Lack of clinically relevant drug interactions between Elvitegravir/Cobicistat/Emtricitabine/Tenofovir disoproxil fumarate and Telaprevir.
^
Study Design
16 healthy patients received treatment sequentially: telaprevir (TVR) 750mg three times a day plus stribild (STB) once daily for 10 days, then STB once daily for 10 days, then TVR three times a day for 10 days, with a washout between each period. Study treatments were administered with a standardized meal of approximately 400kcal with 20g of fat, and 240ml of water. Pharmacokinetic (PK) analyses over 24 hours were performed on the last day of each treatment.
Study Results
All treatments were well tolerated and all subjects completed the study. Following co-administration of TVR and STB, there were no clinically relevant PK changes for TVR or any of the components of STB (Elvitegravir/Cobicistat/Emtricitabine/Tenofovir disoproxil fumarate), relative to TVR or STB alone. Using a 90%CI, the mean ratio of AUCtau for Elvitegravir/Cobicistat/Emtricitabine/Tenofovir disoproxil fumarate was 83.8 (78.6-89.2), 1.02 (95.5-1.09), 94.8 (91.9-97.8), and 1.06 (1.02-1.09), respectively for each of the components. The mean ratios of AUCtau for TVR was 1.13 (1.00-1.28), Cmax was 1.06 (96.5-1.16) and Ct was 1.15 (1.05-1.25) when co-administered with STB. Based on these data, the authors state that no dose adjustment is necessary.
Study Conclusions
No known interaction or dose adjustments are expected
References
Custodio JM, Guo S, Lawson E. Lack of clinically relevant drug interactions between elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate and telaprevir. Interscience Conference On Antimicrobial Agents And Chemotherapy . Denver, CO, USA. 53; September 2013.
icon on your home screen.