| Revista: | Annals of hepatology |
| Base de datos: | PERIÓDICA |
| Número de sistema: | 000411606 |
| ISSN: | 1665-2681 |
| Autors: | Jensen, Donald M1 Asselah, Tarik2 Dieterich, Douglas3 Foster, Graham R4 Sulkowski, Mark S5 Zeuzem, Stefan6 Mantry, Parvez7 Yoshida, Eric M8 Moreno, Christophe9 Ouzan, Denis10 Wright, Mark11 Morano, Luis E12 Buynak, Robert13 Bourliere, Marc14 Hassanein, Tarek15 Nishiguchi, Shuhei16 Kao, Jia-Horng17 Omata, Masao18 Paik, Seung W19 Wong, David K20 Tam, Edward21 Kaita, Kelly22 Feinman, S. Victor23 Stern, Jerry O24 Scherer, Joseph24 Quinson, Anne-Marie24 Voss, Florian25 Gallivan, John-Paul25 Bocher, Wulf O25 Ferenci, Peter26 |
| Institucions: | 1University of Chicago, Chicago, Illinois. Estados Unidos de América 2University Paris-Diderot, Clichy. Francia 3Icahn School of Medicine at Mount Sinai, Nueva York. Estados Unidos de América 4Queen Mary University of London, Londres. Reino Unido 5Johns Hopkins University, School of Medicine, Baltimore, Maryland. Estados Unidos de América 6J.W. Goethe Universitat, University Hospital, Frankfurt, Hessen. Alemania 7Methodist Dallas Medical Center, The Liver Institute , Dallas, Texas. Estados Unidos de América 8University of British Columbia, Vancouver, Columbia Británica. Canadá 9Universite Libre de Bruxelles, CUB Hopital Erasme, Bruselas. Bélgica 10Institut Arnault Tzanck, Niza, Alpes Marítimos. Francia 11Wellcome Trust Clinical Research Facility, Southampton, Hampshire. Reino Unido 12Hospital Meixoeiro, Vigo, Pontevedra. España 13Northwest Indiana Center for Clinical Research, Valparaiso, Indiana. Estados Unidos de América 14Hopital Saint Joseph, Marseille, Bouches-du-Rhone. Francia 15Southern California Liver Centers, Coronado, California. Estados Unidos de América 16Hyogo College of Medicine, Hyogo. Japón 17National Taiwan University Hospital, Taipei. Taiwán 18Yamanashi Central and Kita Hospitals, Yamanashi, Honshu. Japón 19Sungkyunkwan University, Samsung Medical Center, Seúl. Corea del Sur 20Toronto Western Hospital, Liver Center, Toronto, Ontario. Canadá 21LAIR Centre, Vancouver, Columbia Británica. Canadá 22HSC University of Manitoba, Winnipeg, Manitoba. Canadá 23University of Toronto, Mount Sinai Hospital, Toronto, Ontario. Canadá 24Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, Connecticut. Estados Unidos de América 25Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim. Alemania 26Medical University of Vienna, Viena. Austria |
| Any: | 2016 |
| Període: | May-Jun |
| Volum: | 15 |
| Número: | 3 |
| Paginació: | 333-349 |
| País: | México |
| Idioma: | Inglés |
| Tipo de documento: | Artículo |
| Enfoque: | Experimental, caso clínico |
| Resumen en inglés | Faldaprevir is a potent once-daily (q.d.) hepatitis C virus (HCV) NS3/4A protease inhibitor. The STARTVerso1 and STARTVerso2 phase 3 studies evaluated faldaprevir plus peginterferon alfa-2a/ribavirin (PegIFN/RBV) in treatment-naïve patients with chronic HCV genotype-1 infection. Material and methods. Material and methods. Patients were randomized 1:2:2 to receive placebo, faldaprevir 120 mg q.d. (12 or 24 weeks) or faldaprevir 240 mg q.d. (12 weeks) all with PegIFN/RBV (24–48 weeks). Faldaprevir 120 mg for 12 weeks only (STARTVerso1 only) required early treatment success (ETS, HCV RNA < 25 IU/mL at week 4 and undetected at week 8). All faldaprevir-treated patients with ETS stopped PegIFN/RBV at week 24. Primary endpoint: sustained virologic response 12 weeks post-treatment (SVR12). Results. SVR12 rates were significantly higher for patients treated with faldaprevir 120 or 240 mg (72% and 73%, respectively) compared with placebo (50%); estimated differences (adjusted for trial, race, and genotype-1 subtype) faldaprevir 120 mg 24% (95% CI: 17–31%, P < 0.0001), faldaprevir 240 mg 23% (95% CI: 16–30%, P < 0.0001). Subgroup analyses consistently showed higher SVR12 rates for patients receiving faldaprevir compared with placebo. The incidence of adverse events (AEs) was similar in faldaprevir 120-mg and placebo groups and slightly higher in the faldaprevir 240-mg group. Serious AEs were reported in 6%, 7%, and 8% of patients in placebo, faldaprevir 120-mg, and faldaprevir 240-mg groups, respectively. Conclu- Conclusion. Addition of faldaprevir to PegIFN/RBV increased SVR12 in patients with HCV genotype-1, and was well tolerated. Faldaprevir 120 mg is effective in the treatment of HCV genotype-1. ClinicalTrials.gov: NCT01343888 and NCT01297270 |
| Disciplines | Medicina |
| Paraules clau: | Farmacología, Gastroenterología, Microbiología, Terapéutica y rehabilitación, Faldaprevir, Hepatitis C, Antivirales, Peginterferón, Ribavirina, Ensayos clínicos |
| Keyword: | Medicine, Gastroenterology, Microbiology, Pharmacology, Therapeutics and rehabilitation, Faldaprevir, Peginterferon, Ribavirin, Hepatitis C, Antivirals, Clinical assays |
| Text complet: | Texto completo (Ver PDF) |
