Almost half of the people at risk for HIV who are prescribed oral pre-exposure prophylaxis (PrEP) medications have bone and renal risk factors. These risk factors should be incorporated into PrEP treatment selection, according to an analysis of real-world data published in IJID Regions.1
Among the 2 oral agents approved for HIV PrEP, emtricitabine/tenofovir alafenamide (F/TAF) is associated with improved bone and renal health safety endpoints compared with emtricitabine/tenofovir disoproxil fumarate (F/TDF), noted the investigators.
An evidence-based algorithm for individualizing the selection of PrEP medication suggests that F/TAF may be preferred over F/TDF for patients predisposed to or who have bone or renal conditions, according to previous research by study author Sheldon D. Fields, PhD, RN, CRNP, FNP-BC, AACRN, FAANP, FNAP, FAAN, and colleague Elyse Tung.2 However, limited data exist on the prevalence of bone and renal risk factors among individuals newly prescribed oral PrEP.
To address this gap, the researchers examined electronic health records (EHR) from 40,621 people (average age, 38 years; 90% male) prescribed oral PrEP between January 1, 2015, and February 29, 2020, in the Veradigm Health Insights Database. During this period, the only PrEP agents approved for HIV infection were F/TDF, approved in July 2012, and F/TAF, approved in October 2019. Both agents are highly effective but differ in terms of bone and renal health safety profiles, with F/TDF linked to negative outcomes on renal function and bone mineral density in clinical trials and real-world studies.3,4 Some evidence suggests that these outcomes are reversible upon F/TDF discontinuation.4-6
The majority of individuals were prescribed F/TDF (96.3%) and 4% were prescribed F/TAF. Cabotegravir, the first long-acting injectable PrEP agent, was approved in December 2021, after the study period, and has not been linked to negative bone and renal outcomes.7
Rate of Bone and Renal Risk Factors in Patients Taking HIV PrEP
At least 1 risk factor for renal or bone conditions was found in 62.2% and 68.0%, respectively, of the individuals taking F/TDF. Risk factors for both conditions were found in 48.8% of the individuals. After excluding age as a risk factor in the analysis, renal and bone risk factors were found in 46% and 56% of the study population. Of the 15.6% of individuals with estimated glomerular filtration rate (eGFR) measurements available in their EHR, 47.4% showed impaired renal function.
Age-related risk factors were most common (48.8%) followed by medication-related (48.3%), comorbidity-related (44.8%), and clinical-related risk factors (11.5%). The most common risk factors for renal conditions were substance use disorder (18%) and hypertension (17%) and for bone conditions were use of selective serotonin reuptake inhibitors (SSRIs, 17%) and antiepileptic medications (14%).
The findings may be limited by a lack of recording of bone density scans or eGFR data and incomplete EHR data, leading to an underestimation of the prevalence of bone and renal conditions. Also, information on race and clinical disease-specific parameters as well as other factors that may influence study outcomes was not readily available in the dataset.
The high prevalence of risk factors for renal and bone disease in this patient population “suggests the importance of their consideration when choosing the most appropriate regimen for individuals who may benefit from PrEP,” the authors concluded.
The study was funded by Gilead Sciences, manufacturers of both Truvada (F/TDF) and Descovy (F/TAF).
Some study author(s) declared affiliations with biotech, pharmaceutical, and/or device companies including Gilead Sciences. Please see the original reference for a full list of authors’ disclosures.
- Fields SD, Gruber J, Clue J, Gomez Rey G, Diaz Cuervo H. Prevalence of renal and bone risk factors among individuals prescribed oral pre-exposure prophylaxis for HIV. IJID Regions. 2023;6:68-75. doi:10.1016/j.ijregi.2023.01.004
- Fields SD, Tung E. Patient-focused selection of PrEP medication for individuals at risk of HIV: a narrative review. Infect Dis Ther. 2021;10(1):165-186. doi:10.1007/s40121-020-00384-5
- Effectiveness of prevention strategies to reduce the risk of acquiring or transmitting HIV. Centers for Disease Control and Prevention. Updated June 17, 2022. Accessed January 30, 2023. https://www.cdc.gov/hiv/risk/estimates/preventionstrategies.html#anchor_1562942347
- Fong TL, Lee BT, Tien A, Chang M, Lim C, Ahn A, Bae HS. Improvement of bone mineral density and markers of proximal renal tubular function in chronic hepatitis B patients switched from tenofovir disoproxil fumarate to tenofovir alafenamide. J Viral Hepat. 2019;26(5):561-567. doi:10.1111/jvh.13053
- Drak D, Barratt H, Templeton DJ, O’Connor CC, Gracey DM. Renal function and risk factors for renal disease for patients receiving HIV pre-exposure prophylaxis at an inner metropolitan health service. PLoS One. 2019;14(1):e0210106. doi:10.1371/journal.pone.0210106
- Havens PL, Perumean-Chaney SE, Patki A, et al. Changes in bone mass after discontinuation of pre-exposure prophylaxis with tenofovir disoproxil fumarate/emtricitabine in young men who have sex with men: extension phase results of adolescent trials network protocols 110 and 113. Clin Infect Dis. 2020;70(4):687-691. doi:10.1093/cid/ciz486
- Apretude (cabotegravir extended-release injectable suspenion). Prescribing information. ViiV Healthcare, 2021.