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P074 Significant efficacy and long term safety difference with taf-based str in naïve adults
  1. Jose Arribas1,
  2. Melanie Thompson2,
  3. Paul Sax3,
  4. Edwin DeJesus4,
  5. Amanda Clark5,
  6. Moupali Das6,
  7. Scott McCallister6
  1. 1Hospital Universitario La Paz, Madrid, Spain
  2. 2AIDS Research Consortium of Atlanta, Atlanta, GA, USA
  3. 3Brigham and Women’s Hospital, Boston, MA, USA
  4. 4Orlando Immunology Centre, Orlando, FL, USA
  5. 5Brighton and Sussex University Hospitals NHS Trust, Brighton, UK
  6. 6Gilead Sciences Inc, Foster City, CA, USA

Abstract

Introduction At Week(W) 48, elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) was statistically noninferior to E/C/F/tenofovir disoproxil fumarate(TDF) for the proportion of subjects with HIV-1 RNA <50 copies (c)/mL and had significant improvements in renal and bone safety endpoints. We report W144 data.

Methods ARV-naïve participants randomised 1:1 to receive E/C/F/TAF or E/C/F/TDF. W144 viral suppression (HIV-1-RNA <50 and <20 c/mL) by FDA snapshot analysis, pre-defined bone and renal safety, and tolerability endpoints are reported.

Results 1,733 HIV-infected adults were randomised and treated: 15% women, 43% non-white, 23% viral load (VL) >100,000 c/mL. Median baseline characteristics: age 34 years, CD4 count 405 cells/µL, and VL 4.58 log10 c/mL. At W144, E/C/F/TAF met pre-specified criteria for both non-inferiority and superiority to E/C/F/TDF by FDA snapshot algorithm (HIV-1-RNA <50 and <20 c/mL) (Table 1). Mean decrease in BMD was significantly less in the E/C/F/group for lumbar spine and hip (Table1). Multiple measures of renal safety were significantly better for participants on E/C/F/TAF (Table). No cases of renal tubulopathy in the E/C/F/TAF group vs 2 on E/C/F/TDF. No participants on E/C/F/TAF had renal-related discontinuations vs 12 on E/C/F/TDF (p<0.001). Participants on E/C/F/TAF had greater increases in lipids.

Discussion E/C/F/TAF was significantly superior than E/C/F/TDF, driven by fewer participants on E/C/F/TAF with no W144 data. E/C/F/TAF continued to have a statistically superior bone and renal safety profile compared with E/C/F/TDF, demonstrating significant safety advantages over E/C/F/TDF through 3 years of treatment. Individuals on E/C/F/TAF had greater plasma lipid changes, but proportions starting lipid-lowering therapy were comparable.

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