Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate + Omeprazole = Precautionary

Effect on Concentration

Applies within class?
No
Omeprazole
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 22-Nov-2022

Summary

No interactions were seen with famotidine or omeprazole when used concomitantly with EVG/co regardless of dosing schedule of the acid reducing agent.

Sources

Study Design

In study 1, healthy subjects received EVG/COBI 150 for 8 days followed by either famotidine 40 mg staggered from EVG/COBI by 12 hours, omeprazole 20 mg taken 2 hours before EVG/COBI, or ompeprazole 20 mg staggered from EVG/COBI by 12 hours. In study 2, simultaneous coadministration of EVG/COBI and famotidine was studied in a crossover model.

Study Results

All of the treatment arms of both studies failed to show any difference in EVG or COBI in test versus reference assessments. For all groups, a lack of PK interaction was concluded because the lower bound of the 90% confidence interval of the geometric mean ratios of test versus reference were greater than 0.7 for EVG and COBI AUC and Cmax values.

Study Conclusions

References

Srinivasan Ramanathan, Anita Mathias, Xuelian Wei, Gong Shen, Joanna Koziara, Andrew Cheng, Brian P Kearney. Pharmacokinetics of once-daily boosted elvitegravir when administered in combination with acid-reducing agents. Jaids Journal Of Acquired Immune Deficiency Syndromes. 2013; 1: 45-50.