The authors concluded that tenofovir disoproxil fumarate concentrations are not meaningfully altered by concomitant administration of multiple doses of TDF and grazoprevir/elbasvir when compared to administration of multiple doses of TDF alone. This data is suggested to support the concomitant use of tenofovir disoproxil fumarate and grazoprevir/elbasvir (Zepatier).
Grazoprevir/elbasvir vs tenofovir disoproxil fumarate
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Study Design
Fourteen healthy subjects were enrolled in this two period, fixed sequence study. In period 1, oral doses of tenofovir disoproxil fumarate (TDF) 300 mg daily were given for seven days. In the second period, oral doses of TDF were given with the fixed dose combination of grazoprevir/elbasvir (Zepatier) daily for twelve days. All medications were given under fasted conditions. Pharmacokinetic analysis was done on samples collected up to 24 hours after the last dose of medications given to determine TDF concentrations.
Study Results
The TDF AUC, Cmax and C24 GMRs (90% CIs) for Zepatier + TDF versus TDF alone were 1.27 (1.2, 1.35), 1.14 (0.95, 1.36), and 1.2 (1.09, 1.4), respectively. The 1.35 upper limit for the GMR 90% CI of TDF AUC is below the 1.43 clinical relevance bound for TDF.
References
Feng HP, L Caro, Z Guo, D Wolford, M Iwamoto, W Yeh, et al. Coadministration of zepatier tm (grazoprevir/elbasvir) with tenofovir disoproxil fumarate resulted in no clinically meaningful drug-drug interaction in healthy subjects. 17th International Workshop On Clinical Pharmacology Of Hiv And Hepatitis Therapy. Washington, DC, USA. ; 2016.
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