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The Effect of Moderate- and High-Fat Meals on the Bioavailability of Dolutegravir/Rilpivirine Fixed-Dose Combination Tablet

Authors Mehta R, Piscitelli J, Wolstenholme A, Fu C, Crauwels H, Wynne B, Adkison K

Received 3 March 2020

Accepted for publication 19 May 2020

Published 8 June 2020 Volume 2020:12 Pages 49—52

DOI https://doi.org/10.2147/CPAA.S250751

Checked for plagiarism Yes

Review by Single anonymous peer review

Peer reviewer comments 2

Editor who approved publication: Professor Arthur Frankel


Rashmi Mehta,1 Joseph Piscitelli,2 Allen Wolstenholme,3 Caifeng Fu,4 Herta Crauwels,5 Brian Wynne,6 Kimberly Adkison7

1GlaxoSmithKline, Research Triangle Park, NC, USA; 2UNC Eshelman School of Pharmacy, Chapel Hill, NC, USA; 3GlaxoSmithKline, Collegeville, PA, USA; 4PAREXEL International, Durham, NC, USA; 5Janssen Pharmaceutical Companies, Beerse, Belgium; 6ViiV Healthcare, Collegeville, PA, USA; 7ViiV Healthcare, Research Triangle Park, NC, USA

Correspondence: Kimberly Adkison
ViiV Healthcare, 5 Moore Drive, Research Triangle Park, NC 27709, USA
Tel +1 919 483-5867
Email kim.k.adkison@viivhealthcare.com

Abstract: Dolutegravir 50 mg (DTG) and rilpivirine 25 mg (RPV) are a newly approved 2-drug regimen for the treatment of HIV in virally suppressed patients. A 2-part study evaluated the relative bioavailability and food effect of five experimental fixed-dose combination (FDC) tablet formulations of DTG/RPV. When given with a moderate- or high-fat meal, the absorption of both DTG and RPV was increased, resulting in higher exposures. As per product labelling, DTG/RPV FDC should be taken with a meal.

Keywords: food effect, pharmacokinetics, dolutegravir, rilpivirine

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