Clinical Pharmacology: Advances and Applications (Jun 2020)
The Effect of Moderate- and High-Fat Meals on the Bioavailability of Dolutegravir/Rilpivirine Fixed-Dose Combination Tablet
Abstract
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, USACorrespondence: Kimberly AdkisonViiV Healthcare, 5 Moore Drive, Research Triangle Park, NC 27709, USATel +1 919 483-5867Email [email protected]: 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
