Pitavastatin May Lower Hypertension and CV Risk in People With HIV: Study

A thorough secondary analysis of the REPRIEVE trial (NCT02344290) was conducted by the investigators. The REPRIEVE trial was an immensely large, multinational, randomized, double-blind, placebo-controlled phase 3 clinical trial. The trial recruited adult individuals who were infected with HIV from the age group 40 to 75 years having a low-to-moderate risk for atherosclerotic heart disease with a stable regimen of antiretroviral therapy. In order to conduct this particular secondary analysis, very stringent filters were applied by the researchers so that a completely clean baseline could be created. Participants who had absolutely no documented record of high blood pressure at the time of enrollment into the trial were included in the study.

Individuals who had a history of being hypertensive, taking any antihypertensive drugs, or having a baseline systolic blood pressure >140 mm Hg or a diastolic blood pressure ≥90 mm Hg were strictly excluded. Normotensive participants were randomly assigned to take a single dose of pitavastatin or placebo orally each day. Clinically diagnosed MACE in newly developed cases was correlated using Cox and Fine-Gray models with the follow-up period ranging from a median of 5.0 years.

Key findings:

• From the 7,769 participants who joined the REPRIEVE global trial, 4,989 (64%) subjects without any baseline hypertension qualified and made up the final pool of patients.
• The final pool of participants was well-balanced, with 2,496 patients assigned to the pitavastatin treatment and 2,493 individuals assigned to the placebo group.
• The participant pool was comprised of patients aged 49 years on average (interquartile range: 45–54 years), where the number of females and males were 1,464 (29%) and 3,525 (71%), respectively.
• At baseline, participants’ systolic and diastolic blood pressure were found to be healthy, with a median of 102 mm Hg and 76 mm Hg, respectively.
• After a median follow-up period of 5.0 years, 13% of patients experienced high blood pressure, but the rate was significantly low in the pitavastatin group, which had a rate of 24.7 per 1,000 person-years compared to 29.6 per 1,000 person-years in the placebo group, giving 17% relative risk reduction (HR 0.83; 95% CI, 0.71–0.97; P = 0.017).
• The primary risk factors driving the sudden onset of hypertension included advanced age, elevated body mass index (BMI), pre-existing metabolic syndrome, a reduced estimated glomerular filtration rate (eGFR), and identifying as Black within high-income geographic regions.
• Among the 668 participants who developed high blood pressure, 581 individuals (87%) initiated standard antihypertensive medications; out of a subset of 213 tracked over time, 159 patients (74.6%) achieved successful blood pressure control 4 years after their initial diagnosis.
• The development of high blood pressure was associated with a dramatic, significant surge in life-threatening complications, demonstrating a more than doubled risk of experiencing subsequent major adverse cardiovascular events (subdistribution HR 2.16; 95% CI, 1.32–3.52) in fully adjusted statistical models.

In conclusion, these results indicate more cardiovascular effects of pitavastatin in individuals with HIV for their hypertension in terms of cardiovascular disease prevention. This extensive secondary analysis of the REPRIEVE trial is a very important turning point for global public health in general, and shows that early statins therapy provides a strong and multifaceted protection against the latent vascular threats to which HIV-positive patients are exposed.

Reference:

Martínez, E., Watanabe, M., Hoffman, R., Zanni, M. V., Pozniak, A., Shakil, S. S., McCallum, S., Chu, S. M., Srinivasa, S., Malvestutto, C. D., Fichtenbaum, C. J., Bloomfield, G. S., Sponseller, C. A., Lu, A. B., Lu, M. T., Aberg, J. A., Currier, J. S., Douglas, P. S., Ribaudo, H. J., … REPRIEVE Investigators. (2026). Incidence, risk factors, and cardiovascular impact of hypertension in people with HIV: a secondary analysis of the REPRIEVE trial. The Lancet. HIV, 13(5), e327–e337. https://doi.org/10.1016/S2352-3018(26)00036-6