Eviplera should not be co-administered with proton pump inhibitors, such as omeprazole, as significant decreases in rilpivirine plasma concentrations may occur (reduced absorption due to gastric pH increase), which may result in loss of therapeutic effect of Eviplera. The interaction between omeprazole and emtricitabine or tenofovir disoproxil has not been studied. Coadministration of omeprazole (20 mg once daily) and rilpivirine decreased omeprazole AUC and Cmax both by 14%; rilpivirine AUC, Cmin and Cmax decreased by 40%, 33% and 40%, respectively. (This interaction study has been performed with a dose higher than the recommended dose for rilpivirine hydrochloride assessing the maximal effect on the co-administered medicinal product. The dosing recommendation is applicable to the recommended dose of rilpivirine of 25 mg once daily.)

Coadministration is predicted to decrease rilpivirine concentrations. Complera is contraindicated when coadministered with omeprazole; coadministration may result in loss of virologic response and possible resistance to Complera or to the class of NNRTIs. Coadministration of omeprazole (20 mg once daily) and rilpivirine (150 mg once daily) was studied in 16 subjects. Rilpivirine Cmax, AUC and Cmin decreased by 40%, 40% and 33%, respectively. Omeprazole Cmax and AUC both decreased by 14% (n=15). [The interaction study has been performed with a dose higher than the recommended dose for RPV (25 mg once daily) assessing the maximal effect on the coadministered drug.]

Coadministration of rilpivirine (150 mg once daily) and omeprazole (20 mg once daily) was studied in 16 HIV-negative subjects. Rilpivirine Cmax, AUC and Cmin decreased by 40%, 40% and 37%, respectively. Omeprazole Cmax and AUC both decreased by 14%.