Steady-State Pharmacokinetics of Rilpivirine under Different Meal Conditions in HIV-1-Infected Ugandan Adults

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dc.contributor.authorLamorde, Mohammed
dc.contributor.authorWalimbwa, Stephen
dc.contributor.authorKibwika, Pauline Byakika
dc.contributor.authorKatwere, Michael
dc.contributor.authorMukisa, Lillian
dc.contributor.authorSempa, Joseph B.
dc.contributor.authorElse, Laura
dc.contributor.authorBack, David J.
dc.contributor.authorKhoo, Saye H.
dc.contributor.authorMerry, Concepta
dc.date.accessioned2022-03-13T16:58:51Z
dc.date.available2022-03-13T16:58:51Z
dc.date.issued2015
dc.description.abstractTo investigate the effect of food on the steady-state pharmacokinetics of rilpivirine when administered as a fixed-dose combination tablet containing tenofovir disoproxil fumarate, emtricitabine plus rilpivirine (TDF/FTC/RPV) in HIV-1-infected Ugandan patients.This was an open-label, three-period, longitudinal pharmacokinetic study with patients serving as their own controls. Fifteen consenting and virologically suppressed HIV-1-infected adults were switched from an efavirenz-based regimen to TDF/FTC/RPV for 56 days. Enrolled patients underwent 24 h blood sampling with TDF/FTC/RPV dosing in the fasted state (day 42), with a low-fat meal (11 g of fat/353 kcal, day 49) and with a moderate-fat meal (19 g of fat/589 kcal, day 56; reference). A viral load assessment was performed on day 56.Rilpivirine AUC0–24 was significantly decreased by 16% (geometric mean ratio, 90% CI: 0.84, 0.73–0.96) during administration in the fasted state when compared with AUC0–24 during administration with a moderate-fat meal. Similarly, rilpivirine C24 was significantly decreased by 21% (0.79, 0.65–0.97) in the fasted state compared with a moderate-fat meal. Pharmacokinetic parameters were unchanged during administration with a low-fat meal, except for C24, which was significantly increased by 15% (1.15, 1.01–1.31) when compared with the moderate-fat meal. Rilpivirine Cmax was similar under the three meal conditions. Virological suppression was unchanged at the end of the study.A food effect was observed for steady-state pharmacokinetic parameters of rilpivirine (AUC0–24 and C24) when TDF/FTC/RPV was administered in the fasted state compared with the moderate-fat meal. The TDF/FTC/RPV formulation can be administered with either a low-fat or moderate-fat meal.en_US
dc.identifier.citationLamorde, M., Walimbwa, S., Byakika-Kibwika, P., Katwere, M., Mukisa, L., Sempa, J. B., ... & Merry, C. (2015). Steady-state pharmacokinetics of rilpivirine under different meal conditions in HIV-1-infected Ugandan adults. Journal of Antimicrobial Chemotherapy, 70(5), 1482-1486.https://doi.org/10.1093/jac/dku575en_US
dc.identifier.urihttps://nru.uncst.go.ug/xmlui/handle/123456789/2796
dc.language.isoenen_US
dc.publisherJournal of Antimicrobial Chemotherapyen_US
dc.subjectComplera, food–drug interactions, sub-Saharan Africaen_US
dc.titleSteady-State Pharmacokinetics of Rilpivirine under Different Meal Conditions in HIV-1-Infected Ugandan Adultsen_US
dc.typeArticleen_US
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