1 Ocak 2022 Dergi makalesi Açık Erişim

Parvez, Md Masud; Kalkisim, Said; Nguyen, Phuong Thi Thu; Jung, Jin Ah; Park, Jeong-Kon; Ghim, Jong-Lyul; Kim, Eun-Young; Cho, Yong-Soon; Babaoglu, Melih O.; Shin, Jae-Gook

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    <subfield code="a">Para-aminosalicylic acid significantly reduced tenofovir exposure in human subjects: Mismatched findings from in vitro to in vivo translational research</subfield>
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    <subfield code="p">BRITISH JOURNAL OF CLINICAL PHARMACOLOGY</subfield>
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    <subfield code="a">Aims Tenofovir and para-aminosalicylic acid (PAS) may be coprescribed to treat patients with concomitant infections of human immunodeficiency virus and Mycobacterium tuberculosis bacteria. Both drugs are known to have remarkable renal uptake transporter-mediated clearance. Owing to the lack of clinical studies on drug-drug interaction between the 2 drugs, we conducted a translational clinical study to investigate the effect of PAS on tenofovir pharmacokinetics (PK). Methods Initially, we studied in vitro renal uptake transporter-mediated drug-drug interactions using stably transfected cells with human organic anion transporters (OAT1 and OAT3). Later, we estimated clinical drug interactions using static and physiologically based PK modelling. Finally, we investigated the effects of PAS-calcium formulation (PAS-Ca) on tenofovir disoproxil fumarate PK in healthy male Korean subjects. Results PAS inhibited OAT1- and OAT3-mediated tenofovir uptake in vitro. The physiologically based PK drug-drug interaction model suggested a 1.26-fold increase in tenofovir peak plasma concentration when coadministered with PAS. By contrast, an open-label, randomized, crossover clinical trial evaluating the effects of PAS-Ca on tenofovir PK showed significantly altered geometric mean ratio (90% confidence intervals) of maximum plasma concentration (C-max) and area under the curve (AUC(0-inf)) by 0.33 (0.28-0.38) and 0.29 (0.26-0.33), respectively. Conclusion Our study findings suggest that the PAS-Ca formulation significantly reduced systemic exposure to tenofovir through an unexplained mechanism, which was contrary to the initial prediction. Caution should be exercised while predicting in vivo PK profiles from in vitro data, particularly when there are potential confounders such as pharmaceutical interactions.</subfield>
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    <subfield code="a">Nguyen, Phuong Thi Thu</subfield>
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    <subfield code="u">Inje Univ Coll Med, PharmacoGen Res Ctr, Dept Pharmacol &amp; Clin Pharmacol, Busan, South Korea</subfield>
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    <subfield code="c">2022-01-01</subfield>
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