| Revista: | Annals of hepatology |
| Base de datos: | PERIÓDICA |
| Número de sistema: | 000412940 |
| ISSN: | 1665-2681 |
| Autores: | Rodriguez Torres, Maribel1 Yoshida, Eric M2 Marcellin, Patrick3 Srinivasan, Subasree4 Purohit, Vivek S4 Wang, Cunshan4 Hammond, Jennifer L4 |
| Instituciones: | 1Escuela de Medicina San Juan Bautista, San Juan. Puerto Rico 2University of British Columbia, Vancouver, Columbia Británica. Canadá 3Universite Paris Diderot, Clichy, París. Francia 4Pfizer Laboratories, Global Innovative Pharma Business Unit, Groton, Connecticut. Estados Unidos de América |
| Año: | 2014 |
| Periodo: | Jul-Ago |
| Volumen: | 13 |
| Número: | 4 |
| Paginación: | 364-375 |
| País: | México |
| Idioma: | Inglés |
| Tipo de documento: | Artículo |
| Enfoque: | Experimental, caso clínico |
| Resumen en inglés | Objectives. Filibuvir is a non-nucleoside inhibitor of hepatitis C virus (HCV) polymerase. This study evaluated the safety and efficacy of filibuvir plus pegylated interferon alfa-2a (pegIFN)/ribavirin. Material and methods. Treatment-naïve, HCV genotype-1 patients were randomized to receive filibuvir 300 or 600 mg twice daily (BID) or placebo plus pegIFN (180 μg/wk) and ribavirin (1,000/1,200 mg BID) for 24 weeks. Filibuvir patients who achieved defined response through week 24 discontinued therapy at week 24. All other patients continued on open-label pegIFN/ribavirin through week 48. The primary endpoint was the proportion of patients who achieved sustained virologic response (SVR) defined as HCV RNA < 15 IU/mL at end of treatment (weeks 24 or 48) and week 72. Results. Overall, 288 patients were randomized and treated. SVR was achieved by 41.7, 39.6, and 45.8% of patients in the filibuvir 300 mg, 600 mg, and placebo arms, respectively. While the addition of filibuvir to pegIFN/ribavirin improved on-treatment virologic response parameters, this did not translate into improved SVR rates due to a high rate of virologic relapse following completion of therapy (300 mg: 35.9%; 600 mg: 42.9%; placebo: 25.4%). The most commonly reported adverse events were nausea, fatigue, headache, and insomnia, and were reported at similar rates across arms. Conclusions. Filibuvir plus pegIFN/ribavirin did not improve the percentage of patients achieving SVR compared with administration of pegIFN/ribavirin alone. However, the agent was well tolerated and was associated with higher on-treatment virologic response parameters. Further evaluation of filibuvir in combination with other direct-acting antiviral agents may be considered |
| Disciplinas: | Medicina |
| Palabras clave: | Gastroenterología, Terapéutica y rehabilitación, Hepatitis C, NS5B, Inhibidores, Seguridad, Eficacia, Filibuvir, Interferón pegilado |
| Keyword: | Medicine, Gastroenterology, Therapeutics and rehabilitation, Hepatitis C, NS5B, Inhibitors, Safety, Efficacy, Filibuvir, Pegylated interferon |
| Texto completo: | Texto completo (Ver PDF) |
