Maraviroc + Nevirapine = Precautionary

Effect on Concentration

Maraviroc
Increase
Applies within class?
No
Nevirapine
No change
Applies within class?
No

Pharmacologic Effects

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

Interaction History

N/A

Last Updated 20-Jul-2018

Summary

Note Well: The interaction studied nevirapine in combination with lamivudine and tenofovir.

Sources

Maraviroc versus Nevirapine ^

Study Design

The design was a phase two study comprised of four cohorts of HIV-positive patients. In this cohort patients were on the combined therapy of nevirapine/lamivudine/tenofovir while also receiving a single dose of maraviroc. (n=8) HIV-1 infected men aged 18-55 were enrolled to investigate the influence of nevirapine/lamivudine/tenofovir on the plasma pharmacokinetics of maraviroc. Subjects received a single oral dose of 300mg of maraviroc while concomitantly taking nevirapine 200mg BID and lamivudine 150mg BID, tenofovir 300mg QD was administered 1 hour after maraviroc with food. On the study day, all subjects received the maraviroc between 8-10h with water while concomitantly taking their self-provided ART regimen. Screening was done 21 days before dosing, and after the study day there was a follow-up period of 7-10 days after the study drug administration. Serial blood samples and urine samples were collected over 12h post dose. Geometric least squares ratios and 90% confidence intervals were estimated.

Study Results

Based on GMRs and 90% confidence intervals, when compared with maraviroc alone there was a 101% increase in AUC12 (65.1, 155) and a 154% increase in Cmax (94.3, 251) of maraviroc upon administration with the ART regimen of nevirapine/lamivudine/tenofovir + maraviroc. This combination was generally well tolerated with only mild to moderate adverse events, and no adverse events leading to treatment discontinuation.

Study Conclusions

Per the authors, clinically significant alterations in maraviroc exposure can be attributed to the co-administration with other HIV ART

References

Pozniak A, Boffito M, Russell D, Ridgway CE, Muirhead GJ. A novel probe drug interaction study to investigate the effect of selected antiretroviral combinations on the pharmacokinetics of a single oral dose of maraviroc in hiv-positive subjects. British Journal Of Clinical Pharmacology. 2008; S1: 54-59.