The Efficacy, Pharmacokinetics and Safety of a Nevirapine to Rilpivirine Switch in Virologically Suppressed HIV-1 Infected Patients.

ABSTRACT: This prospective, open-label, non-randomized controlled trial evaluated the efficacy, safety and pharmacokinetics of substituting nevirapine/emtricitabine/tenofovir for rilpivirine/emtricitabine/tenofovir in 50 suppressed HIV-1 switchers. 139 Non-switchers remained on nevirapine as controls. Week 12 HIV-1 RNA was <50copies/mL in 92.0% of switchers and was <50copies/mL at week 24 in 88.0% of switchers and 90.6% of non-switchers (difference 2.6%, 95%CI:-7.6% - 12.8%). Week 3 geometric-mean nevirapine concentration was undetectable and week 1 geometric-mean rilpivirine concentration (0.083mg/L) was comparable to phase III trial (P=.747). Substituting nevirapine for rilpivirine resulted in ongoing virological suppression and did not have clinically relevant pharmacokinetic effects by cytochrome P450 interactions.

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