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1. Evolocumab in HIV-Infected Patients With Dyslipidemia

Author

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

Subjects
medicine.medical_specialty, Statin, medicine.drug_class, business.industry, 030204 cardiovascular system & hematology, medicine.disease, Placebo, 3. Good health, Double blind, 03 medical and health sciences, Evolocumab, 0302 clinical medicine, Internal medicine, medicine, Clinical endpoint, Hiv infected patients, lipids (amino acids, peptides, and proteins), 030212 general & internal medicine, Cardiology and Cardiovascular Medicine, Adverse effect, business, Dyslipidemia
Abstract

Background People living with HIV (PLHIV) are at increased risk of atherosclerotic cardiovascular disease (ASCVD) and 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 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 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% CI: 61.6%, 52.3%) from baseline to week 24 versus placebo. An LDL-C level of 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.

Published
2020
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2. Long-term effects of evolocumab in participants with HIV and dyslipidemia: results from the open-label extension period

Author

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

Subjects
Male, Immunology, HIV Infections, Cholesterol, LDL, Middle Aged, Antibodies, Monoclonal, Humanized, Atherosclerosis, Infectious Diseases, Cholesterol, Treatment Outcome, Double-Blind Method, Immunology and Allergy, Humans, Female, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Triglycerides, Dyslipidemias
Abstract

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.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.Efficacy was assessed by percentage change from baseline in LDL-C, triglycerides, and atherogenic lipoproteins. Treatment-emergent adverse events (TEAEs) were examined.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.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.NCT02833844.http://links.lww.com/QAD/C441.

Published
2022

3. Risk Factor Associated with Negative Spouse HIV Seroconversion among Sero-Different Couples: A Nested Case-Control Retrospective Survey Study in 30 Counties in Rural China.

Author

Houlin Tang, Zunyou Wu, Yurong Mao, Javier Cepeda, and Jamie Morano

Subjects
Medicine, Science
Abstract

Antiretroviral therapy (ART) and condom use have been proven to reduce the risk of sexual transmission of human immunodeficiency virus (HIV) among HIV sero-different couples, but its full implementation remains a challenge. This study aims to assess HIV seroconversion rate of HIV-negative spouse and its associated risk factors among HIV sero-different couples in rural China.An open cohort of HIV sero-different couples enrolled in 30 counties in China between October 1, 2010, and September 30, 2012, and followed-up to December 31, 2012, was constructed retrospectively. A nested case-control study of risk factors of HIV seroconversion among sero-different couples was conducted in April and May of 2013, based on the open cohort. Sero-different couples with the HIV-negative spouse seroconverting at least 3 months after the previous negative diagnosis during cohort observation period were labeled as "case couples". The "control couples" were selected randomly from the same cohort that did not have the HIV-negative spouse seroconversion during the same period. The "case couples" and "control couples" were matched on gender, age, and region of residence. Sexual behaviors among HIV sero-different couples before and after the index spouses notifying their HIV infection status to their HIV-negative spouses were collected via face-to-face interview. Univariate and multivariate logistic regression models were used to assess factors associated with HIV seroconversion among HIV sero-different couples.Of 4481 HIV sero-different couples, a total of 53 seroconversions were observed within 5218 person-years of follow-up. The incidence rate was 1.02 (95%CI: 0.76-1.33) per 100 person-years. Forty "case couples" confirmed HIV-negative spouse seroconversions infected via marital sexual transmission, were matched to 80 "control couples". Of the 120 couples, 81(67.5%) were receiving ART, and 70 (58.3%) reported consistently used condoms during intercourse after the index spouse was diagnosed HIV infection. Multivariate conditional logistic regression analysis showed that the desire to conceive a child (OR = 5.18, 95% CI: 1.19-22.58) significantly increased the odds of HIV seroconversion. Protective factors of spousal HIV seroconversion were currently receiving ART (OR = 0.09, 95% CI: 0.01-0.67) and consistent condom use (OR = 0.05, 95% CI: 0.01-0.28).Intention to conceive a child is the most important risk factor for HIV seroconversion among sero-different couples. Specific efforts on scientific use of ART to assist sero-different couples to achieve their wish to conceive a healthy child are needed to minimize the risk of HIV transmission.

Published
2016
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4. Evolocumab in HIV-Infected Patients With Dyslipidemia: Primary Results of the Randomized, Double-Blind BEIJERINCK Study

Author

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

Subjects
hypercholesterolemia, low-density lipoprotein cholesterol (LDL-C), cardiovascular disease, people living with HIV (PLHIV), proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor
Published
2020

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