Dose Frequency Ranging Pharmacokinetic Study of Tenofovir-Emtricitabine After Directly Observed Dosing in Healthy Volunteers to Establish Adherence Benchmarks (HPTN 066)
作者： Craig W. Hendrix , Adriana Andrade , Namandjé N. Bumpus , Angela D. Kashuba , Mark A. Marzinke
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摘要: Abstract Oral preexposure prophylaxis (PrEP) trials report disparate efficacy attributed to variable adherence. HPTN 066 was conducted establish objective, quantitative benchmarks for discrete, regular levels of adherence using directly observed dosing tenofovir (TFV) disoproxil fumarate (TDF)/emtricitabine (FTC). Healthy, HIV-uninfected men and women were randomized one four oral regimens fixed-dose TDF 300 mg/FTC 200 mg tablet 5 weeks with all doses observed: weekly (one/week), twice (two/week), two tablets (four/week), or daily (seven/week). Trough serum TFV FTC, peripheral blood mononuclear cell (PBMC), CD4+ TFV-diphosphate (TFV-DP) FTC-triphosphate (FTC-TP) concentrations determined throughout 2 after the last dose. Rectosigmoidal, semen, cervicovaginal samples collected drug assessment at end later in a subset participants. The 49 enrolled participants toler...
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