Renal impairment in a large-scale HIV pre-exposure prophylaxis implementation cohort.

BACKGROUND HIV pre-exposure prophylaxis (PrEP) with fixed-dose tenofovir disoproxil fumarate (TDF) and emtricitabine has been associated with low rates of renal impairment in clinical trials. Large-scale PrEP implementation may result in higher rates, as the prevalence of associated risk factors may be higher than in trial populations. METHODS A post-hoc analysis of EPIC-NSW, a large Australian multi-centre PrEP implementation trial for patients at high-risk of HIV infection. Participants were eligible for inclusion if they commenced PrEP between 1 March 2016 and of 30 April 2018, and had renal function assessed at baseline and at least once more before the censor date. The primary outcome was new onset renal impairment, defined as an estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73m2. RESULTS 6808 participants were eligible for inclusion. Almost all were male (99%), with a median age of 35 years (IQR: 28 to 44). Approximately one-quarter (26%) had a baseline eGFR < 90 mL/min/1.73m2. Over a median follow-up period of 1.2 years (IQR 0.6 to 1.7), the rate of renal impairment was 5.8 episodes per 1000 person years (95%CI: 4.0 to 7.8). In multivariable Cox regression, there was higher risk of renal impairment in participants aged ≥50 years (HR 14.7, 95%CI: 5.0 to 43.3, p< 0.001) and those with an eGFR < 90 mL/min/1.73m2 (HR 28.9, 95%CI: 6.9 to 121.9) at baseline. CONCLUSION In a large-scale implementation study, TDF-containing PrEP was associated with a low risk of renal impairment overall, while older patients and those with pre-existing renal dysfunction were at substantially increased risk.