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Switching to coformulated rilpivirine ( RPV ), emtricitabine ( FTC ) and tenofovir alafenamide from either RPV , FTC and tenofovir disoproxil fumarate ( TDF ) or efavirenz, FTC and TDF : 96‐week results from two randomized clinical trials
Author(s) -
Hagins D,
Orkin C,
Daar ES,
Mills A,
Brinson C,
DeJesus E,
Post FA,
MoralesRamirez J,
Thompson M,
Osiyemi O,
Rashbaum B,
Stellbrink HJ,
Martorell C,
Liu H,
Liu YP,
Porter D,
Collins SE,
SenGupta D,
Das M
Publication year - 2018
Publication title -
hiv medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.53
H-Index - 79
eISSN - 1468-1293
pISSN - 1464-2662
DOI - 10.1111/hiv.12664
Subject(s) - rilpivirine , tenofovir alafenamide , medicine , emtricitabine , efavirenz , pharmacology , tolerability , regimen , adverse effect , human immunodeficiency virus (hiv) , virology , viral load , antiretroviral therapy
Objectives The single‐tablet regimen rilpivirine, emtricitabine and tenofovir alafenamide ( RPV / FTC / TAF ) for treatment of HIV ‐1‐infected adults was approved based on bioequivalence. We assessed the clinical efficacy, safety and tolerability of switching to RPV / FTC / TAF from either RPV / FTC /tenofovir disoproxil fumarate ( TDF ) or efavirenz ( EFV )/ FTC / TDF . Methods We conducted two distinct randomized, double‐blind, active‐controlled, noninferiority trials in participants taking RPV / FTC / TDF (Study 1216) and EFV / FTC / TDF (Study 1160). Each study randomized virologically suppressed ( HIV ‐1 RNA < 50 copies/ mL ) adults (1:1) to switch to RPV / FTC / TAF or continue their current regimen for 96 weeks. We evaluated efficacy as the proportion with HIV ‐1 RNA < 50 copies/ mL using the Food and Drug Administration snapshot algorithm and prespecified bone and renal endpoints at week 96. Results We randomized and treated 630 participants in Study 1216 ( RPV / FTC / TAF, n = 316; RPV / FTC / TDF , n = 314) and 875 in Study 1160 ( RPV / FTC / TAF , n = 438; EFV / FTC / TDF, n = 437). In both studies, the efficacy of switching to RPV / FTC / TAF was noninferior to that of continuing baseline therapy at week 96, with respective percentages of patients with HIV RNA < 50 copies/ mL being 89.2% versus 88.5% in Study 1216 [difference 0.7%; 95% confidence interval ( CI ) −4.3 to +5.8%] and 85.2% versus 85.1% in Study 1160 (difference 0%; 95% CI −4.8 to +4.8%). No participant on RPV / FTC / TAF developed treatment‐emergent resistance versus two on EFV / FTC / TDF and one on RPV / FTC / TDF . Compared with continuing baseline therapy, significant improvements in bone mineral density and renal tubular markers were observed in the RPV / FTC / TAF groups ( P < 0.001). Conclusions Switching to RPV / FTC / TAF from RPV / FTC / TDF or EFV / FTC / TDF was safe and effective and improved bone mineral density and renal biomarkers up to 96 weeks with no cases of treatment‐emergent resistance.