Elbasvir (Single Agent) + Buprenorphine/Naloxone = Unknown or no reaction

Effect on Concentration

Elbasvir (Single Agent)
No change
Applies within class?
No
Buprenorphine/Naloxone
No change
Applies within class?
No

Pharmacologic Effects

Elbasvir (Single Agent)
Effect
N/A
Applies within class?
No
Buprenorphine/Naloxone
Effect
N/A
Applies within class?
No

Interaction History

N/A

Last Updated 22-Nov-2022

Summary

In this study, coadministration of EBR with BUP/NAL had no clinically meaningful effect on the PK of EBR, BUP, NOR, or free NAL. Investigators concluded that EBR and BUP/NAL may be coadministered in patients on opioid substitution therapy.

Sources

Elbasvir vs buprenorphine/naloxone ^

Study Design

In an open-label, fixed-sequence, 3-period study, non-tobacco smokers (n=16) were given a single sublingual buprenorphine/naloxone (BUP/NAL) 8/2 mg (Period 1) under fasted conditions. After a 15-day washout, subjects received a single oral dose of elbasvir (EBR) 50 mg under fasted conditions (Period 2). After a 13-day washout, subjects received a single oral dose of EBR 50 mg, followed by administration of a single sublingual BUP/NAL 8/2 mg within 5 minutes (Period 3). To avoid adverse effects of BUP, subjects received naltrexone (NTX) 50 mg 14 hours and 2 hours before and 10 hours after the BUP/NAL dose in Periods 1 and 3.

Study Results

Coadministration of EBR (50 mg) with a single dose of BUP/NAL (8/2 mg) resulted in no significant effect on pharmacokinetic (PK)parameters of either BUP or norbuprenorphine (Nor-BUP; a major active metabolite of BUP).The geometric mean ratios (GMRs; EBR + BUP/NAL / BUP/NAL) [90% CIs] of BUP were: 0.94 [0.82, 1.08] for Cmax, 0.98 [0.89, 1.08] for AUC24, 0.98 [0.88, 1.09] for C24GMRs (EBR + BUP/NAL / BUP/NAL) [90% CIs] of NOR were: 1.10 [0.98, 1.23] for Cmax, 0.97 [0.86, 1.09] for AUC24, 0.97 [0.87, 1.09] for C24Coadministration of EBR (50 mg) with a single dose of BUP/NAL (8/2 mg) slightly decreased PKs of NAL. GMRs (EBR + BUP/NAL/ BUP/NAL) [90% CIs] of Cmax and AUC for NAL were 0.85 [0.66, 1.09] and 0.88 [0.78, 1.00], respectively.BUP/NAL slightly increased PK of EBR. The geometric mean ratios (GMRs; EBR + BUP/NAL / EBR) [90% CIs] of EBR were: 1.13[0.87, 1.46] for Cmax, 1.22 [0.98, 1.52] for AUC24, 1.22 [0.99, 1.51] for C24.

Study Conclusions

References

Marshall WL, T Marenco, Feng HP, et al. Pharmacokinetic interaction between hcv ns5a inhibitor elbasvir and buprenorphine/naloxone in healthy volunteers. 66th Annual Meeting Of The American Association For The Study Of Liver Diseases (aasld). San Francisco, CA. ; 2015.