Scientific article
Open access

Long-term effects of evolocumab in participants with HIV and dyslipidemia: results from the open-label extension period

Published inAIDS, vol. 36, no. 5, p. 675-682
Publication date2022-04
First online date2022-01-12

Objectives: People with HIV (PWH) are at an increased risk of atherosclerotic cardiovascular disease. Suboptimal responses to statin therapy in PWH may result from antiretroviral therapies (ARTs). This open-label extension study aimed to evaluate the long-term safety and efficacy of evolocumab up to 52 weeks in PWH.

Design: This final analysis of a multinational, placebo-controlled, double-blind, randomized phase 3 trial evaluated the effect of monthly subcutaneous evolocumab 420 mg on low-density lipoprotein cholesterol (LDL-C) during the open-label period (OLP) following 24 weeks of double-blind period in PWH with hypercholesterolemia/mixed dyslipidemia. All participants enrolled had elevated LDL-C or nonhigh-density lipoprotein cholesterol (non-HDL-C) and were on stable maximally tolerated statin and stable ART.

Methods: Efficacy was assessed by percentage change from baseline in LDL-C, triglycerides, and atherogenic lipoproteins. Treatment-emergent adverse events (TEAEs) were examined.

Results: Of the 467 participants randomized in the double-blind period, 451 (96.6%) received at least one dose of evolocumab during the OLP (mean age of 56.4 years, 82.5% male, mean duration with HIV of 17.4 years). By the end of the 52-week OLP, the overall mean (SD) percentage change in LDL-C from baseline was-57.8% (22.8%). Evolocumab also reduced triglycerides, atherogenic lipid parameters (non-HDL-C, apolipoprotein B, total cholesterol, very-low-density lipoprotein cholesterol, and lipoprotein[a]), and increased HDL-C. TEAEs were similar between placebo and evolocumab during the OLP.

Conclusion: Long-term administration of evolocumab lowered LDL-C and non-HDL-C, allowing more PWH to achieve recommended lipid goals with no serious adverse events.

Trail registration: NCT02833844.

Video abstract: http://links.lww.com/QAD/C441.

  • Antibodies, Monoclonal, Humanized / adverse effects
  • Atherosclerosis / chemically induced
  • Atherosclerosis / drug therapy
  • Cholesterol
  • Cholesterol, LDL
  • Double-Blind Method
  • Dyslipidemias / complications
  • Dyslipidemias / drug therapy
  • Female
  • HIV Infections / complications
  • HIV Infections / drug therapy
  • Humans
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors / therapeutic use
  • Male
  • Middle Aged
  • Treatment Outcome
  • Triglycerides / therapeutic use
  • Antibodies, Monoclonal, Humanized
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors
  • Triglycerides
  • Evolocumab
Research group
Citation (ISO format)
BOCCARA, Franck et al. Long-term effects of evolocumab in participants with HIV and dyslipidemia: results from the open-label extension period. In: AIDS, 2022, vol. 36, n° 5, p. 675–682. doi: 10.1097/QAD.0000000000003175
Main files (1)
Article (Published version)
Secondary files (2)
ISSN of the journal0269-9370

Technical informations

Creation02/23/2022 2:31:00 PM
First validation02/23/2022 2:31:00 PM
Update time03/16/2023 6:48:16 AM
Status update03/16/2023 6:48:14 AM
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