Is dose adjustment of dolutegravir necessary in Chinese adults living with HIV across different body weight levels? A population pharmacokinetics analysis

BACKGROUND: Dolutegravir (DTG) is an integrase strand transfer inhibitor indicated for human immunodeficiency virus (HIV) infection. Although intrinsic factors show no ethnic-specific impact on DTG pharmacokinetics, extrinsic factors may modulate its pharmacokinetic profile. RESEARCH DESIGN AND METHODS: This study developed a population pharmacokinetic model for DTG in Chinese adults living with HIV and to identify key covariates influencing its pharmacokinetics using a nonlinear mixed-effects modeling. RESULTS: < 0.01) covariate influencing apparent clearance. Monte Carlo simulations indicated that under the standard 50 mg once-daily regimen, DTG exposure was comparable across the WT range of 40-100 kg. CONCLUSION: The findings may contribute to more personalized and effective treatment for Chinese adults living with HIV. In this predominantly male cohort, WT-based dose adjustment was generally not warranted among patients weighing 40-100 kg who received DTG 50 mg once daily.