1. A randomized, controlled study of peginterferon lambda-1a/ribavirin ± daclatasvir for hepatitis C virus genotype 2 or 3
- Author
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Megan Wind-Rotolo, Adrián Gadano, Christophe Hézode, Yukiko Inada, Joji Toyota, Anna Linda Zignego, Simone I. Strasser, Giovanni Battista Gaeta, Subasree Srinivasan, Jeong Heo, Simon Portsmouth, Sheng-Nan Lu, Patrick Marcellin, Wan-Long Chuang, Heather Myler, Seung Woon Paik, David Cohen, Christophe Moreno, Hiromitsu Kumada, Alexander J. Thompson, Matthew Hruska, Graham R. Foster, Fiona McPhee, Martti Färkkilä, Hugo Fainboim, Stuart K. Roberts, Kazuaki Chayama, John M. Vierling, Foster, Graham R., Chayama, Kazuaki, Chuang, Wan Long, Fainboim, Hugo, Farkkila, Martti, Gadano, Adrian, Gaeta, Giovanni Battista, Hézode, Christophe, Inada, Yukiko, Heo, Jeong, Kumada, Hiromitsu, Lu, Sheng Nan, Marcellin, Patrick, Moreno, Christophe, Roberts, Stuart K., Strasser, Simone I., Thompson, Alexander J., Toyota, Joji, Paik, Seung Woon, Vierling, John M., Zignego, Anna L., Cohen, David, Mcphee, Fiona, Wind Rotolo, Megan, Srinivasan, Subasree, Hruska, Matthew, Myler, Heather, Portsmouth, Simon D., Clinicum, Department of Medicine, and Gastroenterologian yksikkö
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0301 basic medicine ,medicine.medical_specialty ,Daclatasvir ,Hepatitis C virus ,Peginterferon alfa-2a ,Population ,Peginterferon-alfa ,medicine.disease_cause ,THERAPY ,Gastroenterology ,HCV GENOTYPE-2 ,03 medical and health sciences ,chemistry.chemical_compound ,0302 clinical medicine ,Internal medicine ,INFECTION ,Genotype ,medicine ,PLUS SOFOSBUVIR ,education ,CIRRHOSIS ,education.field_of_study ,Multidisciplinary ,business.industry ,Research ,Ribavirin ,Peginterferon lambda-1a ,virus diseases ,Genotype 2 ,Genotype 3 ,Virology ,digestive system diseases ,3. Good health ,030104 developmental biology ,chemistry ,Tolerability ,3121 General medicine, internal medicine and other clinical medicine ,Technologie de la sécurité ,030211 gastroenterology & hepatology ,RIBAVIRIN ,Hepatitis C viru ,business ,medicine.drug - 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., SCOPUS: ar.j, info:eu-repo/semantics/published
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- 2016
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