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A randomized, controlled study of peginterferon lambda-1a/ribavirin ± daclatasvir for hepatitis C virus genotype 2 or 3

Identifieur interne : 002440 ( Main/Exploration ); précédent : 002439; suivant : 002441

A randomized, controlled study of peginterferon lambda-1a/ribavirin ± daclatasvir for hepatitis C virus genotype 2 or 3

Auteurs : Graham R. Foster [Royaume-Uni] ; Kazuaki Chayama [Japon] ; Wan-Long Chuang [Taïwan] ; Hugo Fainboim [Argentine] ; Martti Farkkila [Finlande] ; Adrian Gadano [Argentine] ; Giovanni B. Gaeta [Italie] ; Christophe Hézode [France] ; Yukiko Inada [Japon] ; Jeong Heo [Corée du Sud] ; Hiromitsu Kumada [Japon] ; Sheng-Nan Lu [Taïwan] ; Patrick Marcellin [France] ; Christophe Moreno [Belgique] ; Stuart K. Roberts [Australie] ; Simone I. Strasser ; Alexander J. Thompson [Australie] ; Joji Toyota [Japon] ; Seung Woon Paik [Corée du Sud] ; John M. Vierling [États-Unis] ; Anna L. Zignego [Italie] ; David Cohen [États-Unis] ; Fiona Mcphee [États-Unis] ; Megan Wind-Rotolo [États-Unis] ; Subasree Srinivasan [États-Unis] ; Matthew Hruska [États-Unis] ; Heather Myler [États-Unis] ; Simon D. Portsmouth [États-Unis]

Source :

RBID : PMC:4990525

Abstract

Background and purpose

Peginterferon Lambda was being developed as an alternative to alfa interferon for the treatment of chronic hepatitis C virus (HCV) infection. We compared peginterferon Lambda-1a plus ribavirin (Lambda/RBV) and Lambda/RBV plus daclatasvir (DCV; pangenotypic NS5A inhibitor) with peginterferon alfa-2a plus RBV (alfa/RBV) in treatment-naive patients with HCV genotype 2 or 3 infection.

Methods

In this multicenter, double-blind, phase 3 randomized controlled trial, patients were assigned 2:2:1 to receive 24 weeks of Lambda/RBV, 12 weeks of Lambda/RBV + DCV, or 24 weeks of alfa/RBV. The primary outcome measure was sustained virologic response at post-treatment Week 12 (SVR12).

Results

Overall, 874 patients were treated: Lambda/RBV, n = 353; Lambda/RBV + DCV, n = 349; alfa/RBV, n = 172. Patients were 65 % white and 33 % Asian, 57 % male, with a mean age of 47 years; 52 % were infected with genotype 2 (6 % cirrhotic) and 48 % with genotype 3 (9 % cirrhotic). In the Lambda/RBV + DCV group, 83 % (95 % confidence interval [CI] 78.5, 86.5) achieved SVR12 (90 % genotype 2, 75 % genotype 3) whereas SVR12 was achieved by 68 % (95 % CI 63.1, 72.9) with Lambda/RBV (72 % genotype 2, 64 % genotype 3) and 73 % (95 % CI 66.6, 79.9) with peginterferon alfa/RBV (74 % genotype 2, 73 % genotype 3). Lambda/RBV + DCV was associated with lower incidences of flu-like symptoms, hematological abnormalities, and discontinuations due to adverse events compared with alfa/RBV.

Conclusion

The 12-week regimen of Lambda/RBV + DCV was superior to peginterferon alfa/RBV in the combined population of treatment-naive patients with genotype 2 or 3 infection, with an improved tolerability and safety profile compared with alfa/RBV.

Electronic supplementary material

The online version of this article (doi:10.1186/s40064-016-2920-z) contains supplementary material, which is available to authorized users.


Url:
DOI: 10.1186/s40064-016-2920-z
PubMed: 27588258
PubMed Central: 4990525


Affiliations:


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Le document en format XML

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<name sortKey="Chuang, Wan Long" sort="Chuang, Wan Long" uniqKey="Chuang W" first="Wan-Long" last="Chuang">Wan-Long Chuang</name>
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<name sortKey="Gaeta, Giovanni B" sort="Gaeta, Giovanni B" uniqKey="Gaeta G" first="Giovanni B." last="Gaeta">Giovanni B. Gaeta</name>
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<name sortKey="Inada, Yukiko" sort="Inada, Yukiko" uniqKey="Inada Y" first="Yukiko" last="Inada">Yukiko Inada</name>
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<name sortKey="Heo, Jeong" sort="Heo, Jeong" uniqKey="Heo J" first="Jeong" last="Heo">Jeong Heo</name>
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<name sortKey="Kumada, Hiromitsu" sort="Kumada, Hiromitsu" uniqKey="Kumada H" first="Hiromitsu" last="Kumada">Hiromitsu Kumada</name>
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<name sortKey="Lu, Sheng Nan" sort="Lu, Sheng Nan" uniqKey="Lu S" first="Sheng-Nan" last="Lu">Sheng-Nan Lu</name>
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<name sortKey="Marcellin, Patrick" sort="Marcellin, Patrick" uniqKey="Marcellin P" first="Patrick" last="Marcellin">Patrick Marcellin</name>
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<name sortKey="Moreno, Christophe" sort="Moreno, Christophe" uniqKey="Moreno C" first="Christophe" last="Moreno">Christophe Moreno</name>
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<nlm:aff id="Aff14">Department of Gastroenterology, Hepatopancreatology and Digestive Oncology, CUB Hôpital Erasme, Université Libre de Bruxelles, 808 Route de Lennik, 1070 Brussels, Belgium</nlm:aff>
<country xml:lang="fr">Belgique</country>
<wicri:regionArea>Department of Gastroenterology, Hepatopancreatology and Digestive Oncology, CUB Hôpital Erasme, Université Libre de Bruxelles, 808 Route de Lennik, 1070 Brussels</wicri:regionArea>
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<name sortKey="Roberts, Stuart K" sort="Roberts, Stuart K" uniqKey="Roberts S" first="Stuart K." last="Roberts">Stuart K. Roberts</name>
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<name sortKey="Strasser, Simone I" sort="Strasser, Simone I" uniqKey="Strasser S" first="Simone I." last="Strasser">Simone I. Strasser</name>
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<name sortKey="Toyota, Joji" sort="Toyota, Joji" uniqKey="Toyota J" first="Joji" last="Toyota">Joji Toyota</name>
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<name sortKey="Paik, Seung Woon" sort="Paik, Seung Woon" uniqKey="Paik S" first="Seung Woon" last="Paik">Seung Woon Paik</name>
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<wicri:regionArea>Department of Medicine, Samsung Medical Centre, Sungkyunkwan University School of Medicine, 81 Irwon-ro, Gangnam-gu, Seoul</wicri:regionArea>
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<settlement type="city">Séoul</settlement>
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<name sortKey="Vierling, John M" sort="Vierling, John M" uniqKey="Vierling J" first="John M." last="Vierling">John M. Vierling</name>
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<nlm:aff id="Aff21">Baylor Liver Health, Baylor College of Medicine, 6620 Main Street, Suite 1425, Houston, TX USA</nlm:aff>
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<name sortKey="Zignego, Anna L" sort="Zignego, Anna L" uniqKey="Zignego A" first="Anna L." last="Zignego">Anna L. Zignego</name>
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<nlm:aff id="Aff22">Department of Experimental and Clinical Medicine, MASVE Center, Universita Di Firenze, Largo Brambilia, 3, 50134 Florence, Italy</nlm:aff>
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<wicri:regionArea>Department of Experimental and Clinical Medicine, MASVE Center, Universita Di Firenze, Largo Brambilia, 3, 50134 Florence</wicri:regionArea>
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</author>
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<name sortKey="Cohen, David" sort="Cohen, David" uniqKey="Cohen D" first="David" last="Cohen">David Cohen</name>
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<name sortKey="Mcphee, Fiona" sort="Mcphee, Fiona" uniqKey="Mcphee F" first="Fiona" last="Mcphee">Fiona Mcphee</name>
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<region type="state">Connecticut</region>
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<author>
<name sortKey="Wind Rotolo, Megan" sort="Wind Rotolo, Megan" uniqKey="Wind Rotolo M" first="Megan" last="Wind-Rotolo">Megan Wind-Rotolo</name>
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<nlm:aff id="Aff25">Exploratory Clinical and Translational Research, Bristol-Myers Squibb Company, Princeton, NJ USA</nlm:aff>
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<region type="state">New Jersey</region>
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<wicri:cityArea>Exploratory Clinical and Translational Research, Bristol-Myers Squibb Company, Princeton</wicri:cityArea>
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<author>
<name sortKey="Srinivasan, Subasree" sort="Srinivasan, Subasree" uniqKey="Srinivasan S" first="Subasree" last="Srinivasan">Subasree Srinivasan</name>
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<nlm:aff id="Aff26">Global Clinical Research, Bristol-Myers Squibb Company, 5 Research Parkway, Wallingford, CT 06492 USA</nlm:aff>
<country xml:lang="fr">États-Unis</country>
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<region type="state">Connecticut</region>
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<wicri:cityArea>Global Clinical Research, Bristol-Myers Squibb Company, 5 Research Parkway, Wallingford</wicri:cityArea>
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<name sortKey="Hruska, Matthew" sort="Hruska, Matthew" uniqKey="Hruska M" first="Matthew" last="Hruska">Matthew Hruska</name>
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<nlm:aff id="Aff27">Clinical Pharmacology and Pharmacometrics, Bristol-Myers Squibb Company, Hopewell, NJ USA</nlm:aff>
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<region type="state">New Jersey</region>
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<name sortKey="Myler, Heather" sort="Myler, Heather" uniqKey="Myler H" first="Heather" last="Myler">Heather Myler</name>
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<region type="state">New Jersey</region>
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<wicri:cityArea>Analytical and Bioanalytical Development, Bristol Myers Squibb Company, Princeton</wicri:cityArea>
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<name sortKey="Portsmouth, Simon D" sort="Portsmouth, Simon D" uniqKey="Portsmouth S" first="Simon D." last="Portsmouth">Simon D. Portsmouth</name>
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<nlm:aff id="Aff26">Global Clinical Research, Bristol-Myers Squibb Company, 5 Research Parkway, Wallingford, CT 06492 USA</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<placeName>
<region type="state">Connecticut</region>
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<nlm:aff id="Aff29">Shionogi Inc., 300 Campus Drive, Florham Park, NJ 07932 USA</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<placeName>
<region type="state">New Jersey</region>
</placeName>
<wicri:cityArea>Shionogi Inc., 300 Campus Drive, Florham Park</wicri:cityArea>
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<title xml:lang="en" level="a" type="main">A randomized, controlled study of peginterferon lambda-1a/ribavirin ± daclatasvir for hepatitis C virus genotype 2 or 3</title>
<author>
<name sortKey="Foster, Graham R" sort="Foster, Graham R" uniqKey="Foster G" first="Graham R." last="Foster">Graham R. Foster</name>
<affiliation wicri:level="4">
<nlm:aff id="Aff1">Department of Hepatology, Queen Mary University of London, 4 Newark Street, London, UK</nlm:aff>
<country xml:lang="fr">Royaume-Uni</country>
<wicri:regionArea>Department of Hepatology, Queen Mary University of London, 4 Newark Street, London</wicri:regionArea>
<placeName>
<settlement type="city">Londres</settlement>
<region type="country">Angleterre</region>
<region type="région" nuts="1">Grand Londres</region>
<settlement type="city">Londres</settlement>
</placeName>
<orgName type="university">Université de Londres</orgName>
</affiliation>
</author>
<author>
<name sortKey="Chayama, Kazuaki" sort="Chayama, Kazuaki" uniqKey="Chayama K" first="Kazuaki" last="Chayama">Kazuaki Chayama</name>
<affiliation wicri:level="1">
<nlm:aff id="Aff2">Department of Gastroenterology and Nutrition, Hiroshima University, 1-2-3, Kasumi, Minami-ku, Hiroshima-shi, Hiroshima, Japan</nlm:aff>
<country xml:lang="fr">Japon</country>
<wicri:regionArea>Department of Gastroenterology and Nutrition, Hiroshima University, 1-2-3, Kasumi, Minami-ku, Hiroshima-shi, Hiroshima</wicri:regionArea>
<wicri:noRegion>Hiroshima</wicri:noRegion>
</affiliation>
</author>
<author>
<name sortKey="Chuang, Wan Long" sort="Chuang, Wan Long" uniqKey="Chuang W" first="Wan-Long" last="Chuang">Wan-Long Chuang</name>
<affiliation wicri:level="1">
<nlm:aff id="Aff3">Hepatobiliary Division, Department of Internal Medicine, Kaohsiung Medical University Hospital, Kaohsiung Medical University, No. 100, Shih-Chuan 1st Road, Kaohsiung, Taiwan</nlm:aff>
<country xml:lang="fr">Taïwan</country>
<wicri:regionArea>Hepatobiliary Division, Department of Internal Medicine, Kaohsiung Medical University Hospital, Kaohsiung Medical University, No. 100, Shih-Chuan 1st Road, Kaohsiung</wicri:regionArea>
<wicri:noRegion>Kaohsiung</wicri:noRegion>
</affiliation>
</author>
<author>
<name sortKey="Fainboim, Hugo" sort="Fainboim, Hugo" uniqKey="Fainboim H" first="Hugo" last="Fainboim">Hugo Fainboim</name>
<affiliation wicri:level="1">
<nlm:aff id="Aff4">Liver Unit, Hospital F. J. Muñiz, Uspallata 2272, Buenos Aires, Argentina</nlm:aff>
<country xml:lang="fr">Argentine</country>
<wicri:regionArea>Liver Unit, Hospital F. J. Muñiz, Uspallata 2272, Buenos Aires</wicri:regionArea>
<wicri:noRegion>Buenos Aires</wicri:noRegion>
</affiliation>
</author>
<author>
<name sortKey="Farkkila, Martti" sort="Farkkila, Martti" uniqKey="Farkkila M" first="Martti" last="Farkkila">Martti Farkkila</name>
<affiliation wicri:level="1">
<nlm:aff id="Aff5">Helsinki University and Clinic of Gastroenterology, University of Helsinki, Haartmaninkatu 4, Helsinki, Finland</nlm:aff>
<country xml:lang="fr">Finlande</country>
<wicri:regionArea>Helsinki University and Clinic of Gastroenterology, University of Helsinki, Haartmaninkatu 4, Helsinki</wicri:regionArea>
<wicri:noRegion>Helsinki</wicri:noRegion>
</affiliation>
</author>
<author>
<name sortKey="Gadano, Adrian" sort="Gadano, Adrian" uniqKey="Gadano A" first="Adrian" last="Gadano">Adrian Gadano</name>
<affiliation wicri:level="1">
<nlm:aff id="Aff6">Liver Unit, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina</nlm:aff>
<country xml:lang="fr">Argentine</country>
<wicri:regionArea>Liver Unit, Hospital Italiano de Buenos Aires, Buenos Aires</wicri:regionArea>
<wicri:noRegion>Buenos Aires</wicri:noRegion>
</affiliation>
</author>
<author>
<name sortKey="Gaeta, Giovanni B" sort="Gaeta, Giovanni B" uniqKey="Gaeta G" first="Giovanni B." last="Gaeta">Giovanni B. Gaeta</name>
<affiliation wicri:level="1">
<nlm:aff id="Aff7">Internal and Specialistic Medicine, Viral Hepatitis Unit, Second University of Naples, Via Pansini 5 Bld.3, 08131 Naples, Italy</nlm:aff>
<country xml:lang="fr">Italie</country>
<wicri:regionArea>Internal and Specialistic Medicine, Viral Hepatitis Unit, Second University of Naples, Via Pansini 5 Bld.3, 08131 Naples</wicri:regionArea>
<wicri:noRegion>08131 Naples</wicri:noRegion>
</affiliation>
</author>
<author>
<name sortKey="Hezode, Christophe" sort="Hezode, Christophe" uniqKey="Hezode C" first="Christophe" last="Hézode">Christophe Hézode</name>
<affiliation wicri:level="3">
<nlm:aff id="Aff8">Hepatology, Henri Mondor Hospital, AP-HP, INSERM U955, University Paris-Est, 51 av du Maréchal de Lattre de Tassigny, Créteil, France</nlm:aff>
<country xml:lang="fr">France</country>
<wicri:regionArea>Hepatology, Henri Mondor Hospital, AP-HP, INSERM U955, University Paris-Est, 51 av du Maréchal de Lattre de Tassigny, Créteil</wicri:regionArea>
<placeName>
<region type="region">Île-de-France</region>
<region type="old region">Île-de-France</region>
<settlement type="city">Créteil</settlement>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Inada, Yukiko" sort="Inada, Yukiko" uniqKey="Inada Y" first="Yukiko" last="Inada">Yukiko Inada</name>
<affiliation wicri:level="1">
<nlm:aff id="Aff9">Center for Digestive and Liver Diseases, Miyazaki Medical Center Hospital, 2-16 Takamtsu-cho, Miyazaki-shi, Miyazaki, Japan</nlm:aff>
<country xml:lang="fr">Japon</country>
<wicri:regionArea>Center for Digestive and Liver Diseases, Miyazaki Medical Center Hospital, 2-16 Takamtsu-cho, Miyazaki-shi, Miyazaki</wicri:regionArea>
<wicri:noRegion>Miyazaki</wicri:noRegion>
</affiliation>
</author>
<author>
<name sortKey="Heo, Jeong" sort="Heo, Jeong" uniqKey="Heo J" first="Jeong" last="Heo">Jeong Heo</name>
<affiliation wicri:level="1">
<nlm:aff id="Aff10">Department of Internal Medicine, Pusan National University and Medical Research Institute, College of Medicine, Pusan National University Hospital, 179 Gudeok-Ro, Seo-gu, Pusan, Republic of Korea</nlm:aff>
<country xml:lang="fr">Corée du Sud</country>
<wicri:regionArea>Department of Internal Medicine, Pusan National University and Medical Research Institute, College of Medicine, Pusan National University Hospital, 179 Gudeok-Ro, Seo-gu, Pusan</wicri:regionArea>
<wicri:noRegion>Pusan</wicri:noRegion>
</affiliation>
</author>
<author>
<name sortKey="Kumada, Hiromitsu" sort="Kumada, Hiromitsu" uniqKey="Kumada H" first="Hiromitsu" last="Kumada">Hiromitsu Kumada</name>
<affiliation wicri:level="3">
<nlm:aff id="Aff11">Department of Hepatology, Toranomon Hospital, 2-2-2 Toranomon, Minato-ku, Tokyo, Japan</nlm:aff>
<country xml:lang="fr">Japon</country>
<wicri:regionArea>Department of Hepatology, Toranomon Hospital, 2-2-2 Toranomon, Minato-ku, Tokyo</wicri:regionArea>
<placeName>
<settlement type="city">Tokyo</settlement>
<region type="région">Région de Kantō</region>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Lu, Sheng Nan" sort="Lu, Sheng Nan" uniqKey="Lu S" first="Sheng-Nan" last="Lu">Sheng-Nan Lu</name>
<affiliation wicri:level="1">
<nlm:aff id="Aff12">Section of Hepatology, Division of Hepatogastroenterology, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, 123 Taoei Road, Niaosung District, Kaohsiung, 833 Taiwan</nlm:aff>
<country xml:lang="fr">Taïwan</country>
<wicri:regionArea>Section of Hepatology, Division of Hepatogastroenterology, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, 123 Taoei Road, Niaosung District, Kaohsiung</wicri:regionArea>
<wicri:noRegion>Kaohsiung</wicri:noRegion>
</affiliation>
</author>
<author>
<name sortKey="Marcellin, Patrick" sort="Marcellin, Patrick" uniqKey="Marcellin P" first="Patrick" last="Marcellin">Patrick Marcellin</name>
<affiliation wicri:level="1">
<nlm:aff id="Aff13">Hepatology, Hôpital Beaujon, 100 Bd du Général Leclerc, 92110 Clichy, France</nlm:aff>
<country xml:lang="fr">France</country>
<wicri:regionArea>Hepatology, Hôpital Beaujon, 100 Bd du Général Leclerc, 92110 Clichy</wicri:regionArea>
<wicri:noRegion>92110 Clichy</wicri:noRegion>
<wicri:noRegion>92110 Clichy</wicri:noRegion>
</affiliation>
</author>
<author>
<name sortKey="Moreno, Christophe" sort="Moreno, Christophe" uniqKey="Moreno C" first="Christophe" last="Moreno">Christophe Moreno</name>
<affiliation wicri:level="4">
<nlm:aff id="Aff14">Department of Gastroenterology, Hepatopancreatology and Digestive Oncology, CUB Hôpital Erasme, Université Libre de Bruxelles, 808 Route de Lennik, 1070 Brussels, Belgium</nlm:aff>
<country xml:lang="fr">Belgique</country>
<wicri:regionArea>Department of Gastroenterology, Hepatopancreatology and Digestive Oncology, CUB Hôpital Erasme, Université Libre de Bruxelles, 808 Route de Lennik, 1070 Brussels</wicri:regionArea>
<placeName>
<region type="land" nuts="2">Vienne (Autriche)</region>
<settlement type="city">Vienne (Autriche)</settlement>
<settlement type="city">Bruxelles</settlement>
</placeName>
<orgName type="university">Université libre de Bruxelles</orgName>
</affiliation>
</author>
<author>
<name sortKey="Roberts, Stuart K" sort="Roberts, Stuart K" uniqKey="Roberts S" first="Stuart K." last="Roberts">Stuart K. Roberts</name>
<affiliation wicri:level="3">
<nlm:aff id="Aff15">Gastroenterology, Alfred Hospital, 99 Commercial Road, Melbourne, Australia</nlm:aff>
<country xml:lang="fr">Australie</country>
<wicri:regionArea>Gastroenterology, Alfred Hospital, 99 Commercial Road, Melbourne</wicri:regionArea>
<placeName>
<settlement type="city">Melbourne</settlement>
<region type="état">Victoria (État)</region>
</placeName>
</affiliation>
<affiliation wicri:level="3">
<nlm:aff id="Aff16">Department of Medicine, Monash University, Melbourne, Australia</nlm:aff>
<country xml:lang="fr">Australie</country>
<wicri:regionArea>Department of Medicine, Monash University, Melbourne</wicri:regionArea>
<placeName>
<settlement type="city">Melbourne</settlement>
<region type="état">Victoria (État)</region>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Strasser, Simone I" sort="Strasser, Simone I" uniqKey="Strasser S" first="Simone I." last="Strasser">Simone I. Strasser</name>
<affiliation>
<nlm:aff id="Aff17">AW Morrow Gastroenterology and Liver Centre, Royal Prince Alfred Hospital, Missenden Rd, Camperdown, Sydney, NSW 20150 Australia</nlm:aff>
<wicri:noCountry code="subfield">NSW 20150 Australia</wicri:noCountry>
</affiliation>
</author>
<author>
<name sortKey="Thompson, Alexander J" sort="Thompson, Alexander J" uniqKey="Thompson A" first="Alexander J." last="Thompson">Alexander J. Thompson</name>
<affiliation wicri:level="4">
<nlm:aff id="Aff18">Department of Gastroenterology, St. Vincent’s Hospital and the University of Melbourne, SVHM Level 4 Daly Wing, 35 Victoria Pde, PO Box 29000, Fitzroy, Australia</nlm:aff>
<country xml:lang="fr">Australie</country>
<wicri:regionArea>Department of Gastroenterology, St. Vincent’s Hospital and the University of Melbourne, SVHM Level 4 Daly Wing, 35 Victoria Pde, PO Box 29000, Fitzroy</wicri:regionArea>
<orgName type="university">Université de Melbourne</orgName>
<placeName>
<settlement type="city">Melbourne</settlement>
<region type="état">Victoria (État)</region>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Toyota, Joji" sort="Toyota, Joji" uniqKey="Toyota J" first="Joji" last="Toyota">Joji Toyota</name>
<affiliation wicri:level="1">
<nlm:aff id="Aff19">Department of Hepatology, Sapporo Kosei General Hospital, Kita 3 Higashi 8-5, Chuo-ku, Sapporo, Japan</nlm:aff>
<country xml:lang="fr">Japon</country>
<wicri:regionArea>Department of Hepatology, Sapporo Kosei General Hospital, Kita 3 Higashi 8-5, Chuo-ku, Sapporo</wicri:regionArea>
<wicri:noRegion>Sapporo</wicri:noRegion>
</affiliation>
</author>
<author>
<name sortKey="Paik, Seung Woon" sort="Paik, Seung Woon" uniqKey="Paik S" first="Seung Woon" last="Paik">Seung Woon Paik</name>
<affiliation wicri:level="3">
<nlm:aff id="Aff20">Department of Medicine, Samsung Medical Centre, Sungkyunkwan University School of Medicine, 81 Irwon-ro, Gangnam-gu, Seoul, Republic of Korea</nlm:aff>
<country xml:lang="fr">Corée du Sud</country>
<wicri:regionArea>Department of Medicine, Samsung Medical Centre, Sungkyunkwan University School of Medicine, 81 Irwon-ro, Gangnam-gu, Seoul</wicri:regionArea>
<placeName>
<settlement type="city">Séoul</settlement>
<region type="capital">Région capitale de Séoul</region>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Vierling, John M" sort="Vierling, John M" uniqKey="Vierling J" first="John M." last="Vierling">John M. Vierling</name>
<affiliation wicri:level="2">
<nlm:aff id="Aff21">Baylor Liver Health, Baylor College of Medicine, 6620 Main Street, Suite 1425, Houston, TX USA</nlm:aff>
<country>États-Unis</country>
<placeName>
<region type="state">Texas</region>
</placeName>
<wicri:cityArea>Baylor Liver Health, Baylor College of Medicine, 6620 Main Street, Suite 1425, Houston</wicri:cityArea>
</affiliation>
</author>
<author>
<name sortKey="Zignego, Anna L" sort="Zignego, Anna L" uniqKey="Zignego A" first="Anna L." last="Zignego">Anna L. Zignego</name>
<affiliation wicri:level="1">
<nlm:aff id="Aff22">Department of Experimental and Clinical Medicine, MASVE Center, Universita Di Firenze, Largo Brambilia, 3, 50134 Florence, Italy</nlm:aff>
<country xml:lang="fr">Italie</country>
<wicri:regionArea>Department of Experimental and Clinical Medicine, MASVE Center, Universita Di Firenze, Largo Brambilia, 3, 50134 Florence</wicri:regionArea>
<wicri:noRegion>50134 Florence</wicri:noRegion>
</affiliation>
</author>
<author>
<name sortKey="Cohen, David" sort="Cohen, David" uniqKey="Cohen D" first="David" last="Cohen">David Cohen</name>
<affiliation wicri:level="2">
<nlm:aff id="Aff23">Bristol-Myers Squibb Global Biometric Sciences, 5 Research Parkway, Wallingford, CT USA</nlm:aff>
<country>États-Unis</country>
<placeName>
<region type="state">Connecticut</region>
</placeName>
<wicri:cityArea>Bristol-Myers Squibb Global Biometric Sciences, 5 Research Parkway, Wallingford</wicri:cityArea>
</affiliation>
</author>
<author>
<name sortKey="Mcphee, Fiona" sort="Mcphee, Fiona" uniqKey="Mcphee F" first="Fiona" last="Mcphee">Fiona Mcphee</name>
<affiliation wicri:level="2">
<nlm:aff id="Aff24">Discovery Virology, Bristol-Myers Squibb, 5 Research Parkway, Wallingford, CT USA</nlm:aff>
<country>États-Unis</country>
<placeName>
<region type="state">Connecticut</region>
</placeName>
<wicri:cityArea>Discovery Virology, Bristol-Myers Squibb, 5 Research Parkway, Wallingford</wicri:cityArea>
</affiliation>
</author>
<author>
<name sortKey="Wind Rotolo, Megan" sort="Wind Rotolo, Megan" uniqKey="Wind Rotolo M" first="Megan" last="Wind-Rotolo">Megan Wind-Rotolo</name>
<affiliation wicri:level="2">
<nlm:aff id="Aff25">Exploratory Clinical and Translational Research, Bristol-Myers Squibb Company, Princeton, NJ USA</nlm:aff>
<country>États-Unis</country>
<placeName>
<region type="state">New Jersey</region>
</placeName>
<wicri:cityArea>Exploratory Clinical and Translational Research, Bristol-Myers Squibb Company, Princeton</wicri:cityArea>
</affiliation>
</author>
<author>
<name sortKey="Srinivasan, Subasree" sort="Srinivasan, Subasree" uniqKey="Srinivasan S" first="Subasree" last="Srinivasan">Subasree Srinivasan</name>
<affiliation wicri:level="2">
<nlm:aff id="Aff26">Global Clinical Research, Bristol-Myers Squibb Company, 5 Research Parkway, Wallingford, CT 06492 USA</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<placeName>
<region type="state">Connecticut</region>
</placeName>
<wicri:cityArea>Global Clinical Research, Bristol-Myers Squibb Company, 5 Research Parkway, Wallingford</wicri:cityArea>
</affiliation>
</author>
<author>
<name sortKey="Hruska, Matthew" sort="Hruska, Matthew" uniqKey="Hruska M" first="Matthew" last="Hruska">Matthew Hruska</name>
<affiliation wicri:level="2">
<nlm:aff id="Aff27">Clinical Pharmacology and Pharmacometrics, Bristol-Myers Squibb Company, Hopewell, NJ USA</nlm:aff>
<country>États-Unis</country>
<placeName>
<region type="state">New Jersey</region>
</placeName>
<wicri:cityArea>Clinical Pharmacology and Pharmacometrics, Bristol-Myers Squibb Company, Hopewell</wicri:cityArea>
</affiliation>
</author>
<author>
<name sortKey="Myler, Heather" sort="Myler, Heather" uniqKey="Myler H" first="Heather" last="Myler">Heather Myler</name>
<affiliation wicri:level="2">
<nlm:aff id="Aff28">Analytical and Bioanalytical Development, Bristol Myers Squibb Company, Princeton, NJ USA</nlm:aff>
<country>États-Unis</country>
<placeName>
<region type="state">New Jersey</region>
</placeName>
<wicri:cityArea>Analytical and Bioanalytical Development, Bristol Myers Squibb Company, Princeton</wicri:cityArea>
</affiliation>
</author>
<author>
<name sortKey="Portsmouth, Simon D" sort="Portsmouth, Simon D" uniqKey="Portsmouth S" first="Simon D." last="Portsmouth">Simon D. Portsmouth</name>
<affiliation wicri:level="2">
<nlm:aff id="Aff26">Global Clinical Research, Bristol-Myers Squibb Company, 5 Research Parkway, Wallingford, CT 06492 USA</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<placeName>
<region type="state">Connecticut</region>
</placeName>
<wicri:cityArea>Global Clinical Research, Bristol-Myers Squibb Company, 5 Research Parkway, Wallingford</wicri:cityArea>
</affiliation>
<affiliation wicri:level="2">
<nlm:aff id="Aff29">Shionogi Inc., 300 Campus Drive, Florham Park, NJ 07932 USA</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<placeName>
<region type="state">New Jersey</region>
</placeName>
<wicri:cityArea>Shionogi Inc., 300 Campus Drive, Florham Park</wicri:cityArea>
</affiliation>
</author>
</analytic>
<series>
<title level="j">SpringerPlus</title>
<idno type="eISSN">2193-1801</idno>
<imprint>
<date when="2016">2016</date>
</imprint>
</series>
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<front>
<div type="abstract" xml:lang="en">
<sec>
<title>Background and purpose</title>
<p>Peginterferon Lambda was being developed as an alternative to alfa interferon for the treatment of chronic hepatitis C virus (HCV) infection. We compared peginterferon Lambda-1a plus ribavirin (Lambda/RBV) and Lambda/RBV plus daclatasvir (DCV; pangenotypic NS5A inhibitor) with peginterferon alfa-2a plus RBV (alfa/RBV) in treatment-naive patients with HCV genotype 2 or 3 infection.</p>
</sec>
<sec>
<title>Methods</title>
<p>In this multicenter, double-blind, phase 3 randomized controlled trial, patients were assigned 2:2:1 to receive 24 weeks of Lambda/RBV, 12 weeks of Lambda/RBV + DCV, or 24 weeks of alfa/RBV. The primary outcome measure was sustained virologic response at post-treatment Week 12 (SVR12).</p>
</sec>
<sec>
<title>Results</title>
<p>Overall, 874 patients were treated: Lambda/RBV,
<italic>n</italic>
 = 353; Lambda/RBV + DCV,
<italic>n</italic>
 = 349; alfa/RBV,
<italic>n</italic>
 = 172. Patients were 65 % white and 33 % Asian, 57 % male, with a mean age of 47 years; 52 % were infected with genotype 2 (6 % cirrhotic) and 48 % with genotype 3 (9 % cirrhotic). In the Lambda/RBV + DCV group, 83 % (95 % confidence interval [CI] 78.5, 86.5) achieved SVR12 (90 % genotype 2, 75 % genotype 3) whereas SVR12 was achieved by 68 % (95 % CI 63.1, 72.9) with Lambda/RBV (72 % genotype 2, 64 % genotype 3) and 73 % (95 % CI 66.6, 79.9) with peginterferon alfa/RBV (74 % genotype 2, 73 % genotype 3). Lambda/RBV + DCV was associated with lower incidences of flu-like symptoms, hematological abnormalities, and discontinuations due to adverse events compared with alfa/RBV.</p>
</sec>
<sec>
<title>Conclusion</title>
<p>The 12-week regimen of Lambda/RBV + DCV was superior to peginterferon alfa/RBV in the combined population of treatment-naive patients with genotype 2 or 3 infection, with an improved tolerability and safety profile compared with alfa/RBV.</p>
</sec>
<sec>
<title>Electronic supplementary material</title>
<p>The online version of this article (doi:10.1186/s40064-016-2920-z) contains supplementary material, which is available to authorized users.</p>
</sec>
</div>
</front>
<back>
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