Phase III BEIJERINCK trial of Repatha shows reduction of LDL-C in HIV patients with dyslipidaemia.- Amgen

Amgen announced positive results from the EvolocumaB Effect on LDL-C LowerIng in SubJEcts with Human Immunodeficiency ViRus and INcreased Cardiovascular RisK (BEIJERINCK) study evaluating the efficacy and safety of Repatha (evolocumab) in patients who are human immunodeficiency virus-positive (HIV+) and have high low-density lipoprotein cholesterol (LDL-C) despite stable background lipid-lowering therapy. The study demonstrated that treatment with Repatha significantly reduced LDL-C. Results from the double-blind 24-week study show that in people living with HIV (PLHIV) with hypercholesterolemia or mixed dyslipidemia, monthly treatment with Repatha reduced LDL-C by 56.9% from baseline compared to placebo, meeting its primary endpoint. Patients treated with Repatha also demonstrated improved secondary outcomes versus placebo with 71.9% of patients achieving an LDL-C reduction of more than or equal to 50% from baseline and 65.4% of patients achieving an LDL-C of less than 70 mg/dL. No new safety concerns were identified in the BEIJERINCK trial. The subject incidence of treatment-emergent adverse events was comparable among both groups.The results were featured as an oral presentation during the virtual American College of Cardiology's 69th Annual Scientific Session with publication in the Journal of the American College of Cardiology. Approximately 38 million individuals live with HIV worldwide, with 1.1 million in the United States. Cardiovascular (CV) risk is estimated to be nearly double in PLHIV compared to individuals who do not have HIV, and PLHIV face significant health challenges at earlier ages than people who do not have HIV. The global burden of HIV-associated cardiovascular disease has tripled over the past two decades, and it will continue to increase as the population of individuals living with HIV ages. Today, 75 percent of PLHIV are over age 45. See-Bocarra F., et al. "Evolocumab Use in Patients With Human Immunodeficiency Virus and Dyslipidemia: Primary Results of a Double-Blind, Placebo-Controlled Study (BEIJERINCK)". To be presented at ACC Scientific Sessions, Abstract Number 913-08 (2020).