Bedaquiline + Nevirapine = Unknown or no reaction

Effect on Concentration

Bedaquiline
No change
Applies within class?
No
Nevirapine
No change
Applies within class?
No

Pharmacologic Effects

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

Interaction History

N/A

Last Updated 15-Oct-2023

Summary

Coadministration of Bedaquiline and Nevirapine does not cause a change in concentraton of either medication

Sources

Nevirapine versus Bedaquiline ^

Study Design

Antiretroviral-naive, HIV-1 infected subjects (n=16) were administered a single dose of bedaquiline (TMC207) 400 mg and underwent PK sampling for the drug and its less active metabolite (M2) for 14 days. Two to four weeks after the administration of bedaquiline, an antiretroviral regimen of nevirapine 200 mg twice daily plus 2 N(t)RTIs was initiated. A second dose of bedaquiline 400 mg was administered after at least 4 weeks of antiretroviral therapy, and bedaquiline and M2 PK sampling was again conducted for 14 days. Nevirapine morning trough concentrations were measured at selected time points.

Study Results

Nevirapine decreased the bedaquiline Cmax by 20%, but did not affect AUC. The ratios of the least means squares and 90% confidence interval of bedaquiline Cmax and AUC were 0.80 (0.62-1.04) and 1.03 (0.87-1.22), respectively. There was no change in M2 Cmax or AUC with the addition of nevirapine. Bedaquiline did not affect nevirapine concentrations. Another PK study conducted by Pandie et al showed that nevirapine had no significant effect on bedaquiline and M2 PK parameters in HIV-1 infected patients.2 When 16 patients who were stable on nevirapine-based treatment received bedaquiline 400 mg once daily for 2 weeks, followed by 200 mg 3 times weekly for 22 weeks, bedaquiline AUC [90% CI] was increased by 15% [-20%, 65%]; however this increase was not significant (p=0.428).

Study Conclusions

Concomitant use of bedaquiline with nevirapine in patients with HIV infection did not have a clinically important effect on the AUC of bedaquiline.Dosage adjustment of bedaquiline is not necessary when the drug is used concomitantly with nevirapine.

References

Pandie M, Wiesner L, McIlleron H, Hughes J, Siwendu S, Conradie F, Maartens G. Drug–drug interactions between bedaquiline and the antiretrovirals lopinavir/ritonavir and nevirapine in hiv-infected patients with drug-resistant tb. Antimicrobial Agents And Chemotherapy . 2016; 4: 1037-1040.

Nevirapine versus Bedaquiline ^

Study Design

Antiretroviral-naive, HIV-1 infected subjects (n16) were administered a single dose of bedaquiline (TMC207) 400 mg and underwent PK sampling for the drug and its less active metabolite (M2) for 14 days. Two to four weeks after the administration of bedaquiline, an antiretroviral regimen of nevirapine 200 mg twice daily plus 2 N(t)RTIs was initiated. A second dose of bedaquiline 400 mg was administered after at least 4 weeks of antiretroviral therapy, and bedaquiline and M2 PK sampling was again conducted for 14 days. Nevirapine morning trough concentrations were measured at selected time points.

Study Results

Nevirapine decreased the bedaquiline Cmax by 20, but did not affect AUC. The ratios of the least means squares and 90 confidence interval of bedaquiline Cmax and AUC were 0.80 (0.62-1.04) and 1.03 (0.87-1.22), respectively. There was no change in M2 Cmax or AUC with the addition of nevirapine. Bedaquiline did not affect nevirapine concentrations. Another PK study conducted by Pandie et al showed that nevirapine had no significant effect on bedaquiline and M2 PK parameters in HIV-1 infected patients.2 When 16 patients who were stable on nevirapine-based treatment received bedaquiline 400 mg once daily for 2 weeks, followed by 200 mg 3 times weekly for 22 weeks, bedaquiline AUC 90 CI was increased by 15 -20, 65; however this increase was not significant (p0.428).

Study Conclusions

Concomitant use of bedaquiline with nevirapine in patients with HIV infection did not significantly affect bedaquiline exposure or the antiretroviral affected M2 exposure. Dosage adjustment of bedaquiline is not necessary when the drug is used concomitantly with nevirapine.

References

Pandie, M, Wiesner, L, Mcllleron, H, Hughes, J, Siwendu, S, Conradie, F, Variava, E, Maartens, G. Drug-drug interactions between bedaquiline and the antiretrovirals lopinavir/ritonavir and nevirapine in hiv-infected patients with drug-resistant tb. Journal Of Antimicrobial Chemotherapy. 2016; 4: 1037-1040.