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Early Viral Response Rates in Treatment-naïve Patients with Chronic Hepatitis C Genotype 1 Infection Treated with MK-7009, a Novel NS3/4a Protease Inhibitor, in Combination with Pegylated Interferon Alfa-2a and Ribavirin for 28 Days
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Reported by Jules Levin
AASLD Nov 2 2009 Boston, MA
Michael P. Manns1, Edward Gane2, Maribel Rodriguez-Torres3, Albrecht Stoehr4, Chau-Ting Yeh5, Patrick Marcellin6, Richard Wiedmann7, Peggy M. Hwang8, Richard J.O. Barnard9, Erin Quirk7, Nicholas Kartsonis7, and Andrew W. Lee7,*
*for the MK-7009 Protocol 007 Study Group
1Medical School of Hannover, Germany, 2Auckland Clinical Studies, New Zealand, 3Fundacion de Investigacion de Diego, and Ponce School of Medicine, Puerto Rico, 4 ifi-institute for interdisciplinary medicine, Hamburg, Germany, 5Liver Research Unit, Chang Gung Medical Center, Taipei, Taiwan, 6Service d'Hepatologie, Hopital Beaujon, Clichy, France, 7 ID/Vaccines Clinical Research, 8 Biostatistics, and 9Antiviral Research, Merck Research Laboratories, North Wales and 9West Point, PA, USA
AUTHOR CONCLUSION
MK-7009 is well-tolerated when given in combination with peg-IFN/RBV
No dose-limiting toxicity observed
Robust viral suppression continues for MK-7009 treated subjects during peg-IFN/RBV
- 69 to 82% RVR
- 77 to 89% EVR
A Phase IIB study of MK-7009 + peg-IFN/RBV in treatment-experienced subjects is ongoing
Viral resistance mutations R155K, D168T were stable between week 4 and 12
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