A preliminary study on plasma concentration, short-term efficacy, and safety profile of dolutegravir in Chinese people with HIV

Abstract

ABSTRACT Background This study examined the plasma concentration, clinical efficacy, and safety of dolutegravir (DTG) in Chinese people with HIV(PWH). Methods In this observational study, HIV-positive individuals on DTG-based regimens for at least six months were included. Plasma DTG concentrations were measured one month after initiating treatment. Viral loads (VL) and CD4+ T cell counts were evaluated at baseline and after one and six months of therapy. High-performance liquid chromatography was used for measuring DTG concentrations, polymerase chain reaction for VL, and flow cytometry for CD4+ T cell counts. Safety assessments included monitoring liver enzymes, serum creatinine estimated glomerular filtration rate and adverse reactions. Results Eighty-two Chinese PWH were enrolled. Average VL decreased significantly from baseline by 3.1 log at one month and 3.5 log at six months. CD4+ T cell counts increased from 273 cells/mm3 at baseline to 378 cells/mm3 and 446 cells/mm3 after one and six months, respectively. 75% achieved undetectable VLs (<20 copies/mL) by six months. Cmax and Cτ were 4.63 and 1.98 μg/mL, respectively. Safety profile was favorable with only 4.88% experiencing transient dizziness. Conclusion Preliminary findings suggest higher DTG plasma concentrations in Chinese PWH compared to Western populations, with promising short-term efficacy and safety.