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1. Inadequate use of antibiotics in the covid-19 era: effectiveness of antibiotic therapy

Author

Alejandro David Bendala Estrada, Jorge Calderón Parra, Eduardo Fernández Carracedo, Antonio Muiño Míguez, Antonio Ramos Martínez, Elena Muñez Rubio, Manuel Rubio-Rivas, Paloma Agudo, Francisco Arnalich Fernández, Vicente Estrada Perez, María Luisa Taboada Martínez, Anxela Crestelo Vieitez, Paula Maria Pesqueira Fontan, Marta Bustamante, Santiago J. Freire, Isabel Oriol-Bermúdez, Arturo Artero, Julián Olalla Sierra, María Areses Manrique, H. Francisco Javier Carrasco-Sánchez, Vanessa Carolina Vento, Gema María García García, Pablo Cubero-Morais, José-Manuel Casas-Rojo, and Jesús Millán Núñez-Cortés

Subjects
COVID-19, SARS-CoV-2, Antibiotics, Survival, Macrolides, Azithromycin, Infectious and parasitic diseases, RC109-216
Abstract

Abstract Background Since December 2019, the COVID-19 pandemic has changed the concept of medicine. This work aims to analyze the use of antibiotics in patients admitted to the hospital due to SARS-CoV-2 infection. Methods This work analyzes the use and effectiveness of antibiotics in hospitalized patients with COVID-19 based on data from the SEMI-COVID-19 registry, an initiative to generate knowledge about this disease using data from electronic medical records. Our primary endpoint was all-cause in-hospital mortality according to antibiotic use. The secondary endpoint was the effect of macrolides on mortality. Results Of 13,932 patients, antibiotics were used in 12,238. The overall death rate was 20.7% and higher among those taking antibiotics (87.8%). Higher mortality was observed with use of all antibiotics (OR 1.40, 95% CI 1.21–1.62; p

Published
2021
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2. Prognostic Impact of Hyponatremia and Hypernatremia in COVID-19 Pneumonia. A HOPE-COVID-19 (Health Outcome Predictive Evaluation for COVID-19) Registry Analysis

Author

Jorge Gabriel Ruiz-Sánchez, Ivan J. Núñez-Gil, Martin Cuesta, Miguel A. Rubio, Charbel Maroun-Eid, Ramón Arroyo-Espliguero, Rodolfo Romero, Victor Manuel Becerra-Muñoz, Aitor Uribarri, Gisela Feltes, Daniela Trabattoni, María Molina, Marcos García Aguado, Martino Pepe, Enrico Cerrato, Emilio Alfonso, Alex Fernando Castro Mejía, Sergio Raposeiras Roubin, Luis Buzón, Elvira Bondia, Francisco Marin, Javier López Pais, Mohammad Abumayyaleh, Fabrizio D’Ascenzo, Elisa Rondano, Jia Huang, Cristina Fernandez-Perez, Carlos Macaya, Paz de Miguel Novoa, Alfonso L. Calle-Pascual, Vicente Estrada Perez, Isabelle Runkle, and HOPE COVID-19 investigators

Subjects
hyponatremia, hypernatremia, COVID-19, SARS-COV2, mortality, sepsis, Diseases of the endocrine glands. Clinical endocrinology, RC648-665
Abstract

Dysnatremia is associated with increased mortality in patients with community-acquired pneumonia. SARS-COV2 (Severe-acute-respiratory syndrome caused by Coronavirus-type 2) pneumonia can be fatal. The aim of this study was to ascertain whether admittance dysnatremia is associated with mortality, sepsis, or intensive therapy (IT) in patients hospitalized with SARS-COV2 pneumonia. This is a retrospective study of the HOPE-COVID-19 registry, with data collected from January 1th through April 31th, 2020. We selected all hospitalized adult patients with RT-PCR-confirmed SARS-COV2 pneumonia and a registered admission serum sodium level (SNa). Patients were classified as hyponatremic (SNa 145 mmol/L). Multivariable analyses were performed to elucidate independent relationships of admission hyponatremia and hypernatremia, with mortality, sepsis, or IT during hospitalization. Four thousand six hundred sixty-four patients were analyzed, median age 66 (52–77), 58% males. Death occurred in 988 (21.2%) patients, sepsis was diagnosed in 551 (12%) and IT in 838 (18.4%). Hyponatremia was present in 957/4,664 (20.5%) patients, and hypernatremia in 174/4,664 (3.7%). Both hyponatremia and hypernatremia were associated with mortality and sepsis. Only hyponatremia was associated with IT. In conclusion, hyponatremia and hypernatremia at admission are factors independently associated with mortality and sepsis in patients hospitalized with SARS-COV2 pneumonia.Clinical Trial Registrationhttps://clinicaltrials.gov/ct2/show/NCT04334291, NCT04334291.

Published
2020
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3. Impact of CD4 and CD8 dynamics and viral rebounds on loss of virological control in HIV controllers.

Author

Fanny Chereau, Yoann Madec, Caroline Sabin, Niels Obel, Ezequiel Ruiz-Mateos, Georgios Chrysos, Sarah Fidler, Clara Lehmann, Robert Zangerle, Linda Wittkop, Peter Reiss, Osamah Hamouda, Vicente Estrada Perez, Manuel Leal, Amanda Mocroft, Patricia Garcia De Olalla, Adriana Ammassari, Antonella D'Arminio Monforte, Cristina Mussini, Ferran Segura, Antonella Castagna, Matthias Cavassini, Sophie Grabar, Philippe Morlat, Stéphane De Wit, Olivier Lambotte, Laurence Meyer, and HIV Controllers Project Working Group for the Collaboration of Observational HIV Epidemiological Research Europe (COHERE) in EuroCOORD

Subjects
Medicine, Science
Abstract

HIV controllers (HICs) spontaneously maintain HIV viral replication at low level without antiretroviral therapy (ART), a small number of whom will eventually lose this ability to control HIV viremia. The objective was to identify factors associated with loss of virological control.HICs were identified in COHERE on the basis of ≥5 consecutive viral loads (VL) ≤500 copies/mL over ≥1 year whilst ART-naive, with the last VL ≤500 copies/mL measured ≥5 years after HIV diagnosis. Loss of virological control was defined as 2 consecutive VL >2000 copies/mL. Duration of HIV control was described using cumulative incidence method, considering loss of virological control, ART initiation and death during virological control as competing outcomes. Factors associated with loss of virological control were identified using Cox models. CD4 and CD8 dynamics were described using mixed-effect linear models.We identified 1067 HICs; 86 lost virological control, 293 initiated ART, and 13 died during virological control. Six years after confirmation of HIC status, the probability of losing virological control, initiating ART and dying were 13%, 37%, and 2%. Current lower CD4/CD8 ratio and a history of transient viral rebounds were associated with an increased risk of losing virological control. CD4 declined and CD8 increased before loss of virological control, and before viral rebounds.Expansion of CD8 and decline of CD4 during HIV control may result from repeated low-level viremia. Our findings suggest that in addition to superinfection, other mechanisms, such as low grade viral replication, can lead to loss of virological control in HICs.

Published
2017
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4. 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

5. 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

6. Changes in the profile of newly HIV-diagnosed men who have sex with men, Madrid, 2014 to 2019

Author

Vicente Estrada Perez, Jorge Del Romero Guerrero, Enrique Fuentes Ferrer, Oskar Ayerdi Aguirrebengoa, Clara Lejarrag Cañas, Petunia Clavo Escribano, Juan Ballesteros Martín, Montserrat Raposo Utrilla, Mar Vera Garcia, Teresa Puerta López, and Carmen Rodríguez Martín

Subjects
Adult, Male, medicine.medical_specialty, seroconvertors, Latin Americans, Sexual Behavior, chemsex, Population, Human immunodeficiency virus (HIV), Sexually Transmitted Diseases, HIV Infections, Newly diagnosed, medicine.disease_cause, Men who have sex with men, Sexual and Gender Minorities, prevention, Virology, Epidemiology, medicine, Humans, Seroconversion, Homosexuality, Male, education, education.field_of_study, Unsafe Sex, business.industry, Research, Public Health, Environmental and Occupational Health, HIV, Observational study, epidemiology, business, Demography
Abstract

Introduction Knowing the factors associated with HIV transmission is necessary in order to design preventive programmes tailored to the epidemiological situation in each region and population. Aim Our objective was to study the sociodemographic, clinical and behavioural characteristics of men who have sex with men (MSM) who were newly diagnosed with HIV infection. Methods We carried out an observational, descriptive, study on all MSM newly diagnosed with HIV infection in one clinic for sexually transmitted infections (STI) and HIV clinic in Madrid between 2014 and 2019. Information on sociodemographic, clinical, and behavioural characteristics of participants per year of diagnosis was collected. Results We detected a total of 1,398 people with HIV infection, 253 of whom were recent seroconverters (rSCV) with a median duration of documented seroconversion of 6 months. From the total, 97.9% infections were sexually transmitted and 2.1% involved injected drugs, i.e. slam practices. The average age was 32.9 years (range: 15.6–74.9), 51.8% were Spanish and 40% Latin American. These diagnoses decreased in Spanish people and increased in Latin Americans during the study period. Of the rSCV, 73.9% had condomless sex under the influence of drugs and 28.9% participated in chemsex sessions. Apps were used by 92.6% rSCV for sexual encounters and 70.4% of them attributed HIV transmission to their use. Conclusions Combination of HIV prevention strategies, as pre-exposure prophylaxis, should be reinforced among young MSM, especially those born in Latin America, those who use drugs for sex, and those who use apps in search of sexual contacts.

Published
2021

7. Inadequate use of antibiotics in the covid-19 era: effectiveness of antibiotic therapy

Author

Francisco Arnalich Fernández, H Francisco Javier Carrasco-Sánchez, Jesús Millán Núñez-Cortés, Santiago Jesús Freire, Gema María García García, Julián Olalla Sierra, Paloma Agudo, María Luisa Taboada Martínez, José-Manuel Casas-Rojo, Pablo Cubero-Morais, Elena Rubio, Vanessa Carolina Vento, Manuel Rubio-Rivas, Jorge Calderón Parra, Paula Maria Pesqueira Fontan, Antonio Ramos Martínez, Isabel Oriol-Bermúdez, Marta Bustamante, María Areses Manrique, Anxela Crestelo Vieitez, Antonio Muiño Miguez, Alejandro David Bendala Estrada, Arturo Artero, Eduardo Fernández Carracedo, and Vicente Estrada Perez

Subjects
medicine.medical_specialty, Survival, medicine.drug_class, Antibiotics, Antibiòtics, Infectious and parasitic diseases, RC109-216, Disease, Azithromycin, Medical microbiology, Pandemic, Clinical endpoint, medicine, Humans, Intensive care medicine, Supervivència, Pandemics, business.industry, SARS-CoV-2, Medical record, Mortality rate, Research, COVID-19, Anti-Bacterial Agents, COVID-19 Drug Treatment, Infectious Diseases, Macrolides, business, medicine.drug
Abstract

BackgroundSince December 2019, the COVID-19 pandemic has changed the concept of medicine. This work aims to analyze the use of antibiotics in patients admitted to the hospital due to SARS-CoV-2 infection.MethodsThis work analyzes the use and effectiveness of antibiotics in hospitalized patients with COVID-19 based on data from the SEMI-COVID-19 registry, an initiative to generate knowledge about this disease using data from electronic medical records. Our primary endpoint was all-cause in-hospital mortality according to antibiotic use. The secondary endpoint was the effect of macrolides on mortality.ResultsOf 13,932 patients, antibiotics were used in 12,238. The overall death rate was 20.7% and higher among those taking antibiotics (87.8%). Higher mortality was observed with use of all antibiotics (OR 1.40, 95% CI 1.21–1.62;p p ConclusionsBacterial co-infection was uncommon among COVID-19 patients, yet use of antibiotics was high. There is insufficient evidence to support widespread use of empiric antibiotics in these patients. Most may not require empiric treatment and if they do, there is promising evidence regarding azithromycin as a potential COVID-19 treatment.

Published
2021

8. Low use of condom and high STI incidence among men who have sex with men in PrEP programs

Author

Nuria Fernandez Piñeiro, Estefanía Hurtado Gallegos, Mónica García Lotero, Carmen Rodríguez Martín, Petunia Clavo Escribano, Juan Ballesteros Martín, Oskar Ayerdi Aguirrebengoa, Montserrat Raposo Utrilla, Natalia Gil García, Clara Lejarraga Cañas, Daniel Arias Ramírez, Manuel Ferrer, Mar Vera Garcia, Teresa Puerta López, Vicente Estrada Perez, and Jorge Del Romero Guerrero

Subjects
Bacterial Diseases, RNA viruses, Male, Multivariate analysis, Epidemiology, Hepacivirus, 030204 cardiovascular system & hematology, Treponematoses, Chlamydia Infection, law.invention, Men who have sex with men, Condoms, Medical Conditions, 0302 clinical medicine, law, Medicine and Health Sciences, Medicine, Public and Occupational Health, 030212 general & internal medicine, Pathology and laboratory medicine, Multidisciplinary, Chlamydia, Hepatitis C virus, Incidence, Incidence (epidemiology), virus diseases, Medical microbiology, Infectious Diseases, Viruses, Anatomy, Pathogens, Research Article, Neglected Tropical Diseases, Adult, Referral, Urology, Science, Sexually Transmitted Diseases, Microbiology, Young Adult, 03 medical and health sciences, Risk-Taking, Condom, Humans, Syphilis, Homosexuality, Male, Flaviviruses, Prophylaxis, Genitourinary Infections, business.industry, Rectum, Organisms, Viral pathogens, Biology and Life Sciences, Tropical Diseases, medicine.disease, Hepatitis viruses, Microbial pathogens, Gastrointestinal Tract, Risk compensation, Medical Risk Factors, Rectal gonorrhea, Pre-Exposure Prophylaxis, Preventive Medicine, business, Digestive System, Demography
Abstract

Objective Since the recent introduction of preexposure prophylaxis (PrEP), several studies have reported a decrease in the use of condoms and a rise in STIs among users. This rise in risk behavior associated with the advent of PrEP is known as “risk compensation.” The aim of this study is to measure clinical and behavioral changes associated with the introduction of PrEP by analyzing condom use for anal intercourse, number of sexual partners, sexualized drug use and STI incidence. Methods We performed a retrospective descriptive study of PrEP users followed every 3months over a 2-year period spanning 2017–2019 in a referral clinic specializing in STI/HIV in Madrid, Spain. One hundred ten men who have sex with men and transgender women underwent regular screening for STIs and hepatitis C virus (HCV) infection. Sociodemographic, clinical, and behavioral data were gathered for all subjects studied. Results The risk compensation observed in this study consisted primarily of a lower rate of condom use, while the number of sexual partners and recreational drug consumption remained stable. We observed a very high incidence of STIs in this sample, particularly rectal gonorrhea and chlamydia. The factors shown to be independently associated with the presence of an STI on multivariate analysis were age below 30 years and over 10 sexual partners/month. Conclusion The incidence of STI acquisition was higher than expected, indicating a need for strategies to minimize this impact, particularly among younger individuals with a higher number of sexual partners.

Published
2021

9. 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

10. Dolutegravir plus lamivudine versus dolutegravir plus tenofovir disoproxil fumarate and emtricitabine in antiretroviral-naive adults with HIV-1 infection (GEMINI-1 and GEMINI-2): week 48 results from two multicentre, double-blind, randomised, non-inferiority, phase 3 trials

Author

Pedro Cahn, Juan Sierra Madero, José Ramón Arribas, Andrea Antinori, Roberto Ortiz, Amanda E Clarke, Chien-Ching Hung, Jürgen K Rockstroh, Pierre-Marie Girard, Jörg Sievers, Choy Man, Alexander Currie, Mark Underwood, Allan R Tenorio, Keith Pappa, Brian Wynne, Anna Fettiplace, Martin Gartland, Michael Aboud, Kimberly Smith, Lidia Cassetti, Daniel David, Laura Figueras, Marcelo Losso, Gustavo Lopardo, Sergio Lupo, Norma Porteiro, Marisa Sánchez, Mark Bloch, David Cooper, Robert Finlayson, Anthony Kelleher, Kenneth Koh, David Lewis, James McMahon, Richard Moore, Norman Roth, Matthew Shields, Stephane De Wit, Eric Florence, Jean-Christophe Goffard, Remy Demeester, Patrick Lacor, Bernard Vandercam, Linos Vandekerckhove, Jonathan Angel, Jean-Guy Baril, Brian Conway, Alexandra De Pokomandy, Jason Szabo, Sharon Walmsley, Olivier Bouchaud, Christian Chidiac, Pierre Delobel, Cecile Goujard, Christine Katlama, Jean-Michel Molina, Gilles Pialoux, Patrick Philibert, Johannes Bogner, Stefan Esser, Ivanka Krznaric, Clara Lehmann, Christoph Spinner, Hans-Jurgen Stellbrink, Christoph Stephan, Albrecht Stoehr, Enrico Barchi, Pietro Caramello, Francesco Castelli, Anna Maria Cattelan, Antonella D'Arminio Monforte, Antonio Di Biagio, Giovanni Di Perri, Andrea Gori, Franco Maggiolo, Barbara Menzaghi, Guglielmo Migliorino, Cristina Mussini, Giovanni Penco, Massimo Puoti, Giuliano Rizzardini, Roberto Gulminetti, Adriano Lazzarin, Tiziano Quirino, Laura Sighinolfi, Pierluigi Viale, Gerardo Amaya Tapia, Jaime Andrade Villanueva, Enrique R Granados Reyes, Alma Perez Rios, Mario Santoscoy Gomez, Jan Den Hollander, Bart Rijnders, José A Hidalgo, Luis Hercilla Vasquez, Luis Illescas, Anita Olczak, Kamal Mansinho, Patricia Paula Correia Pacheco, Eugénio Teófilo, Jose Saraiva da Cunha, Rui Sarmento e Castro, Rosário Serrão, Manuela Arbune, Cristian Jianu, Anca Oprea, Liliana Preotescu, Liviu-Jany Prisacariu, Elena Belonosova, Olga Borodkina, Oxana Chernova, Natalia Gankina, Svetlana Kizhlo, Valeriy Kulagin, Nadezhda Kurina, Firaya Nagimova, Vadim Pokrovsky, Elena Ryamova, Evgeny Voronin, Alexey Yakovlev, Richard Kaplan, Sun Hee Lee, Shin-Woo Kim, Sang-Il Kim, Woo Joo Kim, Antonio Antela Lopez, Jose L Casado Osorio, Manuel A Castaño Carracedo, Ignacio De Los Santos Gil, Vicente Estrada Perez, Vicenç Falco Ferrer, Luis Force, Maria Jose Galinda Puerto, Miguel Garcia Deltoro, Josep M Gatell, Miguel A Goenaga Sanchez, Ana González Cordón, Hernando Knobel, Juan Carlos Lopez Bernaldo de Quiros, Juan E Losa Garcia, Mar Masia, Marta Montero-Alsonso, Antonio Ocampo Hermida, Juan Pasquau Liaño, Joaquin Portilla Sogorb, Federico Pulido Ortega, Antonio Rivera Roman, Jose Ramon Santos Fernandez, Rafael Torres Perea, Jesus Troya Garcia, Pompeyo Viciana Fernandez, Alexandra Calmy, Christoph Hauser, Jan Fehr, Shu-Hsing Cheng, Wen-Chien Ko, Hsi-Hsun Lin, Po-Liang Lu, Yu-Ting Tseng, Ning-Chi Wang, Wing-Wai Wong, Chia-Jui Yang, Roberto Arduino, Paul Benson, Mezgebe Berhe, Fritz Bredeek, Cynthia Brinson, Thomas Campbell, Gordon Crofoot, Douglas Cunningham, Edwin DeJesus, Robin Dretler, Joseph Eron, Kenneth Fife, Carl Fichtenbaum, Jason Flamm, Deborah Goldstein, Samir Gupta, Debbie Hagins, Margaret Hoffman-Terry, Dushyantha Jayaweera, Clifford Kinder, Daniel Klein, Cheryl McDonald, Anthony Mills, Ronald Nahass, Olayemi Osiyemi, Edgar Overton, David Parks, David Prelutsky, Moti Ramgopal, Shannon Schrader, Beverly Sha, Gary Simon, James Sims, Daniel Skiest, Jihad Slim, Karen Tashima, Blair Thedinger, Brian Gazzard, Julie Fox, Margaret Johnson, Stephen Kegg, Saye Khoo, Charles Mazhude, Chloe Orkin, Gabriel Schembri, Andrew Ustianowski, Clinical sciences, Microbiology and Infection Control, Internal Medicine, Cahn, P, Madero, J, Arribas, J, Antinori, A, Ortiz, R, Clarke, A, Hung, C, Rockstroh, J, Girard, P, Sievers, J, Man, C, Currie, A, Underwood, M, Tenorio, A, Pappa, K, Wynne, B, Fettiplace, A, Gartland, M, Aboud, M, Smith, K, Cassetti, L, David, D, Figueras, L, Losso, M, Lopardo, G, Lupo, S, Porteiro, N, Sanchez, M, Bloch, M, Cooper, D, Finlayson, R, Kelleher, A, Koh, K, Lewis, D, Mcmahon, J, Moore, R, Roth, N, Shields, M, De Wit, S, Florence, E, Goffard, J, Demeester, R, Lacor, P, Vandercam, B, Vandekerckhove, L, Angel, J, Baril, J, Conway, B, De Pokomandy, A, Szabo, J, Walmsley, S, Bouchaud, O, Chidiac, C, Delobel, P, Goujard, C, Katlama, C, Molina, J, Pialoux, G, Philibert, P, Bogner, J, Esser, S, Krznaric, I, Lehmann, C, Spinner, C, Stellbrink, H, Stephan, C, Stoehr, A, Barchi, E, Caramello, P, Castelli, F, Cattelan, A, D'Arminio Monforte, A, Di Biagio, A, Di Perri, G, Gori, A, Maggiolo, F, Menzaghi, B, Migliorino, G, Mussini, C, Penco, G, Puoti, M, Rizzardini, G, Gulminetti, R, Lazzarin, A, Quirino, T, Sighinolfi, L, Viale, P, Amaya Tapia, G, Andrade Villanueva, J, Granados Reyes, E, Perez Rios, A, Santoscoy Gomez, M, Den Hollander, J, Rijnders, B, Hidalgo, J, Hercilla Vasquez, L, Illescas, L, Olczak, A, Mansinho, K, Correia Pacheco, P, Teofilo, E, Saraiva da Cunha, J, Sarmento e Castro, R, Serrao, R, Arbune, M, Jianu, C, Oprea, A, Preotescu, L, Prisacariu, L, Belonosova, E, Borodkina, O, Chernova, O, Gankina, N, Kizhlo, S, Kulagin, V, Kurina, N, Nagimova, F, Pokrovsky, V, Ryamova, E, Voronin, E, Yakovlev, A, Kaplan, R, Lee, S, Kim, S, Kim, W, Antela Lopez, A, Casado Osorio, J, Castano Carracedo, M, De Los Santos Gil, I, Estrada Perez, V, Falco Ferrer, V, Force, L, Galinda Puerto, M, Garcia Deltoro, M, Gatell, J, Goenaga Sanchez, M, Gonzalez Cordon, A, Knobel, H, Lopez Bernaldo de Quiros, J, Losa Garcia, J, Masia, M, Montero-Alsonso, M, Ocampo Hermida, A, Pasquau Liano, J, Portilla Sogorb, J, Pulido Ortega, F, Rivera Roman, A, Santos Fernandez, J, Torres Perea, R, Troya Garcia, J, Viciana Fernandez, P, Calmy, A, Hauser, C, Fehr, J, Cheng, S, Ko, W, Lin, H, Lu, P, Tseng, Y, Wang, N, Wong, W, Yang, C, Arduino, R, Benson, P, Berhe, M, Bredeek, F, Brinson, C, Campbell, T, Crofoot, G, Cunningham, D, Dejesus, E, Dretler, R, Eron, J, Fife, K, Fichtenbaum, C, Flamm, J, Goldstein, D, Gupta, S, Hagins, D, Hoffman-Terry, M, Jayaweera, D, Kinder, C, Klein, D, Mcdonald, C, Mills, A, Nahass, R, Osiyemi, O, Overton, E, Parks, D, Prelutsky, D, Ramgopal, M, Schrader, S, Sha, B, Simon, G, Sims, J, Skiest, D, Slim, J, Tashima, K, Thedinger, B, Gazzard, B, Fox, J, Johnson, M, Kegg, S, Khoo, S, Mazhude, C, Orkin, C, Schembri, G, and Ustianowski, A

Subjects
Male, HIV Dolutegravir, HIV Infections, 030204 cardiovascular system & hematology, Piperazines, chemistry.chemical_compound, 0302 clinical medicine, Abacavir, Heterocyclic Compounds, Emtricitabine, 030212 general & internal medicine, Viral, Tenofovir/adverse effects, Lamivudine/adverse effects, Medicine(all), education.field_of_study, Adult, Anti-HIV Agents, Anti-Retroviral Agents, Double-Blind Method, Drug Therapy, Combination, Female, HIV-1, Heterocyclic Compounds, 3-Ring, Humans, Lamivudine, Middle Aged, RNA, Viral, Tenofovir, Viral Load, Heterocyclic Compounds, 3-Ring/adverse effects, General Medicine, Emtricitabine/adverse effects, Tolerability, Dolutegravir, Combination, medicine.drug, medicine.medical_specialty, Pyridones, Population, HIV Infections/drug therapy, Anti-Retroviral Agents/adverse effects, 3-Ring, 03 medical and health sciences, Drug Therapy, SDG 3 - Good Health and Well-being, Internal medicine, Oxazines, medicine, HIV-1/isolation & purification, RNA, Viral/blood, education, business.industry, Viral Load/drug effects, Regimen, chemistry, RNA, Anti-HIV Agents/adverse effects, Ritonavir, business
Abstract

Summary Background Effective two-drug regimens could decrease long-term drug exposure and toxicity with HIV-1 antiretroviral therapy (ART). We therefore aimed to evaluate the efficacy and safety of a two-drug regimen compared with a three-drug regimen for the treatment of HIV-1 infection in ART-naive adults. Methods We conducted two identically designed, multicentre, double-blind, randomised, non-inferiority, phase 3 trials: GEMINI-1 and GEMINI-2. Both studies were done at 192 centres in 21 countries. We included participants (≥18 years) with HIV-1 infection and a screening HIV-1 RNA of 500 000 copies per mL or less, and who were naive to ART. We randomly assigned participants (1:1) to receive a once-daily two-drug regimen of dolutegravir (50 mg) plus lamivudine (300 mg) or a once-daily three-drug regimen of dolutegravir (50 mg) plus tenofovir disoproxil fumarate (300 mg) and emtricitabine (200 mg). Both drug regimens were administered orally. We masked participants and investigators to treatment assignment: dolutegravir was administered as single-entity tablets (similar to its commercial formulation, except with a different film colour), and lamivudine tablets and tenofovir disoproxil fumarate and emtricitabine tablets were over-encapsulated to visually match each other. Primary endpoint was the proportion of participants with HIV-1 RNA of less than 50 copies per mL at week 48 in the intention-to-treat-exposed population, using the Snapshot algorithm and a non-inferiority margin of −10%. Safety analyses were done on the safety population. GEMINI-1 and GEMINI-2 are registered with ClinicalTrials.gov, numbers NCT02831673 and NCT02831764, respectively. Findings Between July 18, 2016, and March 31, 2017, 1441 participants across both studies were randomly assigned to receive either the two-drug regimen (n=719) or three-drug regimen (n=722). At week 48 in the GEMINI-1 intention-to-treat-exposed population, 320 (90%) of 356 participants receiving the two-drug regimen and 332 (93%) of 358 receiving the three-drug regimen achieved plasma HIV-1 RNA of less than 50 copies per mL (adjusted treatment difference −2·6%, 95% CI −6·7 to 1·5); in GEMINI-2, 335 (93%) of 360 in the two-drug regimen and 337 (94%) of 359 in the three-drug regimen achieved HIV-1 RNA of less than 50 copies per mL (adjusted treatment difference −0·7%, 95% CI −4·3 to 2·9), showing non-inferiority at a −10% margin in both studies (pooled analysis: 655 [91%] of 716 in the two-drug regimen vs 669 [93%] of 717 in the three-drug regimen; adjusted treatment difference −1·7%, 95% CI −4·4 to 1·1). Numerically, more drug-related adverse events occurred with the three-drug regimen than with the two-drug regimen (169 [24%] of 717 vs 126 [18%] of 716); few participants discontinued because of adverse events (16 [2%] in the three-drug regimen and 15 [2%] in the two-drug regimen). Two deaths were reported in the two-drug regimen group of GEMINI-2, but neither was considered to be related to the study medication. Interpretation The non-inferior efficacy and similar tolerability profile of dolutegravir plus lamivudine to a guideline-recommended three-drug regimen at 48 weeks in ART-naive adults supports its use as initial therapy for patients with HIV-1 infection. Funding ViiV Healthcare.

Published
2019

11. Vitamin D and sarcopenia in HIV-infected patients

Author

Villar Noemi Gonzelez Perez de, M Teresa Martinez Larrad, Gloria Cánovas Molina, Azucena Rodríguez Robles, Vicente Estrada Perez, Manuel Serrano Ríos, Rivera Jose M Pena Sanchez de, Rosa Villar Vicente, Emilia Cancer Minchot, and Antonio Zapatero Gaviria

Subjects
medicine.medical_specialty, education.field_of_study, Waist, business.industry, Population, Type 2 diabetes, medicine.disease, Circumference, Sarcopenia, Internal medicine, Cohort, Coinfection, medicine, Vitamin D and neurology, business, education
Abstract

Figure 1. DXA scan. Ta ble 1. General characteristics of cohort population. GENERAL FEATURES N 321 AGE (years) 38 (32-45) MALES 0,854 HIV DURATION (years) 4,0 (1,6-10,0) ON ART 0,542 ART DURATION (months) 25 (12-60) HCV COINFECTION 0,188 SMOKING 0,506 TYPE 2 DIABETES 0,01 HYPERTENSION 0,181 BMI (Kg/m) 23,8 (22,1-26,0) WAIST CIRCUMFERENCE (cm) 85 (79-90) LYPODYSTROPHY 0,023 Data expressed in median (IQR) or %.

Published
2013

12. Low use of condom and high STI incidence among men who have sex with men in PrEP programs.

Author

Oskar Ayerdi Aguirrebengoa, Mar Vera García, Daniel Arias Ramírez, Natalia Gil García, Teresa Puerta López, Petunia Clavo Escribano, Juan Ballesteros Martín, Clara Lejarraga Cañas, Nuria Fernandez Piñeiro, Manuel Enrique Fuentes Ferrer, Mónica García Lotero, Estefanía Hurtado Gallegos, Montserrat Raposo Utrilla, Vicente Estrada Pérez, Jorge Del Romero Guerrero, and Carmen Rodríguez Martín

Subjects
Medicine, Science
Abstract

ObjectiveSince the recent introduction of preexposure prophylaxis (PrEP), several studies have reported a decrease in the use of condoms and a rise in STIs among users. This rise in risk behavior associated with the advent of PrEP is known as "risk compensation." The aim of this study is to measure clinical and behavioral changes associated with the introduction of PrEP by analyzing condom use for anal intercourse, number of sexual partners, sexualized drug use and STI incidence.MethodsWe performed a retrospective descriptive study of PrEP users followed every 3months over a 2-year period spanning 2017-2019 in a referral clinic specializing in STI/HIV in Madrid, Spain. One hundred ten men who have sex with men and transgender women underwent regular screening for STIs and hepatitis C virus (HCV) infection. Sociodemographic, clinical, and behavioral data were gathered for all subjects studied.ResultsThe risk compensation observed in this study consisted primarily of a lower rate of condom use, while the number of sexual partners and recreational drug consumption remained stable. We observed a very high incidence of STIs in this sample, particularly rectal gonorrhea and chlamydia. The factors shown to be independently associated with the presence of an STI on multivariate analysis were age below 30 years and over 10 sexual partners/month.ConclusionThe incidence of STI acquisition was higher than expected, indicating a need for strategies to minimize this impact, particularly among younger individuals with a higher number of sexual partners.

Published
2021
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