Evolocumab treatment in patients with HIV and hypercholesterolemia/mixed dyslipidemia: BEIJERINCK study design and baseline characteristics

Boccara, Franck; Kumar, Princy; Caramelli, Bruno; Calmy, Alexandra; López, J. Antonio G.; Bray, Sarah; Cyrille, Marcoli; Rosenson, Robert S.

doi:10.1016/j.ahj.2019.11.004

Cited by 9 publications

(5 citation statements)

References 34 publications

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“…This nding was consistent with the literature report that among patients living with HIV for a mean duration of 17.4 years, 35.6% had ASCVD, and of those without ASCVD, 53-86% had intermediate or moderate-to-high 10year ASCVD risk scores, cardiovascular risk factors including HIV, 31.9% had low high-density lipoprotein cholesterol levels, and 79.3% needed to receive statin therapy [30].…”

Section: Discussionsupporting

confidence: 91%

Gradual Increasing Dyslipidemia in Male Patients With Human Immunodeficiency Virus Primarily Treated With Tenofovir Plus Lamivudine Plus Efavirenz for Three Years

Liu

Zhang

Kang

et al. 2021

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Introduction: Since the development of antiretroviral therapy (ART) with TDF plus 3TC plus EFV, this specific regimen has not been studied enough with long-term lipid and uric acid monitoring.Methods: A prospective follow-up cohort study was performed. Sixty-one treatment-naive male patients with human immunodeficiency virus (HIV) were divided into three groups based on their baseline CD4+ cell count (26, 12, and 23 patients in the <200, 200 to 350, and >350 groups, respectively). The lipid and purine metabolism parameters of the patients over 144 weeks were analyzed.Result: Within 144 weeks, TG, LDL-c, TC and HDL-c gradually increased, especially the latter two (P=0.001, 0.000, respectively). Moreover, the percentages of hypercholesterolemia, hyper LDL cholesterolemia, hypertriglyceridemia and low HDL cholesterolemia also gradually increased, especially the latter (P=0.0007). The lower the baseline CD4+ cell counts were, the higher the TG levels were and the lower the TC, LDL-c and HDL-c levels were. But there was significant difference of only baseline LDL-c levels between the three groups (P=0.0457). No significant difference of the UA level and the percentages of hyperuricemia was found between the different follow-up time point groups or between the three groups (all P>0.05). The risk factors for dyslipidemia included age, anthropometric parameters and follow-up weeks, and for hyperuricemia was virus load.Conclusions: Gradual increasing dyslipidemia was found in male patients with human immunodeficiency virus primarily treated with tenofovir plus lamivudine plus efavirenz for three years. There-fore lipid metabolism parameters should be closely monitored during long-term ART with the TDF plus 3TC plus EFV regimen.

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Section: Discussionsupporting

confidence: 91%

Gradual Increasing Dyslipidemia in Male Patients With Human Immunodeficiency Virus Primarily Treated With Tenofovir Plus Lamivudine Plus Efavirenz for Three Years

Liu

Zhang

Kang

et al. 2021

Preprint

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“…Literature reported that of patients lived with HIV for mean duration 17.4 years, 35.6% had ASCVD, of those without ASCVD 53-86% had intermediate or moderate-to-high 10-year ASCVD risk scores, the cardiovascular risk factors including HIV, 31.9% low high-density lipoprotein cholesterol, 79.3% needed to receive statin therapy [34].…”

Section: Discussionmentioning

confidence: 99%

Gradually increased dyslipidemia in human immunodeficiency virus infected male patients with tenofovir plus lamivudine plus efavirenz primary treatment: a 3-year follow-up study

Liu

Zhao

Zhang

et al. 2020

Preprint

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IntroductionSince the start of highly active antiretroviral therapy (HAART) with TDF plus 3TC plus EFV, the long-term dynamic characteristics of lipid and purine metabolism in patients infected with human immunodeficiency virus (HIV) was unclear and worth studying.MethodsA prospective follow-up cohort study was the way. Sixty-one treatment-naive HIV infected male patients were divided into three groups based on the baseline CD4 + T cell count (26, 12, 23cases in < 200, from 200 to 350, > 350 three groups, respectively). Lipid and purine metabolism parameters of those patients within 144 weeks were analyzed.ResultTG, TC, LDL-c and HDL-c level all gradually increased within 144 weeks, but statistical significances of TC level and HDL-c level were only found (F = 4.214, 5.518, P = 0.001, 0.000 ,respectively). Moreover the percentage of hypercholesterolemia, hyper LDL cholesterolemia and hypertriglyceridemia all gradually increased, low HDL cholesterolemia gradually decreased, but there was only obvious difference of the latter (χ2 = 16.105, P = 0.0007).Furthermore the lower the baseline CD4 + T lymphocyte counts, the higher TG level, the lower TC level, LDL-c level and HDL-c level, but only significant difference of LDL-c level between three groups at baseline was found (F = 3.256,P = 0.0457).Although UA level and the percentages of hyperuricemia gradually increased within 144 weeks, but there was no significant difference between different follow-up time points groups and between three CD4 + T cell count groups (all P༞0.05).ConclusionsThese findings provide a reference for clinicians to monitor lipid metabolism parameters closely during long-term HAART with TDF plus 3TC plus EFV regimen.

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“…Participants were to demonstrate fasting triglycerides 600 mg/dl or less and HIV viral load 50 copies/ml or less at screening, and cluster of differentiation 4 (CD4) at least 250 cells/ml and HIV viral load 200 copies/ml or less for at least 6 months prior to randomization. Detailed inclusion and exclusion criteria have been published previously [14].…”

Section: Study Design and Participant Populationmentioning

confidence: 99%

“…The design and primary results of the BEIJERINCK study have been previously published [13,14]. This trial had two phases: in the 24 weeks of double-blind treatment period, participants were randomized (2 : 1) to monthly subcutaneous evolocumab 420 mg or placebo, after which participants who received a dose of evolocumab at week 20 continued in an open-label period (OLP).…”

Section: Study Design and Participant Populationmentioning

confidence: 99%

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

Boccara

Caramelli

Calmy³

et al. 2022

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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:NCT02833844Video abstract:http://links.lww.com/QAD/C441

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Evolocumab treatment in patients with HIV and hypercholesterolemia/mixed dyslipidemia: BEIJERINCK study design and baseline characteristics

Cited by 9 publications

References 34 publications

Gradual Increasing Dyslipidemia in Male Patients With Human Immunodeficiency Virus Primarily Treated With Tenofovir Plus Lamivudine Plus Efavirenz for Three Years

Gradual Increasing Dyslipidemia in Male Patients With Human Immunodeficiency Virus Primarily Treated With Tenofovir Plus Lamivudine Plus Efavirenz for Three Years

Gradually increased dyslipidemia in human immunodeficiency virus infected male patients with tenofovir plus lamivudine plus efavirenz primary treatment: a 3-year follow-up study

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

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