Positive and negative prediction of sustained virologic response at weeks 2 and 4 of treatment with albinterferon alfa-2b or peginterferon alfa-2a in treatment-naïve patients with genotype 1, chronic hepatitis C
Identifieur interne : 008154 ( Main/Exploration ); précédent : 008153; suivant : 008155Positive and negative prediction of sustained virologic response at weeks 2 and 4 of treatment with albinterferon alfa-2b or peginterferon alfa-2a in treatment-naïve patients with genotype 1, chronic hepatitis C
Auteurs : Avidan U. Neumann [Israël] ; Stephen Pianko [Australie] ; Stefan Zeuzem [Allemagne] ; Eric M. Yoshida [Canada] ; Yves Benhamou [France] ; Moshe Mishan [Israël] ; John G. Mchutchison [États-Unis] ; Erik Pulkstenis [États-Unis] ; G. Mani Subramanian [États-Unis]Source :
- Journal of hepatology [ 0168-8278 ] ; 2009.
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- Pascal (Inist)
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- topic : Homme.
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- KwdEn :
Abstract
Background/Aims: Albinterferon alfa-2b is a novel, long-acting, fusion polypeptide that is dosed q2wk or q4wk. The predictive value of early virologic response during albinterferon alfa-2b or peginterferon alfa-2a treatment was investigated in interferon-naïve patients with genotype 1, chronic hepatitis C. Methods: Four hundred and fifty-eight patients were randomized to: albinterferon 900 or 1200 μg q2wk, or 1200 μg q4wk, or peginterferon 180 μg qwk. HCV RNA was measured by real-time PCR. A linear exhaustive search algorithm was used to determine the best SVR prediction algorithm in the per-protocol population (n = 368), with inclusion of key ITT analyses to assess impact. Results: SVR rate: 54-67% (P = NS between arms). Rapid initial virologic response rate at week 2 (RIVR; viral decline >2log10IU/mL) was 32-50% and gave rise to positive predictive value of 88-97% for SVR. No initial virologic response at week 4 (NIVR; viral decline <2log10IU/mL; viral load >5.5log10IU/mL) demonstrated a 100% negative predictive value for SVR. A sequential prediction algorithm based on viral kinetics at weeks 2 and 4 identified four prediction groups that reliably predicted SVR, positively or negatively, in 65-72% of patients. Conclusions:Improved SVR prediction was obtained by integrating absolute levels and reduction of HCV RNA at treatment week 2 and 4. Patients with RIVR had a high likelihood of achieving SVR.
Affiliations:
- Allemagne, Australie, Canada, France, Israël, États-Unis
- District de Darmstadt, Hesse (Land), Île-de-France
- Francfort-sur-le-Main, Paris
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<author><name sortKey="Subramanian, G Mani" sort="Subramanian, G Mani" uniqKey="Subramanian G" first="G. Mani" last="Subramanian">G. Mani Subramanian</name>
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<series><title level="j" type="main">Journal of hepatology</title>
<title level="j" type="abbreviated">J. hepatol.</title>
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<profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Albinterferon alfa-2b</term>
<term>Antineoplastic agent</term>
<term>Antiviral</term>
<term>Gastroenterology</term>
<term>Genotype</term>
<term>Hepatitis C virus</term>
<term>Human</term>
<term>Immunomodulator</term>
<term>Peginterferon alfa-2a</term>
<term>Predictive factor</term>
<term>Treatment</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>Peginterféron alfa-2a</term>
<term>Facteur prédictif</term>
<term>Traitement</term>
<term>Homme</term>
<term>Virus hépatite C</term>
<term>Génotype</term>
<term>Typage</term>
<term>Gastroentérologie</term>
<term>Antiviral</term>
<term>Immunomodulateur</term>
<term>Anticancéreux</term>
</keywords>
<keywords scheme="Wicri" type="topic" xml:lang="fr"><term>Homme</term>
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<front><div type="abstract" xml:lang="en">Background/Aims: Albinterferon alfa-2b is a novel, long-acting, fusion polypeptide that is dosed q2wk or q4wk. The predictive value of early virologic response during albinterferon alfa-2b or peginterferon alfa-2a treatment was investigated in interferon-naïve patients with genotype 1, chronic hepatitis C. Methods: Four hundred and fifty-eight patients were randomized to: albinterferon 900 or 1200 μg q2wk, or 1200 μg q4wk, or peginterferon 180 μg qwk. HCV RNA was measured by real-time PCR. A linear exhaustive search algorithm was used to determine the best SVR prediction algorithm in the per-protocol population (n = 368), with inclusion of key ITT analyses to assess impact. Results: SVR rate: 54-67% (P = NS between arms). Rapid initial virologic response rate at week 2 (RIVR; viral decline >2log<sub>10</sub>
IU/mL) was 32-50% and gave rise to positive predictive value of 88-97% for SVR. No initial virologic response at week 4 (NIVR; viral decline <2log<sub>10</sub>
IU/mL; viral load >5.5log<sub>10</sub>
IU/mL) demonstrated a 100% negative predictive value for SVR. A sequential prediction algorithm based on viral kinetics at weeks 2 and 4 identified four prediction groups that reliably predicted SVR, positively or negatively, in 65-72% of patients. Conclusions:Improved SVR prediction was obtained by integrating absolute levels and reduction of HCV RNA at treatment week 2 and 4. Patients with RIVR had a high likelihood of achieving SVR.</div>
</front>
</TEI>
<affiliations><list><country><li>Allemagne</li>
<li>Australie</li>
<li>Canada</li>
<li>France</li>
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<li>États-Unis</li>
</country>
<region><li>District de Darmstadt</li>
<li>Hesse (Land)</li>
<li>Île-de-France</li>
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<tree><country name="Israël"><noRegion><name sortKey="Neumann, Avidan U" sort="Neumann, Avidan U" uniqKey="Neumann A" first="Avidan U." last="Neumann">Avidan U. Neumann</name>
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<name sortKey="Mishan, Moshe" sort="Mishan, Moshe" uniqKey="Mishan M" first="Moshe" last="Mishan">Moshe Mishan</name>
</country>
<country name="Australie"><noRegion><name sortKey="Pianko, Stephen" sort="Pianko, Stephen" uniqKey="Pianko S" first="Stephen" last="Pianko">Stephen Pianko</name>
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<country name="Allemagne"><region name="Hesse (Land)"><name sortKey="Zeuzem, Stefan" sort="Zeuzem, Stefan" uniqKey="Zeuzem S" first="Stefan" last="Zeuzem">Stefan Zeuzem</name>
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<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>
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</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="États-Unis"><noRegion><name sortKey="Mchutchison, John G" sort="Mchutchison, John G" uniqKey="Mchutchison J" first="John G." last="Mchutchison">John G. Mchutchison</name>
</noRegion>
<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>
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</tree>
</affiliations>
</record>
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