In a current examine printed in JAMA Community Open, a bunch of researchers assessed the danger of hypertension and statin initiation in adults beginning Human Immunodeficiency Virus (HIV) Pre-exposure prophylaxis (PrEP) with emtricitabine/tenofovir alafenamide fumarate (TAF) in comparison with these taking emtricitabine/tenofovir disoproxil fumarate (TDF), utilizing information from Kaiser Permanente Southern California (KPSC).
Research: Use of Tenofovir Alafenamide Fumarate for HIV Pre-Publicity Prophylaxis and Incidence of Hypertension and Initiation of Statins. Picture Credit score: PENpics Studio/Shutterstock.com
PrEP reduces Human Immunodeficiency Virus (HIV) an infection danger and is pivotal for HIV elimination in the US (US). As of 2023, two every day PrEP regimens obtained US Meals and Drug Administration (FDA) approval: TDF in 2012 and TAF in 2019.
Whereas each reveal comparable HIV prevention efficacy, the DISCOVER trial revealed these on TAF confirmed improved bone and kidney well being however elevated weight.
Conversely, TDF customers had lowered ldl cholesterol. TAF utilization for HIV remedy additionally indicated weight and ldl cholesterol will increase, elements related to heart problems. The trial confirmed no important distinction in lipid-modifying agent initiation however didn’t assess different cardiometabolic circumstances.
Observational research from the TriNetX database recommend increased statin initiation and blood strain elevation with TAF.
Additional analysis is required as a result of inconsistencies between medical trial information and real-world proof concerning the cardiometabolic results of TAF and TDF, with considerations about underestimating outcomes in observational research.
Concerning the examine
The current examine was performed on adults beginning PrEP throughout the KPSC system. The built-in healthcare system in Southern California serves a large demographic, with members’ healthcare journeys meticulously documented in digital well being data (EHRs).
Researchers recognized adults who started PrEP between October 1, 2019, and Might 31, 2022, excluding these with prior HIV analysis, continual kidney illness, indicators of kidney, liver, or blood abnormalities, or those that had been members for lower than 30 days post-PrEP initiation.
Two distinct analytic cohorts emerged from this inhabitants, specializing in the danger of growing hypertension and the initiation of statins. Members with out a historical past of hypertension or statin use had been included and subsequently shaped into matched cohorts for extra in-depth evaluation.
The first publicity was the initiation of PrEP with both TAF or TDF inside KPSC. Researchers consulting outpatient pharmacy data recognized the primary crammed PrEP prescription between the designated dates.
Major outcomes of curiosity had been the onset of hypertension and the beginning of statins inside two years after starting PrEP. The technique of ascertaining these outcomes concerned varied strategies, akin to diagnostic codes, outpatient measurements, and pharmacy data.
Baseline variables thought-about within the examine included race, age, gender, socio-economic markers, insurance coverage particulars, physique measurements, lab outcomes, and related danger scores. The current examine used a number of statistical strategies to investigate the information, akin to propensity rating matching, logistic regression, and time-to-event evaluation.
Sensitivity analyses had been additionally executed, particularly for these aged 40 or above, as this group has an elevated danger of hypertension and is commonly advisable for statin initiation.
The current examine analyzed 6,824 people eligible to start out PrEP, with a median age of 34 years and 97% male.
When contrasting the eligible people with these excluded from the examine, it was discovered that the eligible individuals had been usually youthful, had a decrease chance of getting Medicare/Medicaid insurance coverage, had been extra incessantly on TDF, and had fewer preliminary cardiometabolic points.
Out of the pool, 5,523 individuals didn’t have hypertension when the examine started. When evaluating these taking TDF to these taking TAF, the latter had been usually older, predominantly non-Hispanic White, and had the next likelihood of getting diabetes from the outset.
They had been, nonetheless, much less prone to be Hispanic or insured by Medicare/Medicaid or industrial insurance coverage suppliers. The TAF group additionally displayed a decrease estimated Glomerular Filtration Charge (eGFR) and a shorter common follow-up time.
As soon as matching was accomplished, the evaluation cohort consisted of 1,855 people on PrEP, with 20% on TAF and 80% on TDF. This matching course of minimized variations in baseline metrics between TAF and TDF takers.
Apparently, inside two years of beginning PrEP, 2.2% of the TAF group developed hypertension, in comparison with the TDF group’s charge of 1.3%. This reveals that TAF utilization is correlated with a barely increased danger of hypertension inside two years of beginning PrEP in comparison with TDF use.
The current examine additionally performed a sensitivity evaluation, contemplating a particular blood strain degree because the cutoff for hypertension analysis, and recognized 3,454 people becoming the standards. This take a look at once more discovered that these on TAF had the next incidence of hypertension than these on TDF, supporting the examine’s main findings.
In one other facet of the examine regarding statin initiation, 6,149 individuals with no prior statin utilization historical past had been recognized. Upon evaluating TDF customers to TAF customers, the latter had been older on common, extra incessantly non-Hispanic White, and fewer prone to be Hispanic or have sure varieties of insurance coverage.
They had been additionally much less prone to have hypertension on the outset. Nonetheless, TAF takers had the next Atherosclerotic Cardiovascular Illness (ASCVD) danger rating and shorter common follow-up time.
Of the matched cohort for this facet, 1,855 individuals had been included. Inside two years of beginning PrEP, 1.6% of the TAF group started statin remedy, in comparison with the TDF group’s charge of 1.0%.
This means that these taking TAF may need a barely increased likelihood of initiating statins inside two years post-PrEP graduation. When focusing solely on individuals aged 40 or older, the danger disparity related to TAF was much more pronounced.