Positive results were announced from the phase 3 BEIJERINCK study evaluating evolocumab (Repatha; Amgen) in adult patients with HIV who have high low-density lipoprotein cholesterol (LDL-C) despite stable background lipid-lowering therapy.
The multicenter, double-blind, placebo-controlled study assessed the efficacy and safety of evolocumab, a proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitor, in 467 HIV patients with hyperlipidemia or mixed dyslipidemia who were on stable HIV therapy for ≥6 months and had been treated with maximally tolerated lipid-lowering therapy for ≥4 weeks. Patients were randomized 2:1 to receive evolocumab 420mg once monthly or placebo for 24 weeks. The primary end point was the change from baseline in LDL-C at week 24.
Results showed that treatment with evolocumab was associated with a 56.9% reduction in LDL-C from baseline compared with placebo. Additionally, evolocumab met key secondary end points with 71.9% of patients achieving an LDL-C reduction of ≥50% from baseline and 65.4% of patients achieving an LDL-C of <70 mg/dL.
With regard to safety, the incidence of treatment-emergent adverse events was comparable between evolocumab and placebo with no new safety concerns. Patients who completed the first portion of the BEIJERINCK study were enrolled in a 24-week open-label extension period.
“This is the first phase 3 study to demonstrate that a PCSK9 inhibitor can effectively and safely reduce LDL-C in people living with HIV at risk for cardiovascular disease who have high cholesterol level despite statin treatment,” said Professor Franck Boccara, MD, PhD, cardiologist and primary study investigator, Sorbonne Université, Paris. “Addressing uncontrolled LDL-C in this high-risk patient population is critical to maintain the progress that has been achieved in improving the lives of people living with HIV.”
Study findings were presented during the virtual American College of Cardiology’s 69th Annual Scientific Session and published in the Journal of the American College of Cardiology (JACC).
Repatha is currently approved to reduce the risk of myocardial infarction, stroke, and coronary revascularization in adults with established cardiovascular disease. It is also indicated as an adjunct to diet, alone or in combination with other lipid-lowering therapies (eg, statins, ezetimibe) for the treatment of adults with primary hyperlipidemia (including heterozygous familial hypercholesterolemia) to reduce LDL-C; and as an adjunct to diet and other LDL-lowering therapies (eg, statins, ezetimibe, LDL apheresis) in patients with homozygous familial hypercholesterolemia who require additional lowering of LDL-C.
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