Switching to coformulated rilpivirine ( RPV RPV ), emtricitabine ( FTC FTC ) and tenofovir alafenamide from either RPV RPV , FTC FTC and tenofovir disoproxil fumarate ( TDF TDF ) or efavirenz, FTC FTC and TDF TDF : 96‐week results from two randomized clinical trials

摘要

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.