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Multicenter Study
. 2021 Nov 15;35(14):2319-2326.
doi: 10.1097/QAD.0000000000003035.

Renal impairment in a large-scale HIV preexposure prophylaxis implementation cohort

Douglas Drak  1   2 , Hamish Mcmanus  3 , Tobias Vickers  3 , Jack E Heron  4 , Stefanie Vaccher  3 , Iryna Zablotska  5   6   7 , Rebecca Guy  3 , Benjamin Bavinton  3 , Fengyi Jin  3 , Andrew E Grulich  3 , Mark Bloch  8 , Catherine C O'Connor  3 , David M Gracey  1   4 ; Expanded PrEP Implementation in Communities New South Wales (EPIC-NSW) research group
Affiliations
Multicenter Study

Renal impairment in a large-scale HIV preexposure prophylaxis implementation cohort

Douglas Drak et al. AIDS. .

Abstract

Background: HIV preexposure 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 posthoc analysis of EPIC-NSW, a large Australian multicentre 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 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 per 1.73 m2.

Results: A total of 6808 participants were eligible for inclusion. Almost all were male (99%), with a median age of 35 years [interquartile range (IQR): 28-44]. Approximately one-quarter (26%) had a baseline eGFR <90 ml/min per 1.73 m2. Over a median follow-up period of 1.2 years (IQR: 0.6-1.7), the rate of renal impairment was 5.8 episodes per 1000 person-years [95% confidence interval (CI): 4.0-7.8]. In multivariable Cox regression, there was a higher risk of renal impairment in participants aged ≥50 years [hazard ratio (HR) 14.7, 95% CI: 5.0-43.3, P < 0.001] and those with an eGFR <90 ml/min per 1.73 m2 (HR 28.9, 95% CI: 6.9-121.9) at baseline.

Conclusion: In a large-scale implementation study, TDF-containing PrEP was associated with a low risk of renal impairment overall, whereas older patients and those with preexisting renal dysfunction were at substantially increased risk.

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References

    1. Molina JM, Capitant C, Spire B, Pialoux G, Cotte L, Charreau I, et al. On-demand preexposure prophylaxis in men at high risk for HIV-1 infection . N Engl J Med 2015; 373:2237–2246.
    1. McCormack S, Dunn DT, Desai M, Dolling DI, Gafos M, Gilson R, et al. Preexposure prophylaxis to prevent the acquisition of HIV-1 infection (PROUD): effectiveness results from the pilot phase of a pragmatic open-label randomised trial . Lancet 2016; 387:53–60.
    1. Grant RM, Lama JR, Anderson PL, McMahan V, Liu AY, Vargas L, et al. Preexposure chemoprophylaxis for HIV prevention in men who have sex with men . N Engl J Med 2010; 363:2587–2599.
    1. Grulich AE, Guy R, Amin J, Jin F, Selvey C, Holden J, et al. Population-level effectiveness of rapid, targeted, high-coverage roll-out of HIV preexposure prophylaxis in men who have sex with men: the EPIC-NSW prospective cohort study . Lancet HIV 2018; 5:e629–e637.
    1. Mugwanya K, Baeten J, Celum C, Donnell D, Nickolas T, Mugo N, et al. Low risk of proximal tubular dysfunction associated with emtricitabine-tenofovir disoproxil fumarate preexposure prophylaxis in men and women . J Infect Dis 2016; 214:1050–1057.

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