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O016 Renal function at baseline and month 1 in the PROUD study, a pragmatic open label randomised trial of Truvada as Pre-Exposure Prophylaxis
  1. Iain Reeves1,
  2. Ellen White2,
  3. Elizabeth Brodnicki2,
  4. David Dunn2,
  5. Sheena McCormack2,
  6. Tristan Barber3,
  7. Ann Sullivan3,
  8. Charles Lacey5,
  9. Hannah Alexander4
  1. 1Homerton University Hospital, London, UK
  2. 2MRC CTU, London, UK
  3. 3Chelsea and Westminster NHS Trust, London, UK
  4. 4Kings College Hospital, London, UK
  5. 5Hull York Medical School, York, UK

Abstract

Background/introduction Quarterly monitoring of creatinine is likely to be recommended by WHO for those on PrEP, even though there were no significant differences in creatinine in placebo-controlled trials. Establishing the appropriate level of monitoring of PrEP is important.

Methods PROUD is an open-label, randomised trial of Truvada as PrEP in MSM. HIV serology and serum creatinine was done at PrEP baseline (‘start’). Clinics were advised to collect creatinine or urinary protein-creatinine ratio (UPCR) if there was ≥1+ protein on urinalysis at the month 1 visit (m1). Here’we present the renal monitoring results at “start” and m1 with eGFR (ml/min/1.73m2) calculated by the CKD-EPI equation.

Results 445 (93%) of 481 had baseline creatinine, 13 (3%) had UPCR, and 23 (5%) neither. The median eGFR was 106. Only one was <60 (eGFR = 49), probably due to dietary creatinine supplementation. 260 (59%) of 443 had a m1 creatinine, creating 246 paired results. On average, eGFR was 1.50 lower at m1. Seven (4%) of 194 with eGFR >90 dropped 20%, one to 59. He stopped PrEP and did not attend thereafter. Of the 7, none had abnormal urinalysis; 4 had UPCR – all normal. 41 (79%) of 52 with eGFR 60–90 at baseline remained at this level, the remainder increased to >90.

Discussion/conclusion The mean change in eGFR at month 1 is not clinically significant. Excepting one individual who could not be further evaluated, there were no clinically meaningful changes at m1. Further work will explore the relationships between eGFR and proteinuria.

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