title: A Randomized Switch From Nevirapine-Based Antiretroviral Therapy to Single Tablet Rilpivirine/Emtricitabine/Tenofovir Disoproxil Fumarate in Virologically Suppressed Human Immunodeficiency Virus-1-Infected Rwandans.
abstract: Background.Many human immunodeficiency virus (HIV)-infected patients remain on nevirapine-based antiretroviral therapy (ART) despite safety and efficacy concerns. Switching to a rilpivirine-based regimen is an alternative, but there is little experience with rilpivirine in sub-Saharan Africa where induction of rilpivirine metabolism by nevirapine, HIV subtype, and dietary differences could potentially impact efficacy.Methods.We conducted an open-label noninferiority study of virologically suppressed (HIV-1 ribonucleic acid [RNA] < 50 copies/mL) HIV-1-infected Rwandan adults taking nevirapine plus 2 nucleos(t)ide reverse-transcriptase inhibitors. One hundred fifty participants were randomized 2:1 to switch to coformulated rilpivirine-emtricitabine-tenofovir disoproxil fumarate (referenced as the Switch Arm) or continue current therapy. The primary efficacy endpoint was HIV-1 RNA < 200 copies/mL at week 24 assessed by the US Food and Drug Administration Snapshot algorithm with a noninferiority margin of 12%.Results.Between April and September 2014, 184 patients were screened, and 150 patients were enrolled; 99 patients switched to rilpivirine-emtricitabine-tenofovir, and 51 patients continued their nevirapine-based ART. The mean age was 42 years and 43% of participants were women. At week 24, virologic suppression (HIV-1 RNA level <200 copies/mL) was maintained in 93% and 92% in the Switch Arm versus the continuation arm, respectively. The Switch Arm was noninferior to continued nevirapine-based ART (efficacy difference 0.8%; 95% confidence interval, -7.5% to +12.0%). Both regimens were generally safe and well tolerated, although 2 deaths, neither attributed to study medications, occurred in participants in the Switch Arm.Conclusions.A switch from nevirapine-based ART to rilpivirine-emtricitabine-tenofovir disoproxil fumarate had similar virologic efficacy to continued nevirapine-based ART after 24 weeks with few adverse events.
authors.affiliation: Department of Medicine , Stanford University , California.
authors.forename: Sean E
authors.initials: SE
authors.lastname: Collins
authors.affiliation: Department of Medicine , Stanford University , California.
authors.forename: Philip M
authors.initials: PM
authors.lastname: Grant
authors.affiliation: Institute of HIV Disease Prevention and Control , Rwanda Biomedical Center , Kigali.
authors.forename: Francois
authors.initials: F
authors.lastname: Uwinkindi
authors.affiliation: Department of Family Medicine , University of Montreal , Ontario , Canada.
authors.forename: Annie
authors.initials: A
authors.lastname: Talbot
authors.affiliation: Rwanda Military Hospital , Kigali.
authors.forename: Eric
authors.initials: E
authors.lastname: Seruyange
authors.affiliation: Department of Medicine , Stanford University , California.
authors.forename: Deborah
authors.initials: D
authors.lastname: Slamowitz
authors.affiliation: Rwanda Military Hospital , Kigali.
authors.forename: Adeline
authors.initials: A
authors.lastname: Mugeni
authors.affiliation: Institute of HIV Disease Prevention and Control , Rwanda Biomedical Center , Kigali.
authors.forename: Eric
authors.initials: E
authors.lastname: Remera
authors.affiliation: Institute of HIV Disease Prevention and Control , Rwanda Biomedical Center , Kigali.
authors.forename: Simon Pierre
authors.initials: SP
authors.lastname: Niyonsenga
authors.affiliation: Institute of HIV Disease Prevention and Control , Rwanda Biomedical Center , Kigali.
authors.forename: Josbert
authors.initials: J
authors.lastname: Nyirimigabo
authors.affiliation: Institute of HIV Disease Prevention and Control , Rwanda Biomedical Center , Kigali.
authors.forename: Jean Paul
authors.initials: JP
authors.lastname: Uwizihiwe
authors.affiliation: Institute of HIV Disease Prevention and Control , Rwanda Biomedical Center , Kigali.
authors.forename: Pierre
authors.initials: P
authors.lastname: Dongier
authors.affiliation: Institute of HIV Disease Prevention and Control , Rwanda Biomedical Center , Kigali.
authors.forename: Ribakare
authors.initials: R
authors.lastname: Muhayimpundu
authors.affiliation: Institute of HIV Disease Prevention and Control , Rwanda Biomedical Center , Kigali.
authors.forename: Jean-Baptiste
authors.initials: JB
authors.lastname: Mazarati
authors.affiliation: Department of Medicine, Stanford University, California; Viiv Healthcare, Research Triangle Park, North Carolina.
authors.forename: Andrew
authors.initials: A
authors.lastname: Zolopa
authors.affiliation: Institute of HIV Disease Prevention and Control , Rwanda Biomedical Center , Kigali.
authors.forename: Sabin
authors.initials: S
authors.lastname: Nsanzimana
keywords: HIV; Rwanda; antiretroviral therapy; randomized clinical trial; rilpivirine