Atazanavir + Esomeprazole = Precautionary

Effect on Concentration

Atazanavir
Decrease
Applies within class?
No
Esomeprazole
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 26-Jun-2018

Summary

Sources

Study Design

107 HIV infected patients receiving ATV/RTV 300/100mg daily were included in a prospective open-label trial comparing 17 patients receiving the same regimen plus a PPI (omeprazole or rabeprazole). The authors of this study authorized the co-administration of ATV/RTV and proton pump inhibitors.

Study Results

In HIV negative adults, it was determined that coadministration of omeprazole (40 mg once daily) 2 hours before atazanavir/ritonavir (300/100 mg once daily) decreased atazanavir AUC, Cmax, and Cmin by 61%, 66% and 65%, respectively. Coadministration of omeprazole (20 mg once daily) 1 hour before an increased dose of atazanavir and ritonavir (400/100 mg once daily) decreased atazanavir AUC, Cmax and Cmin by 30%, 31% and 31%, relative to atazanavir and ritonavir (300/100 mg once daily) without omeprazole. The decrease in AUC, Cmax and Cmin was not mitigated when an increased dose of atazanavir and ritonavir (400/100 mg once daily) was temporally separated from omeprazole by 12 hours. However, data from HIV positive patients led many authors to conclude that prudent use of these concomitant agents can be warranted. It was concluded that the significant reduction in ATV plasma concentrations reported form trials of healthy volunteers was not confirmed in patients with HIV. Coadministration of atazanavir with proton pump inhibitors is not recommended. Omeprazole decreased atazanavir AUC by 75%. If coadministration is judged unavoidable, close clinical monitoring is recommended and doses of omeprazole should not exceed 20 mg and must be taken approximately 12 hours prior to the atazanavir/ritonavir.

Study Conclusions

The significant reduction in ATV plasma concentrations reported form trials of healthy volunteers was not confirmed in patients with HIV. DHHS Guidelines recommend optimal management of this drug interaction as described in the results section of this entry.

References

Guiard-Schmid JB, Poirier JM, Bonnard P, Meynard JL. Lack of interaction between atazanavir and proton pump inhibitors in hiv-infected patients treated with ritonavir-boosted atazanavir. Jaids Journal Of The Acquired Immunodeficiency Syndrome. 2006; 3: 393-394.