Elvitegravir + Buprenorphine = Unknown or no reaction

Effect on Concentration

Elvitegravir
No change
Applies within class?
No
Buprenorphine
No change
Applies within class?
No

Pharmacologic Effects

Elvitegravir
Effect
N/A
Applies within class?
No
Buprenorphine
Effect
N/A
Applies within class?
No

Interaction History

N/A

Last Updated 18-Jul-2018

Summary

Sources

Boosted Elvitegravir versus Buprenorphine ^

Study Design

A cohort study was conducted to assess the effects of Buprenorphine/Naloxone (BUP/NLX) on the pharmacokinetics of Elvitegravir/Cobicistat (EVG/co). Participants were healthy adults aged 25 to 57 years old. A total of 18 participants were enrolled and 17 participants completed the study. Participants received an individualized stable dose of BUP/NLX a minimum of 2 weeks prior to screening for the study. Doses for BUP/NLX ranged from 16/4mg to 24/6mg per day. On day 1 of the study, participants received their individualized stable dose of BUP/NLX. On days 2 through 11, EVG/Co (150/150mg) was added once daily to their BUP/NLX regimen. PK samplings were performed over 24 hours. Opioid withdrawal/overdose assessments (standardized pharmacodynamics tests) were conducted day 1 through 11. Data was also provided for a major BUP metabolite – norbuprenorphine (norBUP).

Study Results

Drug AUC GMR (90% CI) Cmax GMR (90% CI) Ctau GMR (90% CI) BUP 135 (118-155) 112 (97.9-127) 166 (143-193) norBUP 142 (122 – 167) 124 (10.-149) 157 (131-188) NLX 71.6 (58.6-87.3) 72.1 (61.4-84.7) No dose adjustments were needed during the duration of the study. No participant experienced withdrawal or overdose symptoms.

Study Conclusions

Based on the PK data and patient response during the study, co-administration of BUP/NLX and EVG/co showed no clinically significant changes in PK values of any agent. There are no dose adjustments warranted at this time.

References

Bruce RD, Winkle P, Custodio JM, Wei LX, Rhee MS, Kearney BP, Friedland GH. The pharmacokinetic and pharmacodynamic interactions between buprenorphine/naloxone and elvitegravir/cobicistat in subjects receiving chronic buprenorphine/naloxone treatment. Journal Of Acquired Immunodeficiency Syndromes. 2013; 4: 480-484.