Rationale, design, and baseline characteristicss of the effect of PCSK9 inhibition on cardiovascular risk in treated

Matthew S Durstenfeld1, Marta Levkova-Clark1, Danny Li Ms2

  • 1University of California Los Angeles, Los Angeles, CA; University of California San Francisco, San Francisco, CA.

PubMed

Insights

This study investigated PCSK9 inhibitors for people with HIV (PWH) at high cardiovascular risk. It assessed effects on arterial inflammation and coronary plaque, aiming to clarify potent lipid-lowering mechanisms in PWH.

Area of Science:

  • Cardiology
  • Infectious Diseases
  • Pharmacology

Background:

  • People with HIV (PWH) face elevated cardiovascular disease (CVD) risk.
  • While statins offer moderate lipid lowering, potent strategies like PCSK9 inhibitors require evaluation for PWH.
  • The impact of PCSK9 inhibitors on atherosclerosis markers in PWH is currently unknown.

Purpose of the Study:

  • To evaluate the efficacy of PCSK9 inhibitors in reducing arterial inflammation and coronary plaque in people with HIV.
  • To explore the mechanisms by which potent lipid lowering influences atherosclerosis pathogenesis in PWH.

Main Methods:

  • The EPIC-HIV study is a randomized, placebo-controlled, double-blinded trial.
  • Participants (aged ≥40, treated HIV, ≥1 CVD risk factor or prior event) received alirocumab or placebo (2:1 ratio).
  • Assessments included 18F-FDG PET/CT, coronary CT angiography, and flow-mediated dilation at baseline and 1 year.

Main Results:

  • The primary outcome is the change in arterial inflammation (target-to-background ratio on PET/CT) from baseline to 1 year.
  • Secondary outcomes include changes in noncalcified coronary plaque and endothelial function.
  • Safety was assessed per the intention-to-treat principle.

Conclusions:

  • The EPIC-HIV study will provide crucial evidence on PCSK9 inhibitor effects in PWH.
  • Findings will elucidate how potent lipid lowering impacts atherosclerosis in this population.
Abstract

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