Evolocumab in HIV-Infected Patients With Dyslipidemia Academic Article uri icon

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abstract

  • BACKGROUND: People living with human immunodeficiency virus (PLHIV) are at increased risk of atherosclerotic cardiovascular disease (ASCVD) and are 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 (EvolocumaB Effect on LDL-C Lowering in SubJEcts with Human Immunodeficiency VirRus and INcreased Cardiovascular RisK) 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 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% confidence interval: 61.6% to 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-high-density lipoprotein cholesterol, apolipoprotein B, and lipoprotein(a) (all p < 0.0001). Evolocumab was well tolerated, and treatment-emergent adverse events 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. (Safety, Tolerability & Efficacy on LDL-C of Evolocumab in Subjects With HIV & Hyperlipidemia/Mixed Dyslipidemia; NCT02833844).

authors

  • Boccara, Franck
  • Kumar, Princy N
  • Caramelli, Bruno
  • Calmy, Alexandra
  • López, J Antonio G
  • Bray, Sarah
  • Cyrille, Marcoli
  • Rosenson, Robert S
  • Baker, David
  • Bloch, Mark
  • Finlayson, Robert
  • Hoy, Jennifer
  • Koh, Kenneth
  • Roth, Norman
  • De Wit, Stephane
  • Florence, Eric
  • Vandekerckhove, Linos
  • Caramelli, Bruno
  • Ramalho Madruga, Jose Valdez
  • Wagner Cardoso, Sandra
  • Bondy, Greg
  • Gill, Michael
  • Tsoukas, George
  • Trottier, Sylvie
  • Smieja, Marek
  • Boccara, Franck
  • Katlama, Christine
  • Bonnet, Fabrice
  • Raffi, Francois
  • Cotte, Laurent
  • Molina, Jean-Michel
  • Reynes, Jacques
  • Papadopoulos, Antonios
  • Metallidis, Simeon
  • Paparizos, Vassilios
  • Papastamopoulos, Vasileios
  • Mussini, Cristina
  • Galli, Massimo
  • Antinori, Andrea
  • Di Biagio, Antonio
  • Viale, Pierluigi
  • Horban, Andrzej
  • Marques, Nuno
  • Coutinho, Daniel
  • Oliveira, Joaquim
  • Freitas, Paula
  • Preotescu, Liliana-Lucia
  • Marincu, Iosif
  • Silaghi, Rodica
  • Rugina, Sorin
  • Mwelase, Noluthando
  • Kotze, Sheena
  • Bernardino de la Serna, Jose Ignacio
  • Estrada Perez, Vicente
  • Martinez, Esteban
  • Curran, Adrian
  • Braun, Dominique Laurent
  • Calmy, Alexandra
  • Bernasconi, Enos
  • Cavassini, Matthias
  • Walsh, John
  • Fox, Julie
  • Moyle, Graeme
  • Rosenson, Robert
  • Morano, Jamie
  • Baker, Jason
  • Pierone, Gerald
  • Fichtenbaum, Carl
  • Benson, Paul
  • Goldstein, Deborah
  • Sacco, Joseph
  • Kumar, Princy
  • Grossberg, Robert
  • Chew, Kara
  • DeFilippi, Christopher
  • Drelichman, Vilma
  • Markowitz, Norman
  • Parenti, David
  • Doktor, Katherine
  • Thompson, Paul

publication date

  • May 2020