Alirocumab Phase 3 EPIC-HIV Study Completes Primary Data Collection

The Phase 3 EPIC-HIV Study (NCT03207945), investigating alirocumab (Praluent) for cardiovascular risk in treated HIV infection, reached primary completion on August 24, 2025. This milestone indicates that the trial has finished collecting data for its primary outcome measures.

Background

The EPIC-HIV Study explores the role of PCSK9 inhibition, specifically with alirocumab, in managing cardiovascular risk among individuals with treated HIV infection. Atherosclerosis in HIV-positive patients presents distinct characteristics, including heightened vascular inflammation, worsened endothelial function, and a predominance of non-calcified plaque. These specific outcomes can be assessed using specialized noninvasive imaging techniques, which are known to strongly predict future cardiovascular events in the general population. PCSK9 has emerged as an important pharmacologic target for cholesterol lowering in the general population, and recent studies among individuals without HIV have shown that PCSK9 inhibitor therapy is safely tolerated and significantly reduces major cardiovascular events.

Trial design

The EPIC-HIV Study (NCT03207945) is a Phase 3, completed clinical trial that enrolled 118 participants. The study investigated the effect of alirocumab on cardiovascular risk in individuals with dyslipidemias, cardiovascular diseases, and HIV infections. The trial's primary objective was to assess the impact of PCSK9 inhibition on cardiovascular risk in this specific patient population.

What this means

The primary completion of the EPIC-HIV Study signifies a crucial step towards understanding the potential benefits of alirocumab in a population with unique cardiovascular challenges. Given that atherosclerosis in the setting of HIV infection is distinct, with increased vascular inflammation and a predominance of non-calcified plaque, the findings from this Phase 3 trial are highly anticipated. Results are expected to provide valuable insights into managing dyslipidemia and cardiovascular risk specifically in patients with treated HIV infection, potentially informing future treatment guidelines and patient care strategies tailored to this vulnerable population.

Source

The information regarding the primary completion of this trial was sourced from ClinicalTrials.gov, a public database of clinical studies. The update for study NCT03207945, titled "Effect of PCSK9 Inhibition on Cardiovascular Risk in Treated HIV Infection (EPIC-HIV Study)," was posted on August 24, 2025, on clinicaltrials.gov.