P1157 IMPACT OF BASELINE VARIABLES ON RESPONSE TO FALDAPREVIR PLUS PEGYLATED INTERFERON a-2a AND RIBAVIRIN IN PATIENTS WITH HIV/HCV GENOTYPE-1 COINFECTION IN A PHASE III TRIAL
2014
was considered not to be clinically-relevant based on CMAX and safety data of asunaprevir observed in prior single-agent phase 3 trials. Additionally, asunaprevir AUCINF, which met the criteria for bioequivalence, has been associated with its antiviral activity. Both regimens were generally well-tolerated. Conclusions: The FDC, which is comparable to the formulation being used in the ongoing phase 3 studies, delivers clinicallycomparable component exposures to the concomitant single-agent tablet regimen.
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