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GS-9857 in patients with chronic hepatitis C virus genotype 1-4 infection: a randomized, double-blind, dose-ranging phase 1 study.
Rodriguez-Torres, M; Glass, S; Hill, J; Freilich, B; Hassman, D; Di Bisceglie, A M; Taylor, J G; Kirby, B J; Dvory-Sobol, H; Yang, J C; An, D; Stamm, L M; Brainard, D M; Kim, S; Krefetz, D; Smith, W; Marbury, T; Lawitz, E.
Afiliación
  • Rodriguez-Torres M; Fundación de Investigación, Rio Piedras, Puerto Rico.
  • Glass S; PRA Health Sciences, Philadelphia, PA, USA.
  • Hill J; Avail Clinical Research, LLC, DeLand, FL, USA.
  • Freilich B; Kansas City Research Institute, Kansas City, MO, USA.
  • Hassman D; Comprehensive Clinical Research, Berlin, NJ, USA.
  • Di Bisceglie AM; Saint Louis University Medical Center, Saint Louis, MO, USA.
  • Taylor JG; Gilead Sciences, Inc., Foster City, CA, USA.
  • Kirby BJ; Gilead Sciences, Inc., Foster City, CA, USA.
  • Dvory-Sobol H; Gilead Sciences, Inc., Foster City, CA, USA.
  • Yang JC; Gilead Sciences, Inc., Foster City, CA, USA.
  • An D; Gilead Sciences, Inc., Foster City, CA, USA.
  • Stamm LM; Gilead Sciences, Inc., Foster City, CA, USA.
  • Brainard DM; Gilead Sciences, Inc., Foster City, CA, USA.
  • Kim S; WCCT Global, Costa Mesa, CA, USA.
  • Krefetz D; PRA Health Sciences, Marlton, NJ, USA.
  • Smith W; New Orleans Center for Clinical Research, University of Tennessee Medical Center, Knoxville, TN, USA.
  • Marbury T; Orlando Clinical Research Center, Orlando, FL, USA.
  • Lawitz E; Texas Liver Institute, University of Texas Health Science Center, San Antonio, TX, USA.
J Viral Hepat ; 23(8): 614-22, 2016 08.
Article en En | MEDLINE | ID: mdl-26957110
GS-9857, an inhibitor of the hepatitis C virus (HCV) nonstructural protein (NS) 3/4A, demonstrates potent activity against HCV genotypes 1-6 and improved coverage against commonly encountered NS3 resistance-associated variants (RAVs). In this study, the safety, tolerability, antiviral activity and pharmacokinetics (PK) of GS-9857 were evaluated in patients with chronic HCV genotype 1-4 infection. Patients with genotype 1-4 infection received placebo or once-daily GS-9857 at doses ranging from 50 to 300 mg for 3 days under fasting conditions. GS-9857 was well tolerated; all reported adverse events (AEs) were mild or moderate in severity. Diarrhoea and headache were the most commonly reported AEs. Grade 3 or 4 laboratory abnormalities were observed in 17% of patients receiving GS-9857; there were no Grade 3 or 4 abnormalities in alanine aminotransferase, aspartate aminotransferase or alkaline phosphatase levels. GS-9857 demonstrated potent antiviral activity in patients with chronic HCV infection, achieving mean and median maximum reductions in HCV RNA of ≥3 log10 IU/mL following administration of a 100-mg dose in patients with HCV genotype 1a, 1b, 2, 3 or 4 infection. The antiviral activity of GS-9857 was unaffected by the presence of pretreatment NS3 RAVs. In patients with genotype 1-4 infection, GS-9857 exhibited linear PK and was associated with a median half-life of 29-42 h, supporting once-daily dosing. Thus, the tolerability, efficacy and pharmacokinetic profile of GS-9857 support its further evaluation for treatment of patients with chronic HCV infection.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Antivirales / Sulfonamidas / Hepacivirus / Hepatitis C Crónica / Compuestos Macrocíclicos / Genotipo Tipo de estudio: Clinical_trials Límite: Adolescent / Adult / Aged / Female / Humans / Male / Middle aged Idioma: En Revista: J Viral Hepat Asunto de la revista: GASTROENTEROLOGIA Año: 2016 Tipo del documento: Article País de afiliación: Puerto Rico Pais de publicación: Reino Unido
Texto completo
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Imprimir
XML
PubMed Links
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Antivirales / Sulfonamidas / Hepacivirus / Hepatitis C Crónica / Compuestos Macrocíclicos / Genotipo Tipo de estudio: Clinical_trials Límite: Adolescent / Adult / Aged / Female / Humans / Male / Middle aged Idioma: En Revista: J Viral Hepat Asunto de la revista: GASTROENTEROLOGIA Año: 2016 Tipo del documento: Article País de afiliación: Puerto Rico Pais de publicación: Reino Unido