One PrEP Regimen Linked to Higher Risk of Hypertension, Statin Use Over Another

Use of tenofovir alafenamide fumarate (TAF) for HIV pre-exposure prophylaxis (PrEP) was associated with an increased risk of hypertension and the initiation of statin use within 2 years compared with the use of tenofovir disoproxil fumarate (TDF; Viread), especially for people over age 40, a retrospective cohort study found.

In a cohort of patients without baseline hypertension, the cumulative incidence of hypertension with the use of TAF was 2.2 per 100 persons versus 1.3 per 100 persons in propensity score-matched patients taking TDF (OR 1.64, 95% CI 1.05- 2.56), reported Adovich S. Rivera, MD, PhD, of Southern California Permanente Medical Group in Pasadena, and colleagues.

In a cohort of patients without baseline statin use, the cumulative incidence of statin initiation was 1.6 versus 1.0, respectively (OR 2.33, 95% CI 1.41-3.85), they noted in JAMA Network Open.

Subgroup analyses that only included those ages 40 and older at PrEP initiation showed similar results, with a larger risk difference in statin initiation (risk difference 4.24, 95% CI 1.82-6.26; OR 3.05, 95% CI 1.64-5.67).

“Future studies with larger sample size and longer follow-up period are warranted to provide more evidence to inform clinical decision-making regarding different PrEP regimens, especially among those with increased risk for cardiometabolic disease,” Rivera and team concluded.

A previous study using TriNetX electronic health records found a higher incidence of statin initiation among those taking TAF compared with propensity score-matched patients taking TDF, though elevated blood pressure was more frequent in those taking TDF, despite diagnosis rates of hypertension being similar between the two groups.

Of the current study, Douglas Krakower, MD, of Harvard Medical School in Boston, told MedPage Today that “it is not surprising that this observational study found that TAF use was associated with increased incidence of hypertension and statin initiation, which could be a result of adverse cardiometabolic changes.”

Both TAF and TDF are generally safe, despite some differences in their safety profiles, he said, and “the health benefits of robust HIV prevention are likely to outweigh the risk of adverse effects for many people who are at increased risk for HIV acquisition.”

Both Krakower and the study authors noted that closer monitoring of blood pressure and lipid levels may be warranted for patients using TAF.

“CDC guidelines for PrEP recommend annual lipid monitoring for patients using TAF, so clinicians are likely to detect changes in cholesterol levels from PrEP,” Krakower said, adding that blood pressure monitoring is done at virtually all medical visits, which means that clinicians should be aware of any changes over time.

While there were some differences in some baseline characteristics between the TAF and TDF cohorts, the study used rigorous statistical methods to try to account for confounding, he pointed out. “The findings suggest a true difference in the effects of TAF versus TDF for PrEP.”

Clinicians should educate patients on the differences between these two PrEP options for older patients and those with pre-existing medical conditions to help them choose the safest medication, he added.

This study used the electronic health records of individuals who initiated PrEP at Kaiser Permanente Southern California from October 2019 through May 2022. Propensity score matching was done to generate a ratio of one patient using TAF to four using TDF.

The researchers included 6,824 eligible individuals; mean age was 33.9, and 97% were men. Of these patients, 5,523 did not have hypertension prior to matching, and 6,149 were not taking a statin.

Compared with those taking TDF, those taking TAF were older and more likely to be white, and less likely to be Hispanic and use Medicare/Medicaid or commercial insurance.

The study was conducted at a single integrated healthcare system in the U.S., so its findings may be less generalizable to individuals in other healthcare settings, Rivera and team noted.

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