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Effects of a protein-rich drink or a standard meal on the pharmacokinetics of elvitegravir, cobicistat, emtricitabine and tenofovir in healthy Japanese male subjects: a randomized, three-way crossover study.
J Clin Pharmacol. 2014 Jun; 54(6):640-8.JC

Abstract

This study investigated the effects of ingested food types on the pharmacokinetics of elvitegravir, cobicistat, emtricitabine, and tenofovir as a single-tablet regimen (STR) in Japanese HIV-negative healthy subjects. In this open-label, randomized, three-way crossover study, the pharmacokinetic profiles of elvitegravir, cobicistat, emtricitabine, and tenofovir were evaluated when administered with a standard breakfast, under fasting conditions, or with a nutritional protein-rich drink. All subjects (N = 11) received a single morning dose of elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (150/150/200/300 mg). Administration under fasting conditions resulted in decreases in the mean AUCinf of elvitegravir and tenofovir by 50% and 28%, respectively, relative to administration with a standard breakfast, whereas the bioavailabilities of elvitegravir and tenofovir were comparable when administered with a standard breakfast or a nutritional protein-rich drink. Under fasting conditions, it appears that the bioavailabilities of elvitegravir and tenofovir were not equivalent to those when they were administered with either type of food, although they were bioequivalent to each other under fed conditions. Cobicistat and emtricitabine were bioequivalent under all conditions. These findings suggest that elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate should be administered with food, and that the bioavailability of elvitegravir and tenofovir is not affected by the type of meal ingested.

Authors+Show Affiliations

Clinical Development Department, Pharmaceutical Division, Japan Tobacco Inc., Tokyo, Japan.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

24615728

Citation

Shiomi, Mari, et al. "Effects of a Protein-rich Drink or a Standard Meal On the Pharmacokinetics of Elvitegravir, Cobicistat, Emtricitabine and Tenofovir in Healthy Japanese Male Subjects: a Randomized, Three-way Crossover Study." Journal of Clinical Pharmacology, vol. 54, no. 6, 2014, pp. 640-8.
Shiomi M, Matsuki S, Ikeda A, et al. Effects of a protein-rich drink or a standard meal on the pharmacokinetics of elvitegravir, cobicistat, emtricitabine and tenofovir in healthy Japanese male subjects: a randomized, three-way crossover study. J Clin Pharmacol. 2014;54(6):640-8.
Shiomi, M., Matsuki, S., Ikeda, A., Ishikawa, T., Nishino, N., Kimura, M., & Irie, S. (2014). Effects of a protein-rich drink or a standard meal on the pharmacokinetics of elvitegravir, cobicistat, emtricitabine and tenofovir in healthy Japanese male subjects: a randomized, three-way crossover study. Journal of Clinical Pharmacology, 54(6), 640-8. https://doi.org/10.1002/jcph.283
Shiomi M, et al. Effects of a Protein-rich Drink or a Standard Meal On the Pharmacokinetics of Elvitegravir, Cobicistat, Emtricitabine and Tenofovir in Healthy Japanese Male Subjects: a Randomized, Three-way Crossover Study. J Clin Pharmacol. 2014;54(6):640-8. PubMed PMID: 24615728.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Effects of a protein-rich drink or a standard meal on the pharmacokinetics of elvitegravir, cobicistat, emtricitabine and tenofovir in healthy Japanese male subjects: a randomized, three-way crossover study. AU - Shiomi,Mari, AU - Matsuki,Shunji, AU - Ikeda,Atsushi, AU - Ishikawa,Tomohiro, AU - Nishino,Noriaki, AU - Kimura,Miyuki, AU - Irie,Shin, Y1 - 2014/03/18/ PY - 2013/11/28/received PY - 2014/02/17/accepted PY - 2014/3/12/entrez PY - 2014/3/13/pubmed PY - 2014/12/30/medline KW - Japanese KW - elvitegravir KW - food effect KW - pharmacokinetics KW - stribild SP - 640 EP - 8 JF - Journal of clinical pharmacology JO - J Clin Pharmacol VL - 54 IS - 6 N2 - This study investigated the effects of ingested food types on the pharmacokinetics of elvitegravir, cobicistat, emtricitabine, and tenofovir as a single-tablet regimen (STR) in Japanese HIV-negative healthy subjects. In this open-label, randomized, three-way crossover study, the pharmacokinetic profiles of elvitegravir, cobicistat, emtricitabine, and tenofovir were evaluated when administered with a standard breakfast, under fasting conditions, or with a nutritional protein-rich drink. All subjects (N = 11) received a single morning dose of elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (150/150/200/300 mg). Administration under fasting conditions resulted in decreases in the mean AUCinf of elvitegravir and tenofovir by 50% and 28%, respectively, relative to administration with a standard breakfast, whereas the bioavailabilities of elvitegravir and tenofovir were comparable when administered with a standard breakfast or a nutritional protein-rich drink. Under fasting conditions, it appears that the bioavailabilities of elvitegravir and tenofovir were not equivalent to those when they were administered with either type of food, although they were bioequivalent to each other under fed conditions. Cobicistat and emtricitabine were bioequivalent under all conditions. These findings suggest that elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate should be administered with food, and that the bioavailability of elvitegravir and tenofovir is not affected by the type of meal ingested. SN - 1552-4604 UR - https://www.unboundmedicine.com/medline/citation/24615728/Effects_of_a_protein_rich_drink_or_a_standard_meal_on_the_pharmacokinetics_of_elvitegravir_cobicistat_emtricitabine_and_tenofovir_in_healthy_Japanese_male_subjects:_a_randomized_three_way_crossover_study_ L2 - https://doi.org/10.1002/jcph.283 DB - PRIME DP - Unbound Medicine ER -