Absence of clinically relevant pharmacokinetic interaction between ribavirin and tenofovir in healthy subjects

Journal of Clinical Pharmacology
Srinivasan RamanathanBrian P Kearney

Abstract

This was a 36-day, open-label, fixed-sequence, multiple-dose drug interaction study in 23 healthy subjects to evaluate the effects of multiple doses of tenofovir disoproxil fumarate on the single-dose pharmacokinetics of ribavirin. Subjects received a 600-mg once-daily oral dose of ribavirin on days 1 and 22 and 300-mg once-daily oral doses of tenofovir disoproxil fumarate on days 17 through 24. Pharmacokinetic sampling was performed on days 1 through 4 and 22 through 25. Pharmacokinetics of ribavirin was not altered by its coadministration with tenofovir disoproxil fumarate as the point estimates (day 22 [test treatment]/day 1 [reference treatment]), and the 90% confidence interval for maximum observed concentration (0.95; 88.7-101) and area under the plasma concentration-time curve up to time of last measurable concentration (1.12; 106-117) were within the equivalence bounds of 80% to 125%. Tenofovir pharmacokinetics after ribavirin coadministration was similar to that observed in previous studies. These results indicate that coadministration of tenofovir disoproxil fumarate and ribavirin does not result in substantial changes to their individual pharmacokinetic profiles.

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Citations

Jun 3, 2015·Hepatology : Official Journal of the American Association for the Study of Liver Diseases·Travis B DickMichael R Charlton
Feb 7, 2009·Enfermedades infecciosas y microbiología clínica·Josep Mallolas
Feb 7, 2009·Enfermedades infecciosas y microbiología clínica·Paula TumaVicente Soriano
Apr 17, 2009·Journal of Clinical Pharmacology·Linghui LiEdmund Jon Deoon Lee
Jan 10, 2021·Pharmacology Research & Perspectives·Haleh RezaeeMasoud Nouri-Vaskeh
Feb 7, 2009·Enfermedades infecciosas y microbiología clínica·José Ramón AzanzaAlmudena Gómez-Giu

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