| Revue: | Annals of hepatology |
| Base de datos: | PERIÓDICA |
| Número de sistema: | 000416594 |
| ISSN: | 1665-2681 |
| Autores: | Nelson, David R1 Zeuzem, Stefan2 Andreone, Pietro3 Ferenci, Peter4 Herring, Robert5 Jensen, Donald M6 Marcellin, Patrick7 Pockros, Paul J8 Rodríguez Torres, Maribel9 Rossaro, Lorenzo10 Rustgi, Vinod K11 Sepe, Thomas12 Sulkowski, Mark13 Thomason, Isaac R14 Yoshida, Eric M15 Chan, Anna Hill, George |
| Instituciones: | 1University of Florida, Shands Hospital, Gainesville, Florida. Estados Unidos de América 2J.W. Goethe University Hospital, Department of Medicine, Frankfurt, Hessen. Alemania 3Universita di Bologna, Dipartimento di Medicina Clinica, Bolonia, Emilia Romaña. Italia 4Medical University of Vienna, Department of Internal Medicine III, Viena. Austria 5Nashville Gastrointestinal Specialists Inc, Nashville, Tennessee. Estados Unidos de América 6University of Chicago Medical Center, Center for Liver Diseases, Chicago, Chicago, Illinois. Estados Unidos de América 7Hopital Beaujon, Clinchy. Francia 8The Scripps Clinic, Division of Gastroenterology and Hepatology, Torrey Pines, California. Estados Unidos de América 9Fundación de Investigación de Diego Santurce, Ponce. Puerto Rico 10University of California, Davis Medical Center, Sacramento, California. Estados Unidos de América 11Georgetown University Medical Center, Fairfax, Virginia. Estados Unidos de América 12University Gastroenterology, Providence, Rhode Island. Estados Unidos de América 13Johns Hopkins University School of Medicine, Viral Hepatitis Center, Baltimore, Maryland. Estados Unidos de América 14Intermountain Medical Center, Mountain West Gastroenterology, Salt Lake City, Utah. Estados Unidos de América 15University of British Columbia, Division of Gastroenterology, Vancouver, Columbia Británica. Canadá |
| Año: | 2012 |
| Periodo: | Ene-Feb |
| Volumen: | 11 |
| Número: | 1 |
| Paginación: | 15-31 |
| País: | México |
| Idioma: | Inglés |
| Tipo de documento: | Artículo |
| Enfoque: | Analítico, descriptivo |
| Resumen en inglés | Balapiravir (R1626, RG1626) is the prodrug of a nucleoside analogue inhibitor of the hepatitis C virus (HCV) RNA-dependent RNA polymerase (R1479, RG1479). This phase 2, double-blind international trial evaluated the optimal treatment regimen of balapiravir plus peginterferon alfa-2a (40KD)/ribavirin. Material and methods. Treatment-naive genotype 1 patients (N = 516) were randomized to one of seven treatment groups in which they received balapiravir 500, 1,000, or 1,500 mg twice daily, peginterferon alfa2a (40KD) 180 or 90 µg/week and ribavirin 1,000/1,200 mg/day or peginterferon alfa-2a (40KD)/ribavirin. The planned treatment duration with balapiravir was reduced from 24 to 12 weeks due to safety concerns. Results. The percentage of patients with undetectable HCV RNA was consistently higher in all balapiravir groups from week 2 to 12. However, high rates of dose modifications and discontinuations of one/all study drugs compromised the efficacy assessment and resulted in similar sustained virological response rates in the balapiravir groups (range 32-50%) and the peginterferon alfa-2a (40KD)/ribavirin group (43%). Balapiravir was discontinued for safety reasons in 28-36% of patients (most often for lymphopenia) and the percentage of patients with serious adverse events (especially hematological, infection, ocular events) was dose related. Serious hematological adverse events (particularly neutropenia, lymphopenia) were more common in balapiravir recipients. Two deaths in the balapiravir/peginterferon alfa-2a/ribavirin combination groups were considered possibly related to study medication. Conclusion. Further development of balapiravir for the treatment of chronic hepatitis C has been halted because of the unacceptable benefit to risk ratio revealed in this study (www.ClinicalTrials.gov NCT 00517439) |
| Disciplinas: | Medicina |
| Palabras clave: | Gastroenterología, Farmacología, Hepatitis crónica, Virus de la hepatitis C, Terapia antiviral, Balapiravir, Peginterferon alfa-2a, Ribavirina |
| Keyword: | Gastroenterology, Pharmacology, Chronic hepatitis, Hepatitis C virus, Antiviral therapy, Balapiravir, Peginterferon alfa-2a, Ribavirin |
| Texte intégral: | Texto completo (Ver PDF) |
