Liverpool HIV Interactions

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No Interaction Expected

Emtricitabine/Tenofovir-DF (FTC/TDF, PrEP)

Etravirine (ETR)

Quality of Evidence: Very Low

Summary:

Coadministration with emtricitabine/tenofovir-DF has not been studied. Based on metabolism and clearance a clinically significant interaction with emtricitabine is unlikely. Coadministration with tenofovir-DF (300 mg once daily) decreased etravirine Cmax and AUC (both by 19%) and Cmin by 18%. Tenofovir Cmax and AUC both increased by 15% and Cmin increased by 19%. No dose adjustment needed for emtricitabine/tenofovir-DF or etravirine.

Description:

No significant effect on tenofovir and etravirine PK parameters is seen. Coadministration with tenofovir-DF (300 mg once daily) increased tenofovir AUC (15%), Cmax (15%) and Cmin (19%). Etravirine AUC and Cmax decreased by 19% and Cmin decreased by 18%. Etravirine and tenofovir can be used without dose adjustments.

Intelence Summary of Product Characteristics, Janssen-Cilag Ltd, March 2012.

The interaction between etravirine and tenofovir-DF was evaluated in clinical studies and no dose adjustment is needed for either drug. Coadministration of tenofovir-DF (300 mg once daily) and etravirine was studied in 23 subjects. Etravirine Cmax and AUC decreased by 19%, and Cmin decreased by 18%. Data from 19 subjects showed that tenofovir Cmax and AUC increased by 15% and Cmin increased by 19%.

Intelence Prescribing Information, Tibotec Pharmaceuticals Ltd, March 2012.

Plasma concentrations of etravirine were determined at weeks 4 and 24 in a pharmacokinetic substudy of both DUET trials, and the effect of concomitant tenofovir-DF on etravirine AUC or trough concentration assessed. Data were available from 25 HIV+ subjects at week 4 and 23 HIV+ subjects at week 28. Tenofovir decreased etravirine AUC by 26%.

Pharmacokinetics of etravirine are not affected by sex, age, race, use of enfuvirtide or treatment duration in HIV-1 infected patients. Kakuda TN, Scholler-Gyure M, Peeters M, et al. 9th International Workshop on Clinical Pharmacology of HIV Therapy, New Orleans, April 2008, abstract P34.

Coadministration of tenofovir (300 mg once daily) and etravirine (200 mg twice daily) was studied in 24 HIV- subjects. When combined with tenofovir-DF, etravirine AUC and Cmax both decreased by 19%, and Cmin decreased by 18%. Tenofovir AUC and Cmax both increased by 15%, and Cmin increased by 19%. The changes were not considered to be clinically relevant and the drugs can be co-administered without dose modifications.

Assessment of the steady-state pharmacokinetic interaction between etravirine administered as two different formulations and tenofovir disoproxil fumarate in healthy volunteers. Kakuda TN, Schöller-Gyüre M, De Smedt G et al., HIV Med, 2009 10(3): 173-81.

View all available interactions with Emtricitabine/Tenofovir-DF (FTC/TDF, PrEP) by clicking here.