Renal function and risk factors for renal disease for patients receiving HIV pre-exposure prophylaxis at an inner metropolitan health service

Drak, Douglas; Barratt, Hamish; Templeton, David J; O’Connor, Catherine; Gracey, David

doi:10.1371/journal.pone.0210106

Cited by 15 publications

(22 citation statements)

References 20 publications

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“…Grinsztejn et al [ 4 ] showed that PrEP was feasible and safe, with very few adverse events sufficiently severe to lead to exclusion of participants due to a decline in renal function. Despite the lack of clinical manifestations, a significant and sustained variation in eGFR was recorded, similar to that reported in other studies regarding PrEP users [ 8 , 20 , 21 ]. In our study, eGFR reached its highest variation as early as week 4 of follow-up after the start of TDF/FTC-based PrEP, when compared to the baseline visit, and was maintained until the week 48 follow-up visit.…”

Section: Discussionsupporting

confidence: 87%

Kidney function and daily emtricitabine/tenofovir disoproxil fumarate pre-exposure prophylaxis against HIV: results from the real-life multicentric demonstrative project PrEP Brazil

et al. 2022

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Background Pre-Exposure Prophylaxis (PrEP) has demonstrated efficacy in the reduction of sexually transmitted HIV infections. The prolonged use of tenofovir disoproxil fumarate (TDF) and emtricitabine (FTC) co-formulation (TDF/FTC), however, may result in augmented risk of renal toxicity. We aimed to evaluate changes in the estimated Glomerular Filtration Rate (eGFR) in a real-world population setting of participants enrolled in PrEP Brazil, a 48-week prospective, open-label, demonstration study to assess the feasibility of daily oral TDF/FTC used by men who have sex with men and transgender women at high-risk of HIV infection, all over 18 years old. Methods Kidney function was assessed by serial measurement of serum creatinine and eGFR with the Modification of Diet in Renal Disease Study (MDRD) formula on weeks 4, 12, 24, 36 and 48. Adherence to PrEP was assessed by dosing TDF concentration in dried blood spots at weeks 4 and 48, measured by liquid chromatography-mass spectrometry or mass spectrometry. Results Of 392 participants completing the 48-week follow-up protocol with TDF blood detectable levels and eGFR measures, 43.1% were young adults, of Caucasian ethnic background (57.9%), with BMI below 30 kg/m2, without arterial hypertension. At screening, median eGFR was 93.0 mL/min/1.73 m2. At week 4 follow-up, 90 (23% of the study population) participants presented reductions in eGFR greater than 10 mL/min/1.73 m2 as compared to baseline eGFR, some as large as 59 mL/min/1.73 m2, but with no clinical outcomes (adverse events and renal adverse events) severe enough to demand TDF/FTC discontinuation. A negative relationship was observed between TDF blood levels and eGFR at weeks 4 (r = − 0.005; p < 0.01) and 48 (r = − 0.006; p < 0.01). Conclusions These results suggest that the renal function profile in individuals on TDF/FTC may be assessed on week 4 and then only annually, allowing a more flexible medical follow-up in primary care centers.

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Section: Discussionsupporting

confidence: 87%

Kidney function and daily emtricitabine/tenofovir disoproxil fumarate pre-exposure prophylaxis against HIV: results from the real-life multicentric demonstrative project PrEP Brazil

et al. 2022

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“…In the Discover trial, the mean reduction in creatinine clearance at one year in the TDF/FTC arm was −2.30 mL/min . The mean eGFR reduction was even more pronounced in the EPIC – NSW study (−4.5 mL/min/1.73 m 2 per year) .…”

Section: Discussionmentioning

confidence: 85%

“…In the Discover trial, the mean reduction in creatinine clearance at one year in the TDF/FTC arm was À2.30 mL/min [26]. The mean eGFR reduction was even more pronounced in the EPIC -NSW study (À4.5 mL/min/1.73 m 2 per year) [27]. The overall reduction and intermittent exposure to TDF/ FTC in our study as compared to a daily regimen, may explain the better renal safety of on-demand PrEP.…”

Section: Discussionmentioning

confidence: 99%

Changes in kidney function among men having sex with men starting on demand tenofovir disoproxil fumarate – emtricitabine for HIV pre‐exposure prophylaxis

et al. 2020

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Introduction Daily pre‐exposure prophylaxis (PrEP) with tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) is associated with a small but statistically significant decrease in estimated glomerular filtration rate (eGFR). We assessed the renal safety of on‐demand PrEP with TDF/FTC in HIV‐1 uninfected men. Methods We used data from the randomized double‐blind placebo‐controlled ANRS‐IPERGAY trial and its open‐label extension conducted between February 2012 and June 2016 among HIV‐uninfected MSM starting on‐demand PrEP. Using linear mixed model, we evaluated the mean eGFR decline from baseline over time and determined risks factors associated with eGFR decline during the study. Results During the blind phase, with a median follow‐up of 9.4 months, the mean decline slope of eGFR from baseline was −0.88 and −1.53 mL/min/1.73 m2 per year in the placebo (n = 201) and the TDF/FTC group (n = 198) respectively, with a slope difference of 0.65 mL/min/1.73 m2 per year (p = 0.27). Including both phases, 389 participants started on‐demand TDF/FTC with a median follow‐up of 19.2 months and a mean decline of eGFR from baseline of −1.14 mL/min/1.73 m2 per year (p < 0.001). The slope of eGFR reduction was not significantly different in participants with baseline eGFR ≤ 90 mL/min/1.73 m2 (p = 0.44), age >40 years (p = 0.24) or hypertension (p = 0.21). There was a dose‐response relationship between recent tenofovir exposure and lower eGFR when considering the number of pills taken in the two months prior the visit (eGFR difference of −0.88 mL/min/1.73 m2 between >15 pills/month vs. ≤15 pills/month, p < 0.01) or plasma tenofovir concentrations at the visit (eGFR difference compared to ≤2 ng/mL: >2 to ≤10ng/mL: −0.98 mL/min/1.73 m2, >10 to ≤40ng/mL: −1.28 mL/min/1.73 m2, >40 ng/mL: −1.82 mL/min/1.73 m2, p < 0.001). Three participants discontinued TDF/FTC for eGFR < 60 mL/min/1.73 m2 during the OLE phase. No case of Fanconi syndrome was reported. Conclusions The renal safety of on‐demand PrEP with TDF/FTC was good. The overall reduction and intermittent exposure to TDF/FTC may explain this good renal safety.

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“…We also only had to discontinue PrEP for three patients for medicationrelated kidney issues, which matches the rates of discontinuation for renal toxicity found in the initial and larger physician-run trials. [18][19][20] This point about discontinuation is important because it helps validate our creatinine monitoring pathway, 7 which could facilitate greater taskshifting to healthcare providers who may be less familiar with PrEP and renal function monitoring; for example, RNs or physicians who have not worked with renal function testing ever or in many years. This finding about our participants is also important because it supports previous analyses that found PrEP-RN to be a more cost-effective way to delivery PrEP.…”

Section: Discussionmentioning

confidence: 99%

Nurse-led PrEP-RN clinic: a prospective cohort study exploring task-Shifting HIV prevention to public health nurses

et al. 2021

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ObjectiveTo report the results of a nurse-led pre-exposure prophylaxis (PrEP) delivery service.DesignThis was a prospective cohort study conducted from 5 August 2018 to 4 March 2020. It involved manual chart review to collect data. Variables were described using frequencies and percentages and analysed using χ2 testing. Those significant in bivariate analysis were retained and entered into a binary multiple logistic regression. Hierarchical modelling was used, and only significant factors were retained.SettingThis study occurred in an urban public health unit and community-based sexually transmitted infection (STI) clinic in Ottawa, Canada.ParticipantsOf all persons who were diagnosed with a bacterial STI in Ottawa and everyone who presented to our STI clinic during the study period, there were 347 patients who met our high-risk criteria for PrEP; these criteria included patients who newly presented with any of the following: HIV contacts, diagnosed with a bacterial STI or single use of HIV PEP. Further, eligibility could be determined based on clinical judgement. Patients who met the foregoing criteria were appropriate for PrEP-RN, while lower-risk patients were referred to elsewhere. Of the 347 patients who met our high-risk criteria, 47% accepted and 53% declined. Of those who accepted, 80% selected PrEP-registered nurse (RN).Primary and secondary outcome measuresUptake, acceptance, engagement and attrition factors of participants who obtained PrEP through PrEP-RN.Findings69% of participants who were eligible attended their intake PrEP-RN visit. 66% were retained in care. Half of participants continued PrEP and half were lost to follow-up. We found no significant differences in the uptake, acceptance, engagement and attrition factors of participants who accessed PrEP-RN regarding reason for referral, age, ethnicity, sexual orientation, annual income, education attainted, insurance status, if they have a primary care provider, presence or absence of depression or anxiety and evidence of newly acquired STI during the study period.ConclusionsNurse-led PrEP is an appropriate strategy for PrEP delivery.

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Renal function and risk factors for renal disease for patients receiving HIV pre-exposure prophylaxis at an inner metropolitan health service

Cited by 15 publications

References 20 publications

Kidney function and daily emtricitabine/tenofovir disoproxil fumarate pre-exposure prophylaxis against HIV: results from the real-life multicentric demonstrative project PrEP Brazil

Kidney function and daily emtricitabine/tenofovir disoproxil fumarate pre-exposure prophylaxis against HIV: results from the real-life multicentric demonstrative project PrEP Brazil

Changes in kidney function among men having sex with men starting on demand tenofovir disoproxil fumarate – emtricitabine for HIV pre‐exposure prophylaxis

Nurse-led PrEP-RN clinic: a prospective cohort study exploring task-Shifting HIV prevention to public health nurses

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