title: When food can make the difference: The case of elvitegravir-based co-formulation.
abstract: Stribild should be administered under fed conditions to optimize drugs exposure. Here we assessed to what extent this advice is applied in the real life scenario by therapeutic drug monitoring in 75 HIV-infected patients given Stribild-based antiretroviral therapy. Fifty-three percent of our patients took Stribild at lunch/supper time, 23% in the morning with breakfast, and 24% middle in the morning or late in the evening. Twelve out of the 75 patients had unquantifiable elvitegravir concentrations, whereas in the remaining the levels were largely distributed. Wide inter-individual variability in the tenofovir, cobicistat and darunavir trough concentrations was also observed. In real life settings a significant proportion of patients took Stribild without food, namely in the mid-morning or late in the evening. This resulted in a wide inter-individual variability of antiretroviral drug trough concentrations. To avoid the risk for patients to experience suboptimal drug exposure, it is important that health professionals more convincingly advise their patients to take Stribild in fed conditions. On the other hand, the role of patient education and patient responsibility to correctly take the therapy should not be underestimated.
authors: Unit of Clinical Pharmacology, L. Sacco University Hospital, Milan, Italy. Electronic address: dario.cattaneo@asst-fbf-sacco.it.
authors: Dario
authors: D
authors: Cattaneo
authors: Unit of Clinical Pharmacology, L. Sacco University Hospital, Milan, Italy.
authors: Sara
authors: S
authors: Baldelli
authors: Department of Infectious Diseases, L. Sacco University Hospital, Milan, Italy.
authors: Davide
authors: D
authors: Minisci
authors: Department of Infectious Diseases, L. Sacco University Hospital, Milan, Italy.
authors: Paola
authors: P
authors: Meraviglia
authors: Clinical Pharmacology Unit, CNR Institute of Neuroscience, Dept. Biomedical and Clinical Sciences, L. Sacco University Hospital, Università di Milano, Milan, Italy; Scientific Institute IRCCS E.Medea, 23842 Bosisio Parini, Italy.
authors: Emilio
authors: E
authors: Clementi
authors: Department of Infectious Diseases, L. Sacco University Hospital, Milan, Italy; Università degli Studi di Milano, Milan, Italy.
authors: Massimo
authors: M
authors: Galli
authors: Department of Infectious Diseases, L. Sacco University Hospital, Milan, Italy.
authors: Cristina
authors: C
authors: Gervasoni
mesh_terms: D019380:Anti-HIV Agents / Q000008:administration & dosage* / Q000493:pharmacokinetics; D000069545:Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination / Q000008:administration & dosage* / Q000493:pharmacokinetics*; D005260:Female; D018565:Food-Drug Interactions; D015658:HIV Infections / Q000188:drug therapy; D006801:Humans; D007206:Individuality; D008297:Male; D012189:Retrospective Studies
chemical_list: D019380:Anti-HIV Agents; D000069545:Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
keywords: Cobicistat; Darunavir; Elvitegravir; Food; Tenofovir; Therapeutic drug monitoring