Doravirine + Atorvastatin = Unknown or no reaction

Effect on Concentration

Doravirine
No change
Applies within class?
No
Atorvastatin
Decrease
Applies within class?
No

Pharmacologic Effects

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

Interaction History

N/A

Last Updated 18-Jul-2018

Summary

Sources

Doravirine versus Atorvastatin ^

Study Design

A fixed-sequence, open-label, 2-period pharmacokinetic (PK) study was conducted to evaluate potential drug-drug interactions when atorvastatin is administered with doravirine in 16 healthy subjects. On Day 1 of period 1, subjects received a single dose of atorvastatin (20 mg). After a minimum 72-hour washout period, Period 2 dosing was as follows: doravirine (100 mg) once daily for 8 days, with co-administration of atorvastatin (20 mg) on Day 5. Serial blood samples were collected to measure atorvastatin concentrations prior to atorvastatin dosing through 60-hours post dose in Period 1 and Period 2.

Study Results

14 participants completed the study. The geometric mean ratios (GMRs) and the 90% confidence intervals [CI] of atorvastatin+doravirine/atorvastatin for atorvastatin AUC and Cmax were 0.98 [0.90, 1.06], and 0.67 [0.52, 0.85], respectively. These were not deemed clinically meaningful based on in vitro and clinical data. PK parameters for doravirine were not reported.

Study Conclusions

No dose adjustments are required during coadministration of doravirine + atorvastatin.

References

Khalilieh S, Yee K, Sanchez R. Atorvastatin pharmacokinetics are unaffected to a clinically meaningful extent with co-administration of steady state doravirine. Interscience Conference On Antimicrobial Agents And Chemotherapy Meeting. San Diego, CA, USA. 55; September 2015.