Evolocumab treatment in patients with HIV and hypercholesterolemia/mixed dyslipidemia: BEIJERINCK study design and baseline characteristics

Abstract

Background: People living with human immunodeficiency virus (PLHIV) are at higher risk of atherosclerotic cardiovascular disease (ASCVD) due to traditional and HIV- or antiretroviral treatment (ART)-related risk factors. The use of high-intensity statin therapy is often limited by comorbidities and drug-drug interactions with ART. Herein, we present the design and baseline characteristics of the BEIJERINCK study, which will assess the safety and efficacy of evolocumab in PLHIV and hypercholesterolemia/mixed dyslipidemia.

Methods: Randomized, double-blind, placebo-controlled, multinational trial that investigates monthly subcutaneous evolocumab 420 mg versus placebo in PLHIV with hypercholesterolemia/mixed dyslipidemia who are treated with maximally-tolerated statin therapy. The primary outcome is the baseline to week 24 percent change in low density lipoprotein cholesterol (LDL-C). Secondary outcomes include achievement of LDL-C < 70 mg/dL and percent change in other plasma lipid and lipoprotein levels. Safety will also be examined.

Results: This study enrolled and dosed 464 patients who had a mean age of 56.4 years and were mostly male (82.5%). Mean duration with HIV was 17.4 years, and, by design, HIV viral load at screening was ≤50 copies/mL. ASCVD was documented in 35.6% of patients. Mean LDL-C of enrolled patients at baseline was 133.3 mg/dL. Statin use was prevalent (79.3% overall) with 74.6% receiving moderate or high-intensity statins. In total, 20.7% of patients did not receive statins due to intolerance/contraindications.

Conclusions: The BEIJERINCK study is the first clinical trial to examine the lipid-lowering efficacy and safety of a fully human PCSK9 monoclonal antibody inhibitor in a moderate/high cardiovascular risk population of PLHIV.

Trial registration: ClinicalTrials.gov NCT02833844.

Conflict of interest statement

Disclosures FB reports research grants from Amgen; lecture fees from Janssen, Gilead, ViiV Healthcare, Amgen, Sanofi, MSD, and Servier outside the submitted work. PK reports grants from Amgen, GSK, Merck, Gilead, and TheraTherapeutics, consulting fees from Amgen, GSK, Merck, Gilead, and TheraTherapeutics, and stock in GSK, Merck, Gilead, Pfizer, and Johnson & Johnson. BC receives research support from Boheringer-Ingelheim, Amgen, consulting fees from Amgen, Bayer, honoraria for non-promotional speaking from Servier, Boehringer-Ingelheim, and from Elsevier's Order Sets. AC reports education grants (to the HIV Unit, Geneva University Hospitals) from Janssen, Gilead, ViiV Healthcare, MSD and Amgen. JAGL, SB, and MC are employees and stockholders of Amgen Inc. RSR receives research support from Akcea, Amgen, Medicines Company, Novartis and Regeneron, consulting fees from Amgen, C5, CVS Caremark, Corvidia, Medicines Company, honoraria for non-promotional speaking from Amgen, Kowa, Pfizer and Regeneron, royalties from UpToDate, Inc., and has stock ownership in MediMergent, LLC.

Copyright © 2019. Published by Elsevier Inc.