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This was a 36 day, open-label, fixed-sequence, multiple dose, drug interaction study in 23 healthy adults 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 dose of ribavirin on days 1 and 22, and 300 mg daily doses of tenofovir disoproxil fumarate on days 17-24. Pharmacokinetic sampling was done on days 1 through 4, and 22 through 25.
Pharmacokinetics of ribavirin was not altered by coadministration with tenofovir disoproxil fumarate as the point estimates (day 22 [test treatment]/day 1 [reference treatment] and the 90% confidence interval for the maximum observed concentration (0.95, 88.7 – 101) and AUC (1.12, 106 – 117). Both were within the equivalence bounds of 80% - 125%. Tenofovir pharmacokinetics after administration of ribavirin were similar to those observed in previous studies.
The study authors concluded that coadministration of ribavirin and tenofovir disoproxil fumarate does not result in substantial changes to their individual pharmacokinetic profiles.
Ramanathan S, Cheng A, Mittan A, Ebrahimi R, Kearney BP. Absence of clinically relevant pharmacokinetic interaction between ribavirin and tenofovir in healthy subjects. Journal Of Clinical Pharmacology. 2006; 5: 559-566.