title: The efficacy, pharmacokinetics, and safety of a nevirapine to rilpivirine switch in virologically suppressed HIV-1-infected patients.
abstract: : This prospective, open-label nonrandomized controlled trial evaluated the efficacy, safety, and pharmacokinetics of substituting nevirapine/emtricitabine/tenofovir for rilpivirine/emtricitabine/tenofovir in 50 suppressed HIV-1 switchers. One hundred thirty-nine nonswitchers remained on nevirapine as controls. Week 12 HIV-1 RNA was <50 copies per milliliter in 92.0% of switchers and was <50 copies per milliliter at week 24 in 88.0% of switchers and 90.6% of nonswitchers (difference 2.6%, 95% confidence interval: -7.6% to 12.8%). Week 3 geometric mean nevirapine concentration was undetectable and week 1 geometric mean rilpivirine concentration (0.083 mg/L) was comparable with phase 3 trial (P = 0.747). Substituting nevirapine for rilpivirine resulted in ongoing virological suppression and did not have clinically relevant pharmacokinetic effects by cytochrome P450 interactions.
authors.affiliation: *Department of Internal Medicine, Division of Infectious Diseases, Erasmus University Medical Center, Rotterdam, The Netherlands; and †Department of Pharmacy, Radboud University Medical Center, Nijmegen, The Netherlands.
authors.forename: Casper
authors.initials: C
authors.lastname: Rokx
authors.forename: Maren
authors.initials: M
authors.lastname: Blonk
authors.forename: Annelies
authors.initials: A
authors.lastname: Verbon
authors.forename: David
authors.initials: D
authors.lastname: Burger
authors.forename: Bart J A
authors.initials: BJ
authors.lastname: Rijnders
mesh_terms: D015658:HIV Infections / Q000188:drug therapy*; D015497:HIV-1 / Q000235:genetics / Q000302:isolation & purification; D006801:Humans; D019829:Nevirapine / Q000008:administration & dosage / Q000493:pharmacokinetics / Q000627:therapeutic use*; D009570:Nitriles / Q000008:administration & dosage / Q000493:pharmacokinetics / Q000627:therapeutic use*; D011446:Prospective Studies; D011743:Pyrimidines / Q000008:administration & dosage / Q000493:pharmacokinetics / Q000627:therapeutic use*; D012367:RNA, Viral / Q000235:genetics; D018894:Reverse Transcriptase Inhibitors / Q000008:administration & dosage / Q000493:pharmacokinetics / Q000627:therapeutic use*; D000068696:Rilpivirine; D019562:Viral Load
chemical_list: D009570:Nitriles; D011743:Pyrimidines; D012367:RNA, Viral; D018894:Reverse Transcriptase Inhibitors; D019829:Nevirapine; D000068696:Rilpivirine