Quality of Evidence: Low
Coadministration of bedaquiline (400 mg single dose) and lopinavir/ritonavir (400/100 mg twice daily) to 16 HIV/TB-negative subjects increased bedaquiline AUC by 22% and had no effect on Cmax. Coadministration of bedaquiline (400 mg, once daily loading dose; 200 mg once daily maintenance dose for ~3 months) with lopinavir/ritonavir increased bedaquiline AUC by 62% but had no significant effect on the pharmacokinetics of the bedaquiline M2 metabolite. Bedaquiline and lopinavir have a possible risk or QT prolongation and/or TdP on the CredibleMeds.org website. When bedaquiline is coadministered with other medicinal products that prolong the QTc interval, an additive or synergistic effect on QT prolongation cannot be excluded. Bedaquiline must be used with caution when co-administered with lopinavir/ritonavir and only if the benefit outweighs the risk. The combination of bedaquiline and moderate or strong CYP3A4 inhibitors used systemically for more than 14 consecutive days should be avoided. If coadministration is necessary, clinical monitoring including frequent electrocardiogram assessment and monitoring of transaminases is recommended. There are no clinical data on the safety and efficacy of bedaquiline when co-administered with antiretroviral agents.