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Daclatasvir plus simeprevir with or without ribavirin for the treatment of chronic hepatitis C virus genotype 1 infection

التفاصيل البيبلوغرافية
العنوان: Daclatasvir plus simeprevir with or without ribavirin for the treatment of chronic hepatitis C virus genotype 1 infection
المؤلفون: Stanislas Pol, M. Beumont-Mauviel, Gaston Picchio, Christophe Hézode, Antonio Olveira, Marc Bourlière, Marc Bifano, Adrián Gadano, Stephanie Noviello, Kin Cheung, Joerg Petersen, Ronald Pruitt, Jean-Pierre Bronowicki, Eric Hughes, F. Gea, Mihály Makara, Dominique Thabut, Tivadar Bányai, Maria Buti, Fiona McPhee, M. Tarek Al-Assi, Navdeep Boparai, Stefan Zeuzem, Véronique Loustaud-Ratti, Sivi Ouwerkerk-Mahadevan
المساهمون: Goethe-Universität Frankfurt am Main, Hôpital Henri Mondor, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Henri Mondor-Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12), Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy), Nutrition-Génétique et Exposition aux Risques Environnementaux (NGERE), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lorraine (UL), Pharmacologie des Immunosuppresseurs et de la Transplantation (PIST), Université de Limoges (UNILIM)-CHU Limoges-Génomique, Environnement, Immunité, Santé, Thérapeutique (GEIST FR CNRS 3503)-Institut National de la Santé et de la Recherche Médicale (INSERM), Hospital Universitario La Paz, Vall d'Hebron University Hospital [Barcelona], Pándy Kálmán Hospital, Texas Digestive Disease Consultants (TDCC), Institut für Interdisziplinäre Medizin (IFI Hamburg), CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Hospital Italiano (Hospital Italiano - BUENOS AIRES), Nashville Medical Research Institute, United Saint István and Saint László Municipal Hospital, Service d'hépato-gastro-entérologie, Assistance Publique - Hôpitaux de Marseille (APHM), Hôpital Saint-Joseph [Marseille], Centre d'Immunologie Humaine (CIH), Institut Pasteur [Paris] (IP)-Institut National de la Santé et de la Recherche Médicale (INSERM), Service d'hépatologie médicale [CHU Cochin], Hôpital Cochin [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Janssen Infectious Disease BVBA, BRISTOL-MYERS SQUIBB, This study was supported by Bristol-Myers Squibb., Service d'Hépato-Gastro-Entérologie [CHU Pitié-Salpêtrière], Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Institut Pasteur [Paris]-Institut National de la Santé et de la Recherche Médicale (INSERM), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)
المصدر: Journal of Hepatology
Journal of Hepatology, 2016, 64 (2), pp.292-300. ⟨10.1016/j.jhep.2015.09.024⟩
Journal of Hepatology, Elsevier, 2016, 64 (2), pp.292-300. ⟨10.1016/j.jhep.2015.09.024⟩
بيانات النشر: HAL CCSD, 2016.
سنة النشر: 2016
مصطلحات موضوعية: Simeprevir, Male, Pyrrolidines, [SDV]Life Sciences [q-bio], Hepacivirus, Pharmacology, medicine.disease_cause, Direct-acting antiviral, Gastroenterology, MESH: Dose-Response Relationship, Drug, MESH: Genotype, chemistry.chemical_compound, 0302 clinical medicine, MESH: Drug Monitoring, Clinical endpoint, MESH: Hepacivirus, 030212 general & internal medicine, MESH: Treatment Outcome, MESH: Aged, NS5A inhibitor, MESH: Middle Aged, Hepatitis C virus, Imidazoles, virus diseases, Valine, Middle Aged, Genotype 1, 3. Good health, MESH: Hepatitis C, Chronic, Treatment Outcome, 030211 gastroenterology & hepatology, Female, Drug Monitoring, MESH: Imidazoles, medicine.drug, Adult, MESH: Antiviral Agents, medicine.medical_specialty, Daclatasvir, Genotype, NS3 protease inhibitor, MESH: Drug Administration Schedule, Antiviral Agents, Drug Administration Schedule, 03 medical and health sciences, MESH: Ribavirin, Internal medicine, Ribavirin, medicine, Humans, MESH: Simeprevir, Adverse effect, NS5A, Aged, MESH: Humans, Hepatology, Dose-Response Relationship, Drug, All-oral therapy, business.industry, MESH: Adult, Hepatitis C, Chronic, MESH: Male, Discontinuation, MESH: DNA, Viral, chemistry, DNA, Viral, Carbamates, business, MESH: Female
الوصف: International audience; BACKGROUND & AIMS:We evaluated the combination of daclatasvir (pan-genotypic NS5A inhibitor) and simeprevir (NS3/4A protease inhibitor), with or without ribavirin, in hepatitis C virus genotype 1-infected patients.METHODS:This phase II, open-label study enrolled treatment-naive patients or prior null responders with genotype 1b (n=147) or 1a (n=21) infection. Genotype 1b-infected patients were randomized 1:1 to receive daclatasvir 30mg plus simeprevir 150mg once daily with or without ribavirin; those who completed the initial 12-week treatment were re-randomized 1:1 to stop treatment or continue treatment through to week 24. Genotype 1a-infected patients received daclatasvir plus simeprevir with ribavirin for 24weeks. The primary endpoint was the proportion of patients with sustained virologic response at posttreatment week 12 (SVR12).RESULTS:For genotype 1b, 84.9% (45/53) and 74.5% (38/51) of treatment-naive patients and 69.6% (16/23) and 95.0% (19/20) of prior null responders to peginterferon and ribavirin achieved SVR12 with daclatasvir plus simeprevir alone and with ribavirin, respectively. Treatment duration did not have a well-defined impact on response. For genotype 1a, daclatasvir plus simeprevir with ribavirin provided a 66.7% (8/12) response rate in treatment-naive patients and was not effective in prior null responders. Data suggest that baseline resistance polymorphisms influenced SVR12 rates. Daclatasvir plus simeprevir was well tolerated with or without ribavirin with low incidences of serious adverse events and adverse events leading to discontinuation.CONCLUSIONS:Daclatasvir plus simeprevir, with or without ribavirin, was effective with a 12- or 24-week duration in genotype 1b-infected patients and was well tolerated. ClinicalTrials.gov identifier: NCT01628692.
اللغة: English
تدمد: 0168-8278
1600-0641
URL الوصول: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::31e4ef64cdd9f8996473bd0574365a3d
https://hal.univ-lorraine.fr/hal-01659111
حقوق: CLOSED
رقم الأكسشن: edsair.doi.dedup.....31e4ef64cdd9f8996473bd0574365a3d
قاعدة البيانات: OpenAIRE
الوصف
تدمد:01688278
16000641