Author + information
- Received February 14, 2020
- Revision received March 16, 2020
- Accepted March 17, 2020
- Published online March 28, 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 and
- Robert S. Rosenson, MDf
- 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, USA
- 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, CA, USA
- fCardiometabolics Unit, Mount Sinai Heart, Icahn School of Medicine at Mount Sinai, New York, NY, USA
- ↵∗Address For Correspondence: Franck Boccara, Cardiology Department, Assistance Publique-Hôpitaux de Paris, Sorbonne University, 184, rue du faubourg St-Antoine, 75571 Paris Cedex 12, France. Tel: +33 149282449. Fax: +33 149282683
Background People living with HIV (PLHIV) are at increased risk of atherosclerotic cardiovascular disease (ASCVD) and 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 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 (TEAEs) 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% CI: 61.6%, 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-HDL-C, ApoB, and Lp(a) (all p<0.0001). Evolocumab was well tolerated, and TEAE 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.
- cardiovascular disease
- people living with HIV (PLHIV)
- proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor
- low-density lipoprotein cholesterol (LDL-C)
FUNDING: Study funding was provided by Amgen Inc. (Thousand Oaks, CA, USA)
DISCLOSURE: Dr. Boccara reports research grants from Amgen; lecture fees from Janssen, Gilead, ViiV Healthcare, Amgen, Sanofi, MSD, and Servier outside the submitted work.
Dr. Kumar 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.
Dr. Caramelli receives research support from Boehringer Ingelheim, Amgen; consulting fees from Amgen, Bayer; honoraria for non-promotional speaking from Servier, Boehringer Ingelheim, and from Elsevier’s Order Sets.
Dr. Calmy reports education grants (to the HIV Unit, Geneva University Hospitals) from Janssen, Gilead, ViiV Healthcare, MSD, and Amgen.
Dr. Lopez, Dr. Bray, and Dr. Cyrille are employees and stockholders of Amgen Inc.
Dr. Rosenson 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.
TWEET: BEIJERINCK demonstrates evolocumab is safe and significantly reduces lipid levels in dyslipidemic people living with HIV on maximally-tolerated statin therapy
CLINICAL TRIALS REGISTRATION NCT02833844
- Received February 14, 2020.
- Revision received March 16, 2020.
- Accepted March 17, 2020.
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