JamesG.Farrelly,Ph.D.PharmacologyTeamLeader.pptVIP

James G. Farrelly, Ph.D.Pharmacology Team Leader Division of Antiviral Drug Products Center for Drug Evaluation and Research Food and Drug Administration Entecavir Genetic Toxicity Entecavir is a nucleoside analog, a member of a class of molecules expected to be genetically toxic Mode of action is consistent with its being a mutagen or a clastogen Not an obligate chain terminator It halts DNA synthesis after the addition of a few bases into the growing chain It is clastogenic in vitro in a human lymphocyte assay It is negative in the Ames assay and in a number of in vitro and in vivo genetic