| Revista: | Annals of hepatology |
| Base de datos: | PERIÓDICA |
| Número de sistema: | 000406018 |
| ISSN: | 1665-2681 |
| Autors: | Rodriguez Torres, Maribel Lawitz, Eric1 Yangco, Bienvenido2 Jeffers, Lennox3 Han, Steven-Huy4 Thuluvath, Paul J5 Rustgi, Vinod6 Harrison, Stephen7 Ghalib, Reem8 Vierling, John M9 Luketic, Velimir10 Zamor, Philippe J11 Ravendhran, Natarajan12 Morgan, Timothy R13 Pearlman, Brian14 O'Brien, Christopher15 Khallafi, Hicham16 Pyrsopoulos, Nikolaos17 Kong, George18 McPhee, Fiona18 Yin, Philip D18 Hughes, Eric19 Treitel, Michelle19 |
| Institucions: | 1University of Texas, Health Science Center, San Antonio, Texas. Estados Unidos de América 2Infectious Disease Research Institute, Tampa, Florida. Estados Unidos de América 3Miami VA Medical Center, Miami, Florida. Estados Unidos de América 4Pfleger Liver Institute, Los Angeles, California. Estados Unidos de América 5Mercy Medical Center, Baltimore, Maryland. Estados Unidos de América 6University of Pittsburgh, Medical Center, Pittsburgh, Pensilvania. Estados Unidos de América 7Brooke Army Medical Center, San Antonio, Texas. Estados Unidos de América 8North Texas Research Institute, Arlington, Texas. Estados Unidos de América 9Baylor College of Medicine, Houston, Texas. Estados Unidos de América 10Virginia Commonwealth University, School of Medicine, Richmond, Virginia. Estados Unidos de América 11Carolinas Medical Center, Charlotte, Carolina del Norte. Estados Unidos de América 12Digestive Disease Associates, Catonsville, Maryland. Estados Unidos de América 13VA Long Beach Healthcare System, Long Beach, California. Estados Unidos de América 14Atlanta Medical Center, Atlanta, Georgia. Estados Unidos de América 15University of Miami, Schiff Center for Liver Diseases, Miami, Florida. Estados Unidos de América 16Florida Hospital Transplant Center, Orlando, Florida. Estados Unidos de América 17Rutgers-New Jersey Medical School, Newark, New Jersey. Estados Unidos de América 18Bristol-Myers Squibb, Research and Development, Wallingford, Connecticut. Estados Unidos de América 19Bristol-Myers Squibb, Research and Development, Princeton, New Jersey. Estados Unidos de América 20Estados Unidos de América |
| Any: | 2016 |
| Període: | Nov-Dic |
| Volum: | 15 |
| Número: | 6 |
| Paginació: | 834-845 |
| País: | México |
| Idioma: | Inglés |
| Tipo de documento: | Artículo |
| Enfoque: | Analítico, descriptivo |
| Resumen en inglés | Patient race and ethnicity have historically impacted HCV treatment response. This phase 3 study evaluated daclatasvir with peginterferon-alfa-2a/ribavirin (pegIFN alfa-2a/RBV) in treatment-naive black/African American (AA), Latino, and white non-Latino patients with chronic HCV genotype 1 infection. Material and methods. Material and methods. Material and methods. In this single-arm, open-label study, 246 patients received daclatasvir plus pegIFN alfa-2a and weight-based RBV. Patients with an extended rapid virologic response (eRVR; undetectable HCV-RNA at treatment weeks 4 and 12) received 24 weeks of treatment; those without eRVR received an additional 24 weeks of treatment with pegIFN alfa-2a/RBV. The primary endpoint was sustained virologic response at post-treatment week 12 (SVR12; HCV-RNA < 25 IU/mL) compared with the cohort historical rate. Results. Results. Most patients were IL28B non-CC (84.4% black/AA; 77.6% Latino) genotype 1a-infected (72.7%; 81.3%), with HCV-RNA ≥ 800,000 IU/mL (81.3%; 64.5%). SVR12 rates were 50.8% (65/128; 95% confidence interval [CI], 42.1-59.4) for black/AA and 58.9% (63/107; 95% CI, 49.6-68.2) for Latino patients. The majority (55.5%; 58.9%) received 24 weeks treatment; rapid reductions (> 4-log10) in HCV-RNA levels were observed. Only 60.9% (78/128) of black/AA and 63.6% (68/107) of Latino patients completed treatment. On-treatment serious adverse events (SAEs) occurred in 21 patients. Discontinuations due to adverse events (AEs) occurred in 9 black/AA and 6 Latino patients. Conclusion. clusion. clusion. SVR12 rates for black/AA (50.8%) and Latino (58.9%) cohorts treated with daclatasvir plus pegIFN alfa-2a/RBV and the lower bound of the 95% CIs were higher than the estimated historical control (black/AA, 26% SVR; Latino, 36% SVR) treated with pegIFN alfa-2a/RBV. These data support daclatasvir use in all-oral direct-acting antiviral combinations |
| Disciplines | Medicina |
| Paraules clau: | Farmacología, Gastroenterología, Terapéutica y rehabilitación, Hepatitis C, Terapia antiviral, Daclatasvir, Peginterferon, Ribavirina |
| Keyword: | Medicine, Gastroenterology, Pharmacology, Therapeutics and rehabilitation, Hepatitis C, Antiviral therapy, Daclatasvir, Peginterferon, Ribavirin |
| Text complet: | Texto completo (Ver PDF) |
