A pharmacokinetic/viral kinetic model to evaluate the combination treatment effectiveness of daclata

• 作 者: WANGHe-chuan[1]LILiang[1]RENYu-peng[1]ZHENGJenny[2]LIGai-ling[2]ZHOUTian-yan[3]LUWei[3]
• 机 构: Department of Pharmaceutics , School of Pharmaceutical Sciences, Peking University Beijing 100191, C
• 出 处: 2015年第一届药代动力学朝阳论坛
• 发表日期: 2015年期

　　To develop an integrated pharmacokinetic/viral kinetic (PK/VK) model to predict long-term virological response rates of daclatasvir (DCV) and asunaprevir (ASV) combination therapy in patients infected with genotype 1 (GT1) chronic hepatitis C virus (HCV).A systematic publication search was conducted for DCV or ASV monotherapy or combination therapy in healthy volunteers or patients infected with GT1 HCV.A total of 635 study-level aggregate concentrations from 11 trials were used to build PK models for DCV and ASV separately.An integrated PK/VK model was sequentially developed to characterize the effect of DCV and ASV on HCV viral RNA load based on 952 individuaMevel data from 71 patients in 4 single or multiple ascending dose studies.