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P100 Tenofovir alafenamide (TAF) in a single tablet regimen in initial HIV-1 therapy
  1. Anton Pozniak1,
  2. David Wohl2,
  3. Melanie Thompson3,
  4. Edwin DeJesus4,
  5. Daniel Podzamczer5,
  6. Jean Michel Molina6,
  7. Gordon Crofoot7,
  8. Christian Callebaut8,
  9. Hal Martin8,
  10. Scott McCallister8
  1. 1Chelsea and Westminster NHS Hospital, London, UK
  2. 2North Carolina Department of Corrections, North Carolina, Uganda
  3. 3AIDS Research Consortium of Atlanta, Atlanta, USA
  4. 4Orlando Immunology Center, Orlando, USA
  5. 5L’Hospitalet de Llobregat, Barcelona, USA
  6. 8Gilead Sciences Inc, Foster City, USA
  7. 6Hôpital Saint-Louis, Paris, Spain
  8. 7Premier Medical Practice, Houston, France

Abstract

Background Tenofovir alafenamide (TAF) is a novel tenofovir (TFV) prodrug that, when administered in the single tablet regimen E/C/F/TAF, has >90% lower plasma TFV levels compared to tenofovir disoproxil fumarate (TDF).

Methods Treatment naïve HIV-1+ adults were randomised 1:1 to receive a regimen of E/C/F/TAF or E/C/F/TDF in two Phase 3 double blind studies. Primary endpoint was Week 48 virologic response by FDA Snapshot algorithm in a pre-specified combined analysis.

Results 1,733 subjects were randomised and treated: 15% women, 43% non-White, 23% viral load ≥100,000 copies/mL. The primary objective was met, E/C/F/TAF was non-inferior to E/C/F/TDF with 92% and 90%, respectively having HIV RNA <50 copies/mL at week 48 (difference +2%, 95% CI -0.7% to +4.7%, p = 0.13). Virologic failure with resistance occurred in 0.8% in the E/C/F/TAF arm and 0.6% on E/C/F/TDF. Treatment related SAEs were rare: E/C/F/TAF 0.3% (n = 3), E/C/F/TDF 0.2% (n = 2). There were no reports of proximal renal tubulopathy in either arm. No single AE led to discontinuation of more than 1 subject on E/C/F/TAF. Grade 2, to 4 AEs occurring in ≥ 2% were: diarrhoea (3.3% vs. 2.5%), nausea (2.2% vs. 2.0%), headache (2.9% vs. 2.1%), and URI (3.6% vs. 3.1%) in the E/C/F/TAF vs. E/C/F/TDF arms.

Conclusions Through 48 weeks of treatment, high virologic response rates were seen in patients receiving E/C/F/TAF or E/C/F/TDF. Both regimens were well tolerated, and no unique AEs associated with TAF occurred. These data support the use of E/C/F/TAF, as a potential regimen for initial treatment of patients with HIV-1 infection.

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