Dietary requirements changed in Europe for fixed dose combination rilpivirine/tenofovir/FTC (Eviplera)
1 April 2013. Related: Antiretrovirals, PK and drug interactions.
On 20 March 2013, Gilead isseud a letter noting that the European Medicines Agency (EMA) had modified the Summary of Product Characteristics (SPC) for the fixed dose combination rilpivirine/tenofovir/FTC (Eviplera). [1]
The new recommendation is to take Eviplera “with food”. Previously the indication was “take with a meal” (See Section 4.2 in the SPC). [2]
This was based on a review of results from a pharmacokinetic study that was presented at the Glasgow conference, reporting a slightly different impact of food on rilpivirine absorption when part of the fixed dose combination Eviplera compared to when taken as a separate medication. [3]
This study reported that rilpivirine and tenofovir exposure are increased after intake of a standard (533 kcal, 21 g fat) or light meal (390 kcal, 12 g fat) relative to fasting conditions. Compared to fasting conditions, rilpivirine AUC was 9% and 16% higher with a light meal or standard meal, respectively. Compared to standard meal, RPV AUC was 14% and 6% lower with fasted or light meal administration, respectively. These details have not been added to Section 5.2 of the SPC on pharmacokinetic proterties.
These changes only relate to the prescribing information with regard to food intake for the FDC formulation. The SPC for single agent rilpivirine still retains the requirement to take with a standard (533 kcal) meal.
References:
- Gilead letter to treatment educators. Changes to food Eviplera. 20 March 2013. 188/IHQ/13-03//1074.
- Kearney B et al. Effect of food on the pharmacokinetics of emtricitabine/ rilpivirine/tenofovir disoproxil fumarate single-tablet regimen. 11th International HIV Congress, 11-15 November 2012. Journal of the International AIDS Society 2012, 15(Suppl 4):18333. Poster abstract P68.
http://dx.doi.org/10.7448/IAS.15.6.18333 - Eviplera: Summary of Product Characteristics, (updated 13 February 2013).
http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002312/human_med_001514.jsp&mid=WC0b01ac058001d124