Tenofovir Disoproxil Fumarate + Ribavirin = Unknown or no reaction

Effect on Concentration

Applies within class?
No
Ribavirin
No change
Applies within class?
No

Pharmacologic Effects

Effect
N/A
Applies within class?
No
Effect
N/A
Applies within class?
No

Interaction History

N/A

Last Updated 19-Jul-2018

Summary

Sources

Study Design

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.

Study Results

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.

Study Conclusions

The study authors concluded that coadministration of ribavirin and tenofovir disoproxil fumarate does not result in substantial changes to their individual pharmacokinetic profiles.

References

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.