Long-term effects of evolocumab in participants with HIV and dyslipidemia: results from the open-label extension period.

Abstract

OBJECTIVES:

People with HIV (PWH) are at an increased risk of atherosclerotic cardiovascular disease. Suboptimal responses to statin therapy in PWH may result from antiretroviral therapies (ARTs). This open-label extension study aimed to evaluate the long-term safety and efficacy of evolocumab up to 52 weeks in PWH.

DESIGN:

This final analysis of a multinational, placebo-controlled, double-blind, randomized phase 3 trial evaluated the effect of monthly subcutaneous evolocumab 420 mg on low-density lipoprotein cholesterol (LDL-C) during the open-label period (OLP) following 24 weeks of double-blind period in PWH with hypercholesterolemia/mixed dyslipidemia. All participants enrolled had elevated LDL-C or nonhigh-density lipoprotein cholesterol (non-HDL-C) and were on stable maximally tolerated statin and stable ART.

METHODS:

Efficacy was assessed by percentage change from baseline in LDL-C, triglycerides, and atherogenic lipoproteins. Treatment-emergent adverse events (TEAEs) were examined.

RESULTS:

Of the 467 participants randomized in the double-blind period, 451 (96.6%) received at least one dose of evolocumab during the OLP (mean age of 56.4 years, 82.5% male, mean duration with HIV of 17.4 years). By the end of the 52-week OLP, the overall mean (SD) percentage change in LDL-C from baseline was -57.8% (22.8%). Evolocumab also reduced triglycerides, atherogenic lipid parameters (non-HDL-C, apolipoprotein B, total cholesterol, very-low-density lipoprotein cholesterol, and lipoprotein[a]), and increased HDL-C. TEAEs were similar between placebo and evolocumab during the OLP.

CONCLUSION:

Long-term administration of evolocumab lowered LDL-C and non-HDL-C, allowing more PWH to achieve recommended lipid goals with no serious adverse events.

TRAIL REGISTRATION:

NCT02833844.

VIDEO ABSTRACT:

http://links.lww.com/QAD/C441.

• Authors: Franck Boccara, Bruno Caramelli, Alexandra Calmy, Princy Kumar, J Antonio G López, Sarah Bray, Marcoli Cyrille, Robert S Rosenson, investigators of the BEIJERINCK study
• Journal: AIDS (London, England) (AIDS) Vol. 36 Issue 5 Pg. 675-682 (Apr 01 2022) ISSN: 1473-5571 [Electronic] England
• PMID: 35025817 (Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't, Video-Audio Media)
• Copyright: Copyright © 2022 The Author(s). Published by Wolters Kluwer Health, Inc.

Chemical References

• Antibodies, Monoclonal, Humanized
• Cholesterol, LDL
• Hydroxymethylglutaryl-CoA Reductase Inhibitors
• Triglycerides
• Cholesterol
• evolocumab

Topics

• Antibodies, Monoclonal, Humanized (adverse effects)
• Atherosclerosis (chemically induced, drug therapy)
• Cholesterol
• Cholesterol, LDL
• Double-Blind Method
• Dyslipidemias (complications, drug therapy)
• Female
• HIV Infections (complications, drug therapy)
• Humans
• Hydroxymethylglutaryl-CoA Reductase Inhibitors (therapeutic use)
• Male
• Middle Aged
• Treatment Outcome
• Triglycerides (therapeutic use)