</country>
<wicri:noRegion>Hadassah University</wicri:noRegion>
</affiliation>
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<author><name sortKey="Flisiak, Robert" sort="Flisiak, Robert" uniqKey="Flisiak R" first="Robert" last="Flisiak">Robert Flisiak</name>
<affiliation wicri:level="1"><inist:fA14 i1="07"><s1>Medical University of Bialystok</s1>
<s3>POL</s3>
<sZ>7 aut.</sZ>
</inist:fA14>
<country>Pologne</country>
<wicri:noRegion>Medical University of Bialystok</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Rehak, Vratislav" sort="Rehak, Vratislav" uniqKey="Rehak V" first="Vratislav" last="Rehak">Vratislav Rehak</name>
<affiliation wicri:level="1"><inist:fA14 i1="08"><s1>Spitalul Clinic de Adulti Cluj-Napoca</s1>
<s3>ROU</s3>
<sZ>8 aut.</sZ>
</inist:fA14>
<country>Roumanie</country>
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</affiliation>
</author>
<author><name sortKey="Grigorescu, Mircea" sort="Grigorescu, Mircea" uniqKey="Grigorescu M" first="Mircea" last="Grigorescu">Mircea Grigorescu</name>
<affiliation wicri:level="3"><inist:fA14 i1="09"><s1>Nuselská Poliklinika-Remedis</s1>
<s2>Prague</s2>
<s3>CZE</s3>
<sZ>9 aut.</sZ>
</inist:fA14>
<country>République tchèque</country>
<placeName><settlement type="city">Prague</settlement>
<region type="région" nuts="2">Bohême centrale</region>
</placeName>
</affiliation>
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<author><name sortKey="Kaita, Kelly" sort="Kaita, Kelly" uniqKey="Kaita K" first="Kelly" last="Kaita">Kelly Kaita</name>
<affiliation wicri:level="4"><inist:fA14 i1="10"><s1>University of Manitoba</s1>
<s2>Winnipeg</s2>
<s3>CAN</s3>
<sZ>10 aut.</sZ>
</inist:fA14>
<country>Canada</country>
<placeName><settlement type="city">Winnipeg</settlement>
<region type="state">Manitoba</region>
</placeName>
<orgName type="university">Université du Manitoba</orgName>
</affiliation>
</author>
<author><name sortKey="Cronin, Patrick W" sort="Cronin, Patrick W" uniqKey="Cronin P" first="Patrick W." last="Cronin">Patrick W. Cronin</name>
<affiliation wicri:level="1"><inist:fA14 i1="11"><s1>Human Genome Sciences Inc</s1>
<s2>Rockville, MD</s2>
<s3>USA</s3>
<sZ>11 aut.</sZ>
<sZ>12 aut.</sZ>
<sZ>13 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<wicri:noRegion>Human Genome Sciences Inc</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Pulkstenis, Erik" sort="Pulkstenis, Erik" uniqKey="Pulkstenis E" first="Erik" last="Pulkstenis">Erik Pulkstenis</name>
<affiliation wicri:level="1"><inist:fA14 i1="11"><s1>Human Genome Sciences Inc</s1>
<s2>Rockville, MD</s2>
<s3>USA</s3>
<sZ>11 aut.</sZ>
<sZ>12 aut.</sZ>
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</affiliation>
</author>
<author><name sortKey="Subramanian, G Mani" sort="Subramanian, G Mani" uniqKey="Subramanian G" first="G. Mani" last="Subramanian">G. Mani Subramanian</name>
<affiliation wicri:level="1"><inist:fA14 i1="11"><s1>Human Genome Sciences Inc</s1>
<s2>Rockville, MD</s2>
<s3>USA</s3>
<sZ>11 aut.</sZ>
<sZ>12 aut.</sZ>
<sZ>13 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<wicri:noRegion>Human Genome Sciences Inc</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="12"><s1>Division of Gastroenterology, Duke Clinical Research Institute</s1>
<s2>Durham, NC</s2>
<s3>USA</s3>
<sZ>14 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<wicri:noRegion>Durham, NC</wicri:noRegion>
</affiliation>
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<series><title level="j" type="main">Hepatology : (Baltimore, Md.)</title>
<title level="j" type="abbreviated">Hepatology : (Baltim. Md.)</title>
<idno type="ISSN">0270-9139</idno>
<imprint><date when="2008">2008</date>
</imprint>
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<seriesStmt><title level="j" type="main">Hepatology : (Baltimore, Md.)</title>
<title level="j" type="abbreviated">Hepatology : (Baltim. Md.)</title>
<idno type="ISSN">0270-9139</idno>
</seriesStmt>
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<profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Albinterferon alfa-2b</term>
<term>Gastroenterology</term>
<term>Genotype</term>
<term>Human</term>
<term>Interferon</term>
<term>Typing</term>
<term>Viral hepatitis C</term>
</keywords>
<keywords scheme="Pascal" xml:lang="fr"><term>Hépatite virale C</term>
<term>Albinterféron alfa-2b</term>
<term>Interféron</term>
<term>Homme</term>
<term>Génotype</term>
<term>Typage</term>
<term>Gastroentérologie</term>
</keywords>
<keywords scheme="Wicri" type="topic" xml:lang="fr"><term>Homme</term>
</keywords>
</textClass>
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</teiHeader>
<front><div type="abstract" xml:lang="en">The efficacy and safety of albinterferon alfa-2b (alb-IFN), a novel recombinant protein consisting ofinterferon alfa-2b genetically fused to human albumin, was evaluated in a phase 2b, open-label study of patients with genotype 1, chronic hepatitis C. In all, 458 IFN-alfa treatment-naive patients were randomized to 48-week treatment with peginterferon alfa (PEG-IFNa)-2a 180 μg one time per week (qwk), or alb-IFN 900 or 1,200 μg once every two weeks (q2wk), or 1,200 μg once every four weeks (q4wk), administered subcutaneously, plus weight-based oral ribavirin 1,000 or 1,200 mg/day. Hepatitis C virus RNA was measured by real-time polymerase chain reaction (limit of detection: 10 IU/mL). The primary efficacy endpoint was sustained virologic response (hepatitis C virus RNA < 10 IU/mL 24 weeks after the end of treatment). By intention-to-treat analysis, sustained virologic response rates were 58.5% (69/118) with alb-IFN 900 μg q2wk, 55.5% (61/110) with 1,200 μg q2wk, and 50.9% (59/116) with 1,200 μg q4wk, and 57.9% (66/114) with PEG-IFNa-2a (P = 0.64 for overall test). Discontinuation rates due to adverse events were 9.3% with alb-IFN 900 μg q2wk, 18.2% with 1,200 μg q2wk and 12.1% with 1,200 μg q4wk, and 6.1% with PEG-IFNa-2a (P = 0.04). Hematologic reductions were lowest in the q4wk group and comparable across other groups. At week 12, mean treatment-associated missed workdays were significantly lower with alb-IFN 900 μg q2wk versus PEG-IFNa-2a (1.1 versus 4.3 days; P = 0.006). Conclusion: Alb-IFN administered q2wk or q4wk may offer comparable efficacy, with an improved dosing schedule, compared with PEG-IFNα-2a.</div>
</front>
</TEI>
<affiliations><list><country><li>Allemagne</li>
<li>Australie</li>
<li>Canada</li>
<li>France</li>
<li>Israël</li>
<li>Pologne</li>
<li>Roumanie</li>
<li>République tchèque</li>
<li>États-Unis</li>
</country>
<region><li>Bohême centrale</li>
<li>District de Darmstadt</li>
<li>Hesse (Land)</li>
<li>Manitoba</li>
<li>Île-de-France</li>
</region>
<settlement><li>Francfort-sur-le-Main</li>
<li>Paris</li>
<li>Prague</li>
<li>Winnipeg</li>
</settlement>
<orgName><li>Université du Manitoba</li>
</orgName>
</list>
<tree><country name="Allemagne"><region name="Hesse (Land)"><name sortKey="Zeuzem, Stefan" sort="Zeuzem, Stefan" uniqKey="Zeuzem S" first="Stefan" last="Zeuzem">Stefan Zeuzem</name>
</region>
</country>
<country name="Canada"><noRegion><name sortKey="Yoshida, Eric M" sort="Yoshida, Eric M" uniqKey="Yoshida E" first="Eric M." last="Yoshida">Eric M. Yoshida</name>
</noRegion>
<name sortKey="Bain, Vincent G" sort="Bain, Vincent G" uniqKey="Bain V" first="Vincent G." last="Bain">Vincent G. Bain</name>
<name sortKey="Kaita, Kelly" sort="Kaita, Kelly" uniqKey="Kaita K" first="Kelly" last="Kaita">Kelly Kaita</name>
</country>
<country name="France"><region name="Île-de-France"><name sortKey="Benhamou, Yves" sort="Benhamou, Yves" uniqKey="Benhamou Y" first="Yves" last="Benhamou">Yves Benhamou</name>
</region>
</country>
<country name="Australie"><noRegion><name sortKey="Pianko, Stephen" sort="Pianko, Stephen" uniqKey="Pianko S" first="Stephen" last="Pianko">Stephen Pianko</name>
</noRegion>
</country>
<country name="Israël"><noRegion><name sortKey="Shouval, Daniel" sort="Shouval, Daniel" uniqKey="Shouval D" first="Daniel" last="Shouval">Daniel Shouval</name>
</noRegion>
</country>
<country name="Pologne"><noRegion><name sortKey="Flisiak, Robert" sort="Flisiak, Robert" uniqKey="Flisiak R" first="Robert" last="Flisiak">Robert Flisiak</name>
</noRegion>
</country>
<country name="Roumanie"><noRegion><name sortKey="Rehak, Vratislav" sort="Rehak, Vratislav" uniqKey="Rehak V" first="Vratislav" last="Rehak">Vratislav Rehak</name>
</noRegion>
</country>
<country name="République tchèque"><region name="Bohême centrale"><name sortKey="Grigorescu, Mircea" sort="Grigorescu, Mircea" uniqKey="Grigorescu M" first="Mircea" last="Grigorescu">Mircea Grigorescu</name>
</region>
</country>
<country name="États-Unis"><noRegion><name sortKey="Cronin, Patrick W" sort="Cronin, Patrick W" uniqKey="Cronin P" first="Patrick W." last="Cronin">Patrick W. Cronin</name>
</noRegion>
<name sortKey="Mchutchison, John G" sort="Mchutchison, John G" uniqKey="Mchutchison J" first="John G." last="Mchutchison">John G. Mchutchison</name>
<name sortKey="Pulkstenis, Erik" sort="Pulkstenis, Erik" uniqKey="Pulkstenis E" first="Erik" last="Pulkstenis">Erik Pulkstenis</name>
<name sortKey="Subramanian, G Mani" sort="Subramanian, G Mani" uniqKey="Subramanian G" first="G. Mani" last="Subramanian">G. Mani Subramanian</name>
</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 008E86 | SxmlIndent | more

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{{Explor lien
   |wiki=    Wicri/Asie
   |area=    AustralieFrV1
   |flux=    Main
   |étape=   Exploration
   |type=    RBID
   |clé=     Pascal:08-0384099
   |texte=   Albinterferon Alfa-2b Dosed Every Two or Four Weeks in Interferon-Naïve Patients With Genotype 1 Chronic Hepatitis C
}}

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

Albinterferon Alfa-2b Dosed Every Two or Four Weeks in Interferon-Naïve Patients With Genotype 1 Chronic Hepatitis C

Albinterferon Alfa-2b Dosed Every Two or Four Weeks in Interferon-Naïve Patients With Genotype 1 Chronic Hepatitis C

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Descripteurs français

English descriptors

Abstract

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