ABT-450, Ritonavir, Ombitasvir, and Dasabuvir Achieves 97% and 100% Sustained Virologic Response With or Without Ribavirin in Treatment-Experienced Patients With HCV Genotype 1b Infection
| Autor: | Iftihar Koksal, Peter Ferenci, B. Bernstein, Beat Müllhaupt, Jeffrey Enejosa, Yiran B Hu, Lino Rodrigues, Pietro Andreone, Massimo Colombo, Andreas Maieron, Ola Weiland, Henk W. Reesink, Thomas Podsadecki, Yves Horsmans |
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| Přispěvatelé: | University of Zurich, Andreone, Pietro, UCL - SSS/IREC/ECLI - Pôle d'Essais cliniques, UCL - (SLuc) Service de gastro-entérologie, Gastroenterology and Hepatology, Pietro Andreone, Massimo G. Colombo, Jeffrey V. Enejosa, Iftihar Koksal, Peter Ferenci, Andreas Maieron, Beat Müllhaupt, Yves Horsman, Ola Weiland, Henk W. Reesink, Lino Rodrigue, Yiran B. Hu, Thomas Podsadecki, Barry Bernstein |
| Jazyk: | angličtina |
| Rok vydání: | 2014 |
| Předmět: |
Cyclopropanes
Male Time Factors Hepacivirus Gastroenterology Telaprevir chemistry.chemical_compound 2-Naphthylamine Medicine Anilides Hardware_ARITHMETICANDLOGICSTRUCTURES Hardware_REGISTER-TRANSFER-LEVELIMPLEMENTATION ComputingMilieux_MISCELLANEOUS education.field_of_study Sulfonamides Dasabuvir Interferon-Free Therapy virus diseases Valine Middle Aged Viral Load Hepatitis C Europe Treatment Outcome 10219 Clinic for Gastroenterology and Hepatology RNA Viral Drug Therapy Combination Female medicine.drug Adult medicine.medical_specialty Macrocyclic Compounds Genotype Proline Lactams Macrocyclic Population PEARL-II Ribavirin-Free IFN 610 Medicine & health Antiviral Agents Internal medicine Ombitasvir/paritaprevir/ritonavir Ribavirin Humans 2715 Gastroenterology education Uracil Aged Ritonavir Hepatology business.industry Puerto Rico Ombitasvir United States chemistry Paritaprevir Immunology 2721 Hepatology Carbamates business Biomarkers Hardware_LOGICDESIGN |
| Zdroj: | Gastroenterology, Vol. 147, no. 2, p. 359-365.e1 (2014) Gastroenterology, 147(2), 359-365.e1. W.B. Saunders Ltd |
| ISSN: | 0016-5085 |
| Popis: | BACKGROUND & AIMS: The interferon-free regimen of ABT-450 (a protease inhibitor), ritonavir, ombitasvir (an NS5A inhibitor), dasabuvir (a non-nucleoside polymerase inhibitor), and ribavirin has shown efficacy in patients with hepatitis C virus (HCV) genotype 1b infection-the most prevalent subgenotype worldwide. We evaluated whether ribavirin is necessary for ABT-450, ritonavir, ombitasvir, and dasabuvir to produce high rates of sustained virologic response (SVR) in these patients. METHODS: We performed a multicenter, open-label, phase 3 trial of 179 patients with HCV genotype 1b infection, without cirrhosis, previously treated with peginterferon and ribavirin. Patients were assigned randomly (1:1) to groups given ABT-450, ritonavir, ombitasvir, and dasabuvir, with ribavirin (group 1) or without (group 2) for 12 weeks. The primary end point was SVR 12 weeks after treatment (SVR12). We assessed the noninferiority of this regimen to the rate of response reported (64%) for a similar population treated with telaprevir, peginterferon, and ribavirin. RESULTS: Groups 1 and 2 each had high rates of SVR12, which were noninferior to the reported rate of response to the combination of telaprevir, peginterferon, and ribavirin (group 1: 96.6%; 95% confidence interval, 92.8%-100%; and group 2: 100%; 95% confidence interval, 95.9%-100%). The rate of response in group 2 was noninferior to that of group 1. No virologic failure occurred during the study. Two patients (1.1%) discontinued the study owing to adverse events, both in group 1. The most common adverse events in groups 1 and 2 were fatigue (31.9% vs 15.8%) and headache (24.2% vs 23.2%), respectively. Decreases in hemoglobin level to less than the lower limit of normal were more frequent in group 1 (42.0% vs 5.5% in group 2; P < .001), although only 2 patients had hemoglobin levels less than 10 g/dL. CONCLUSIONS: The interferon-free regimen of ABT-450, ritonavir, ombitasvir, and dasabuvir, with or without ribavirin, produces a high rate of SVR12 in treatment-experienced patients with HCV genotype 1b infection. Both regimens are well tolerated, as shown by the low rate of discontinuations and generally mild adverse events. ClinicalTrials.gov number: NCT01674725. |
| Databáze: | OpenAIRE |
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