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

• Published in: The American heart journal 2020-02, Vol.220, p.203-212
• Main Authors: Boccara, Franck, Kumar, Princy, Caramelli, Bruno, Calmy, Alexandra, López, J. Antonio G., Bray, Sarah, Cyrille, Marcoli, Rosenson, Robert S.
• Format: Article
• Language: English
• Subjects: Antibodies, Monoclonal, Humanized - administration & dosage; Antibodies, Monoclonal, Humanized - adverse effects; Anticholesteremic Agents - administration & dosage; Anticholesteremic Agents - adverse effects; Antiretroviral agents; Antiretroviral therapy; Arteriosclerosis; Atherosclerosis; Cardiology and cardiovascular system; Cardiovascular disease; Cardiovascular diseases; Cholesterol; Cholesterol, LDL - blood; Chronic illnesses; Clinical trials; Control methods; Design; Double-Blind Method; Drug Administration Schedule; Drug development; Drug dosages; Dyslipidemia; Dyslipidemias - blood; Dyslipidemias - complications; Dyslipidemias - drug therapy; Fasting; Female; Health risks; Heart attacks; Hepatitis; HIV; HIV Infections - blood; HIV Infections - complications; HIV Infections - drug therapy; HIV Infections - virology; HIV Long-Term Survivors; Human health and pathology; Human immunodeficiency virus; Humans; Hypercholesterolemia; Hypercholesterolemia - blood; Hypercholesterolemia - complications; Hypercholesterolemia - drug therapy; Hypertension; Inflammation; Intolerance; Life Sciences; Lipids; Lipoproteins; Low density lipoprotein; Male; Medical research; Metabolic disorders; Middle Aged; Monoclonal antibodies; Patients; Pharmaceutical sciences; Pharmacology; Proprotein Convertase 9 - antagonists & inhibitors; Reference Values; Risk analysis; Risk factors; Safety; Statins; Stroke; Therapy; Triglycerides; Viral Load; Viruses
• ISSN: 0002-8703; 1097-6744
• DOI: 10.1016/j.ahj.2019.11.004

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. 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