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Clinical Pharmacology: Advances and Applications Volume 12, 2020 - Issue
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Short Report

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

Rashmi Mehta1 GlaxoSmithKline, Research Triangle Park, NC, USA
,
Joseph Piscitelli2 UNC Eshelman School of Pharmacy, Chapel Hill, NC, USA
,
Allen Wolstenholme3 GlaxoSmithKline, Collegeville, PA, USA
,
Caifeng Fu4 PAREXEL International, Durham, NC, USA
,
Herta Crauwels5 Janssen Pharmaceutical Companies, Beerse, Belgium
,
Brian Wynne6 ViiV Healthcare, Collegeville, PA, USA
&
Kimberly Adkison7 ViiV Healthcare, Research Triangle Park, NC, USACorrespondence[email protected]
ORCID Iconhttps://orcid.org/0000-0001-7361-1732
ORCID Icon show all
Pages 49-52 | Published online: 08 Jun 2020

References

  • Llibre JM, Hung C-C, Brinson C, et al. Efficacy, safety, and tolerability of dolutegravir-rilpivirine for the maintenance of virological suppression in adults with HIV-1: phase 3, randomised, non-inferiority SWORD-1 and SWORD-2 studies. Lancet. 2018;391(10123):839–849. doi:10.1016/S0140-6736(17)33095-729310899
  • Mehta R, Wolstenholme A, Di Lullo KD, et al. Bioequivalence of a fixed-dose combination tablet of the complete two-drug regimen of dolutegravir and rilpivirine for treatment of HIV-1 infection. Antimicrob Agents Chemother. 2018;62(9). doi:10.1128/aac.00748-18
  • Adkison KK, Wolstenholme A, Choukour M, et al. Relative bioavailability and food effect of fixed-dose combination tablets of dolutegravir and rilpivirine in healthy subjects. 17th International Workshop on Clinical Pharmacology of HIV & Hepatitis Therapy; 6 8–10, 2016; Washington, DC.
  • U.S. Department of Health and Human Services Food and Drug Administration. Center for Drug Evaluation and Research. Guidance for Industry: Food-Effect Bioavailability and Fed Bioequivalence Studies; 2002.
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  • Ford SL, Gould E, Chen S, et al. Lack of pharmacokinetic interaction between rilpivirine and integrase inhibitors dolutegravir and GSK1265744. Antimicrob Agents Chemother. 2013;57(11):5472–5477. doi:10.1128/aac.01235-1323979733
  • Crauwels HM, Heeswijk RPV, Buelens A, et al. Impact of food and different meal types on the pharmacokinetics of rilpivirine. J Clin Pharmacol. 2013;53(8):834–840. doi:10.1002/jcph.10723720136
  • Song I, Borland J, Chen S, et al. Effect of food on the pharmacokinetics of the integrase inhibitor dolutegravir. Antimicrob Agents Chemother. 2012;56(3):1627–1629. doi:10.1128/AAC.05739-1122183173
  • Weller S, Chen S, Borland J, et al. Bioequivalence of a dolutegravir, abacavir, and lamivudine fixed-dose combination tablet and the effect of food. J Acquir Immune Defic Syndr. 2014;66(4):393–398. doi:10.1097/qai.000000000000019324798770
  • Ramanathan S, Custodio J, Yin X, et al. Effect of food on the pharmacokinetics of emtricitabine/rilpivirine/tenofovir disoproxil fumarate single-tablet regimen. J Int AIDS Soc. 2012;15(Suppl4):1. doi:10.7448/ias.15.6.18333

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