Brief Report: Pharmacokinetics of Crushed Elvitegravir Combination Tablet Given With or Without Enteral Nutrition.
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.
*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.
Mieke
M
Jongbloed-de Hoon
Angela
A
Colbers
Kirsten
K
Velthoven-Graafland
Marjolijn
M
Duisenberg-van Essenberg
Martine
M
Kruijssen
Evertine
E
Abbink
Reinout
R
van Crevel
David
D
Burger
D000225:Adenine / Q000008:administration & dosage / Q000031:analogs & derivatives / Q000493:pharmacokinetics; D000328:Adult; D019380:Anti-HIV Agents / Q000008:administration & dosage* / Q000493:pharmacokinetics*; D000069547:Cobicistat / Q000008:administration & dosage / Q000493:pharmacokinetics; D018592:Cross-Over Studies; D000068679:Emtricitabine / Q000008:administration & dosage / Q000493:pharmacokinetics; D004750:Enteral Nutrition; D005260:Female; D064368:Healthy Volunteers; D006801:Humans; D008297:Male; D008875:Middle Aged; D010757:Phosphorous Acids / Q000008:administration & dosage / Q000493:pharmacokinetics; D015363:Quinolones / Q000008:administration & dosage* / Q000493:pharmacokinetics*; D013607:Tablets / Q000008:administration & dosage* / Q000493:pharmacokinetics*; D055815:Young Adult
C574165:9-(2-((bis(pivaloyloxymethoxy)phosphinoyl)methoxy)propyl)adenine; D019380:Anti-HIV Agents; D010757:Phosphorous Acids; D015363:Quinolones; D013607:Tablets; C509700:elvitegravir; D000068679:Emtricitabine; D000225:Adenine; D000069547:Cobicistat