Brief Report: Pharmacokinetics of Crushed Elvitegravir Combination Tablet Given With or Without Enteral Nutrition.

Mieke Jongbloed-de Hoon, Angela Colbers, Kirsten Velthoven-Graafland, Marjolijn Duisenberg-van Essenberg, Martine Kruijssen, Evertine Abbink, Reinout van Crevel, David Burger

Journal: Journal of acquired immune deficiency syndromes (1999) 2017;74(5):571-574

PMID: 28166190

Full Text on Ovid Technologies, Inc. View on PubMed

Abstract

We investigated whether a fixed-dose combination tablet of elvitegravir, cobicistat, emtricitabine, and tenofovirDF (Stribild) can be crushed and combined with enteral nutrition without influencing pharmacokinetics. This was an open-label, 3-period, single-dose, randomized, crossover trial in 24 healthy volunteers. Subjects received Stribild whole tablet with breakfast (reference), crushed/suspended Stribild + breakfast, crushed/suspended Stribild + enteral nutrition. Crushed/suspended Stribild + enteral nutrition was bioequivalent (90% confidence interval between 80% and 125%) with a whole Stribild tablet. Crushed/suspended Stribild + breakfast showed bioequivalence for the area under the curve (AUC0-32), but not for maximum concentration (Cmax) (considered not clinically relevant). Patients with swallowing difficulties or an enteral feeding tube can use crushed and suspended Stribild tablets.

Address: *Department of Pharmacy, Radboud University Medical Center, Nijmegen, the Netherlands; †Department of Pharmacy, Elisabeth-TweeSteden Ziekenhuis, Tilburg, the Netherlands; ‡Clinical Research Centre Nijmegen, Radboud University Medical Center, Nijmegen, the Netherlands; and §Department of Internal Medicine, Radboud University Medical Center, Nijmegen, the Netherlands.

DOI: 10.1097/QAI.0000000000001296

Link outs

Free resources

Medical:

Other Literature Sources:

https://scite.ai/reports/28166190

Subscription / membership required

Full Text Sources:

MeSH Terms: Adenine, Adult, Anti-HIV Agents, Cobicistat, Cross-Over Studies, Emtricitabine, Enteral Nutrition, Female, Healthy Volunteers, Humans, Male, Middle Aged, Phosphorous Acids, Quinolones, Tablets, Young Adult