Ran Xiao, Qiang Fu, Ling Chen, Xiaoli Du, Taisheng Li
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Steady-state pharmacokinetics, efficacy, and safety of bictegravir in Chinese patients with HIV: an observational study.
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.
期刊介绍：
Advances in drug development technologies are yielding innovative new therapies, from potentially lifesaving medicines to lifestyle products. In recent years, however, the cost of developing new drugs has soared, and concerns over drug resistance and pharmacoeconomics have come to the fore. Adverse reactions experienced at the clinical trial level serve as a constant reminder of the importance of rigorous safety and toxicity testing. Furthermore the advent of pharmacogenomics and ‘individualized’ approaches to therapy will demand a fresh approach to drug evaluation and healthcare delivery.
Clinical Pharmacology provides an essential role in integrating the expertise of all of the specialists and players who are active in meeting such challenges in modern biomedical practice.
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