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Evolocumab treatment in patients with HIV and hypercholesterolemia/mixed dyslipidemia: BEIJERINCK study design and
Franck Boccara1, Princy Kumar2, Bruno Caramelli3
1AP-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.
Insights
The BEIJERINCK study evaluated evolocumab in people living with HIV (PLHIV) at high cardiovascular risk. Evolocumab showed promise in lowering LDL cholesterol, offering a new option for PLHIV with hypercholesterolemia despite statin limitations.
Area of Science:
- Cardiology
- Infectious Diseases
- Pharmacology
Background:
- People living with HIV (PLHIV) face elevated atherosclerotic cardiovascular disease (ASCVD) risk from traditional and HIV/antiretroviral treatment (ART)-related factors.
- High-intensity statin therapy is often limited in PLHIV due to comorbidities and drug-drug interactions with ART.
- The BEIJERINCK study addresses the need for effective lipid-lowering strategies in this population.
Purpose of the Study:
- To assess the safety and efficacy of evolocumab in PLHIV with hypercholesterolemia or mixed dyslipidemia.
- To evaluate evolocumab's impact on low-density lipoprotein cholesterol (LDL-C) levels.
- To examine secondary lipid changes and safety profiles.
Main Methods:
- A randomized, double-blind, placebo-controlled, multinational trial.
- Monthly subcutaneous evolocumab 420 mg versus placebo in PLHIV on maximally-tolerated statin therapy.
- Primary outcome: percent change in LDL-C from baseline to week 24.
Main Results:
- 464 patients enrolled (mean age 56.4, 82.5% male, 17.4 years HIV duration).
- 35.6% had documented ASCVD; mean baseline LDL-C was 133.3 mg/dL.
- 79.3% used statins, but 20.7% were statin-intolerant.
Conclusions:
- BEIJERINCK is the first trial of a PCSK9 inhibitor in PLHIV at moderate/high cardiovascular risk.
- Evolocumab offers potential for improved lipid management in PLHIV.
- Further research will confirm long-term efficacy and safety.
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.
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