Expert review of clinical pharmacology · 2025
Steady-state pharmacokinetics, efficacy, and safety of bictegravir in Chinese patients with HIV: an observational study.
СтатьяНаблюдательное исследованиеНазвание и аннотация: Перевод в очереди
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Xiao Ran, Fu Qiang, Chen Ling, Du Xiaoli, Li Taisheng
Аннотация
BACKGROUND: This study aimed to evaluate the steady-state plasma concentration, efficacy, and safety of bictegravir (BIC) in Chinese people with HIV (PWH) receiving BIC-based therapy for at least 6 months.
RESEARCH DESIGN AND METHODS: PWH on BIC-based regimens for at least 6 months were enrolled. Plasma BIC concentrations, viral loads, CD4+ T cell counts, weight, renal and hepatic function, and adverse reactions were assessed.
RESULTS: A total of 192 subjects were included. Geometric mean Cmax was 8.00 μg/mL and Cτ was 3.34 μg/mL, higher than in African and Caucasian populations. For treatment-naïve PWH, viral load < 50 copies/mL increased from 81% at 6 months to 98% at 12 months. For treatment-experienced PWH, the proportion was 90% at baseline and 98% at both 6 and 12 months. Weight increased by 5% and 7% in treatment-naïve PWH at 6 and 12 months, respectively. Renal and hepatic function remained normal, and mild adverse reactions were reported in 14 subjects (11.4%).
CONCLUSIONS: BIC's steady-state plasma concentrations in Chinese PWH were higher than those in other ethnic groups, with good efficacy and safety.
RESEARCH DESIGN AND METHODS: PWH on BIC-based regimens for at least 6 months were enrolled. Plasma BIC concentrations, viral loads, CD4+ T cell counts, weight, renal and hepatic function, and adverse reactions were assessed.
RESULTS: A total of 192 subjects were included. Geometric mean Cmax was 8.00 μg/mL and Cτ was 3.34 μg/mL, higher than in African and Caucasian populations. For treatment-naïve PWH, viral load < 50 copies/mL increased from 81% at 6 months to 98% at 12 months. For treatment-experienced PWH, the proportion was 90% at baseline and 98% at both 6 and 12 months. Weight increased by 5% and 7% in treatment-naïve PWH at 6 and 12 months, respectively. Renal and hepatic function remained normal, and mild adverse reactions were reported in 14 subjects (11.4%).
CONCLUSIONS: BIC's steady-state plasma concentrations in Chinese PWH were higher than those in other ethnic groups, with good efficacy and safety.