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Steady-state pharmacokinetics of tenofovir disoproxil fumarate in human immunodeficiency virus-infected Chinese patients.

Steady-state pharmacokinetics of tenofovir disoproxil fumarate in human immunodeficiency virus-infected Chinese patients.
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Du X, Kou H, Fu Q, Li Y, Zhu Z, Li T,


Du X, Kou H, Fu Q, Li Y, Zhu Z, Li T, (click to view)

Du X, Kou H, Fu Q, Li Y, Zhu Z, Li T,

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Expert review of clinical pharmacology 2017 05 1910(7) 783-788 doi 10.1080/17512433.2017.1321480
Abstract
BACKGROUND
The pharmacokinetic (PK) profile of tenofovir disoproxil fumarate in Chinese adults infected with HIV is unknown.

METHODS
A pilot, prospective, open-label study was performed to investigate the steady-state PK profile of tenofovir disoproxil fumarate in 15 Chinese HIV-infected patients among whom eight patients were treated with 300 mg tenofovir disoproxil fumarate, 300 mg lamivudine and 400/100 mg lopinavir/ritonavir, and seven with 300 mg tenofovir disoproxil fumarate, 300 mg lamivudine and 400 mg nevirapine. The plasma concentrations of tenofovir over the 24-h dosing interval were determined by HPLC. The PK parameters were calculated using the non-compartmental model in WinNonlin software.

RESULTS
The PK parameters of tenofovir in the 15 patients were determined as follows (mean ± SD): AUC(0-24 h), 4074.7 ± 1551.9 ng•h/mL; Cmax,ss, 447.1 ± 217.4 ng/mL; Ctrough,ss, 98.7 ± 36.7 ng/mL; tmax,ss, 1.3 ± 0.4 h; plasma t1/2, 21.8 ± 7.6 h; and CLss/F, 45.8 ± 13.0 L/h.

CONCLUSION
Tenofovir demonstrated slower elimination rate and increased plasma concentration in Chinese patients compared to previously published data from Caucasian or African subjects, which may be associated with the higher incidences of renal and bone resorption dysfunction observed in our patient population. Clinicians should be cautious of the differing PK characteristics of tenofovir among people of different races.

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