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P099 Renal Safety of Tenofovir Alafenamide in Patients at High Risk of Kidney Disease
  1. Laura Waters1,
  2. David Wohl2,
  3. Anders Thalme3,
  4. Robert Finlayson4,
  5. Shinichi Oka5,
  6. Moupali Das6,
  7. Stuart Yau7,
  8. Marshall Fordyce6
  1. 1Mortimer Market Centre, London, UK
  2. 2University of North Carolina at Chapel Hill, North Carolina, USA
  3. 3Karolinska University Hospital, Stockholm, Sweden
  4. 4Taylor Square Private Clinic, NSW, Australia
  5. 5National Centre for Global Health and Medicine Hospital, Tokyo, Japan
  6. 6Gilead Sciences, Inc, Foster City, CA, USA
  7. 7Gilead Sciences Ltd, High Holborn., London, UK

Abstract

Background/introduction Compared with tenofovir disoproxil fumarate (TDF), tenofovir alafenamide (TAF) results in significantly reduced plasma tenofovir (TFV) and has demonstrated less impact on surrogate markers of renal and bone health in multiple populations, but renal outcomes in treatment-naïve subjects at risk for chronic kidney disease (CKD) have not been characterised.

Aim(s)/objectives Renal outcomes in treatment-naïve subjects at risk for chronic kidney disease (CKD) were investigated.

Methods Treatment naïve HIV-1+ adults were randomised 1:1 to a single tablet regimen of elvitegravir, cobicistat, emtricitabine, with TAF (E/C/F/TAF) or (E/C/F/TDF) once daily in two double blind studies. Assessments of renal function including markers of proximal renal tubulopathy were carried out. A post-hoc analysis of renal function by group with high risk vs low risk for development of CKD is described.

Results Of 1,733 participants, those with high CKD risk was similar by treatment arm (E/C/F/TAF 28%, E/C/F/TDF 32%). Among high CKD risk participants, significantly fewer subjects on E/C/F/TAF experienced a decline in eGFR to below 60 mL/min compared to E/C/F/TDF: 4.9% vs 9.6% (p = 0.044). Participants with high CKD risk who initiated E/C/F/TAF also had significant declines in multiple measures of quantitative proteinuria. Within the low CKD risk group, significantly fewer participants receiving E/C/F/TAF experienced a decline in eGFR by ≥25% (11.5% vs 24.9%, p < 0.001). High rates of virologic suppression at week 48 were observed in both treatment groups in the high CKD risk category.

Discussion/conclusion Among participants with both low and high CKD risk, participants receiving E/C/F/TAF had more favourable renal outcomes compared with those treated with E/C/F/TDF. These data support the improved renal safety profile of TAF.

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