AustralieFrV1, Main, Exploration, bibRecord, 007017

Albinterferon Alfa-2b Was Not Inferior to Pegylated Interferon-α in a Randomized Trial of Patients With Chronic Hepatitis C Virus Genotype 2 or 3

Identifieur interne : 007017 ( Main/Exploration ); précédent : 007016; suivant : 007018

Albinterferon Alfa-2b Was Not Inferior to Pegylated Interferon-α in a Randomized Trial of Patients With Chronic Hepatitis C Virus Genotype 2 or 3

Auteurs : David R. Nelson [États-Unis] ; Yves Benhamou [France] ; Wan-Long Chuang [Taïwan] ; Eric J. Lawitz [États-Unis] ; Maribel Rodriguez-Torres [Porto Rico] ; Robert Flisiak [Pologne] ; Jens W. F. Rasenack [Allemagne] ; Wiesław Kryczka [Pologne] ; Chuan-Mo Lee [Taïwan] ; Vincent G. Bain [Canada] ; Stephen Pianko [Australie] ; Keyur Patel [États-Unis] ; Patrick W. Cronin [États-Unis] ; Erik Pulkstenis [États-Unis] ; G. Mani Subramanian [États-Unis] ; John G. Mchutchison [États-Unis]

Source :

Gastroenterology [ 0016-5085 ] ; 2010.

RBID : PMC:3175757

Abstract

BACKGROUND & AIMS

A phase 3 active-controlled study was conducted to assess the efficacy/safety of albinterferon alfa-2b (albIFN), a novel, long-acting, genetic fusion polypeptide of recombinant human albumin and interferon alfa-2b, in patients with chronic hepatitis C virus (HCV) genotype 2/3.

METHODS

In all, 933 patients were randomized to open-label subcutaneous treatment with pegylated interferon-alfa-2a (Peg-IFNalfa-2a) 180 μg/wk, or albIFN 900 or 1200 μg every 2 weeks for 24 weeks, each administered with oral ribavirin 800 mg/day. The primary end point of the study was sustained virologic response (SVR) (HCV-RNA level, <15 IU/mL at week 48). During the study, the data monitoring committee recommended dose modification for all patients receiving albIFN 1200 μgto 900 μg, impacting 38% of this treatment arm.

RESULTS

By intention-to-treat analysis, SVR rates were 84.8% (95% confidence interval, 80.4%–88.6%), 79.8% (95% confidence interval, 74.9%–84.1%), and 80.0% (95% confidence interval, 75.1%–84.3%) with Peg-IFNalfa-2a, and albIFN 900 and 1200 μg, respectively. The primary hypothesis of noninferiority of SVR was established for albIFN 900 μg(P = .009) and 1200 μg(P = .006). Independent positive predictors of SVR by multivariate regression analysis were pretreatment HCV-RNA level less than 400,000 IU/mL, age younger than 45 years, body mass index less than 30 kg/m², genotype 2, normal γ-glutamyl transpeptidase and increased alanine aminotransferase levels at baseline, fibrosis stage F0–F2, no steatosis, and Asian geographic region (Peg-IFNalfa-2a only). The 3 treatment groups showed similar rates of serious (7%–8%) and severe (13%–16%) adverse events, and discontinuations owing to adverse events (3.6%–5.5%).

CONCLUSION

Albinterferon alfa-2b 900 μg every 2 weeks provides an alternative efficacious treatment option in patients with chronic HCV genotype 2 or 3.

Url:

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3175757

DOI: 10.1053/j.gastro.2010.06.062
PubMed: 20600017
PubMed Central: 3175757

Affiliations:

Le document en format XML

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<author><name sortKey="Nelson, David R" sort="Nelson, David R" uniqKey="Nelson D" first="David R." last="Nelson">David R. Nelson</name>
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<author><name sortKey="Lawitz, Eric J" sort="Lawitz, Eric J" uniqKey="Lawitz E" first="Eric J." last="Lawitz">Eric J. Lawitz</name>
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<author><name sortKey="Rodriguez Torres, Maribel" sort="Rodriguez Torres, Maribel" uniqKey="Rodriguez Torres M" first="Maribel" last="Rodriguez-Torres">Maribel Rodriguez-Torres</name>
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<author><name sortKey="Flisiak, Robert" sort="Flisiak, Robert" uniqKey="Flisiak R" first="Robert" last="Flisiak">Robert Flisiak</name>
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<country xml:lang="fr">Pologne</country>
<wicri:regionArea>Wojewódzki Szpital Specjalistyczny, Bialystok</wicri:regionArea>
<wicri:noRegion>Bialystok</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Rasenack, Jens W F" sort="Rasenack, Jens W F" uniqKey="Rasenack J" first="Jens W. F." last="Rasenack">Jens W. F. Rasenack</name>
<affiliation wicri:level="3"><nlm:aff id="A7">Albert-Ludwigs-Universität Freiburg, Freiburg, Germany</nlm:aff>
<country xml:lang="fr">Allemagne</country>
<wicri:regionArea>Albert-Ludwigs-Universität Freiburg, Freiburg</wicri:regionArea>
<placeName><region type="land" nuts="1">Bade-Wurtemberg</region>
<region type="district" nuts="2">District de Fribourg-en-Brisgau</region>
<settlement type="city">Fribourg-en-Brisgau</settlement>
</placeName>
</affiliation>
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<author><name sortKey="Kryczka, Wieslaw" sort="Kryczka, Wieslaw" uniqKey="Kryczka W" first="Wiesław" last="Kryczka">Wiesław Kryczka</name>
<affiliation wicri:level="1"><nlm:aff id="A8">Wojewódzki Szpital Zespolony, Kielce, Poland</nlm:aff>
<country xml:lang="fr">Pologne</country>
<wicri:regionArea>Wojewódzki Szpital Zespolony, Kielce</wicri:regionArea>
<wicri:noRegion>Kielce</wicri:noRegion>
</affiliation>
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<author><name sortKey="Lee, Chuan Mo" sort="Lee, Chuan Mo" uniqKey="Lee C" first="Chuan-Mo" last="Lee">Chuan-Mo Lee</name>
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<country xml:lang="fr">Taïwan</country>
<wicri:regionArea>Chang Gung Memorial Hospital–Kaohsiung Medical Center, Chang Gung University College of Medicine, Kaohsiung</wicri:regionArea>
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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>
<affiliation wicri:level="1"><nlm:aff id="A10">University of Alberta, Edmonton, Alberta, Canada</nlm:aff>
<country xml:lang="fr">Canada</country>
<wicri:regionArea>University of Alberta, Edmonton, Alberta</wicri:regionArea>
<wicri:noRegion>Alberta</wicri:noRegion>
</affiliation>
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<author><name sortKey="Pianko, Stephen" sort="Pianko, Stephen" uniqKey="Pianko S" first="Stephen" last="Pianko">Stephen Pianko</name>
<affiliation wicri:level="1"><nlm:aff id="A11">Monash Medical Centre, Clayton, Victoria, Australia</nlm:aff>
<country xml:lang="fr">Australie</country>
<wicri:regionArea>Monash Medical Centre, Clayton, Victoria</wicri:regionArea>
<wicri:noRegion>Victoria</wicri:noRegion>
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<author><name sortKey="Patel, Keyur" sort="Patel, Keyur" uniqKey="Patel K" first="Keyur" last="Patel">Keyur Patel</name>
<affiliation wicri:level="2"><nlm:aff id="A12">Duke Clinical Research Institute and Division of Gastroenterology, Duke University, Durham, North Carolina</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<placeName><region type="state">Caroline du Nord</region>
</placeName>
<wicri:cityArea>Duke Clinical Research Institute and Division of Gastroenterology, Duke University, Durham</wicri:cityArea>
</affiliation>
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<author><name sortKey="Cronin, Patrick W" sort="Cronin, Patrick W" uniqKey="Cronin P" first="Patrick W." last="Cronin">Patrick W. Cronin</name>
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<country xml:lang="fr">États-Unis</country>
<placeName><region type="state">Maryland</region>
</placeName>
<wicri:cityArea>Human Genome Sciences, Inc, Rockville</wicri:cityArea>
</affiliation>
</author>
<author><name sortKey="Pulkstenis, Erik" sort="Pulkstenis, Erik" uniqKey="Pulkstenis E" first="Erik" last="Pulkstenis">Erik Pulkstenis</name>
<affiliation wicri:level="2"><nlm:aff id="A13">Human Genome Sciences, Inc, Rockville, Maryland</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<placeName><region type="state">Maryland</region>
</placeName>
<wicri:cityArea>Human Genome Sciences, Inc, Rockville</wicri:cityArea>
</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="2"><nlm:aff id="A13">Human Genome Sciences, Inc, Rockville, Maryland</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<placeName><region type="state">Maryland</region>
</placeName>
<wicri:cityArea>Human Genome Sciences, Inc, Rockville</wicri:cityArea>
</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="2"><nlm:aff id="A12">Duke Clinical Research Institute and Division of Gastroenterology, Duke University, Durham, North Carolina</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<placeName><region type="state">Caroline du Nord</region>
</placeName>
<wicri:cityArea>Duke Clinical Research Institute and Division of Gastroenterology, Duke University, Durham</wicri:cityArea>
</affiliation>
</author>
</analytic>
<series><title level="j">Gastroenterology</title>
<idno type="ISSN">0016-5085</idno>
<idno type="eISSN">1528-0012</idno>
<imprint><date when="2010">2010</date>
</imprint>
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<front><div type="abstract" xml:lang="en"><sec id="S1"><title>BACKGROUND & AIMS</title>
<p id="P1">A phase 3 active-controlled study was conducted to assess the efficacy/safety of albinterferon alfa-2b (albIFN), a novel, long-acting, genetic fusion polypeptide of recombinant human albumin and interferon alfa-2b, in patients with chronic hepatitis C virus (HCV) genotype 2/3.</p>
</sec>
<sec sec-type="methods" id="S2"><title>METHODS</title>
<p id="P2">In all, 933 patients were randomized to open-label subcutaneous treatment with pegylated interferon-alfa-2a (Peg-IFNalfa-2a) 180 μg/wk, or albIFN 900 or 1200 μg every 2 weeks for 24 weeks, each administered with oral ribavirin 800 mg/day. The primary end point of the study was sustained virologic response (SVR) (HCV-RNA level, <15 IU/mL at week 48). During the study, the data monitoring committee recommended dose modification for all patients receiving albIFN 1200 μgto 900 μg, impacting 38% of this treatment arm.</p>
</sec>
<sec id="S3"><title>RESULTS</title>
<p id="P3">By intention-to-treat analysis, SVR rates were 84.8% (95% confidence interval, 80.4%–88.6%), 79.8% (95% confidence interval, 74.9%–84.1%), and 80.0% (95% confidence interval, 75.1%–84.3%) with Peg-IFNalfa-2a, and albIFN 900 and 1200 μg, respectively. The primary hypothesis of noninferiority of SVR was established for albIFN 900 μg(<italic>P</italic>
 = .009) and 1200 μg(<italic>P</italic>
 = .006). Independent positive predictors of SVR by multivariate regression analysis were pretreatment HCV-RNA level less than 400,000 IU/mL, age younger than 45 years, body mass index less than 30 kg/m<sup>2</sup>
, genotype 2, normal γ-glutamyl transpeptidase and increased alanine aminotransferase levels at baseline, fibrosis stage F0–F2, no steatosis, and Asian geographic region (Peg-IFNalfa-2a only). The 3 treatment groups showed similar rates of serious (7%–8%) and severe (13%–16%) adverse events, and discontinuations owing to adverse events (3.6%–5.5%).</p>
</sec>
<sec id="S4"><title>CONCLUSION</title>
<p id="P4">Albinterferon alfa-2b 900 μg every 2 weeks provides an alternative efficacious treatment option in patients with chronic HCV genotype 2 or 3.</p>
</sec>
</div>
</front>
</TEI>
<affiliations><list><country><li>Allemagne</li>
<li>Australie</li>
<li>Canada</li>
<li>France</li>
<li>Pologne</li>
<li>Porto Rico</li>
<li>Taïwan</li>
<li>États-Unis</li>
</country>
<region><li>Bade-Wurtemberg</li>
<li>Caroline du Nord</li>
<li>District de Fribourg-en-Brisgau</li>
<li>Floride</li>
<li>Maryland</li>
<li>Texas</li>
<li>Île-de-France</li>
</region>
<settlement><li>Fribourg-en-Brisgau</li>
<li>Paris</li>
</settlement>
</list>
<tree><country name="États-Unis"><region name="Floride"><name sortKey="Nelson, David R" sort="Nelson, David R" uniqKey="Nelson D" first="David R." last="Nelson">David R. Nelson</name>
</region>
<name sortKey="Cronin, Patrick W" sort="Cronin, Patrick W" uniqKey="Cronin P" first="Patrick W." last="Cronin">Patrick W. Cronin</name>
<name sortKey="Lawitz, Eric J" sort="Lawitz, Eric J" uniqKey="Lawitz E" first="Eric J." last="Lawitz">Eric J. Lawitz</name>
<name sortKey="Mchutchison, John G" sort="Mchutchison, John G" uniqKey="Mchutchison J" first="John G." last="Mchutchison">John G. Mchutchison</name>
<name sortKey="Patel, Keyur" sort="Patel, Keyur" uniqKey="Patel K" first="Keyur" last="Patel">Keyur Patel</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>
<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="Taïwan"><noRegion><name sortKey="Chuang, Wan Long" sort="Chuang, Wan Long" uniqKey="Chuang W" first="Wan-Long" last="Chuang">Wan-Long Chuang</name>
</noRegion>
<name sortKey="Lee, Chuan Mo" sort="Lee, Chuan Mo" uniqKey="Lee C" first="Chuan-Mo" last="Lee">Chuan-Mo Lee</name>
</country>
<country name="Porto Rico"><noRegion><name sortKey="Rodriguez Torres, Maribel" sort="Rodriguez Torres, Maribel" uniqKey="Rodriguez Torres M" first="Maribel" last="Rodriguez-Torres">Maribel Rodriguez-Torres</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>
<name sortKey="Kryczka, Wieslaw" sort="Kryczka, Wieslaw" uniqKey="Kryczka W" first="Wiesław" last="Kryczka">Wiesław Kryczka</name>
</country>
<country name="Allemagne"><region name="Bade-Wurtemberg"><name sortKey="Rasenack, Jens W F" sort="Rasenack, Jens W F" uniqKey="Rasenack J" first="Jens W. F." last="Rasenack">Jens W. F. Rasenack</name>
</region>
</country>
<country name="Canada"><noRegion><name sortKey="Bain, Vincent G" sort="Bain, Vincent G" uniqKey="Bain V" first="Vincent G." last="Bain">Vincent G. Bain</name>
</noRegion>
</country>
<country name="Australie"><noRegion><name sortKey="Pianko, Stephen" sort="Pianko, Stephen" uniqKey="Pianko S" first="Stephen" last="Pianko">Stephen Pianko</name>
</noRegion>
</country>
</tree>
</affiliations>
</record>

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Albinterferon Alfa-2b Was Not Inferior to Pegylated Interferon-α in a Randomized Trial of Patients With Chronic Hepatitis C Virus Genotype 2 or 3

Albinterferon Alfa-2b Was Not Inferior to Pegylated Interferon-α in a Randomized Trial of Patients With Chronic Hepatitis C Virus Genotype 2 or 3

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