185 results on '"Juan Sierra Madero"'
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2. EFICÁCIA DURADOURA DE DOLUTEGRAVIR MAIS LAMIVUDINA NO TRATAMENTO ANTIRRETROVIRAL DE ADULTOS NAÏVE COM INFECÇÃO PELO HIV-1: RESULTADOS DE 144 SEMANAS DOS ESTUDOS GEMINI EM PARTICIPANTES DE CENTROS LATINO-AMERICANOS
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Norma Porteiro, Pedro Cahn, Juan Sierra Madero, Choy Y. Man, Jörg Sievers, Rimgaile Urbaityte, Andrés Maldonado, Inez Prudente Martinez, and Jean van Wykd Jaime Andrade-villanueva
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Infectious and parasitic diseases ,RC109-216 ,Microbiology ,QR1-502 - Abstract
Introdução: GEMINI-1/-2 demonstrou que dolutegravir (DTG) + lamivudina (3TC) foi não-inferior a DTG + tenofovir disoproxil fumarato/emtricitabina (TDF/FTC) em 48, 96 e 144 semanas em adultos virgens de tratamento. O objetivo desta análise foi examinar a eficácia e segurança de 144 semanas de DTG + 3TC vs DTG + TDF/FTC em participantes de centros latino-americanos incluídos nos estudos GEMINI-1/-2 (post hoc). Métodos: GEMINI-1/-2 são estudos de fase III idênticos, globais, duplo-cegos e multicêntricos; os participantes triados com RNA do HIV-1 ≤500.000 c/mL foram randomizados 1:1 (estratificados por RNA do HIV-1 e contagem de células CD4 +) para DTG + 3TC ou DTG + TDF/FTC, uma vez ao dia. O desfecho primário foi a proporção de participantes com RNA de HIV-1 plasmático
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- 2022
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3. EFICÁCIA DURADOURA DE DOLUTEGRAVIR (DTG) E LAMIVUDINA (3 TC) PARA TERAPIA ANTIRETROVIRAL DE ADULTOS COM INFECÇÃO POR HIV‐1 SEM TRATAMENTO PRÉVIO ‐ RESULTADO DE 3 ANOS DOS ESTUDOS GEMINI
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Pedro Cahn, Juan Sierra Madero, José Ramón Arribas, Jörg Sievers, Choy Man, Rimgaile Urbaityte, Mark Underwood, Jean Andre Van Wyk, Kimberly Smith, and Roberto Zajdenverg
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Infectious and parasitic diseases ,RC109-216 ,Microbiology ,QR1-502 - Published
- 2021
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4. Duration of anti-tuberculosis therapy and timing of antiretroviral therapy initiation: association with mortality in HIV-related tuberculosis.
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Claudia P Cortes, Firas H Wehbe, Catherine C McGowan, Bryan E Shepherd, Stephany N Duda, Cathy A Jenkins, Elsa Gonzalez, Gabriela Carriquiry, Mauro Schechter, Denis Padgett, Carina Cesar, Juan Sierra Madero, Jean W Pape, Daniel R Masys, Timothy R Sterling, and Caribbean, Central American, South American Network for HIV Research of the International Epidemiologic Databases to Evaluate AIDS
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Medicine ,Science - Abstract
Antiretroviral therapy (ART) decreases mortality risk in HIV-infected tuberculosis patients, but the effect of the duration of anti-tuberculosis therapy and timing of anti-tuberculosis therapy initiation in relation to ART initiation on mortality, is unclear.We conducted a retrospective observational multi-center cohort study among HIV-infected persons concomitantly treated with Rifamycin-based anti-tuberculosis therapy and ART in Latin America. The study population included persons for whom 6 months of anti-tuberculosis therapy is recommended.Of 253 patients who met inclusion criteria, median CD4+ lymphocyte count at ART initiation was 64 cells/mm(3), 171 (68%) received >180 days of anti-tuberculosis therapy, 168 (66%) initiated anti-tuberculosis therapy before ART, and 43 (17%) died. In a multivariate Cox proportional hazards model that adjusted for CD4+ lymphocytes and HIV-1 RNA, tuberculosis diagnosed after ART initiation was associated with an increased risk of death compared to tuberculosis diagnosis before ART initiation (HR 2.40; 95% CI 1.15, 5.02; P = 0.02). In a separate model among patients surviving >6 months after tuberculosis diagnosis, after adjusting for CD4+ lymphocytes, HIV-1 RNA, and timing of ART initiation relative to tuberculosis diagnosis, receipt of >6 months of anti-tuberculosis therapy was associated with a decreased risk of death (HR 0.23; 95% CI 0.08, 0.66; P=0.007).The increased risk of death among persons diagnosed with tuberculosis after ART initiation highlights the importance of screening for tuberculosis before ART initiation. The decreased risk of death among persons receiving > 6 months of anti-tuberculosis therapy suggests that current anti-tuberculosis treatment duration guidelines should be re-evaluated.
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- 2013
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5. Rates and reasons for early change of first HAART in HIV-1-infected patients in 7 sites throughout the Caribbean and Latin America.
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Carina Cesar, Bryan E Shepherd, Alejandro J Krolewiecki, Valeria I Fink, Mauro Schechter, Suely H Tuboi, Marcelo Wolff, Jean W Pape, Paul Leger, Denis Padgett, Juan Sierra Madero, Eduardo Gotuzzo, Omar Sued, Catherine C McGowan, Daniel R Masys, Pedro E Cahn, and Caribbean, Central and South America Network for HIV Research (CCASAnet) Collaboration of the International Epidemiologic Databases to Evaluate AIDS (IeDEA) Program
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Medicine ,Science - Abstract
HAART rollout in Latin America and the Caribbean has increased from approximately 210,000 in 2003 to 390,000 patients in 2007, covering 62% (51%-70%) of eligible patients, with considerable variation among countries. No multi-cohort study has examined rates of and reasons for change of initial HAART in this region.Antiretroviral-naïve patients >or= 18 years who started HAART between 1996 and 2007 and had at least one follow-up visit from sites in Argentina, Brazil, Chile, Haiti, Honduras, Mexico and Peru were included. Time from HAART initiation to change (stopping or switching any antiretrovirals) was estimated using Kaplan-Meier techniques. Cox proportional hazards modeled the associations between change and demographics, initial regimen, baseline CD4 count, and clinical stage.Of 5026 HIV-infected patients, 35% were female, median age at HAART initiation was 37 years (interquartile range [IQR], 31-44), and median CD4 count was 105 cells/uL (IQR, 38-200). Estimated probabilities of changing within 3 months and one year of HAART initiation were 16% (95% confidence interval (CI) 15-17%) and 28% (95% CI 27-29%), respectively. Efavirenz-based regimens and no clinical AIDS at HAART initiation were associated with lower risk of change (hazard ratio (HR) = 1.7 (95% CI 1.1-2.6) and 2.1 (95% CI 1.7-2.5) comparing neverapine-based regimens and other regimens to efavirenz, respectively; HR = 1.3 (95% CI 1.1-1.5) for clinical AIDS at HAART initiation). The primary reason for change among HAART initiators were adverse events (14%), death (5.7%) and failure (1.3%) with specific toxicities varying among sites. After change, most patients remained in first line regimens.Adverse events were the leading cause for changing initial HAART. Predictors for change due to any reason were AIDS at baseline and the use of a non-efavirenz containing regimen. Differences between participant sites were observed and require further investigation.
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- 2010
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6. Clinical outcomes and risk factors for immune recovery and all‐cause mortality in Latin Americans living with HIV with virological success: a retrospective cohort study
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Gabriel Castillo‐Rozas, Shengxin Tu, Paula Mendes Luz, Fernando Mejia, Juan Sierra‐Madero, Vanessa Rouzier, Bryan E. Shepherd, and Claudia P. Cortes
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Caribbean Region ,CD4 lymphocyte count ,immune reconstitution ,Latin America ,morbidity ,non‐communicable diseases ,Immunologic diseases. Allergy ,RC581-607 - Abstract
Abstract Introduction Immune reconstitution following antiretroviral therapy (ART) initiation is crucial to prevent AIDS and non‐AIDS‐related comorbidities. Patients with suppressed viraemia who fail to restore cellular immunity are exposed to an increased risk of morbidity and mortality during long‐term follow‐up, although the underlying mechanisms remain poorly understood. We aim to describe clinical outcomes and factors associated with the worse immune recovery and all‐cause mortality in people living with HIV (PLWH) from Latin America following ART initiation. Methods Retrospective cohort study using the CCASAnet database: PLWH ≥18 years of age at ART initiation using a three drug‐based combination therapy and with medical follow‐up for ≥24 months after ART initiation and undetectable viral load were included. Patients were divided into four immune recovery groups based on rounded quartiles of increase in CD4 T‐cell count at 2 years of treatment (350 cells/mm3). Primary outcomes included all‐cause mortality, AIDS‐defining events and non‐communicable diseases that occurred >2 years after ART initiation. Factors associated with an increase in CD4 T‐cell count at 2 years of treatment were evaluated using a cumulative probability model with a logit link. Results In our cohort of 4496 Latin American PLWH, we found that patients with the lowest CD4 increase (
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- 2024
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7. Late-onset opportunistic infections while receiving anti-retroviral therapy in Latin America: burden and risk factors
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Isaac Núñez, Brenda Crabtree-Ramirez, Bryan E. Shepherd, Timothy R. Sterling, Pedro Cahn, Valdiléa G. Veloso, Claudia P Cortes, Denis Padgett, Eduardo Gotuzzo, Juan Sierra-Madero, Catherine C. McGowan, Anna K. Person, and Yanink Caro-Vega
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Opportunistic infections ,HIV ,AIDS ,Latin America ,Tuberculosis ,Cohort studies ,Infectious and parasitic diseases ,RC109-216 - Abstract
Objectives: The aim of this study was to describe the incidence, clinical characteristics, and risk factors of late-onset opportunistic infections (LOI) in people who live with HIV (PWLHA) within the Caribbean, Central and South America network for HIV epidemiology. Methods: We performed a retrospective cohort study including treatment-naive PWLHA enrolled at seven sites (Argentina, Brazil, Chile, Peru, Mexico, and two sites in Honduras). Follow-up began at 6 months after treatment started. Outcomes were LOI, loss to follow-up, and death. We used a Cox proportional hazards model and a competing risks model to evaluate risk factors. Results: A total of 10,583 patients were included. Median follow up was at 5.4 years. LOI occurred in 895 (8.4%) patients. Median time to opportunistic infection was 2.1 years. The most common infections were tuberculosis (39%), esophageal candidiasis (10%), and Pneumocystis jirovecii (P. jirovecii) pneumonia (10%). Death occurred in 576 (5.4%) patients, and 3021 (28.5%) patients were lost to follow-up.A protease inhibitor–based regimen (hazard ratio 1.25), AIDS-defining events during the first 6 months of antiretroviral-treatment (hazard ratio 2.12), starting antiretroviral-treatment in earlier years (hazard ratio 1.52 for 2005 vs 2010), and treatment switch (hazard ratio 1.31) were associated with a higher risk of LOI. Conclusion: LOI occurred in nearly one in 10 patients. People with risk factors could benefit from closer follow-up.
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- 2022
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8. Tuberculosis treatment intermittency in the continuation phase and mortality in HIV-positive persons receiving antiretroviral therapy
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Brenda Crabtree-Ramirez, Cathy A. Jenkins, Bryan E. Shepherd, Karu Jayathilake, Valdilea G. Veloso, Gabriela Carriquiry, Eduardo Gotuzzo, Claudia P. Cortes, Dennis Padgett, Catherine McGowan, Juan Sierra-Madero, Serena Koenig, Jean W. Pape, Timothy R. Sterling, and the CCASAnet Region of IeDEA
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Tuberculosis ,Tuberculosis treatment ,HIV ,Intermittent treatment ,ART ,TB maintenance treatment ,Infectious and parasitic diseases ,RC109-216 - Abstract
Abstract Background Some tuberculosis (TB) treatment guidelines recommend daily TB treatment in both the intensive and continuation phases of treatment in HIV-positive persons to decrease the risk of relapse and acquired drug resistance. However, guidelines vary across countries, and treatment is given 7, 5, 3, or 2 days/week. The effect of TB treatment intermittency in the continuation phase on mortality in HIV-positive persons on antiretroviral therapy (ART), is not well-described. Methods We conducted an observational cohort study among HIV-positive adults treated for TB between 2000 and 2018 and after enrollment into the Caribbean, Central, and South America network for HIV epidemiology (CCASAnet; Brazil, Chile, Haiti, Honduras, Mexico and Peru). All received standard TB therapy (2-month initiation phase of daily isoniazid, rifampin or rifabutin, pyrazinamide ± ethambutol) and continuation phase of isoniazid and rifampin or rifabutin, administered concomitantly with ART. Known timing of ART and TB treatment were also inclusion criteria. Kaplan–Meier and Cox proportional hazards methods compared time to death between groups. Missing model covariates were imputed via multiple imputation. Results 2303 patients met inclusion criteria: 2003(87%) received TB treatment 5–7 days/week and 300(13%) 2–3 days/week in the continuation phase. Intermittency varied by site: 100% of patients from Brazil and Haiti received continuation phase treatment 5–7 days/week, followed by Honduras (91%), Peru (42%), Mexico (7%), and Chile (0%). The crude risk of death was lower among those receiving treatment 5–7 vs. 2–3 days/week (HR = 0.68; 95% CI = 0.51—0.91; P = 0.008). After adjusting for age, sex, CD4, ART use at TB diagnosis, site of TB disease (pulmonary vs. extrapulmonary), and year of TB diagnosis, mortality risk was lower, but not significantly, among those treated 5–7 days/week vs. 2–3 days/week (HR 0.75, 95%CI 0.55–1.01; P = 0.06). After also stratifying by study site, there was no longer a protective effect (HR 1.42, 95%CI 0.83–2.45; P = 0.20). Conclusions TB treatment 5–7 days/week was associated with a marginally decreased risk of death compared to TB treatment 2–3 days/week in the continuation phase in multivariable, unstratified analyses. However, little variation in TB treatment intermittency within country meant the results could have been driven by other differences between study sites. Therefore, randomized trials are needed, especially in heterogenous regions such as Latin America.
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- 2022
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9. Prevención y control de la infección por coronavirus SARS-CoV-2 (Covid-19) en unidades de hemodiálisis
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Olynka Vega-Vega, Mauricio Arvizu-Hernández, José Guillermo Domínguez-Cherit, Juan Sierra-Madero, and Ricardo Correa-Rotter
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hemodiálisis ,prevención primaria ,pandemia ,infección por coronavirus ,recomendaciones ,Public aspects of medicine ,RA1-1270 - Abstract
La pandemia del SARS-CoV-2 representa un riesgo especial para los pacientes en hemodiálisis crónica por su estado de inmunosupresión, edad avanzada y coexistencia de comorbilidades importantes, en particular patología cardiovascular, diabetes mellitus y otras. Adicionalmente, esta población constituye un conglomerado cerrado ya que los pacientes acuden a tratamiento con regularidad y permanecen horas en los lugares de tratamiento, expuestos a una posible adquisición de la infección. El hecho de acudir necesaria y regularmente a su tratamiento impide que permanezcan en aislamiento domiciliario y con exposición potencial en el traslado. Las presentes recomendaciones resumen las intervenciones propuestas por tres organizaciones internacionales, a las que se agregan algunas sugeridas por expertos nacionales, con el objetivo de identificar precozmente a los pacientes y personal de la salud en riesgo para disminuir el riesgo de infección.
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- 2020
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10. Favipiravir in patients hospitalised with COVID-19 (PIONEER trial): a multicentre, open-label, phase 3, randomised controlled trial of early intervention versus standard care
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Pallav L Shah, Christopher M Orton, Beatriz Grinsztejn, Gavin C Donaldson, Brenda Crabtree Ramírez, James Tonkin, Breno R Santos, Sandra W Cardoso, Andrew I Ritchie, Francesca Conway, Maria P D Riberio, Dexter J Wiseman, Anand Tana, Bavithra Vijayakumar, Cielito Caneja, Craig Leaper, Bobby Mann, Anda Samson, Pankaj K Bhavsar, Marta Boffito, Mark R Johnson, Anton Pozniak, Michael Pelly, Damon Foster, Nadia Shabbir, Simon Connolly, Andrea Cartier, Sajjida Jaffer, Carmen Winpenny, Doris Daby, Samuel Pepper, Christine Adamson, Jamie Carungcong, Kribashnie Nundlall, Serge Fedele, Pardina Samson-Fessale, Alexandra Schoolmeesters, Laura Gomes de Almeida Martins, Rhian Bull, Patricia Correia Da Costa, Carina Bautista, Maria Eleanor Flores, Shameera Maheswaran, Lester Macabodbod, Rosalie Houseman, Marie-Louise Svensson, Amrinder Sayan, Carrie Fung, Justin Garner, Dilys Lai, Mark Nelson, Luke Moore, Shewta Gidwani, Gary Davies, Beatrice Ouma, Clovis Salinos, Jad Salha, Redasaad Yassein, Abdul Abbasi, Metod Oblak, Angelica Steward, Mini Thankachen, Amy Barker, Candida Fernandes, Veronica Beatriz, Leah Flores, Alfredo Soler-Carracedo, Alessandra Rocca, Carmela Martella, Charlotte Lloyd, Ciara Nolan, Latoya Horsford, Laura Martins, Lervina Thomas, Mark Winstanley, Miriam Bourke, Nicholas Branch, Orhan Orhan, Richard Morton, Sangeetha Saunder, Shashank Patil, Stephen Hughes, Wu Zhe, Ashley De Leon, Ayaan Farah, Grace Rya, Katrin Alizadeh, Kirsty Leong, Laure Trepte, Nupur Goel, Patrick McGown, Ursula Kirwan, Tamiris Vilela Baião, Luana Marins, Sandro Nazer, Raquel Malaguthi de Souza, Marcella Feitosa, Flavia Lessa, Elizabeth Silva de Magalhães, Jamile Costenaro, Rita de Cassia Alves Lira, Ana Carolina, Andréa Cauduro de Castro, Andre Machado Da Silva, Dimas Kliemann, Rita De Cassia Alves Lira, Gemma Walker, Donna Norton, Vicki Lowthorpe, Monica Ivan, Patrick Lillie, Nicholas Easom, Juan Sierra Madero, Álvaro López Iñiguez, Guadalupe Patricia Muñuzuri Nájera, Claudia Paola Alarcón Murra, Audelia Alanis Vega, Teresa Muñoz Trejo, and Olivia Pérez Rodríguez
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Pulmonary and Respiratory Medicine - Abstract
COVID-19 has overwhelmed health services globally. Oral antiviral therapies are licensed worldwide, but indications and efficacy rates vary. We aimed to evaluate the safety and efficacy of oral favipiravir in patients hospitalised with COVID-19.We conducted a multicentre, open-label, randomised controlled trial of oral favipiravir in adult patients who were newly admitted to hospital with proven or suspected COVID-19 across five sites in the UK (n=2), Brazil (n=2) and Mexico (n=1). Using a permuted block design, eligible and consenting participants were randomly assigned (1:1) to receive oral favipiravir (1800 mg twice daily for 1 day; 800 mg twice daily for 9 days) plus standard care, or standard care alone. All caregivers and patients were aware of allocation and those analysing data were aware of the treatment groups. The prespecified primary outcome was the time from randomisation to recovery, censored at 28 days, which was assessed using an intention-to-treat approach. Post-hoc analyses were used to assess the efficacy of favipiravir in patients aged younger than 60 years, and in patients aged 60 years and older. The trial was registered with clinicaltrials.gov, NCT04373733.Between May 5, 2020 and May 26, 2021, we assessed 503 patients for eligibility, of whom 499 were randomly assigned to favipiravir and standard care (n=251) or standard care alone (n=248). There was no significant difference between those who received favipiravir and standard care, relative to those who received standard care alone in time to recovery in the overall study population (hazard ratio [HR] 1·06 [95% CI 0·89-1·27]; n=499; p=0·52). Post-hoc analyses showed a faster rate of recovery in patients younger than 60 years who received favipiravir and standard care versus those who had standard care alone (HR 1·35 [1·06-1·72]; n=247; p=0·01). 36 serious adverse events were observed in 27 (11%) of 251 patients administered favipiravir and standard care, and 33 events were observed in 27 (11%) of 248 patients receiving standard care alone, with infectious, respiratory, and cardiovascular events being the most numerous. There was no significant between-group difference in serious adverse events per patient (p=0·87).Favipiravir does not improve clinical outcomes in all patients admitted to hospital with COVID-19, however, patients younger than 60 years might have a beneficial clinical response. The indiscriminate use of favipiravir globally should be cautioned, and further high-quality studies of antiviral agents, and their potential treatment combinations, are warranted in COVID-19.LifeArc and CW+.
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- 2023
11. Burden and severity of mpox in Mexico 6 months into the outbreak
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Isaac Núñez, Juan Sierra-Madero, Arturo Galindo-Fraga, Santa E. Ceballos-Liceaga, Gustavo Reyes-Terán, and Sergio Iván Valdés-Ferrer
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Microbiology (medical) ,Infectious Diseases ,General Medicine - Published
- 2023
12. Mexican perspective on the Mosaico HIV vaccine trial
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Brenda Crabtree Ramírez, Luz Alicia González Hernández, Carlos Cabrera, Carlos del Río, Andrea González Rodríguez, and Juan Sierra Madero
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Infectious Diseases ,Epidemiology ,Virology ,Immunology - Published
- 2023
13. Exceptional T CD4+ Recovery Post-antiretroviral Is Linked to a Lower HIV Reservoir with a Specific Immune Differentiation Pattern
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José Miguel Rodriguez-Castañon, Andrew Mcnaughton, Jonnathan Cázares-Lara, Mónica Viveros-Rogel, Santiago Pérez-Patrigeon, Andrea C Tello-Mercado, Rocio Jaramillo-Jante, Luis L. Fuentes-Romero, Ayleen Cárdenas-Ochoa, Graciela Leal-Gutiérrez, Barbara Antuna-Puente, Juan José Romero-Carvajal, Juan Sierra-Madero, Moisés Vergara-Mendoza, Antonio Camiro-Zúñiga, Luis E. Soto-Ramirez, and Arturo Galindo-Fraga
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0301 basic medicine ,business.industry ,T cell ,Immunology ,Human immunodeficiency virus (HIV) ,medicine.disease_cause ,Pathogenesis ,03 medical and health sciences ,030104 developmental biology ,0302 clinical medicine ,Infectious Diseases ,Immune system ,medicine.anatomical_structure ,Virology ,Cohort ,medicine ,Antiretroviral treatment ,030212 general & internal medicine ,business - Abstract
We present a cohort of individuals who reached CD4+ T cell counts of greater than 1,000 cells/mm3 (Hypers) after starting antiretroviral treatment (ART) and compared them with those who reached bet...
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- 2022
14. Incomplete ART Adherence Is Associated with Lower CD4-CD8 Ratio in Virally Suppressed Patients with HIV-infection in Mexico
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Pablo F, Belaunzaran-Zamudio, Lizbeth, Naranjo, Yanink, Caro-Vega, Jose R, Castillo-Mancilla, Antonio, Camiro-Zúñiga, Ruth, Fuentes-García, Brenda Eloísa, Crabtree-Ramírez, and Juan, Sierra-Madero
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Suboptimal antiretroviral therapy (ART) adherence in people with HIV, even during sustained viral suppression, is associated with persistent inflammation, immune activation, and coagulopathy. Persistently low CD4-CD8 Ratio has been also associated with residual inflammation, is a good predictor of increased risk of death and more widely available than inflammatory biomarkers. We tested the hypothesis that the CD4-CD8 Ratio is associated with ART adherence during periods of complete viral suppression. We used the Medication Possession Ratio based in pharmacy registries as measure of adherence and time-varying, routine care CD4 and CD8 measurements as outcome. We used a linear mixed model for longitudinal data including fixed effects for sex, age, education, date of ART initiation, AIDS-related conditions, and baseline CD4 to model the outcome. In 988 adults with a median follow-up of 4.13 years, higher ART adherence was independently associated with a modest increase in CD4-CD8. For each increasing percentage point in adherence, the CD4-CD8 Ratio increased 0.000857 (95%CI -0.000494, 0.002209, p=0.213731) in the first year after achieving viral suppression; 0.001057 (95%CI 0.000262, 0.001853, p=0.009160) in years 1 to 3; 0.000323 (95%CI -0.000448, 0.001095, p=0.411441) in years 3 to 5; and 0.000850 (95%CI 0.000272, 0.001429, p=0.003946) 5-10 years after achieving viral suppression. The magnitude of the effect of adherence over CD4-CD8 Ratios varied over time and by baseline CD4 count, with increasing adherence having a larger effect early after ART initiation in people with higher baseline CD4 (500 cells/uL) and in later years in people with lower baseline CD4 count (200cells/uL). Our findings expand on previous evidence suggesting that the benefits of optimal adherence to modern ART regimens goes beyond maintaining viral suppression. These results highlight the importance of including objective measurements of adherence as part of routine care, even in patients with complete HIV suppression over long-term follow-up.
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- 2023
15. Development of the HIV360 international core set of outcome measures for adults living with HIV: A consensus process
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João Marques‐Gomes, Matthew J. Salt, Rita Pereira‐Neto, Franca S. Barteldes, Vera Gouveia‐Barros, Alexandre Carvalho, Antonella d’Arminio‐Monforte, Alethse De‐la‐Torre‐Rosas, Amy Harris, Catarina Esteves, Carcom Maor, Cristina Mora, Carla Oliveira, Cristina Sousa, Douglas D. Richman, Esteban Martinez, Fábio Cota‐Medeiros, Filipa Gramacho, Georg M. N. Behrens, Graça Gonçalves, Helena Farinha, Isabel Nabais, Inês Vaz‐Pinto, Juan Sierra‐Madero, Joaquim Sousa‐Gago, John Thornhill, José Vera, Maja Erceg‐Tusek, Margarida Tavares, Miguel Vasconcelos, Nuno Fernandes, Nicola Gianotti, Nienke Langebeek, Paulo Anjos, Raquel Couto, Ricardo Fernandes, Reena Rajasuriar, Rosário Serrão, Shaun Watson, Teresa Branco, Tiago Teixeira, Vicente Soriano, and Repositório da Universidade de Lisboa
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Adult ,Consensus ,Outcome Assessment ,Health Personnel ,Clinical Sciences ,8.1 Organisation and delivery of services ,Patient-centred care ,HIV Infections ,Outcomes ,outcomes ,Value-based healthcare ,Clinical Research ,Virology ,Outcome Assessment, Health Care ,Behavioral and Social Science ,Scopus ,Humans ,Pharmacology (medical) ,Patient Reported Outcome Measures ,CD4-CD8 ratio ,Health Policy ,abacavir ,HIV ,Health Services ,Health Care ,AIDS ,Treatment Outcome ,Infectious Diseases ,patient-centred care ,JCR ,value-based healthcare ,HIV/AIDS ,human immunodeficiency virus 1 - Abstract
© 2021 British HIV Association, Objectives: HIV outcomes centre primarily around clinical markers with limited focus on patient-reported outcomes. With a global trend towards capturing the outcomes that matter most to patients, there is agreement that standardizing the definition of value in HIV care is key to their incorporation. This study aims to address the lack of routine, standardized data in HIV care. Methods: An international working group (WG) of 37 experts and patients, and a steering group (SG) of 18 experts were convened from 14 countries. The project team (PT) identified outcomes by conducting a literature review, screening 1979 articles and reviewing the full texts of 547 of these articles. Semi-structured interviews and advisory groups were performed with the WG, SG and people living with HIV to add to the list of potentially relevant outcomes. The WG voted via a modified Delphi process - informed by six Zoom calls - to establish a core set of outcomes for use in clinical practice. Results: From 156 identified outcomes, consensus was reached to include three patient-reported outcomes, four clinician-reported measures and one administratively reported outcome; standardized measures were included. The WG also reached agreement to measure 22 risk-adjustment variables. This outcome set can be applied to any person living with HIV aged > 18 years. Conclusions: Adoption of the HIV360 outcome set will enable healthcare providers to record, compare and integrate standardized metrics across treatment sites to drive quality improvement in HIV care.
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- 2021
16. Pyridostigmine reduces mortality of patients with severe SARS-CoV-2 infection: A phase 2/3 randomized controlled trial
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Sergio Fragoso-Saavedra, Isaac Núñez, Belem M. Audelo-Cruz, Sarahi Arias-Martínez, Daniel Manzur-Sandoval, Alejandro Quintero-Villegas, H. Benjamín García-González, Sergio L. Carbajal-Morelos, Sergio PoncedeLeón-Rosales, José Gotés-Palazuelos, José A. Maza-Larrea, J. Javier Rosales-de la Rosa, Dafne Diaz-Rivera, Edgar Luna-García, Elvira Piten-Isidro, Perla M. Del Río-Estrada, Mario Fragoso-Saavedra, Yanink Caro-Vega, Isabella Batina, León Islas-Weinstein, David A. Iruegas-Nunez, Juan J. Calva, Pablo F. Belaunzarán-Zamudio, Juan Sierra-Madero, José C. Crispín, and Sergio Iván Valdés-Ferrer
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Adult ,Male ,Inflammation ,SARS-CoV-2 ,Middle Aged ,Respiration, Artificial ,COVID-19 Drug Treatment ,Treatment Outcome ,Genetics ,Humans ,Molecular Medicine ,Female ,Molecular Biology ,Genetics (clinical) ,Pyridostigmine Bromide - Abstract
Background: Respiratory failure in severe coronavirus disease 2019 (COVID-19) is associated with a severe inflammatory response. Acetylcholine (ACh) reduces systemic inflammation in experimental bacterial and viral infections. Pyridostigmine increases the half-life of endogenous ACh, potentially reducing systemic inflammation. We aimed to determine if pyridostigmine decreases a composite outcome of invasive mechanical ventilation (IMV) and death in adult patients with severe COVID-19. Methods: We performed a double-blinded, placebo-controlled, phase 2/3 randomized controlled trial of oral pyridostigmine (60 mg/day) or placebo as add-on therapy in adult patients admitted due to confirmed severe COVID-19 not requiring IMV at enrollment. The primary outcome was a composite of IMV or death by day 28. Secondary outcomes included reduction of inflammatory markers and circulating cytokines, and 90-day mortality. Adverse events (AEs) related to study treatment were documented and described. Results: We recruited 188 participants (94 per group); 112 (59.6%) were men; the median (IQR) age was 52 (44–64) years. The study was terminated early due to a significant reduction in the primary outcome in the treatment arm and increased difficulty with recruitment. The primary outcome occurred in 22 (23.4%) participants in the placebo group vs. 11 (11.7%) in the pyridostigmine group (hazard ratio, 0.47, 95% confidence interval 0.24–0.9; P = 0.03). This effect was driven by a reduction in mortality (19 vs. 8 deaths, respectively). Conclusion: Our data indicate that adding pyridostigmine to standard care reduces mortality among patients hospitalized for severe COVID-19.
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- 2022
17. Three-year durable efficacy of dolutegravir plus lamivudine in antiretroviral therapy – naive adults with HIV-1 infection
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Martin Gartland, Juan Sierra Madero, Andrea Antinori, Brian Wynne, Jean van Wyk, Pedro Cahn, Keith A. Pappa, Choy Y. Man, Pierre-Marie Girard, Mark R. Underwood, Daisy J. Brandon, Lloyd Curtis, Roberto Ortiz, Jose R. Arribas, Chien-Ching Hung, Jürgen K. Rockstroh, Michael Aboud, Jörg Sievers, Amanda Clarke, Rimgaile Urbaityte, Kimberly Y. Smith, and UAM. Departamento de Medicina
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Adult ,medicine.medical_specialty ,Medicina ,Anti-HIV Agents ,Pyridones ,Immunology ,Human immunodeficiency virus (HIV) ,nucleoside reverse transcriptase inhibitor ,integrase strand transfer inhibitor ,HIV Infections ,Emtricitabine ,medicine.disease_cause ,Gastroenterology ,Piperazines ,chemistry.chemical_compound ,Internal medicine ,Oxazines ,medicine ,Humans ,Immunology and Allergy ,two-drug regimen ,Adverse effect ,business.industry ,treatment-naive ,Lamivudine ,Clinical Science ,Antiretroviral therapy ,dolutegravir ,Treatment Outcome ,Infectious Diseases ,chemistry ,Tolerability ,Relative risk ,Dolutegravir ,HIV-1 ,Drug Therapy, Combination ,business ,Heterocyclic Compounds, 3-Ring ,medicine.drug - Abstract
To assess efficacy and safety of dolutegravir (DTG) + lamivudine (3TC) vs. DTG + tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) in treatment-naive adults with HIV-1 in the prespecified 144-week secondary analyses of GEMINI-1 and GEMINI-2.Design:Identical, multicenter, phase III, randomized, non-inferiority studies (double-blind through 96 weeks).Methods:Participants with HIV-1 RNA ≤500 000 copies/ml and no major viral resistance mutations to nucleoside reverse transcriptase inhibitors, nonnucleoside reverse transcriptase inhibitors, or protease inhibitors were randomized 1:1 to once-daily DTG + 3TC or DTG + TDF/FTC.Results:At week 144, DTG + 3TC (N = 716) was noninferior to DTG + TDF/FTC (N = 717) in proportion of participants achieving HIV-1 RNA, This study was funded by ViiV Healthcare
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- 2021
18. Mesenchymal Stem Cells for the Compassionate Treatment of Severe Acute Respiratory Distress Syndrome Due to COVID 19
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Alejandro Zentella-Dehesa, Carol A Zepeda Carrillo, Guillermo Domínguez-Cherit, Patricia Butrón, Ivan Torre-Villalvazo, José de Jesús Rodriguez-Andoney, Hector F Nario-Chaidez, Tatiana S. Rodríguez-Reyna, Alexia Lozada-Estrada, Erik A. Torre-Anaya, Juan Sierra-Madero, Fernando P Téllez-Pallares, Armando R. Tovar-Palacio, Verónica Espisosa-Cruz, Julio Granados-Arriola, Aldo J Vázquez-Mézquita, and Martin Iglesias
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0301 basic medicine ,ARDS ,Umbilical cord ,Orginal Article ,Pathology and Forensic Medicine ,03 medical and health sciences ,0302 clinical medicine ,Interquartile range ,Medicine ,Respiratory function ,Adverse effect ,cell transplantation ,mesenchymal stem cell ,biology ,business.industry ,C-reactive protein ,COVID-19 ,Cell Biology ,stromal cell ,medicine.disease ,030104 developmental biology ,medicine.anatomical_structure ,Anesthesia ,biology.protein ,Compassionate Treatment ,Neurology (clinical) ,Geriatrics and Gerontology ,business ,Cytokine storm ,030217 neurology & neurosurgery - Abstract
Mesenchymal stem cells (MSC) have received particular attention due to their ability to inhibit inflammation caused by cytokine storm induced by COVID-19. In this way some patients have been treated successfully. The aim of this study was to evaluate the safety and describe the clinical changes after IV administration of allogeneic human umbilical cord MSC (ahUCMSC), in patients with bilateral pneumonia caused by COVID-19, complicated with severe ARDS, as compassionate treatment. This was a pilot, open-label, prospective, longitudinal study. Five patients that did not improve in their clinical conditions after 48 hours of receiving the standard medical management used by the Medical Center and with persistent PaO2/FiO2 less than 100 mmHg were enrolled. ahUCMSC were infused IV, at dose of 1x106 per Kg of body weight over 15 minutes. Patients were monitored after the infusion to detect adverse event. Pa02/FiO2, vital signs, D-dimer, C reactive protein and total lymphocytes were monitored for 21 days after the infusion or until the patient was discharged from the hospital. Descriptive statistics were used with means or medians and standard deviation or interquartile range according to the type of variable. The Wilcoxon's rank-sum was used for stationary samples. Adverse events occurred in three patients and were easily and quickly controlled. Immediately after the infusion of ahUCMSC, constant rise of PaO2/FiO2 was observed in all patients during the first 7 days, with statistical significance. Three patients survived and were extubated on the ninth day post-infusion. Two patients died at 13 and 15 days after infusion. The infusion of ahUCMSC in patients with severe ARDS caused by COVID-19, was safe, and demonstrated its anti-inflammatory capacity in the lungs, by improving the respiratory function expressed by PaO2 / FiO2, which allowed the survival of 3 patients, with extubation at 9 days.
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- 2021
19. Health outcomes among HIV‐positive Latinos initiating antiretroviral therapy in North America versus Central and South America
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Carina Cesar, John R Koethe, Mark J Giganti, Peter Rebeiro, Keri N Althoff, Sonia Napravnik, Angel Mayor, Beatriz Grinsztejn, Marcelo Wolff, Denis Padgett, Juan Sierra‐Madero, Eduardo Gotuzzo, Timothy R Sterling, James Willig, Julie Levison, Mari Kitahata, Maria C Rodriguez‐Barradas, Richard D Moore, Catherine McGowan, Bryan E Shepherd, Pedro Cahn, and for the Caribbean, Central and South America Network for HIV epidemiology (CCASAnet) and the North American AIDS Cohort Collaboration on Research and Design (NA‐ACCORD)
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HIV ,antiretroviral therapy ,highly active ,mortality ,Latin America ,North America ,Immunologic diseases. Allergy ,RC581-607 - Abstract
Introduction Latinos living with HIV in the Americas share a common ethnic and cultural heritage. In North America, Latinos have a relatively high rate of new HIV infections but lower rates of engagement at all stages of the care continuum, whereas in Latin America antiretroviral therapy (ART) services continue to expand to meet treatment needs. In this analysis, we compare HIV treatment outcomes between Latinos receiving ART in North America versus Latin America. Methods HIV‐positive adults initiating ART at Caribbean, Central and South America Network for HIV (CCASAnet) sites were compared to Latino patients (based on country of origin or ethnic identity) starting treatment at North American AIDS Cohort Collaboration on Research and Design (NA‐ACCORD) sites in the United States and Canada between 2000 and 2011. Cox proportional hazards models compared mortality, treatment interruption, antiretroviral regimen change, virologic failure and loss to follow‐up between cohorts. Results The study included 8400 CCASAnet and 2786 NA‐ACCORD patients initiating ART. CCASAnet patients were younger (median 35 vs. 37 years), more likely to be female (27% vs. 20%) and had lower nadir CD4 count (median 148 vs. 195 cells/µL, p
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- 2016
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20. A picture is worth a thousand words: maps of HIV indicators to inform research, programs, and policy from NA‐ACCORD and CCASAnet clinical cohorts
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Keri N Althoff, Peter F Rebeiro, David B Hanna, Denis Padgett, Michael A Horberg, Beatriz Grinsztejn, Alison G Abraham, Robert Hogg, M John Gill, Marcelo J Wolff, Angel Mayor, Anita Rachlis, Carolyn Williams, Timothy R Sterling, Mari M Kitahata, Kate Buchacz, Jennifer E Thorne, Carina Cesar, Fernando M Cordero, Sean B Rourke, Juan Sierra‐Madero, Jean W Pape, Pedro Cahn, Catherine McGowan, and for the North American Aids Cohort Collaboration on Research and Design (na‐Accord) and the Caribbean, Central and the South America Network for Hiv Epidemiology (ccasanet)
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Map ,HIV indicators ,CD4 T‐lymphocyte count ,retention in care ,antiretroviral therapy ,HIV RNA suppression ,Immunologic diseases. Allergy ,RC581-607 - Abstract
Introduction Maps are powerful tools for visualization of differences in health indicators by geographical region, but multi‐country maps of HIV indicators do not exist, perhaps due to lack of consistent data across countries. Our objective was to create maps of four HIV indicators in North, Central, and South American countries. Methods Using data from the North American AIDS Cohort Collaboration on Research and Design (NA‐ACCORD) and the Caribbean, Central, and South America network for HIV epidemiology (CCASAnet), we mapped median CD4 at presentation for HIV clinical care, proportion retained in HIV primary care, proportion prescribed antiretroviral therapy (ART), and the proportion with suppressed plasma HIV viral load (VL) from 2010 to 2012 for North, Central, and South America. The 15 Canadian and US clinical cohorts and 7 clinical cohorts in Argentina, Brazil, Chile, Haiti, Honduras, Mexico, and Peru represented approximately 2–7% of persons known to be living with HIV in these countries. Results Study populations were selected for each indicator: median CD4 at presentation for care was estimated among 14,811 adults; retention was estimated among 87,979 adults; ART use was estimated among 84,757 adults; and suppressed VL was estimated among 51,118 adults. Only three US states and the District of Columbia had a median CD4 at presentation >350 cells/mm3. Haiti, Mexico, and several states had >85% retention in care; lower (50–74%) retention in care was observed in the US West, South, and Mid‐Atlantic, and in Argentina, Brazil, and Peru. ART use was highest (90%) in Mexico. The percentages of patients with suppressed VL in the US South and Northeast were lower than in most of Central and South America. Conclusions These maps provide visualization of gaps in the quality of HIV care and allow for comparison between and within countries as well as monitoring policy and programme goals within geographical boundaries.
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- 2016
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21. Time to HAART Initiation after Diagnosis and Treatment of Opportunistic Infections in Patients with AIDS in Latin America.
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Brenda Crabtree-Ramírez, Yanink Caro-Vega, Bryan E Shepherd, Beatriz Grinsztejn, Marcelo Wolff, Claudia P Cortes, Denis Padgett, Gabriela Carriquiry, Valeria Fink, Karu Jayathilake, Anna K Person, Catherine McGowan, Juan Sierra-Madero, and Caribbean, Central and South America Network for HIV Epidemiology (CCASAnet), of the International Epidemiologic Databases to Evaluate AIDS (IeDEA) Program
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Medicine ,Science - Abstract
BACKGROUND:Since 2009, earlier initiation of highly active antiretroviral therapy (HAART) after an opportunistic infection (OI) has been recommended based on lower risks of death and AIDS-related progression found in clinical trials. Delay in HAART initiation after OIs may be an important barrier for successful outcomes in patients with advanced disease. Timing of HAART initiation after an OI in "real life" settings in Latin America has not been evaluated. METHODS:Patients in the Caribbean, Central and South America network for HIV Epidemiology (CCASAnet) ≥18 years of age at enrolment, from 2001-2012 who had an OI before HAART initiation were included. Patients were divided in an early HAART (EH) group (those initiating within 4 weeks of an OI) and a delayed HAART (DH) group (those initiating more than 4 weeks after an OI). All patients with an AIDS-defining OI were included. In patients with more than one OI the first event reported was considered. Calendar trends in the proportion of patients in the EH group (before and after 2009) were estimated by site and for the whole cohort. Factors associated with EH were estimated using multivariable logistic regression models. RESULTS:A total of 1457 patients had an OI before HAART initiation and were included in the analysis: 213 from Argentina, 686 from Brazil, 283 from Chile, 119 from Honduras and 156 from Mexico. Most prevalent OI were Tuberculosis (31%), followed by Pneumocystis pneumonia (24%), Invasive Candidiasis (16%) and Toxoplasmosis (9%). Median time from OI to HAART initiation decreased significantly from 5.7 (interquartile range [IQR] 2.8-12.1) weeks before 2009 to 4.3 (IQR 2.0-7.1) after 2009 (p
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- 2016
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22. A parallel-group, multicenter randomized, double-blinded, placebo-controlled, phase 2/3, clinical trial to test the efficacy of pyridostigmine bromide at low doses to reduce mortality or invasive mechanical ventilation in adults with severe SARS-CoV-2 infection: the Pyridostigmine In Severe COvid-19 (PISCO) trial protocol
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Alejandro Quintero-Villegas, Verónica Luqueño-Martínez, Sergio L. Carbajal-Morelos, Sarahi Arias-Martínez, Sergio Fragoso-Saavedra, Alejandra González-Duarte, Belem M. Audelo-Cruz, Juan Sierra-Madero, Yanink Caro-Vega, Pablo F. Belaunzarán-Zamudio, Sergio I. Valdés-Ferrer, Juan J. Calva, H. Benjamín García-González, Brenda Crabtree-Ramírez, Isaac Núñez, David A. Iruegas-Nunez, and José C. Crispín
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Adult ,0301 basic medicine ,ARDS ,medicine.medical_treatment ,SARS-Cov-2 ,Pneumonia, Viral ,Placebo-controlled trial ,Inflammatory reflex ,Placebo-controlled study ,lcsh:Infectious and parasitic diseases ,Immunomodulation ,Betacoronavirus ,Study Protocol ,03 medical and health sciences ,0302 clinical medicine ,Humans ,Medicine ,lcsh:RC109-216 ,Mortality ,Invasive mechanical ventilation ,Lung ,Pandemics ,Pyridostigmine ,Inflammation ,Mechanical ventilation ,business.industry ,COVID-19 ,medicine.disease ,Respiration, Artificial ,Clinical trial ,030104 developmental biology ,Infectious Diseases ,Respiratory failure ,Anesthesia ,ACh ,Pyridostigmine Bromide ,Cholinesterase Inhibitors ,Coronavirus Infections ,business ,030217 neurology & neurosurgery ,medicine.drug - Abstract
Background Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, the causative agent of coronavirus disease 2019 (COVID-19), may lead to severe systemic inflammatory response, pulmonary damage, and even acute respiratory distress syndrome (ARDS). This in turn may result in respiratory failure and in death. Experimentally, acetylcholine (ACh) modulates the acute inflammatory response, a neuro-immune mechanism known as the inflammatory reflex. Recent clinical evidence suggest that electrical and chemical stimulation of the inflammatory reflex may reduce the burden of inflammation in chronic inflammatory diseases. Pyridostigmine (PDG), an ACh-esterase inhibitor (i-ACh-e), increases the half-life of endogenous ACh, therefore mimicking the inflammatory reflex. This clinical trial is aimed at evaluating if add-on of PDG leads to a decrease of invasive mechanical ventilation and death among patients with severe COVID-19. Methods A parallel-group, multicenter, randomized, double-blinded, placebo-controlled, phase 2/3 clinical trial to test the efficacy of pyridostigmine bromide 60 mg/day P.O. to reduce the need for invasive mechanical ventilation and mortality in hospitalized patients with severe COVID-19. Discussion This study will provide preliminary evidence of whether or not -by decreasing systemic inflammation- add-on PDG can improve clinical outcomes in patients with severe COVID-19. Trial registration ClinicalTrials.gov NCT04343963 (registered on April 14, 2020).
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- 2020
23. Escala de apreciación cognitiva del VIH/SIDA: adaptación y evaluación psicométrica en población mexicana
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Ana Fresán-Orellana, María José Nogueda-Orozco, Juan Sierra-Madero, Juan José Sánchez-Sosa, Ariel Vite-Sierra, and Rebeca Robles-García
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SIDA ,Apreciación ,Varimax rotation ,VIH ,Construct validity ,Cognition ,cognitiva ,medicine.disease ,Psicología ,Clinical Practice ,validez ,Acquired immunodeficiency syndrome (AIDS) ,Cronbach's alpha ,Scale (social sciences) ,Psychological adaptation ,medicine ,Psychology ,Social psychology - Abstract
La apreciación cognitiva es el proceso por el que un individuo evalúa o juzga un evento potencialmente estresante de acuerdo con la amenaza que éste le pueda representar a su bienestar. Los objetivos de este estudio fueron traducir al español y evaluar las propiedades psicométricas de la Escala de Apreciación Cognitiva del VIH/SIDA (EAC-VIH) en población mexicana. La validez de contenido y traducción al español fue validada por jueceo. La validez de constructo fue evaluada por medio del análisis factorial con rotación varimax y consistencia interna mediante alfa de Cronbach. La muestra fue de 180 pacientes con infección por VIH, del Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán. La versión en español de la EAC-VIH mantuvo 11 reactivos y una solución de tres factores (amenaza, desafío y control) que explica un 71.30% de la varianza. Los índices α Cronbach fueron para amenaza .89, desafío .84 y control .51. Asimismo, se comparó de forma concurrente con una escala de adhesión y de afectividad y resultó una escala confiable que puede considerarse un instrumento de utilidad tanto en la práctica clínica como en la investigación de la adaptación psicológica al VIH.
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- 2020
24. Effect of Tocilizumab in Mortality among Patients with Severe and Critical Covid-19: Experience in a Third-Level Medical Center
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Carlos A. Aguilar-Salinas, Sandra Rajme-López, Bernardo A Martinez-Guerra, Carla M Roman-Montes, José Sifuentes-Osornio, Juan Sierra-Madero, Nereyda A de-León-Cividanes, María F González-Lara, Edgar Ortiz-Brizuela, Karla M Tamez-Torres, and Alfredo Ponce-de-León
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Male ,musculoskeletal diseases ,medicine.medical_specialty ,Coronavirus disease 2019 (COVID-19) ,medicine.medical_treatment ,Hospital mortality ,Disease ,Antibodies, Monoclonal, Humanized ,chemistry.chemical_compound ,Tocilizumab ,Tocilizumab. COVID-19. SARS-CoV-2. Mexico ,Internal medicine ,medicine ,Humans ,Hospital Mortality ,Prospective Studies ,Prospective cohort study ,Retrospective Studies ,Mechanical ventilation ,Cross Infection ,In hospital mortality ,business.industry ,SARS-CoV-2 ,COVID-19 ,General Medicine ,Respiration, Artificial ,RC31-1245 ,COVID-19 Drug Treatment ,Hospitalization ,Treatment Outcome ,chemistry ,Propensity score matching ,business - Abstract
Background: Trials evaluating safety and efficacy of tocilizumab in coronavirus disease 19 (COVID-19) show contradictory results. Objective: The objective of the study was to evaluate the effect of tocilizumab in hospital mortality among patients with severe COVID-19 in a third-level medical center. Methods: This prospective cohort study included patients with severe and critical COVID-19. Primary outcome was death during hospitalization. Secondary outcomes included invasive mechanical ventilation (IMV), days on IMV, ventilator-free days (VFDs), length of hospital stay (LOS), and development of hospitalacquired infections (HAIs). Bivariate, multivariate, and propensity score matching analysis were performed. Results: During the study period, 99/794 (12%) patients received tocilizumab. Male patients, health care workers, and patients with increased inflammatory markers received tocilizumab more frequently. No difference in hospital mortality was observed between groups (34% vs. 34%, p = 0.98). Tocilizumab was not independently associated with mortality. No significant treatment effects were observed in propensity score analysis. IMV was more frequent (46% vs. 11%, p < 0.01) and LOS was longer (12 vs. 7 days, p < 0.01) in the tocilizumab group, reflecting increased severity. Although HAIs were more frequent in the tocilizumab group (22% vs. 10%, p < 0.01), no difference was seen after adjusting for IMV (38% vs. 40%, p = 0.86). Conclusions: In our study, tocilizumab was not associated with decreased hospital mortality among patients with severe COVID-19.
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- 2022
25. Late-onset opportunistic infections while receiving anti-retroviral therapy in Latin America: burden and risk factors
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Isaac Núñez, Brenda Crabtree-Ramirez, Bryan E. Shepherd, Timothy R. Sterling, Pedro Cahn, Valdiléa G. Veloso, Claudia P Cortes, Denis Padgett, Eduardo Gotuzzo, Juan Sierra-Madero, Catherine C. McGowan, Anna K. Person, and Yanink Caro-Vega
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Microbiology (medical) ,HIV ,HIV Infections ,General Medicine ,Opportunistic Infections ,CD4 Lymphocyte Count ,AIDS ,Infectious Diseases ,Latin America ,Risk Factors ,Tuberculosis ,Cohort studies ,Humans ,Opportunistic infections ,Brazil ,Retrospective Studies - Abstract
Objectives: The aim of this study was to describe the incidence, clinical characteristics, and risk factors of late-onset opportunistic infections (LOI) in people who live with HIV (PWLHA) within the Caribbean, Central and South America network for HIV epidemiology. Methods: We performed a retrospective cohort study including treatment-naive PWLHA enrolled at seven sites (Argentina, Brazil, Chile, Peru, Mexico, and two sites in Honduras). Follow-up began at 6 months after treatment started. Outcomes were LOI, loss to follow-up, and death. We used a Cox proportional hazards model and a competing risks model to evaluate risk factors. Results: A total of 10,583 patients were included. Median follow up was at 5.4 years. LOI occurred in 895 (8.4%) patients. Median time to opportunistic infection was 2.1 years. The most common infections were tuberculosis (39%), esophageal candidiasis (10%), and Pneumocystis jirovecii (P. jirovecii) pneumonia (10%). Death occurred in 576 (5.4%) patients, and 3021 (28.5%) patients were lost to follow-up. A protease inhibitor–based regimen (hazard ratio 1.25), AIDS-defining events during the first 6 months of antiretroviral-treatment (hazard ratio 2.12), starting antiretroviral-treatment in earlier years (hazard ratio 1.52 for 2005 vs 2010), and treatment switch (hazard ratio 1.31) were associated with a higher risk of LOI. Conclusion: LOI occurred in nearly one in 10 patients. People with risk factors could benefit from closer follow-up.
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- 2021
26. Higher Veterans Aging Cohort Study 2.0 Index Score Predicts Functional Decline Among Older Adults Living with HIV
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Virgilio Hernandez-Ruiz, Brenda Crabtree-Ramírez, Hélène Amieva, Kristine M. Erlandson, Omar Y Bello-Chavola, Celia Gabriela Hernández-Favela, Juan Sierra-Madero, and José Alberto Avila-Funes
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Aged, 80 and over ,Male ,Aging ,Index (economics) ,business.industry ,Immunology ,Human immunodeficiency virus (HIV) ,MEDLINE ,HIV Infections ,Middle Aged ,medicine.disease_cause ,Cohort Studies ,Infectious Diseases ,Virology ,Medicine ,Humans ,Longitudinal Studies ,Functional decline ,Risk factor ,business ,Viral load ,Cohort study ,Demography ,Aged ,Veterans - Abstract
Living with HIV has been proposed as a risk factor for the early development of functional decline. Composite marker tools like the Veterans Aging Cohort Study (VACS) Index, which includes HIV-associated and non-HIV-related markers of disease may better reflect multiorgan system injury and potentially predict functional outcomes. Therefore, the objective of this work is to determine whether higher VACS 2.0 Index scores predicts functional decline among older adults living with HIV (OALWH). Longitudinal study, including 131 adults ages 50 or older who underwent a comprehensive geriatric assessment at baseline and follow-up, at least a year apart. Functional status was determined by the gait speed (seconds for a 4-m distance). Linear regression models were constructed to determine the relationship between VACS 2.0 Index at baseline with gait speed at follow-up adjusted for potential confounders. The median for age was 58.0 years (range 50-84), and 81.7% were male. At baseline, the median VACS 2.0 Index score was 50.4 (interquartile range 42.2-65.3). The adjusted linear regression analysis found that higher baseline VACS 2.0 Index scores were significantly associated with a decline in gait speed (
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- 2021
27. Immediate treatment of acute HIV in a tertiary healthcare center: bridging gaps in communication using smartphones
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S. Navarro-Álvarez, Santiago Pérez-Patrigeon, Juan Sierra-Madero, Christian Hernández-León, Luis E. Soto-Ramírez, Brenda Crabtree-Ramírez, Juan J. Calva, Pablo F. Belaunzarán-Zamudio, Antonio Camiro-Zúñiga, M.D.R. Jaramillo-Jante, and Juan L. Mosqueda-Gómez
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0301 basic medicine ,Acute HIV infection ,medicine.medical_specialty ,business.industry ,Health Policy ,Human immunodeficiency virus (HIV) ,medicine.disease_cause ,030112 virology ,Antiretroviral therapy ,03 medical and health sciences ,Chronic infection ,0302 clinical medicine ,Infectious Diseases ,Emergency medicine ,Cohort ,Epidemiology ,Medicine ,Pharmacology (medical) ,030212 general & internal medicine ,business ,Survival analysis ,Tertiary healthcare - Abstract
Objectives Early initiation of antiretroviral therapy (ART) during acute HIV infection is associated with favourable clinical and epidemiological outcomes. Barriers to prompt treatment initiation limit the benefits of universal access to ART in Mexico. We sought to create an algorithm for the immediate detection and treatment of patients with acute HIV infection. Methods A nationwide cohort of patients with acute HIV infection was created in 2015. In order to identify cases and treat them promptly at our centre, an interdisciplinary group coordinated through an instant-messaging tool using smart phones was established. When a probable case was detected, a discussion was initiated to confirm the diagnosis and facilitate the administrative processes to initiate ART as soon as possible. We compared time to ART initiation with that in a comparison group of patients with chronic HIV infection enrolled during the same period (May 2015 to February 2017) through routine care, using survival analysis estimators and log-rank tests. Results We recruited 29 patients with acute HIV infection. The median time to ART initiation was 2 days in these patients, in contrast to 21 days for patients with chronic infection. There were no significant differences in the percentages of patients engaged in care, on treatment or virologically suppressed at 1 year of follow-up. Conclusions Implementing immediate ART initiation programmes is feasible in Mexico, in spite of the substantial administrative barriers that exist in the country. More extensive replication of this model in other centres and in patients with chronic infection is warranted to evaluate its effect on the continuum of care.
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- 2019
28. Comparing the efficacy of efavirenz and boosted lopinavir using viremia copy‐years
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Viviane D Lima, Juan Sierra‐Madero, Zunyou Wu, Joel Singer, Evan Wood, Mark W Hull, Paul Richard Harrigan, and Julio SG Montaner
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HIV‐1 plasma viral load ,antiretroviral therapy ,clinical trial ,area under the curve ,cumulative viremia ,efficacy ,Immunologic diseases. Allergy ,RC581-607 - Abstract
Introduction HIV‐1 plasma viral load during treatment can be highly variable. Thus, there is the need to find a measure of cumulative viremia that can be used to assess both the short‐ and long‐term efficacy of highly active antiretroviral therapy (HAART). Here, we validate a measure of cumulative viremia to evaluate HAART efficacy. Methods We accessed HAART efficacy using data from a randomized clinical trial conducted in Mexico. We compared the proportion of individuals achieving a viral load
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- 2014
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29. 2021 update to HIV-TRePS: a highly flexible and accurate system for the prediction of treatment response from incomplete baseline information in different healthcare settings
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E Schuelter, Schlomo Staszewski, Karl Hesse, Julio Montaner, Gerardo Alvarez-Uria, Stefano Vella, Peter Reiss, Dolphina Cogill, Colette Smith, Gaston Picchio, Christopher J. Hoffmann, Hugo Tempelman, Gordana Dragovic, Maurizio Zazzi, Laura Monno, Maria-Jesus Perez-Elias, Julio S. G. Montaner, Omar Sued, Adrian Streinu-Cercel, Raph L Hamers, Robin Wood, Lidia Ruiz, J A Metcalf, Brian Gazzard, Sundhiya Mandalia, Emanuel Vlahakis, Raph L. Hamers, Shanmugam Saravanan, Juan Sierra Madero, Kim C. E. Sigaloff, Cliff Lane, Brian K. Agan, José M. Gatell, Richard Harrigan, Ricardo Sobhie Diaz, Brendan Larder, Anton Pozniak, Vincent C. Marconi, Pachamuthu Balakrishnan, Wataru Sugiura, David A. Cooper, Andrew Carr, Richard Norris, Roos Barth, Tobias F. Rinke de Wit, Carina Cesar, Gabrielle Dettorre, Sean Emery, Scott Wegner, John D. Baxter, Dechao Wang, Elisa de Lazzari, H. Clifford Lane, Federico García, Carl Morrow, Catherine A Rehm, Rolf Kaiser, Lotty Ledwaba, Paul Khabo, Marie-Pierre deBethune, Cecilia Sucupira, Bonventura Clotet, Luminita Ene, Andrew D. Revell, Ard van Sighem, Mark T. Nelson, Bonaventura Clotet, Tulio de Oliveira, and Carlo Torti
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0301 basic medicine ,Microbiology (medical) ,Treatment response ,Genotype ,Anti-HIV Agents ,030106 microbiology ,Human immunodeficiency virus (HIV) ,HIV Infections ,medicine.disease_cause ,03 medical and health sciences ,0302 clinical medicine ,Antiretroviral Therapy, Highly Active ,Classifier (linguistics) ,Statistics ,medicine ,Humans ,Pharmacology (medical) ,030212 general & internal medicine ,Baseline (configuration management) ,Original Research ,Pharmacology ,Computational model ,business.industry ,HIV ,Viral Load ,Random forest ,CD4 Lymphocyte Count ,Regimen ,Infectious Diseases ,RNA, Viral ,business ,Viral load ,Delivery of Health Care - Abstract
ObjectivesWith the goal of facilitating the use of HIV-TRePS to optimize therapy in settings with limited healthcare resources, we aimed to develop computational models to predict treatment responses accurately in the absence of commonly used baseline data.MethodsTwelve sets of random forest models were trained using very large, global datasets to predict either the probability of virological response (classifier models) or the absolute change in viral load in response to a new regimen (absolute models) following virological failure. Two ‘standard’ models were developed with all baseline variables present and 10 others developed without HIV genotype, time on therapy, CD4 count or any combination of the above.ResultsThe standard classifier models achieved an AUC of 0.89 in cross-validation and independent testing. Models with missing variables achieved AUC values of 0.78–0.90. The standard absolute models made predictions that correlated significantly with observed changes in viral load with a mean absolute error of 0.65 log10 copies HIV RNA/mL in cross-validation and 0.69 log10 copies HIV RNA/mL in independent testing. Models with missing variables achieved values of 0.65–0.75 log10 copies HIV RNA/mL. All models identified alternative regimens that were predicted to be effective for the vast majority of cases where the new regimen prescribed in the clinic failed. All models were significantly better predictors of treatment response than genotyping with rules-based interpretation.ConclusionsThese latest models that predict treatment responses accurately, even when a number of baseline variables are not available, are a major advance with greatly enhanced potential benefit, particularly in resource-limited settings. The only obstacle to realizing this potential is the willingness of healthcare professions to use the system.
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- 2021
30. A Randomized, Controlled Study on the Safety and Efficacy of Maraviroc and/or Favipiravir Vs Currently Used Therapy in Severe COVID-19 Adults. (COMVIVIR, clinicaltrials.gov NCT04475991)
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Elba O. Medina-Hernandez, Maria Luisa Hernández-Medel, Adolfo Perez-Garcia, Joselín Hernández-Ruiz, Diana Sofia Cabrera-Orejuela, Gonzalo Salgado-Montes de Oca, Gustavo Reyes-Teran, Lucia Monserrat Pérez-Navarro, Ana María Espinosa-García, Alma Villalobos-Osnaya, Juan Carlos López-Alvarenga, Santiango Ávila-Ríos, Juan Sierra-Madero, Guadalupe Mercedes Lucia Guerrero-Avendaño, Raúl Serrano-Loyola, Elena Solleiro-Villavicencio, Arianna Rodriguez-Cal Y Mayor, Mireya León-Hernández, and Manli M. Servin-Murillo
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chemistry.chemical_compound ,medicine.medical_specialty ,Coronavirus disease 2019 (COVID-19) ,chemistry ,Randomized controlled trial ,business.industry ,law ,Internal medicine ,Medicine ,Favipiravir ,business ,Maraviroc ,law.invention - Abstract
Background: Multiple studies have now established that hyperinflammatory response induced by SARS CoV-2 is a main cause of complications and death in infected subjects. Such dysfunctional immune response has been described as a dysregulated and exacerbated production of cytokines and chemokines that attracts and activates inflammatory cells, which start and sustain pulmonary and systemic damage, thus causing complications that lead to multi organ failure and death. Therefore, we suggest that blocking key inflammation receptors could help to reduce migration and activation of Th17, monocytes/macrophages and neutrophils, thus mitigating the cytokine storm and averting severe complications and death. Importantly, the optimum treatment for COVID-19 severe patients could combine a modulator of the immune response with a direct antiviral drug against SARS-CoV-2, in order to address both the viral load and the hyperinflammatory effects of the immune dysregulation.Methods: Maraviroc (MVC), a CCR5 antagonist, and Favipiravir (FPV), an antiviral, will be evaluated single and combined, added to the treatment currently used at the Hospital General de México for severe non-critical COVID-19 patients. One hundred patients will be allocated in four arms [Current treatment only (CT), CT+MVC, CT+FPV, CT+MVC+FPV]. Percentage of patients free of mechanical ventilation or death at day 28, immunophenotyping and viral load will be compared between groupsDiscussion: New immune focused therapies are targeting strong inflammation mediators such as IL-6 and IL1-B; nevertheless, to our best knowledge, controlling chemotaxis has not been explored. The use of a drug therapy that addresses both the regulation of the immune response and the inhibition of viral replication could at the same time, help to alleviate the hyperinflammatory condition and reduce the time of the viral clearance process, therefore improving treatment outcomesTrial registration: Clinical Trials (www.clinicaltrials.gov) NCT: 04475991.
- Published
- 2021
31. Systemic and Neurologic Adverse Events Among 704,003 First-Dose Recipients of the Pfizer-Biontech (BNT162b2) mRNA COVID-19 Vaccine in Mexico
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Isaac Núñez, Rogelio Pérez-Padilla, Sergio Fragoso-Saavedra, Carrillo-Mezo Ra, Hugo López-Gatell, Juan L. Mosqueda-Gómez, Díaz-Ortega Jl, Antonio Arauz, Juan Sierra-Madero, Gustavo Reyes-Terán, Miguel García-Grimshaw, Daniel Amado Carrillo-García, Espino-Ojeda A, Galnáres-Olalde Ja, Santa Elizabeth Ceballos-Liceaga, Sandoval Gc, Noé Hernández-Valdivia, Blaisdell-Vidal C, Saniger-Alba MdM, José Luis Alomía-Zegarra, Anaclara Michel-Chávez, Sergio I. Valdés-Ferrer, and Laura E. Hernández-Vanegas
- Subjects
Clinical trial ,Vaccination ,Pediatrics ,medicine.medical_specialty ,Acute Transverse Myelitis ,Neurologic manifestation ,business.industry ,Incidence (epidemiology) ,Cohort ,medicine ,Observational study ,Adverse effect ,business - Abstract
Background: The development of mRNA vaccines to prevent SARS-CoV-2 has been remarkably successful, with highly effective vaccines available less than one year after confirming the first case. Due to the global burden of COVID-19 on health systems, emergency approval was attained after clinical trials with relatively small sample sizes and short follow-up periods. Limited information exists about the incidence of adverse events following immunisation (AEFI), particularly neurologic ones. Here, we describe the neurologic AEFI reported by recipients of the BNT162b2 mRNA COVID-19 vaccine. Methods: We conducted a prospective observational cohort using de-identified information from a database of all systemic and neurologic AEFI reported to the Mexican Ministry of Health throughout a passive Epidemiological Surveillance System by first-dose vaccine recipients, from December 24, 2020 to February 12, 2021. The cut-off date for this data was February 18, 2021. We performed descriptive analyses on demographics, timing from vaccination to AEFI development, event duration, and current outcome. Findings: Nationwide, 704 003 first-doses were administered; 6536 AEFI were reported. Among those, 4258 (65·1%) had at least one neurologic manifestation. Non-serious neurologic AEFI occurred in 99·6%. Headache (62·2%), transient sensory symptoms (3·5%), and weakness (1%) were the most frequent. Thirty-three serious AEFI were reported, of which 17 (2·4/100 000 doses) were neurologic, seven seizures, four functional syndromes, three Guillain-Barre syndrome (GBS) cases, and two of acute transverse myelitis. All GBS cases were related to a gastrointestinal infection before vaccination, 3/7 seizure episodes were related to poor antiepileptic drug compliance, and 2/7 to anaphylactic reactions. At the time of this report, 16/17 cases of serious neurologic AEFI had been discharged with no observed deaths. Interpretation: Our data suggest that the BNT162b2 mRNA vaccine is effective and safe. Their individual and societal benefits outweigh the low-percentage of serious neurologic and non-neurologic AEFI. Funding: Consejo Nacional de Ciencia y Tecnologia, Mexico. Declaration of Interest: None to declare Ethical Approval: The study was revised and approved by the Ethics and Research Committees of the Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran (Ref. NER-3667-2021) and the Mexican Ministry of Health.
- Published
- 2021
32. A Randomized, Controlled Study on the Safety and Efficacy of Maraviroc and/or Favipiravir vs Currently Used Therapy in Severe COVID-19 Adults. 'COMVIVIR' Trial
- Author
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Manli M. Servin-Murillo, Diana Sofia Cabrera-Orejuela, Juan Sierra-Madero, Maria Luisa Hernández-Medel, Joselín Hernández-Ruiz, José D. Carrillo-Ruiz, Helena Solleiro-Villavicencio, Adolfo Perez-Garcia, Santiago Ávila-Ríos, Elba O. Medina-Hernandez, Arianna Rodriguez-Cal Y Mayor, Gustavo Reyes-Teran, Lucia Monserrat Pérez-Navarro, Mireya León-Hernández, Srinivas Mummidi, Ana Maria Espinoza-Garcia, Raúl Serrano-Loyola, Juan Carlos López-Alvarenga, Guadalupe Mercedes Lucia Guerrero-Avendaño, Alma Villalobos-Osnaya, and Gonzalo Salgado-Montes de Oca
- Subjects
medicine.medical_specialty ,chemistry.chemical_compound ,Coronavirus disease 2019 (COVID-19) ,Randomized controlled trial ,chemistry ,law ,business.industry ,Internal medicine ,medicine ,Favipiravir ,business ,law.invention ,Maraviroc - Abstract
Multiple studies have established that hyperinflammatory response induced by SARS CoV-2 is a main cause of complications and death in infected subjects. Such dysfunctional immune response has been described as a dysregulated and exacerbated production of cytokines and chemokines that attracts and activates inflammatory cells, which start and sustain pulmonary and systemic damage, thus causing complications that lead to multi organ failure and death. Therefore, we suggest that blocking key inflammation receptors could help to reduce migration and activation of T cells, monocytes/macrophages and neutrophils, thus mitigating the cytokine dysregulation and averting severe complications and death. Importantly, the optimum treatment for COVID-19 severe patients should combine a modulator of the immune response plus a direct antiviral drug against SARS-CoV-2, in order to address both the hyperinflammatory effects of the immune dysregulation and the viral load. Methods: Maraviroc (MVC), a CCR5 antagonist, and Favipiravir (FPV), an antiviral, will be evaluated single and combined, added to the treatment currently used at the Hospital General de México Dr. Eduardo Liceaga for severe COVID-19 patients. One hundred patients will be allocated in four arms [Current treatment only (CT), CT+MVC, CT+FPV, CT+MVC+FPV]. Percentage of patients free of mechanical ventilation or death at day 28, immunophenotyping and viral load will be compared between groups. Discussion: New immune focused therapies are targeting strong inflammation mediators such as IL-6 and IL1-β; nevertheless, to our best knowledge, only one study explores chemotaxis control. The use of a drug therapy that addresses both the regulation of the immune response and the inhibition of viral replication could at the same time, help to alleviate the hyperinflammatory condition and reduce the time of the viral clearance process, therefore improving treatment outcomes.
- Published
- 2020
33. Seroepidemiology of SARS-CoV-2 in healthcare personnel working at the largest tertiary COVID-19 referral hospitals in Mexico City
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Yanink Caro-Vega, Gustavo Reyes-Terán, Pedro García-Esparza, Santiago Ávila-Ríos, Vanessa Dávila-Conn, Maribel Soto-Nava, Arturo Galindo-Fraga, Pablo F. Belaunzarán-Zamudio, Juan Sierra-Madero, Héctor E Paz-Juárez, Marissa Pérez-García, and Daniela Tapia-Trejo
- Subjects
Adult ,Male ,History ,medicine.medical_specialty ,Polymers and Plastics ,Referral ,Population ,Declaration ,Industrial and Manufacturing Engineering ,COVID-19 Serological Testing ,Tertiary Care Centers ,Risk Factors ,Seroepidemiologic Studies ,Health care ,medicine ,Humans ,Business and International Management ,education ,Mexico ,education.field_of_study ,Multidisciplinary ,business.industry ,SARS-CoV-2 ,Technician ,COVID-19 ,Odds ratio ,Middle Aged ,Confidence interval ,Personnel, Hospital ,Family medicine ,Residence ,Female ,business - Abstract
Introduction We performed a longitudinal SARS-CoV-2 seroepidemiological study in healthcare personnel of the two largest tertiary COVID-19 referral hospitals in Mexico City. Methods All healthcare personnel, including staff physicians, physicians in training, nurses, laboratory technicians, researchers, students, housekeeping, maintenance, security, and administrative staff were invited to voluntarily participate, after written informed consent. Participants answered a computer-assisted self-administered interview and donated blood samples for antibody testing every three weeks from October 2020 to June 2021. Results A total of 883 participants (out of 3639 registered employees) contributed with at least one blood sample. The median age was 36 years (interquartile range: 28–46) and 70% were women. The most common occupations were nurse (28%), physician (24%), and administrative staff (22%). Two hundred and ninety participants (32.8%) had a positive-test result in any of the visits, yielding an overall adjusted prevalence of 33.5% for the whole study-period. Two hundred and thirty-five positive tests were identified at the baseline visit (prevalent cases), the remaining 55 positive tests were incident cases. Prevalent cases showed associations with both occupational (institution 2 vs. 1: adjusted odds ratio [aOR] = 2.24, 95% confidence interval [CI]: 1.54–3.25; laboratory technician vs. physician: aOR = 4.38, 95% CI: 1.75–10.93) and community (municipality of residence Xochimilco vs. Tlalpan: aOR = 2.03, 95% CI: 1.09–3.79) risk-factors. The incidence rate was 3.0 cases per 100 person-months. Incident cases were associated with community-acquired risk, due to contact with suspect/confirmed COVID-19 cases (HR = 2.45, 95% CI: 1.21–5.00). Conclusions We observed that between October 2020 and June 2021, healthcare workers of the two largest tertiary COVID-19 referral centers in Mexico City had similar level of exposure to SARS-CoV-2 than the general population. Most variables associated with exposure in this setting pointed toward community rather than occupational risk. Our observations are consistent with successful occupational medicine programs for SARS-CoV-2 infection control in the participating institutions but suggest the need to strengthen mitigation strategies in the community.
- Published
- 2022
34. 'Myocardial inflammatory changes before and after antiretroviral therapy initiation in people with advanced HIV disease'
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Ayleen Cárdenas-Ochoa, Alicia Piñeirúa-Menéndez, R Flores-Miranda, M Morelos-Guzmán, Juan Sierra-Madero, Z Vázquez-Ortiz, Brenda Crabtree-Ramírez, Santiago Pérez-Patrigeon, S Rosales-Uvera, C Orihuela-Sandoval, R Ortega-Pérez, Jorge Vázquez-Lamadrid, Pablo F. Belaunzarán-Zamudio, J Oseguera-Moguel, D Sánchez-Nava, and J Galindo-Uribe
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0301 basic medicine ,medicine.medical_specialty ,education.field_of_study ,Myocarditis ,medicine.diagnostic_test ,business.industry ,medicine.medical_treatment ,030106 microbiology ,Population ,Magnetic resonance imaging ,Immunosuppression ,Disease ,medicine.disease ,03 medical and health sciences ,0302 clinical medicine ,Infectious Diseases ,Oncology ,Immune reconstitution inflammatory syndrome ,Internal medicine ,Medicine ,030212 general & internal medicine ,Transthoracic echocardiogram ,business ,Prospective cohort study ,education - Abstract
Because high frequency and late presentation of HIV disease in our population, we decided to explore the presence of myocarditis among people with HIV-infection and advanced immunosuppression (less than 200 CD4+ cells/μL), and to describe the inflammatory changes observed after combined antiretroviral therapy (cART) initiation in an observational, longitudinal, prospective cohort performing cardiovascular MRI (cMRI) and doppler trans-thoracic echocardiogram (TTE).
- Published
- 2020
35. Clinical Characteristics and Mortality of Health-Care Workers With Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection in Mexico City
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Yanink Caro-Vega, Juan Sierra-Madero, Brenda Crabtree-Ramírez, and Lorena Guerrero-Torres
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Microbiology (medical) ,medicine.medical_specialty ,Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) ,Health Personnel ,education ,030204 cardiovascular system & hematology ,Lower risk ,03 medical and health sciences ,0302 clinical medicine ,Mexico city ,Internal medicine ,Health care ,Pandemic ,Major Article ,Healthcare workers ,Medicine ,Humans ,030212 general & internal medicine ,Mexico ,Pandemics ,business.industry ,SARS-CoV-2 ,Mortality rate ,COVID-19 ,Odds ratio ,medicine.disease ,mortality ,Comorbidity ,AcademicSubjects/MED00290 ,Infectious Diseases ,Female ,business - Abstract
Background We evaluated the risk of death for health-care workers (HCW) with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection in Mexico City during the coronavirus disease 2019 (COVID-19) pandemic, and describe the associated factors in hospitalized HCW, compared with non-HCW. Methods We analyzed data from laboratory-confirmed SARS-CoV-2 cases registered from 27 February–31 August 2020 in Mexico City’s public database. Individuals were classified as non-HCW or HCW (subcategorized as physicians, nurses, and other HCW). In hospitalized individuals, a multivariate logistic regression model was used to analyze the potential factors associated with death and compare mortality risks among groups. Results A total of 125 665 patients were included. Of these, 13.1% were HCW (28% physicians, 38% nurses, and 34% other HCW). Compared with non-HCW, HCW were more frequently female, were younger, and had fewer comorbidities. Overall, 25 771 (20.5%) were treated as inpatients and 11 182 (8.9%) deaths were reported. Deaths in the total population (9.9% vs 1.9%, respectively; P Conclusions HCW represent an important proportion of individuals with SARS-CoV-2 infection in Mexico City. While the mortality risk is lower in HCW compared to non-HCW, a high mortality rate in hospitalized patients was observed in this study. Among HCW, nurses had a lower risk of death compared to physicians and other HCW.
- Published
- 2020
36. Clinical and Epidemiological Characteristics of Patients Diagnosed with COVID-19 in a Tertiary Care Center in Mexico City: A Prospective Cohort Study
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Maria Del P. Ramos-Cervantes, Bruno A. Díaz-Mejía, José de J Vidal-Mayo, José L. Cárdenas, Esteban Pérez-García, Lorena Guerrero-Torres, Guillermo M. Ruiz-Palacios, Lorena Torres-González, Eric Ochoa-Hein, María de la L. Morales-Ortega, Guillermo Domínguez-Cherit, David Kershenobich-Stalnikowitz, Marco Villanueva-Reza, Bernardo A Martinez-Guerra, Violeta Ibarra-González, Karla M Tamez-Torres, Edgar Ortiz-Brizuela, María de L. Guerrero-Almeida, Luz E Cervantes-Villar, Alvaro López-Iñiguez, Aldo N. Hernández-Alemón, Sandra Rajme-López, Alfredo Ponce-de-León, María F González-Lara, Ever A. Corral-Herrera, Juan J. Calva-Mercado, Yamile G. Serrano-Pinto, Nereyda A de-León-Cividanes, Cristian E. Espejo-Ortiz, Juan Sierra-Madero, Oscar Arturo Lozano-Cruz, Thierry Hernández-Gilsoul, Carla M Roman-Montes, Eduardo Rivero-Sigarroa, Maria de Los Á. Tovar-Vargas, Antonio Olivas-Martinez, Alfonso Gulias-Herrero, Fabián A. Carrera-Patiño, Brenda Crabtree-Ramírez, José Sifuentes-Osornio, Arturo Galindo-Fraga, and Oscar A. Fernández-García
- Subjects
Gynecology ,medicine.medical_specialty ,Coronavirus disease 2019 (COVID-19) ,business.industry ,030209 endocrinology & metabolism ,General Medicine ,Dolor abdominal ,Tertiary care ,03 medical and health sciences ,0302 clinical medicine ,Family medicine ,Mexico city ,Intensive care ,Ambulatory ,Epidemiology ,medicine ,Center (algebra and category theory) ,Median body ,030212 general & internal medicine ,Prospective cohort study ,business - Abstract
espanolAntecedentes: la informacion regional sobre las caracteristicas de los pacientes con enfermedad por coronavirus (COVID) -19 es necesaria para una mejor comprension de la pandemia. Objetivo: El objetivo del estudio es describir las caracteristicas clinicas de los pacientes con COVID-19 diagnosticados en un centro de atencion terciaria en la Ciudad de Mexico y evaluar las diferencias segun el ambito del tratamiento (ambulatorio versus hospitalario) y la necesidad de cuidados intensivos ( IC). Metodos: Realizamos una cohorte prospectiva, que incluyo pacientes consecutivos con COVID-19 desde el 26 de febrero de 2020 hasta el 11 de abril de 2020. Resultados:Se identificaron 309 pacientes (140 pacientes hospitalizados y 169 pacientes ambulatorios). La mediana de edad fue de 43 anos (rango intercuartilico, 33-54), 59,2% varones y 18,6% trabajadores sanitarios (12,3% de nuestro centro). La mediana del indice de masa corporal (IMC) fue de 29,00 kg / m2 y el 39,6% tenia obesidad. En comparacion con los pacientes ambulatorios, los pacientes hospitalizados eran de mayor edad, tenian comorbilidades, tos y disnea con mayor frecuencia. Veintinueve (20,7%) pacientes hospitalizados requirieron tratamiento en la unidad de CI (UCI). Los antecedentes de diabetes (tipo 1 o 2) y el dolor abdominal fueron mas comunes en los pacientes de la UCI en comparacion con los pacientes que no estaban en la UCI. Los pacientes de la UCI tenian IMC mas altos, frecuencias respiratorias mas altas y saturaciones de oxigeno capilar de aire ambiente mas bajas. Los pacientes de la UCI mostraron una respuesta inflamatoria mas severa segun lo evaluado por el recuento de globulos blancos, recuento de neutrofilos y plaquetas, proteina C reactiva, ferritina, procalcitonina y niveles de albumina. Conclusiones: Los pacientes con comorbilidades, ya sean obesos de mediana edad o ancianos que se quejan de fiebre, tos o disnea, fueron mas propensos a ser ingresados. Al ingreso, los pacientes con diabetes, IMC alto y hallazgos clinicos o de laboratorio compatibles con un estado inflamatorio severo tenian mas probabilidades de requerir IC. EnglishBackground: Regional information regarding the characteristics of patients with coronavirus disease (COVID)-19 is needed for a better understanding of the pandemic. Objective: The objective of the study to describe the clinical features of COVID-19 patients diagnosed in a tertiary-care center in Mexico City and to assess differences according to the treatment setting (ambulatory vs. hospital) and to the need of intensive care (IC). Methods: We conducted a prospective cohort, including consecutive patients with COVID-19 from February 26, 2020 to April 11, 2020. Results: We identified 309 patients (140 inpatients and 169 outpatients). The median age was 43 years (interquartile range, 33-54), 59.2% men, and 18.6% healthcare workers (12.3% from our center). The median body mass index (BMI) was 29.00 kg/m2 and 39.6% had obesity. Compared to outpatients, inpatients were older, had comorbidities, cough, and dyspnea more frequently. Twenty-nine (20.7%) inpatients required treatment in the IC unit (ICU). History of diabetes (type 1 or 2) and abdominal pain were more common in ICU patients compared to non-ICU patients. ICU patients had higher BMIs, higher respiratory rates, and lower room-air capillary oxygen saturations. ICU patients showed a more severe inflammatory response as assessed by white blood cell count, neutrophil and platelet count, C-reactive protein, ferritin, procalcitonin, and albumin levels. By the end of the study period, 65 inpatients had been discharged because of improvement, 70 continued hospitalized, and five had died. Conclusions: Patients with comorbidities, either middle-age obese or elderly complaining of fever, cough, or dyspnea, were more likely to be admitted. At admission, patients with diabetes, high BMI, and clinical or laboratory findings consistent with a severe inflammatory state were more likely to require IC.
- Published
- 2020
37. [Prevention and control of SARS-CoV-2 (Covid-19) coronavirus infection in hemodialysis units.]
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Olynka, Vega-Vega, Mauricio, Arvizu-Hernández, José Guillermo, Domínguez-Cherit, Juan, Sierra-Madero, and Ricardo, Correa-Rotter
- Subjects
SARS-CoV-2 ,Pneumonia, Viral ,COVID-19 ,Disinfection ,Primary Prevention ,Betacoronavirus ,Early Diagnosis ,Patient Education as Topic ,Renal Dialysis ,Humans ,Renal Insufficiency, Chronic ,Coronavirus Infections ,Pandemics ,Personal Protective Equipment ,Algorithms - Abstract
The SARS-CoV-2 pandemic is of hich risk for patients on chronic hemodialysis due to their immunosuppressed state, advanced age, and the coexistence of significant comorbidities, in particular cardiovascular disease, diabetes mellitus, and others. Additionally, they constitute a closed conglomerate since they come to treatment regularly, spending hours in the treatment places, exposed to a possible acquisition of the infection. Finally, going to their treatment regularly prevents them from remaining in home isolation and with potential exposure. These recommendations summarize the interventions proposed by three international organizations and add some suggested by national experts, with the aim to early identify the patients and health personnel at risk and reducing the risk of infection.La pandemia del SARS-CoV-2 representa un riesgo especial para los pacientes en hemodiálisis crónica por su estado de inmunosupresión, edad avanzada y coexistencia de comorbilidades importantes, en particular patología cardiovascular, diabetes mellitus y otras. Adicionalmente, esta población constituye un conglomerado cerrado ya que los pacientes acuden a tratamiento con regularidad y permanecen horas en los lugares de tratamiento, expuestos a una posible adquisición de la infección. El hecho de acudir necesaria y regularmente a su tratamiento impide que permanezcan en aislamiento domiciliario y con exposición potencial en el traslado. Las presentes recomendaciones resumen las intervenciones propuestas por tres organizaciones internacionales, a las que se agregan algunas sugeridas por expertos nacionales, con el objetivo de identificar precozmente a los pacientes y personal de la salud en riesgo para disminuir el riesgo de infección.
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- 2020
38. The HIV epidemic in Latin America: a time to reflect on the history of success and the challenges ahead
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Miguel Morales, Pedro Cahn, Anton Pozniak, Omar Sued, Pablo F. Belaunzarán-Zamudio, Claudia P. Cortes, Brenda Crabtree-Ramírez, Juan Sierra-Madero, and Beatriz Grinsztejn
- Subjects
Economic growth ,Latin Americans ,business.industry ,Hiv epidemic ,Public Health, Environmental and Occupational Health ,Human immunodeficiency virus (HIV) ,HIV ,Hiv testing ,medicine.disease_cause ,migration ,HIV testing ,Viewpoints ,Infectious Diseases ,Viewpoint ,Latin America ,HIV epidemic ,PrEP in Latin America ,Medicine ,business ,ART - Published
- 2020
39. High prevalent human papillomavirus infections of the oral cavity of asymptomatic HIV-positive men
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Miriam Guido-Jiménez, Juan Sierra-Madero, Silvia Maldonado-Frías, Yanink Caro-Vega, Brenda Crabtree-Ramírez, Salvador Vázquez-Vega, José Guadalupe Rendón-Maldonado, Rocío Méndez-Martínez, and Alejandro García-Carrancá
- Subjects
Male ,0301 basic medicine ,Genotyping Techniques ,Anal Canal ,HIV Infections ,Polymerase Chain Reaction ,Gastroenterology ,Men who have sex with men ,Sexual and Gender Minorities ,0302 clinical medicine ,Medical microbiology ,Risk Factors ,Prevalence ,Human papillomavirus 16 ,Incidence ,Incidence (epidemiology) ,virus diseases ,Middle Aged ,Anal canal ,Types and variants MSM ,Infectious Diseases ,medicine.anatomical_structure ,030220 oncology & carcinogenesis ,Research Article ,Adult ,HPV ,medicine.medical_specialty ,lcsh:Infectious and parasitic diseases ,Young Adult ,03 medical and health sciences ,Internal medicine ,medicine ,Humans ,lcsh:RC109-216 ,Homosexuality, Male ,Risk factor ,Mexico ,Tropism ,Mouth ,HIV + ,business.industry ,Papillomavirus Infections ,CD4 Lymphocyte Count ,Oral cavity ,Intestinal Diseases ,Cross-Sectional Studies ,030104 developmental biology ,Parasitology ,Asymptomatic Diseases ,Tropical medicine ,Mouth Diseases ,business - Abstract
Background Incidence of anal and oral infections with Human Papillomavirus (HPV) is increasing, particularly among Human Immunodeficiency Virus-positive (HIV+) men. HPV type 16 has exhibited the highest incidence and only limited data is available on other prevalent types, variants of HPV16, as well as associated factors. We were interested in identifying prevalent HPV types, variants of type 16, as well as factors associated with HPV16 infections in the oral cavity of HIV+ men who have sex with men (MSM). Methods A cross-sectional study of oral cavity samples from HIV+ MSM, that in a previous study were identified as positive for HPV16 in the anal canal. Cells from the oral cavity (102 samples, paired with 102 from the anal canal of same patient) were used to extract DNA and detect HPV infections using INNO-LiPA HPV Genotyping Extra II, and PCR. From these, 80 samples (paired, 40 anal and 40 oral) were used to identify variants of type 16 by sequencing. Statistical differences were estimated by the X2 test, and p values equal to or less than 0.05 were considered significant. SPSS ver. Twenty-four statistical software (IBM Corp) was used. Results We found a high prevalence of High-Risk HPV (HR-HPV) and Low-Risk HPV (LR-HPV). Patients were positive in the oral cavity for HR types; 16, 39 and 18 (80.4, 61.8 and 52.9% respectively) and LR types 11 and 6 (53.9 and 34.3% respectively). Surprisingly, only European variants of type 16 were found in the oral cavity, although American Asian (22.5%) and African (2.5%) variants were identified in the anal canal. The analysis showed that CD4 counts could be the most important risk factor associated with HR-HPV infections in the oral cavity, anal canal or both anatomical regions. The risk of infection of the oral cavity with type 18 increased in men diagnosed with HIV for more than 6 years. Conclusions Prevalence of both HR and LR HPV’s in the oral cavity of Mexican HIV+ MSM is very high. The fact that only European variants of HPV16 were found in the oral cavity suggest a possible tropism not previously described.
- Published
- 2020
40. Durable Efficacy of Dolutegravir Plus Lamivudine in Antiretroviral Treatment-Naive Adults With HIV-1 Infection: 96-Week Results From the GEMINI-1 and GEMINI-2 Randomized Clinical Trials
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Brian Wynne, Choy Y. Man, Daisy J. Brandon, Andrea Antinori, Jose R. Arribas, Pedro Cahn, Pierre-Marie Girard, Mark R. Underwood, Kimberly Y. Smith, Amanda Clarke, Juan Sierra Madero, Jean van Wyk, Jörg Sievers, Martin Gartland, Rimgaile Urbaityte, Michael Aboud, Keith A. Pappa, Chien-Ching Hung, Allan R Tenorio, Roberto Ortiz, and Jürgen K. Rockstroh
- Subjects
Oncology ,Adult ,Male ,medicine.medical_specialty ,Adolescent ,Anti-HIV Agents ,Pyridones ,HIV Infections ,Emtricitabine ,Tenofovir alafenamide ,Piperazines ,chemistry.chemical_compound ,Young Adult ,Pharmacotherapy ,Maintenance therapy ,Acquired immunodeficiency syndrome (AIDS) ,Double-Blind Method ,Abacavir ,Internal medicine ,Oxazines ,medicine ,Humans ,Pharmacology (medical) ,business.industry ,Lamivudine ,Middle Aged ,medicine.disease ,Infectious Diseases ,chemistry ,Dolutegravir ,HIV-1 ,RNA, Viral ,Drug Therapy, Combination ,Female ,business ,Heterocyclic Compounds, 3-Ring ,medicine.drug - Abstract
Two-drug regimens (2DRs) can potentially reduce long-term cumulative drug exposure and decrease treatment-associated costs for HIV-1–infected individuals, who require lifelong therapy.1 The core antiretroviral agent in a 2DR must have high potency and a high barrier to resistance.1 As such, early studies investigating 2DRs as initial or maintenance therapy for HIV infection evaluated the pairing of the potent, well-tolerated nucleoside reverse transcriptase inhibitor (NRTI) lamivudine with pharmacologically boosted protease inhibitors (PIs), which have a high barrier to resistance.2–6 Although noninferior efficacy was shown against 3-drug regimens (3DRs), PIs are associated with adverse metabolic effects, long-term toxicities, and drug–drug interactions, limiting their appeal as components of lifelong therapy.7,8 Thus, a need remains for well-tolerated, potent 2DRs with a high barrier to resistance. The integrase strand transfer inhibitor (INSTI) dolutegravir has a high barrier to resistance, making it a well-suited candidate for inclusion in a 2DR,9 particularly when paired with lamivudine,10 as previously observed.11,12 In primary week 48 analyses of the 2 phase III studies GEMINI-1 and GEMINI-2 in treatment-naive adults, dolutegravir + lamivudine was noninferior to dolutegravir + tenofovir disoproxil fumarate/emtricitabine in achieving HIV-1 RNA
- Published
- 2019
41. Temporal changes in ART initiation in adults with high CD4 counts in Latin America: a cohort study
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Eduardo Gotuzzo, Pablo F. Belaunzarán-Zamudio, Peter F Rebeiro, Catherine C. McGowan, Brenda Crabtree-Ramírez, Yanink Caro-Vega, Anna K. Person, Claudia P. Cortes, Bryan E. Shepherd, Valdilea G. Veloso, Denis Padgett, and Juan Sierra-Madero
- Subjects
Cart ,Adult ,Male ,Latin Americans ,Time Factors ,Adolescent ,HIV Infections ,Cohort Studies ,03 medical and health sciences ,0302 clinical medicine ,Acquired immunodeficiency syndrome (AIDS) ,Interquartile range ,Medicine ,HIV care continuum ,Humans ,030212 general & internal medicine ,Research Articles ,linkage to care ,Proportional Hazards Models ,030505 public health ,Proportional hazards model ,business.industry ,Hazard ratio ,Public Health, Environmental and Occupational Health ,virus diseases ,Middle Aged ,medicine.disease ,Confidence interval ,3. Good health ,CD4 Lymphocyte Count ,Infectious Diseases ,Latin America and the Carribean ,Latin America ,Adherence ,ARV ,Female ,0305 other medical science ,business ,Cohort study ,Demography ,Research Article - Abstract
Introduction In 2013, the World Health Organization (WHO) recommended initiating combination ART (cART) in all adults with HIV and CD4+ lymphocyte counts (CD4)
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- 2019
42. Metabolic Profiles of Individuals Switched to Second-Line Antiretroviral Therapy after Failing Standard First-Line Therapy for Treatment of HIV-1 Infection in a Randomized, Controlled Trial
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Paddy Mallon, Sean Emery, Cecilia L. Moore, Stephen J. Kerr, Amanda H Yao, David A. Cooper, Mark A. Boyd, Jean-Michel Molina, Juan Sierra Madero, and Poh Lian Lim
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Adult ,Male ,0301 basic medicine ,medicine.medical_specialty ,Anti-HIV Agents ,Human immunodeficiency virus (HIV) ,MEDLINE ,HIV Infections ,medicine.disease_cause ,Drug Substitution ,law.invention ,03 medical and health sciences ,0302 clinical medicine ,First line therapy ,Second line ,Randomized controlled trial ,law ,Antiretroviral Therapy, Highly Active ,Internal medicine ,medicine ,Humans ,Pharmacology (medical) ,Treatment Failure ,030212 general & internal medicine ,Pharmacology ,business.industry ,Middle Aged ,030112 virology ,Antiretroviral therapy ,Virological failure ,Treatment Outcome ,Infectious Diseases ,Retreatment ,Metabolome ,Female ,business ,Biomarkers - Abstract
Background To investigate metabolic changes associated with second-line antiretroviral therapy (ART) following virological failure of first-line ART. Methods SECOND-LINE was an open-label randomized controlled trial. Participants were randomized 1:1 to receive ritonavir-boosted lopinavir (LPV/r) with 2–3 nucleoside/nucleotide reverse transcriptase inhibitors (N[t]RTI group) or raltegravir (RAL group). 210 participants had a dual energy X-ray absorptiometry (DXA)-scan at baseline, week 48 and 96. We categorized participants according to second-line ART backbone: thymidine analogue (ta-NRTI) + lamivudine/emtricitabine (3[F]TC; ta-NRTI group); tenofovir (TDF)+3(F)TC (TDF group); TDF+ta-NRTI ±3(F)TC (TDF+ta-NRTI group); RAL. Changes in fasted total cholesterol (TC), low-density lipoprotein (LDL)-cholesterol, high-density lipoprotein (HDL)-cholesterol, TC/HDL-cholesterol ratio, triglycerides and glucose from baseline to week 96 were examined. We explored the association between metabolic and DXA-assessed soft-tissue changes. Linear regression methods were used. Results We analysed 454 participants. Participants in RAL group had greater TC increases, TC (adjusted mean difference [aMD]=0.65, 95% CI 0.33, 0.96), LDL-c (aMD=0.38, 95% CI 0.15, 0.61) and glucose (aMD=0.47, 95% CI -0.01, 0.92) compared to TDF group, and had greater increases in TC (aMD=0.65, 95% CI 0.28, 1.03), HDL-c (aMD=0.12, 95% CI 0.02, 0.23) and LDL-c (aMD=0.41, 95% CI 0.13, 0.69) compared to TDF+ta-NRTI group. TC/HDL ratio and triglycerides increased in all groups without significant differences between groups. A 1 kg increase in trunk fat mass was associated with an increase in TC. Conclusions We observed metabolic changes of limited clinical significance in the relatively young population enrolled in this study. However, the metabolic changes observed may have greater clinical significance in older people living with HIV or those with other concomitant cardiovascular risks.
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- 2018
43. Retention in Care, Mortality, Loss-to-Follow-Up, and Viral Suppression among Antiretroviral Treatment-Naïve and Experienced Persons Participating in a Nationally Representative HIV Pre-Treatment Drug Resistance Survey in Mexico
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Fernando Alarid-Escudero, Juan Sierra-Madero, Gustavo Reyes-Terán, Santiago Ávila-Ríos, Yanink Caro-Vega, Claudia García-Morales, Carlos Chivardi, Alicia Piñeirúa-Menéndez, Sandra G. Sosa-Rubí, and Eva A. Enns
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Microbiology (medical) ,medicine.medical_specialty ,Efavirenz ,Nevirapine ,Context (language use) ,Drug resistance ,Article ,Men who have sex with men ,03 medical and health sciences ,chemistry.chemical_compound ,0302 clinical medicine ,Interquartile range ,Internal medicine ,medicine ,Immunology and Allergy ,030212 general & internal medicine ,Mexico ,Molecular Biology ,0303 health sciences ,drug resistance ,General Immunology and Microbiology ,030306 microbiology ,business.industry ,Public health ,public health ,Hazard ratio ,HIV ,surveillance ,3. Good health ,Infectious Diseases ,chemistry ,Medicine ,business ,medicine.drug - Abstract
We describe associations of pretreatment drug resistance (PDR) with clinical outcomes such as remaining in care, loss to follow-up (LTFU), viral suppression, and death in Mexico, in real-life clinical settings. We analyzed clinical outcomes after a two-year follow up period in participants of a large 2017–2018 nationally representative PDR survey cross-referenced with information of the national ministry of health HIV database. Participants were stratified according to prior ART exposure and presence of efavirenz/nevirapine PDR. Using a Fine-Gray model, we evaluated virological suppression among resistant patients, in a context of competing risk with lost to follow-up and death. A total of 1823 participants were followed-up by a median of 1.88 years (Interquartile Range (IQR): 1.59–2.02): 20 (1%) were classified as experienced + resistant; 165 (9%) naïve + resistant; 211 (11%) experienced + non-resistant; and 1427 (78%) as naïve + non-resistant. Being ART-experienced was associated with a lower probability of remaining in care (adjusted Hazard Ratio(aHR) = 0.68, 0.53–0.86, for the non-resistant group and aHR = 0.37, 0.17–0.84, for the resistant group, compared to the naïve + non-resistant group). Heterosexual cisgender women compared to men who have sex with men [MSM], had a lower viral suppression (aHR = 0.84, 0.70–1.01, p = 0.06) ART-experienced persons with NNRTI-PDR showed the worst clinical outcomes. This group was enriched with women and persons with lower education and unemployed, which suggests higher levels of social vulnerability.
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- 2021
44. Pilot, randomized study assessing safety, tolerability and efficacy of simplified LPV/r maintenance therapy in HIV patients on the 1 PI-based regimen.
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Pedro Cahn, Julio Montaner, Patrice Junod, Patricia Patterson, Alejandro Krolewiecki, Jaime Andrade-Villanueva, Isabel Cassetti, Juan Sierra-Madero, Arnaldo David Casiró, Raul Bortolozzi, Sergio Horacio Lupo, Nadia Longo, Emmanouil Rampakakis, Nabil Ackad, and John S Sampalis
- Subjects
Medicine ,Science - Abstract
To compare the efficacy and safety of an individualized treatment-simplification strategy consisting of switching from a highly-active anti-retroviral treatment (HAART) with a ritonavir-boosted protease inhibitor (PI/r) and 2 nucleoside reverse-transcriptase inhibitors (NRTIs) to lopinavir/ritonavir (LPV/r) monotherapy, with intensification by 2 NRTIs if necessary, to that of continuing their HAART.This is a one-year, randomized, open-label, multi-center study in virologically-suppressed HIV-1-infected adults on their first PI/r-containing treatment, randomized to either LPV/r-monotherapy or continue their current treatment. Treatment efficacy was determined by plasma HIV-1 RNA viral load (VL), time-to-virologic rebound, patient-reported outcomes (PROs) and CD4+T-cell-count changes. Safety was assessed with the incidence of treatment-emergent adverse events (AE).Forty-one patients were randomized to LPV/r and 39 to continue their HAART. No statistically-significant differences between the two study groups in demographics and baseline characteristics were observed. At day-360, 71(39:LPV/r;32:HAART) patients completed treatment, while 9(2:LPV/r;7:HAART) discontinued. In a Last Observation Carried Forward Intent-to-Treat analysis, 40(98%) patients on LPV/r and 37(95%) on HAART had VL
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- 2011
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45. Neurologic adverse events among 704,003 first-dose recipients of the BNT162b2 mRNA COVID-19 vaccine in Mexico: A nationwide descriptive study
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Carlos Blaisdell-Vidal, Hugo López-Gatell, Daniel Amado Carrillo-García, Santa Elizabeth Ceballos-Liceaga, Rogelio Pérez-Padilla, Sergio I. Valdés-Ferrer, Gustavo Reyes-Terán, Miguel García-Grimshaw, Laura E. Hernández-Vanegas, Roger A. Carrillo-Mezo, Juan Sierra-Madero, Guillermo Carbajal-Sandoval, José Luis Díaz-Ortega, Sergio Fragoso-Saavedra, Juan L. Mosqueda-Gómez, María del Mar Saniger-Alba, Noé Hernández-Valdivia, Antonio Arauz, Javier Andrés Galnares-Olalde, Isaac Núñez, José Luis Alomía-Zegarra, Anaclara Michel-Chávez, and Alba Espino-Ojeda
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Adult ,Male ,Adverse event ,0301 basic medicine ,Pediatrics ,medicine.medical_specialty ,COVID-19 Vaccines ,Coronavirus disease 2019 (COVID-19) ,Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) ,Immunology ,Cohort Studies ,03 medical and health sciences ,0302 clinical medicine ,Full Length Article ,medicine ,Humans ,Immunology and Allergy ,Prospective Studies ,Adverse effect ,Prospective cohort study ,Mexico ,BNT162 Vaccine ,Vaccines, Synthetic ,SARS-CoV-2 ,business.industry ,Incidence (epidemiology) ,COVID-19 ,Middle Aged ,030104 developmental biology ,Immunization ,Female ,BNT162b2 ,Observational study ,Nervous System Diseases ,business ,Vaccine ,030215 immunology ,Cohort study - Abstract
mRNA vaccines against SARS-CoV-2 are remarkably effective. Limited information exists about the incidence of adverse events following immunization (AEFI) with their use. We conducted a prospective observational study including data from 704,003 first-doses recipients; 6536 AEFI were reported, of whom 65.1% had at least one neurologic AEFI (non-serious 99.6%). Thirty-three serious events were reported; 17 (51.5%) were neurologic (observed frequency, 2.4/100,000 doses). At the time of writing this report, 16/17 cases had been discharged without deaths. Our data suggest that the BNT162b2 mRNA COVID-19 vaccine is safe; its individual and societal benefits outweigh the low percentage of serious neurologic AEFI. This information should help to dissipate hesitancy towards this new vaccine platform.
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- 2021
46. Burden of HIV, Syphilis, and Hepatitis B and C Among Inmates in a Prison State System in Mexico
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Juan Sierra-Madero, Pablo F. Belaunzarán-Zamudio, Macías-Hernández Ae, Juan L. Mosqueda-Gómez, Chris Beyrer, and Sonia Rodríguez-Ramírez
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Adult ,Male ,medicine.medical_specialty ,Adolescent ,Cross-sectional study ,Hepatitis C virus ,Immunology ,HIV Infections ,medicine.disease_cause ,Young Adult ,03 medical and health sciences ,Risk-Taking ,0302 clinical medicine ,Surveys and Questionnaires ,Virology ,Internal medicine ,Prevalence ,Humans ,Medicine ,Syphilis ,030212 general & internal medicine ,Young adult ,Mexico ,Aged ,Hepatitis B virus ,030505 public health ,business.industry ,Prisoners ,virus diseases ,Hepatitis C ,Middle Aged ,Hepatitis B ,medicine.disease ,Confidence interval ,Cross-Sectional Studies ,Infectious Diseases ,Prisons ,Female ,0305 other medical science ,business - Abstract
We studied the prevalence of HIV, syphilis, hepatitis B virus (HBV), and hepatitis C virus (HCV) infection and associated risk behaviors in the prison state system of Guanajuato, Mexico between September 2011 and February 2012. Blood samples were drawn from adult inmates in all State prisons who agreed to participate in this cross-sectional study. Data on risk behaviors were collected by using self-administered questionnaires. The prevalence of HIV, syphilis, HBV, and HCV infection was 0.6% [95% confidence interval (CI) = 0.2-1.1], 0.7% (95% CI = 0.4-1.0), 0.4 (95% CI = 0.04-0.74), and 4.8 (95% CI = 3.6-5.9), respectively. Female inmates had a higher prevalence of HIV (1.5% vs. 0.6%, p = .05), whereas male inmates had a higher prevalence of HCV (1% vs. 5%, p = .008). Twenty percent (n = 443, 95% CI = 15-26) of the participants were tattooed during incarceration, and most of them were tattooed with recycled materials. Around 60% (57%, 95% CI = 49-65) used drugs before incarceration, and 9.2% (n = 205) used injected drugs. During incarceration, 30% (95% CI = 23-39) used drugs and 43 continued injecting (20% of users). Consistent condom use was low among men before incarcerations but decreased by half during incarceration. The highest consistent condom use before incarceration was among men who have sex with men (MSM) (17.7%, 95% CI = 14-22), but it decreased (9%, 95% CI = 3-14) during incarceration. The prevalence of HIV, HBV, HCV, and syphilis in these inmates is higher than that of the local adult population. Most inmates had sex in prison, but few used condoms consistently. Access to condoms is apparently harder for MSM. Interventions to increase condom use, reduce use of shared or recycled materials for tattooing and injecting drugs, and treatment for drug abuse are needed.
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- 2017
47. Country of residence is associated with distinct inflammatory biomarker signatures in HIV-infected patients
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Wenjuan Gu, Adam Rupert, Irini Sereti, Pablo F. Belaunzarán-Zamudio, Ian Sanne, Juan Sierra-Madero, Maura Manion, Laura W. Musselwhite, Bruno B. Andrade, Rebecca DerSimonian, and Michael M. Lederman
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0301 basic medicine ,Tuberculosis ,Epidemiology ,Immunology ,Human immunodeficiency virus (HIV) ,Inflammation ,Fibrinogen ,medicine.disease_cause ,Microbiology ,Pathogenesis ,03 medical and health sciences ,Virology ,medicine ,Original Research ,business.industry ,Public Health, Environmental and Occupational Health ,HIV ,biomarkers ,nationality ,medicine.disease ,QR1-502 ,030104 developmental biology ,Infectious Diseases ,inflammation ,Biomarker (medicine) ,Residence ,Public aspects of medicine ,RA1-1270 ,medicine.symptom ,Inflammatory biomarker ,business ,medicine.drug - Abstract
Background: Inflammation and coagulation biomarkers are independent predictors of morbidity and mortality in HIV-infected patients. The impact of sa:country of residence on these biomarkers is unknown and was investigated in persons at similar stages of HIV infection. Methods: Cryopreserved plasma specimens were analysed from 267 ART-naive patients with CD4 cell counts
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- 2017
48. 1024. Impact of Treatment Adherence on Efficacy of DTG/3TC and DTG + TDF/FTC: Pooled Analysis of the GEMINI 1 and 2 Clinical Trials
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Richard Grove, Jörg Sievers, Rimgaile Urbaityte, Debbie Hagins, Roberto Gulminetti, Hung-Chin Tsai, Jean van Wyk, Juan Sierra Madero, Mounir Ait-Khaled, Brian Wynne, Vicente Estrada, C. Man, and Andrew Zolopa
- Subjects
Oncology ,medicine.medical_specialty ,Intention-to-treat analysis ,business.industry ,Treatment adherence ,Emtricitabine ,Clinical trial ,Therapy naive ,chemistry.chemical_compound ,AcademicSubjects/MED00290 ,Infectious Diseases ,Pooled analysis ,chemistry ,Viral Load result ,Internal medicine ,Poster Abstracts ,Dolutegravir ,Medicine ,business ,medicine.drug - Abstract
Background GEMINI 1 & 2 are global double-blind, multi-center phase III non-inferiority studies evaluating efficacy and safety of dolutegravir (DTG) + lamivudine (3TC) once daily in treatment-naive HIV-1-infected adults with Screening HIV-1 RNA ≤ 500,000 c/mL (ClinicalTrials.gov: NCT02831673/NCT02831764). Participants were randomized 1:1 to treatment with DTG+3TC or DTG + tenofovir disoproxil fumarate (TDF)/emtricitabine (FTC). The primary endpoint was the proportion of participants with plasma HIV-1 RNA < 50 c/mL at Week 48 (Snapshot algorithm). DTG+3TC was non-inferior to DTG+TDF/FTC at Weeks 48 and 96. Here we evaluate the impact of treatment adherence on Week 48 virologic response (VR) within the GEMINI trials as a post-hoc analysis. Methods Adherence was estimated using pill counts data and categorized as follows: ≥ 90% vs < 90%. Week 48 VR was measured as % of participants with HIV-1 RNA < 50 c/mL by Food and Drug Administration Snapshot and by last on treatment viral load (VL) for the intention to treat–exposed population for which adherence could be derived. VR and differences between treatment arms within each adherence category were calculated along with exact unadjusted 95% confidence intervals. Results 5% of participants had < 90% adherence in both treatment arms. Baseline VL and CD4+ cell counts were similar across adherence categories. VR was lower in the < 90% adherence group than the ≥ 90% group, but not different between the 2 treatment arms within the same adherence category: In the low adherence group, DTG+3TC VR was 69% compared to 65% in DTG+TDF/FTC arm by Snapshot and 91% and 85% respectively by last on treatment VL analysis (Table). Table. Conclusion In the GEMINI studies, a lower Week 48 VR was observed in participants with < 90% adherence, but the impact of lower adherence on VR was similar in the DTG+3TC compared with DTG+TDF/FTC arms. One limitation of the analysis is the small number of participants in the lower adherence subgroup. However, the results add further information about the robustness of DTG+3TC compared to 3-drug DTG-containing regimens and may suggest similar regimen forgiveness. Disclosures Mounir Ait-Khaled, PhD, ViiV Healthcare (Employee, Shareholder) Choy Man, BSc, ViiV Healthcare (Employee, Shareholder) Jorg Sievers, DPhil, ViiV Healthcare (Employee) Richard Grove, MSc, GSK/ViiV (Employee, Shareholder) Brian Wynne, MD, ViiV Healthcare (Employee) Rimgaile Urbaityte, MSc, GlaxoSmithKline (Employee, Shareholder) Jean A. van Wyk, MB,ChB, ViiV Healthcare (Employee, Shareholder) Debbie Hagins, MD, Gilead Sciences Inc. (Consultant, Grant/Research Support, Scientific Research Study Investigator, Advisor or Review Panel member)Janssen (Grant/Research Support)Merck (Consultant, Grant/Research Support, Advisor or Review Panel member)Viiv Healthcare (Consultant, Grant/Research Support, Advisor or Review Panel member) Andrew Zolopa, MD, ViiV Healthcare (Employee)
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- 2020
49. Pretreatment HIV-drug resistance in Mexico and its impact on the effectiveness of first-line antiretroviral therapy: a nationally representative 2015 WHO survey
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Juan Sierra-Madero, Claudia García-Morales, Gustavo Reyes-Terán, Santiago Ávila-Ríos, Verónica S Quiroz-Morales, Helena Reyes-Gopar, Carlos Magis-Rodriguez, Karla Romero-Mora, Eddie A León-Juárez, Daniela Tapia-Trejo, Patricia Uribe-Zúñiga, Paul Sandstrom, Jesús Casillas-Rodríguez, Margarita Matías-Florentino, Marisol Valenzuela-Lara, and Hezhao Ji
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Adult ,Cyclopropanes ,Male ,0301 basic medicine ,medicine.medical_specialty ,Efavirenz ,Anti-HIV Agents ,Epidemiology ,Immunology ,Federal Government ,HIV Infections ,Drug resistance ,World Health Organization ,Emtricitabine ,Logistic regression ,Young Adult ,03 medical and health sciences ,chemistry.chemical_compound ,Antiretroviral Therapy, Highly Active ,Surveys and Questionnaires ,Virology ,Internal medicine ,Drug Resistance, Viral ,medicine ,Humans ,Young adult ,Mexico ,business.industry ,High-Throughput Nucleotide Sequencing ,Viral Load ,Antiretroviral therapy ,Benzoxazines ,CD4 Lymphocyte Count ,030104 developmental biology ,Infectious Diseases ,chemistry ,Alkynes ,HIV-1 ,RNA, Viral ,Reverse Transcriptase Inhibitors ,Female ,business ,Viral load ,HIV drug resistance ,Follow-Up Studies ,medicine.drug - Abstract
WHO has developed a global HIV-drug resistance surveillance strategy, including assessment of pretreatment HIV-drug resistance. We aimed to do a nationally representative survey of pretreatment HIV-drug resistance in Mexico using WHO-recommended methods.Among 161 Ministry of Health antiretroviral therapy (ART) clinics in Mexico, the largest, including 90% of ART initiators within the Ministry of Health (66 in total), were eligible for the survey. We used a probability-proportional-to-size design method to sample 25 clinics throughout the country. Consecutive ART-naive patients with HIV about to initiate treatment were invited to participate in the survey; individuals with previous exposure to ART were excluded. We assessed pretreatment HIV-drug resistance by Sanger sequencing and next-generation sequencing of viruses from plasma specimens from eligible participants with Stanford University HIV Drug Resistance Database methods. We obtained follow-up data for a median of 9·4 months (range 6-12) after enrolment. We investigated possible relations between demographic variables and pretreatment drug resistance with univariate and multivariate logistic regression.Between Feb 3 and July 30, 2015, we screened 288 patients in 25 clinics, from whom 264 provided successfully sequenced viruses with no evidence of current exposure to antiretroviral drugs. With the Sanger method, of these 264 participants, 41 (15·5%, 95% CI 11·4-20·5) had pretreatment resistance to any antiretroviral drug and 28 (10·6%, 7·2-15·0) had pretreatment resistance to non-nucleoside reverse transcriptase inhibitors (NNRTIs). At least low-level pretreatment resistance (Stanford penalty score ≥15) was noted in 13 (4 · 9%) of participants to efavirenz and in 23 (8·7%) to the combination tenofovir plus emtricitabine plus efavirenz. With next-generation sequencing, of 264 participants, 38 (14·4%, 95% CI 10·4-19·2) had pretreatment resistance to any antiretroviral drug and 26 (9·8%, 6·5-14·1) had pretreatment resistance to NNRTIs. After median follow-up of 8 months (IQR 6·5-9·4, range 5-11) after ART initiation, 97 (72%) of 135 NNRTI initiators achieved viral suppression (50 copies per mL) compared with ten (40%) of 25 individuals who started with protease inhibitor-based regimens (p=0·0045). After multivariate regression considering pretreatment resistance and initial ART regimen as composite variables, people starting NNRTIs with pretreatment drug resistance achieved significantly lower viral suppression (odds ratio 0·24, 95% CI 0·07-0·74; p=0·014) than patients without NNRTI resistance.High levels of pretreatment drug resistance were noted in Mexico, and NNRTI pretreatment drug resistance significantly reduced the effectiveness of first-line ART regimens based on these drugs. Baseline HIV-drug resistance testing for initial ART follow-up and decision making should be considered.The Mexican Government and Consejo Nacional de Ciencia y Tecnología.
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- 2016
50. III. THE ROLE OF THE RESEARCH ETHICS COMMITTEES IN THE REGULATION OF PHARMA-SPONSORED STUDIES
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Alvar Loria-Acereto, Martha Kaufer-Horwitz, Elena Zambrano-González, Alejandra González-Duarte, Carlos A. Aguilar-Salinas, Juan Sierra-Madero, and Virginia Pascual-Ramos
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Research ethics ,Clinical Trials as Topic ,Informed Consent ,Drug Industry ,Process (engineering) ,education ,Late stage ,Ethics committee ,General Medicine ,Institutional review board ,Intervention (law) ,Work (electrical) ,Informed consent ,Political science ,Research Support as Topic ,Humans ,Engineering ethics ,Ethics Committees, Research - Abstract
Participants of Pharma-sponsored research are exposed to risks, benefits, and uncertainties that do not occur in other forms of clinical studies. Ethics committees represent the subjects' first line of protection. This responsibility begins with the study review and ends after all study subjects finish the intervention. The objective of this paper is to review the most common controversial issues found in Pharma-sponsored studies. Potential solutions are proposed to prevent or resolve the polemical aspects. However, different challenges will be faced in the near future (e.g., when new therapies reach their late stage of development). All parties involved in research should work together to guarantee the protection of participants, the paramount principle on which clinical investigation is based. Pharma-sponsored research is a crucial driver to develop and implement innovative approaches to improve the informed consent process and the execution of the studies.
- Published
- 2019
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