Patients
The current population PK analysis of yimitasvir was performed using
rich and sparse PK samples collected from 6 clinical pharmacology trials
(4 phase 1 [7], 1 phase 1b [8] and 1 phase 2
studies) in Chinese healthy volunteers and HCV-infected patients. Rich
sampling entailed serial blood sampling at defined time points, and
sparse sampling (single sample) only in phase 2 study entailed blood
collection at every study visits. Patients with genotype 1 HCV infection
were eligible, while patients with prior use of direct-acting antiviral
agents (DAA) for HCV infection treatment were excluded in phase 1b and
phase 2 studies. Detailed study design and sampling schedule are shown
in Table 1.
All studies were conducted in accordance with the Declaration of
Helsinki. Study protocols were approved by local ethics committees.
Written informed consent was obtained from all subjects prior to study.