Author + information
- Received February 14, 2020
- Revision received March 16, 2020
- Accepted March 17, 2020
- Published online May 18, 2020.
- Franck Boccara, MD, PhDa,∗ (, )@BoccaraFranck,
- Princy N. Kumar, MDb,
- Bruno Caramelli, MD, PhDc,
- Alexandra Calmy, MD, FMH, PhDd,
- J. Antonio G. López, MDe,
- Sarah Bray, PhDe,
- Marcoli Cyrille, MDe,
- Robert S. Rosenson, MDf,
- for the BEIJERINCK Investigators
- aAP-HP, Hôpitaux de l'Est Parisien, Hôpital Saint-Antoine, Department of Cardiology, Sorbonne Université-INSERM UMR S_938, Centre de Recherche Saint-Antoine, Paris, France
- bDivision of Infectious Diseases and Travel Medicine, Georgetown University School of Medicine, Washington, DC
- cInterdisciplinary Medicine in Cardiology Unit, InCor, University of São Paulo, São Paulo, Brazil
- dHIV/AIDS Unit, Division of Infectious Diseases, Geneva University Hospitals, Geneva, Switzerland
- eGlobal Development, Amgen Inc., Thousand Oaks, California
- fCardiometabolics Unit, Mount Sinai Heart, Icahn School of Medicine at Mount Sinai, New York, New York
- ↵∗Address for correspondence:
Dr. Franck Boccara, Cardiology Department, Assistance Publique-Hôpitaux de Paris, Sorbonne University, 184, rue du faubourg St-Antoine, 75571 Paris Cedex 12, France.
Background People living with human immunodeficiency virus (PLHIV) are at increased risk of atherosclerotic cardiovascular disease (ASCVD) and are prone to statin-related adverse events from drug–drug interactions with certain antiretroviral regimens.
Objectives This study sought to evaluate the efficacy and safety of evolocumab in dyslipidemic PLHIV.
Methods BEIJERINCK (EvolocumaB Effect on LDL-C Lowering in SubJEcts with Human Immunodeficiency VirRus and INcreased Cardiovascular RisK) is a randomized, double-blind, multinational trial comparing monthly subcutaneous evolocumab 420 mg with placebo in PLHIV with hypercholesterolemia/mixed dyslipidemia taking maximally-tolerated statin therapy. The primary endpoint was the percent change (baseline to week 24) in low-density lipoprotein cholesterol (LDL-C); secondary endpoints included achievement of LDL-C <70 mg/dl and percent change in other plasma lipid and lipoprotein levels. Treatment-emergent adverse events were also examined.
Results A total of 464 patients were analyzed (mean age of 56.4 years, 82.5% male, mean duration with HIV of 17.4 years). ASCVD was documented in 35.6% of patients, and statin intolerance/contraindications to statin use were present in 20.7% of patients. Evolocumab reduced LDL-C by 56.9% (95% confidence interval: 61.6% to 52.3%) from baseline to week 24 versus placebo. An LDL-C level of <70 mg/dl was achieved in 73.3% of patients in the evolocumab group versus 7.9% in the placebo group. Evolocumab also significantly reduced other atherogenic lipid levels, including non–high-density lipoprotein cholesterol, apolipoprotein B, and lipoprotein(a) (all p < 0.0001). Evolocumab was well tolerated, and treatment-emergent adverse events patient incidence was similar among evolocumab and placebo groups.
Conclusions Evolocumab was safe and significantly reduced lipid levels in dyslipidemic PLHIV on maximally-tolerated statin therapy. Evolocumab is an effective therapy for lowering atherogenic lipoproteins in PLHIV with high cardiovascular risk. (Safety, Tolerability & Efficacy on LDL-C of Evolocumab in Subjects With HIV & Hyperlipidemia/Mixed Dyslipidemia; NCT02833844)
- cardiovascular disease
- low-density lipoprotein cholesterol (LDL-C)
- people living with HIV (PLHIV)
- proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor
Study funding was provided by Amgen Inc. Dr. Boccara has received research grants from Amgen; has received lecture fees from Janssen, Gilead, ViiV Healthcare, Amgen, Sanofi, Merck Sharp and Dohme, and Servier outside of the submitted work. Dr. Kumar has received grants from Amgen, GlaxoSmithKline, Merck, Gilead, and Thera-technologies; has received consulting fees from Amgen, GlaxoSmithKline, Merck, Gilead, and TheraTherapeutics; and has stock in GlaxoSmithKline, Merck, Gilead, Pfizer, and Johnson & Johnson. Dr. Caramelli has received research support from Boehringer Ingelheim and Amgen; has received consulting fees from Amgen and Bayer; and has received honoraria for nonpromotional speaking from Servier, Boehringer Ingelheim, and from Elsevier’s Order Sets. Dr. Calmy has received education grants to the HIV Unit, Geneva University Hospitals from Janssen, Gilead, ViiV Healthcare, Merck Sharp and Dohme, and Amgen. Drs. Lopez, Bray, and Cyrille are employees and stockholders of Amgen Inc. Dr. Rosenson has received research support from Akcea, Amgen, The Medicines Company, Novartis, and Regeneron; has received consulting fees from Amgen, C5, CVS Caremark, Corvidia, and The Medicines Company; has received honoraria for nonpromotional speaking from Amgen, Kowa, Pfizer, and Regeneron; has received royalties from UpToDate, Inc.; and has stock ownership in MediMergent, LLC.
The authors attest they are in compliance with human studies committees and animal welfare regulations of the authors’ institutions and Food and Drug Administration guidelines, including patient consent where appropriate. For more information, visit the JACC author instructions page.
- Received February 14, 2020.
- Revision received March 16, 2020.
- Accepted March 17, 2020.
- 2020 The Authors