Doravirine + Pantoprazole = Unknown or no reaction

Effect on Concentration

Doravirine
No change
Applies within class?
No
Pantoprazole
No change
Applies within class?
No

Pharmacologic Effects

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

Interaction History

N/A

Last Updated 23-Jul-2018

Summary

Sources

Doravirine versus Pantoprazole ^

Study Design

This was an open-label, 3-period, fixed-sequence drug-interaction study in thirteen healthy adult subjects. In Period 1, a single dose (SD) of a doravirine 100mg tablet was administered. In Period 2, a SD of a doravirine 100mg tablet was coadministered with a SD of 20mL of an antacid suspension containing 1600mg of each aluminum hydroxide and magnesium hydroxide and 160mg of simethicone. In Period 3, a pantoprazole sodium 40mg delayed-release tablet was administered on Days 1-5 and a SD of a doravirine 100mg tablet was administered on Day 5. There was a washout of 10 days between each period. Blood samples to measure doravirine plasma concentrations were collected predose and through 72 hours post dose in all periods.

Study Results

Following co-administration with an aluminum/magnesium containing antacid, doravirine PK was not affected to a clinical meaningful extent. The geometric mean ratios (GMR) (90% confidence intervals) [doravirine + antacid/doravirine] for Cmax, AUC0-∞, and C24 were 0.86 (0.74,1.01), 1.01 (0.92,1.11), and 1.03 (0.94,1.12), respectively. Following co-administration with pantoprazole, there was no clinically significant effect on doravirine PK. The GMR (90% confidence intervals) [doravirine + pantoprazole/ doravirine] for Cmax, AUC0-∞, and C24 were 0.88 (0.76,1.01), 0.83 (0.76,0.91), and 0.84 (0.77, 0.92), respectively. There were no serious adverse experiences (AEs) and all AEs were mild in intensity. Overall, 3 (21%) subjects reported at least one AE during the study. The most common AE was headache reported by 3 subjects.

Study Conclusions

The authors concluded that doravirine is generally well tolerated when administered alone or with an aluminum/magnesium containing antacid or with the proton pump inhibitor, pantoprazole. Coadministration of either of these agents with doravirine does not have a clinically meaningful effect on doravirine PK.

References

Khalilieh S, Yee KL, Sanchez RI, Vaynshteyn K, Deschamps K, Fan L. Co-administration of doravirine with an aluminum/magnesium containing antacid or pantoprazole, a proton pump inhibitor, does not have a clinically meaningful effect on doravirine pharmacokinetics . International Aids Society Conference On Hiv Science. Paris, France. 9; July 2017.