Brief Report: Pharmacokinetics of Crushed Elvitegravir Combination Tablet Given With or Without Enteral Nutrition
until further notice
SourceJAIDS : Journal of Acquired Immune Deficiency Syndromes, 74, 5, (2017), pp. 571-574
Article / Letter to editor
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JAIDS : Journal of Acquired Immune Deficiency Syndromes
SubjectRadboudumc 4: lnfectious Diseases and Global Health RIHS: Radboud Institute for Health Sciences
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.
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