TY - JOUR
T1 - Renal impairment associated with tenofovir disoproxil fumarate for antiretroviral therapy and HIV pre-exposure prophylaxis
T2 - An observational cohort study
AU - ACCESS collaboration
AU - Heron, Jack E.
AU - McManus, Hamish
AU - Vickers, Tobias
AU - Ryan, Kathleen
AU - Wright, Edwina
AU - Carter, Allison
AU - Stoove, Mark
AU - Asselin, Jason
AU - Grulich, Andrew
AU - Donovan, Basil
AU - Guy, Rebecca
AU - Varma, Rick
AU - Chen, Marcus
AU - Ryder, Nathan
AU - Lewis, David A.
AU - Templeton, David J.
AU - O’Connor, Catherine C.
AU - Gracey, David M.
AU - Bastian, Lisa
AU - Bateson, Deborah
AU - Bowden, Scott
AU - Boyd, Mark
AU - Callander, Denton
AU - Aung, Htein Linn
AU - Cogle, Aaron
AU - Costello, Jane
AU - Dimech, Wayne
AU - Dittmer, Jennifer
AU - El-Hayek, Carol
AU - Ellard, Jeanne
AU - Fairley, Christopher
AU - Franklin, Lucinda
AU - Hellard, Margaret
AU - Hocking, Jane
AU - Kim, Jules
AU - McGill, Scott
AU - Nolan, David
AU - Patel, Prital
AU - Pendle, Stella
AU - Polkinghorne, Victoria
AU - Nguyen, Long
AU - Nguyen, Thi
AU - O’Connor, Catherine
AU - Reed, Philip
AU - Roth, Norman
AU - Selvey, Christine
AU - Traeger, Michael
AU - Walker, Melanie
AU - West, Michael
N1 - Publisher Copyright:
© 2023 Heron et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
PY - 2023/2
Y1 - 2023/2
N2 - Background Tenofovir disoproxil fumarate (TDF) is associated with adverse renal outcomes when prescribed for HIV infection. There are few data concerning real-world renal outcomes amongst patients prescribed TDF for pre-exposure prophylaxis (PrEP). Methods and findings Data were extracted from 52 sexual health clinics across Australia from 2009–2019. All patients prescribed TDF-containing antiretroviral therapy and PrEP were included. Rates of renal impairment (a fall in eGFR to <60 ml/min/1·73m2) were calculated for people living with HIV (PLWHIV) prescribed TDF and HIV negative PrEP-users. Risk factors were assessed using Cox-proportional hazards models. Sensitivity analysis of risk using 1:1 propensity-score matching to adjust for potential imbalance in HIV and PrEP cohorts was conducted. 5,973 patients on PrEP and 1,973 PLWHIV were included. There were 39 (0.7%) instances of renal impairment in the PrEP group and 81 (4.1%) in the PLWHIV cohort (hazard ratio [HR]:0.35 95% confidence interval [CI]: 0.22–0.56). Rates of renal impairment were 4.01/1000 person-years (95%CI:2.93–5.48) in the PrEP cohort and 16.18/1000 person-years (95%CI:13.01–20.11) in the PLWHIV cohort (p<0.001). Predictors of renal impairment were: older age (40–49 years (HR:5.09 95%CI: 2.12–12.17) and 50–82 years (HR:13.69 95%CI: 5.92–31.67) (compared with 30–39 years) and baseline eGFR<90ml/min (HR:61.19 95%CI: 19.27–194.30). After adjusting for age and baseline eGFR the rate of renal impairment remained lower in the PrEP cohort (aHR:0.62 95%CI: 0.40–0.94, p = 0.023). In propensity-matched analysis using 1,622 patients per cohort the risk of renal impairment remained higher in the PLWHIV cohort (log-rank p = 0.001). Conclusion Patients prescribed TDF-based PrEP had lower rates of renal impairment than patients prescribed TDF for HIV infection. In propensity analysis, after matching for some risk factors, rates of renal impairment remained higher amongst patients with HIV.
AB - Background Tenofovir disoproxil fumarate (TDF) is associated with adverse renal outcomes when prescribed for HIV infection. There are few data concerning real-world renal outcomes amongst patients prescribed TDF for pre-exposure prophylaxis (PrEP). Methods and findings Data were extracted from 52 sexual health clinics across Australia from 2009–2019. All patients prescribed TDF-containing antiretroviral therapy and PrEP were included. Rates of renal impairment (a fall in eGFR to <60 ml/min/1·73m2) were calculated for people living with HIV (PLWHIV) prescribed TDF and HIV negative PrEP-users. Risk factors were assessed using Cox-proportional hazards models. Sensitivity analysis of risk using 1:1 propensity-score matching to adjust for potential imbalance in HIV and PrEP cohorts was conducted. 5,973 patients on PrEP and 1,973 PLWHIV were included. There were 39 (0.7%) instances of renal impairment in the PrEP group and 81 (4.1%) in the PLWHIV cohort (hazard ratio [HR]:0.35 95% confidence interval [CI]: 0.22–0.56). Rates of renal impairment were 4.01/1000 person-years (95%CI:2.93–5.48) in the PrEP cohort and 16.18/1000 person-years (95%CI:13.01–20.11) in the PLWHIV cohort (p<0.001). Predictors of renal impairment were: older age (40–49 years (HR:5.09 95%CI: 2.12–12.17) and 50–82 years (HR:13.69 95%CI: 5.92–31.67) (compared with 30–39 years) and baseline eGFR<90ml/min (HR:61.19 95%CI: 19.27–194.30). After adjusting for age and baseline eGFR the rate of renal impairment remained lower in the PrEP cohort (aHR:0.62 95%CI: 0.40–0.94, p = 0.023). In propensity-matched analysis using 1,622 patients per cohort the risk of renal impairment remained higher in the PLWHIV cohort (log-rank p = 0.001). Conclusion Patients prescribed TDF-based PrEP had lower rates of renal impairment than patients prescribed TDF for HIV infection. In propensity analysis, after matching for some risk factors, rates of renal impairment remained higher amongst patients with HIV.
UR - https://www.scopus.com/pages/publications/85148952763
U2 - 10.1371/journal.pone.0280339
DO - 10.1371/journal.pone.0280339
M3 - Article
C2 - 36827395
AN - SCOPUS:85148952763
SN - 1932-6203
VL - 18
JO - PLoS ONE
JF - PLoS ONE
IS - 2 February
M1 - e0280339
ER -
