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Kearney B
Kearney B
United States
Publications
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Research Article
Bioequivalence of Two Co-formulations of Emtricitabine/Tenofovir Alafenamide Fixed-Dose Combinations with 200/10 mg and 200/25 mg
Author(s): Zack J, Chu H, Chuck S, Rhee M, Koziara J, West S, Fang L and Kearney BZack J, Chu H, Chuck S, Rhee M, Koziara J, West S, Fang L and Kearney B
Emtricitabine/tenofovir alafenamide (FTC/TAF) is the next advancement in nucleotide reverse transcriptase inhibitor (NRTI) backbone for the treatment of HIV-1 in adults. Tenofovir disoproxil fumarate (TDF), an oral prodrug of tenofovir (TFV), is a preferred NRTI, but it is also associated with nephrotoxicity and reduced bone mineral density (BMD). TDF has been replaced by TAF, a novel, prodrug of TFV with a unique metabolic pathway leading to >90% lower circulating plasma of TFV. Less nephrotoxicity, less BMD reduction in treatment-naïve subjects, and BMD increase in virologically suppressed patients on TAF in clinical trials. The two studies presented here were conducted in healthy subjects. Study 1472 evaluated the pharmacokinetics (PK) and bioequivalence (BE) of the components of FTC/TAF 200/10 mg fixed-dose combination (FDC) administered with e.. View More»
DOI: 10.4172/jbb.1000270