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Randomized Controlled Trial
. 2018 Nov;19(10):724-733.
doi: 10.1111/hiv.12664. Epub 2018 Aug 12.

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

D Hagins  1 , C Orkin  2 , E S Daar  3 , A Mills  4 , C Brinson  5 , E DeJesus  6 , F A Post  7 , J Morales-Ramirez  8 , M Thompson  9 , O Osiyemi  10 , B Rashbaum  11 , H-J Stellbrink  12 , C Martorell  13 , H Liu  14 , Y-P Liu  14 , D Porter  14 , S E Collins  14 , D SenGupta  14 , M Das  14
Affiliations
Randomized Controlled Trial

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

D Hagins et al. HIV Med. 2018 Nov.

Abstract

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.

Keywords: HIV; bone mineral density; renal disease; rilpivirine; tenofovir alafenamide.

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Figures

Figure 1
Figure 1
Disposition of study participants at week 96. (a) Study 1216: Switch to rilpivirine, emtricitabine and tenofovir alafenamide (RPV/FTC/TAF) from RPV/FTC/tenofovir disoproxil fumarate (TDF). (b) Study 1160: switch to RPV/FTC/TAF from efavirenz (EFV)/FTC/TDF.
Figure 2
Figure 2
Changes in bone mineral density (BMD) at the hip and spine from baseline to week 96. BMD, bone mineral density; CI, confidence interval. P‐values are from the analysis of variance (ANOVA) model including treatment as a fixed effect.
See this image and copyright information in PMC

References

    1. Mollan KR, Smurzynski M, Eron JJ et al Association between efavirenz as initial therapy for HIV‐1 infection and increased risk for suicidal ideation or attempted or completed suicide: an analysis of trial data. Ann Intern Med 2014; 161: 1–10. - PMC - PubMed
    1. Maggiolo F. Efavirenz: a decade of clinical experience in the treatment of HIV. J Antimicrob Chemother 2009; 64: 910–928. - PMC - PubMed
    1. Shubber Z, Calmy A, Andrieux‐Meyer I et al Adverse events associated with nevirapine and efavirenz‐based first‐line antiretroviral therapy: a systematic review and meta‐analysis. AIDS 2013; 27: 1403–1412. - PubMed
    1. Arribas JR, Thompson M, Sax PE et al Brief report: randomized, double‐blind comparison of tenofovir alafenamide (TAF) vs tenofovir disoproxil fumarate (TDF), each coformulated with elvitegravir, cobicistat, and emtricitabine (E/C/F) for initial HIV‐1 treatment: week 144 results. J Acquir Immune Defic Syndr 2017; 75: 211–218. - PubMed
    1. Raffi F, Orkin C, Clarke A et al Brief report: long‐term (96‐Week) efficacy and safety after switching from tenofovir disoproxil fumarate to tenofovir alafenamide in HIV‐infected, virologically suppressed adults. J Acquir Immune Defic Syndr 2017; 75: 226–231. - PMC - PubMed

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