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1. Contemporary use of cefazolin for MSSA infective endocarditis: analysis of a national prospective cohort

Author

Laura Herrera-Hidalgo, Patricia Muñoz, Ana Álvarez-Uría, David Alonso-Menchén, Rafael Luque-Marquez, Encarnación Gutiérrez-Carretero, María Del Carmen Fariñas, Jose Maria Miró, Miguel Angel Goenaga, Luis Eduardo López-Cortés, Basilio Angulo-Lara, Lucia Boix-Palop, Arístides de Alarcón, Fernando Fernández Sánchez, José Mª García de Lomas, Gabriel Rosas, Javier de la Torre Lima, Elena Bereciartua, María José Blanco Vidal, Roberto Blanco, María Victoria Boado, Marta Campaña Lázaro, Alejandro Crespo, Laura Guio Carrión, Mikel Del Álamo Martínez de Lagos, Gorane Euba Ugarte, Ane Josune Goikoetxea, Marta Ibarrola Hierro, José Ramón Iruretagoyena, Josu Irurzun Zuazabal, Leire López-Soria, Miguel Montejo, Javier Nieto, David Rodrigo, Regino Rodríguez, Yolanda Vitoria, Roberto Voces, Mª Victoria García López, Radka Ivanova Georgieva, Guillermo Ojeda, Isabel Rodríguez Bailón, Josefa Ruiz Morales, Ignacio Álvarez Rodríguez, Harkaitz Azkune Galparsoro, Elisa Berritu Boronat, Mª Jesús Bustinduy Odriozola, Cristina del Bosque Martín, Tomás Echeverría, Alberto Eizaguirre Yarza, Ana Fuentes, Miguel Ángel Goenaga, Muskilda Goyeneche del Río, Ángela Granda Bauza, José Antonio Iribarren, Xabier Kortajarena Urkola, José Ignacio Pérez-Moreiras López, Ainhoa Rengel Jiménez, Karlos Reviejo, Alberto Sáez Berbejillo, Elou Sánchez Haza, Rosa Sebastián Alda, Itziar Solla Ruiz, Irati Unamuno Ugartemendia, Diego Vicente Anza, Iñaki Villanueva Benito, Mar Zabalo Arrieta, Rafael Carrasco, Vicente Climent, Patricio Llamas, Esperanza Merino, Joaquín Plazas, Sergio Reus, Alberto Bouzas, Brais Castelo, José Cuenca, Laura Gutiérrez, Lucía Ramos, María Rodríguez Mayo, Joaquín Manuel Serrano, Dolores Sousa Regueiro, Francisco Javier Martínez, Mª del Mar Alonso, Beatriz Castro, Teresa Delgado Melian, Javier Fernández Sarabia, Dácil García Rosado, Julia González González, Juan Lacalzada, Lissete Lorenzo de la Peña, Alina Pérez Ramírez, Pablo Prada Arrondo, Fermín Rodríguez Moreno, Antonio Plata Ciezar, José Mª Reguera Iglesias, Víctor Asensi Álvarez, Carlos Costas, Jesús de la Hera, Jonnathan Fernández Suárez, Lisardo Iglesias Fraile, Víctor León Arguero, José López Menéndez, Pilar Mencia Bajo, Carlos Morales, Alfonso Moreno Torrico, Carmen Palomo, Begoña Paya Martínez, Ángeles Rodríguez Esteban, Raquel Rodríguez García, Mauricio Telenti Asensio, Manuel Almela, Juan Ambrosioni, Manuel Azqueta, Mercè Brunet, Marta Bodro, Ramón Cartañá, Guillermo Cuervo, Carlos Falces, Mariana J Fernández-Pittol, Guillermina Fita, David Fuster, Cristina García de la Mària, Delia García-Pares, Marta Hernández-Meneses, Jaume Llopis Pérez, Francesc Marco, José M. Miró, Asunción Moreno, David Nicolás, Salvador Ninot, Eduardo Quintana, Carlos Paré, Daniel Pereda, Juan M. Pericás, José L. Pomar, José Ramírez, Mercè Roque, Irene Rovira, Elena Sandoval, Marta Sitges, Dolors Soy, Adrián Téllez, José M. Tolosana, Bárbara Vidal, Jordi Vila, Iván Adán, David Alonso, Juan Carlos Alonso, Javier Bermejo, Emilio Bouza, Gregorio Cuerpo Caballero, Antonia Delgado Montero, Agustín Estévez, Ramón Fortuny Ribas, Esther Gargallo, Mª Eugenia García Leoni, Ana González Mansilla, Francisco Javier González Moraga, Víctor González Ramallo, Martha Kestler Hernández, Amaia Mari Hualde, Marina Machado, Mercedes Marín, Manuel Martínez-Sellés, Rosa Melero, Diego Monzón, María Olmedo, Álvaro Pedraz, Blanca Pinilla, Ángel Pinto, Cristina Rincón, Hugo Rodríguez-Abella, Marta Rodríguez-Créixems, Eduardo Sánchez-Pérez, Antonio Segado, Neera Toledo, Maricela Valerio, Pilar Vázquez, Eduardo Verde Moreno, Sofía de la Villa, Isabel Antorrena, Belén Loeches, Mar Moreno, Ulises Ramírez, Verónica Rial Bastón, María Romero, Sandra Rosillo, Jesús Agüero Balbín, Cristina Amado Fernández, Carlos Armiñanzas Castillo, Francisco Arnaiz de las Revillas, Manuel Cobo Belaustegui, María Carmen Fariñas, Concepción Fariñas-Álvarez, Marta Fernández Sampedro, Iván García, Claudia González Rico, Laura Gutiérrez-Fernández, Manuel Gutiérrez-Cuadra, José Gutiérrez Díez, Marcos Pajarón, José Antonio Parra, Ramón Teira, Jesús Zarauza, Jorge Calderón Parra, Marta Cobo, Fernando Domínguez, Pablo García Pavía, Ana Fernández Cruz, Antonio Ramos-Martínez, Isabel Sánchez Romero, Tomasa Centella, José Manuel Hermida, José Luis Moya, Pilar Martín-Dávila, Enrique Navas, Enrique Oliva, Alejandro del Río, Jorge Rodríguez-Roda Stuart, Soledad Ruiz, Carmen Hidalgo Tenorio, Sergio Sequera, Manuel Almendro Delia, Omar Araji, José Miguel Barquero, Román Calvo Jambrina, Marina de Cueto, Juan Gálvez Acebal, Irene Méndez, Isabel Morales, José Antonio Lepe, José López-Haldón, Rafael Luque-Márquez, Guillermo Marín, Antonio Ortiz-Carrellán, Eladio Sánchez-Domínguez, Luis Javier Alonso, Pedro Azcárate, José Manuel Azcona Gutiérrez, José Ramón Blanco, Estíbaliz Corral Armas, Lara García-Álvarez, José Antonio Oteo, Antonio Barros Membrilla, Antonino Ginel Iglesias, Sara Grillo, Rubén Leta Petracca, Joaquín López-Contreras, María Alba Rivera Martínez, M. Álvarez, A.L. Fernández, Amparo Martínez, A. Prieto, Benito Regueiro, E. Tijeira, Marino Vega, Amaia Aguirre Quiñonero, Ángela Alonso Miñambres, Juan Carlos Gainzarain Arana, Sara González de Alaiza Ortega, Miguel Ángel Morán Rodríguez, Anai Moreno Rodríguez, Zuriñe Ortiz de Zárate, José Joaquín Portu Zapirain, Ester Sáez de Adana Arroniz, Daisy Carolina Sorto Sánchez, Sánchez-Porto Antonio, Úbeda Iglesias Alejandro, José Mª Arribas Leal, Elisa García Vázquez, Alicia Hernández Torres, Ana Blázquez, Gonzalo de la Morena Valenzuela, Ángel Alonso, Javier Aramburu, Felicitas Elena Calvo, Paola Tarabini-Castellani, Eva Heredero Gálvez, Carolina Maicas Bellido, José Largo Pau, Mª Antonia Sepúlveda, Pilar Toledano Sierra, Sadaf Zafar Iqbal-Mirza, Eva Cascales Alcolea, Ivan Keituqwa Yañez, Julián Navarro Martínez, Ana Peláez Ballesta, Eduardo Moreno Escobar, Alejandro Peña Monje, Valme Sánchez Cabrera, David Vinuesa García, María Arrizabalaga Asenjo, Carmen Cifuentes Luna, Juana Núñez Morcillo, Mª Cruz Pérez Seco, Aroa Villoslada Gelabert, Carmen Aured Guallar, Nuria Fernández Abad, Pilar García Mangas, Marta Matamala Adell, Mª Pilar Palacián Ruiz, Juan Carlos Porres, Begoña Alcaraz Vidal, María Jesús Del Amor Espín, Francisco Buendía, Roberto Jiménez Sánchez, Rosario Mármol, Francisco Martínez, Antonio Meseguer, Beatriz Pérez, Leticia Risco, Zoser Saura, Vanina Silva, Mª Belén Villmarín, Mª Ángels Ribas Blanco, Enrique Ruiz de Gopegui Bordes, Laura Vidal Bonet, Miquel Vives Borràs, Mª Carmen Bellón Munera, Elena Escribano Garaizabal, Antonia Tercero Martínez, Juan Carlos Segura Luque, Cristina Badía, Lucía Boix Palop, Mariona Xercavins, Sónia Ibars, Xerach Bosch, Eloy Gómez Nebreda, Ibalia Horcajada Herrera, Irene Menduiña Gallego, Imanol Pulido, Héctor Marrero Santiago, Isabel de Miguel Martínez, Elena Pisos Álamo, Daniel San Román Sánchez, Jorge Boan Pérez, Eva Mª Aguilar Blanco, Mercedes Catalán González, María Angélica Corres Peiretti, Andrea Eixerés Esteve, Laura Domínguez Pérez, Santiago de Cossío Tejido, Francisco Galván Román, José Antonio García Robles, Francisco López Medrano, Mª Jesús López Gude, Mª Ángeles Orellana Miguel, Patrick Pilkington, Yolanda Revilla Ostalaza, Juan Ruiz Morales, Sebastián Ruiz Solís, Ana Sabín Collado, Marcos Sánchez Fernández, Javier Solera Rallo, Jorge Solís Martín, Francesc Escrihuela-Vidal, Jordi Carratalà, Inmaculada Grau, Carmen Ardanuy, Dámaris Berbel, José Carlos Sánchez Salado, Oriol Alegre, Alejandro Ruiz Majoral, Fabrizio Sbraga, Arnau Blasco, Laura Gracia Sánchez, Iván Sánchez-Rodríguez, Gonzalo Aldamiz, Beatriz Álvarez, Marina Bernal Palacios, Alfonso Cabello Úbeda, Ricardo Fernández Roblas, Rafael Hernández, Victoria Andrea Hortigüela Martín, Andrea Kallmeyer, Cristina Landaeta Kancev, Marta Martín, Miguel Morante Ruiz, Miguel Ángel Navas Lobato, Ana María Pello, Laura Prieto, Marta Tomás Mallebrera, Laura Varela, Mireia de la Peña Triguero, Ruth Esther Figueroa Cerón, Lara Ruiz Gómez, Mireia Ble, Juan Pablo Horcajada Gallego, Antonio José Ginel, Inmaculada López, Alexandra Mas, Antoni Mestres, Lluís Molina, Ramón Serrat, Núria Ribas, Francisca Sánchez, Ana Silverio, Marina Suárez, Luisa Sorlí, Lluís Recasens, Manuel Taurón, María Fernández Regueras, María Ángeles Mantecón Vallejo, José Ángel Pérez Rivera, Nuria Sánchez Mata, Antonia Calvo Cano, Miguel Fajardo Olivares, María Victoria Millán Núñez, and Agustín Muñoz Sanz

Subjects
Infective endocarditis, Methicillin-susceptible Staphylococcus aureus, Cefazolin, Antistaphylococcal penicillin, Infectious and parasitic diseases, RC109-216
Abstract

Objectives: This study aimed to assess the real use of cefazolin for methicillin-susceptible Staphylococcus aureus (MSSA) infective endocarditis (IE) in the Spanish National Endocarditis Database (GAMES) and to compare it with antistaphylococcal penicillin (ASP). Methods: Prospective cohort study with retrospective analysis of a cohort of MSSA IE treated with cloxacillin and/or cefazolin. Outcomes assessed were relapse; intra-hospital, overall, and endocarditis-related mortality; and adverse events. Risk of renal toxicity with each treatment was evaluated separately. Results: We included 631 IE episodes caused by MSSA treated with cloxacillin and/or cefazolin. Antibiotic treatment was cloxacillin, cefazolin, or both in 537 (85%), 57 (9%), and 37 (6%) episodes, respectively. Patients treated with cefazolin had significantly higher rates of comorbidities (median Charlson Index 7, P

Published
2023
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2. DOLAMA 200: Effectiveness and Safety of a Dual Therapy with Dolutegravir Plus Lamivudine in Treatment-Experienced HIV-1 Infected Real World Participants in Spain

Author

Sergio Sequera-Arquelladas, Carmen Hidalgo-Tenorio, Luis López-Cortés, Alicia Gutiérrez, Jesús Santos, Francisco Téllez, Mohamed Omar, Sergio Ferra-Murcia, Elisa Fernández, Rosario Javier, Coral García-Vallecillos, and Juan Pasquau

Subjects
HIV, simplification, ART, dolutegravir, lamivudine, cost-effective, Microbiology, QR1-502
Abstract

The continuous pharmacological advances in antiretroviral treatment (ART) and the increasing understanding of HIV drug resistance has led to a change in the paradigm of ART optimization in the setting of the viral suppression of treatment-experienced patients with the emerging evidence of the effectiveness and safety of dual therapies. The aim of this study is to determine the antiviral efficacy and safety of switching to Dolutegravir + Lamivudine in people living with HIV, and to analyze the rate of patients with virologic failure (VF). A total of 200 patients were included with a median age of 51 years, 189 cells/µL of nadir CD4+, 13 years on ART and four previous ART regimens. Among the 168 patients who completed a follow-up at 48 weeks, a total of five VFs occurred, resulting in a 2.98% (5/168) VF rate. The results of the intention-to-treat analysis were a VF rate of 2.54% (5/197), and the rate of patients/year with viral suppression was 98.3% (298/303) in the observed data analysis. We observed a significant improvement in mean CD4 lymphocytes, the CD4/CD8 ratio and lipid profiles. The optimization of ART to DTG plus 3TC is a cost-effective switch option for treatment-experienced HIV patients, and also improves their lipid profiles.

Published
2024
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3. Use of sera cell free DNA (cfDNA) and exovesicle-DNA for the molecular diagnosis of chronic Chagas disease.

Author

Noelia Lozano, Mercedes Gomez Samblas, Eva Calabuig, María José Giménez Martí, Maria Dolores Gómez Ruiz, José Miguel Sahuquillo Arce, Sergio Sequera-Arquelladas, José Miguel Molina Moreno, M Trelis, and Antonio Osuna

Subjects
Medicine, Science
Abstract

Chagas disease, a neglected tropical disease, is now considered a worldwide health concern as a result of migratory movements from Central and South America to other regions that were considered free of the disease, and where the epidemiological risk is limited to transplacental transmission or blood or organ donations from infected persons. Parasite detection in chronically ill patients is restricted to serological tests that only determine infection by previous infection and not the presence of the parasite, especially in patients undergoing treatment evaluation or in newborns. We have evaluated the use of nucleic acids from both circulating exovesicles and cell-free DNA (cfDNA) from 50 samples twice randomly selected from a total of 448 serum samples from immunologically diagnosed patients in whom the presence of the parasite was confirmed by nested PCR on amplicons resulting from amplification with kinetoplastid DNA-specific primers 121F-122R. Six samples were randomly selected to quantify the limit of detection by qPCR in serum exovesicles. When the nucleic acids thus purified were assayed as a template and amplified with kinetoplastid DNA and nuclear satellite DNA primers, a 100% positivity rate was obtained for all positive samples assayed with kDNA-specific primers and 96% when SAT primers were used. However, isolation of cfDNA for Trypanosoma cruzi and amplification with SAT also showed 100% positivity. The results demonstrate that serum exovesicles contain DNA of mitochondrial and nuclear origin, which can be considered a mixed population of exovesicles of parasitic origin. The results obtained with serum samples prove that both cfDNA and Exovesicle DNA can be used to confirm parasitaemia in chronically ill patients or in samples where it is necessary to demonstrate the active presence of the parasite. The results confirm for the first time the existence of exovesicles of mitochondrial origin of the parasite in the serum of those affected by Chagas disease.

Published
2023
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4. Rildo: Real-World Multicenter Study on the Effectiveness and Safety of Single-Tablet Regimen of Dolutegravir plus Rilpivirine in Treatment-Experienced People Living with HIV

Author

Carmen Hidalgo-Tenorio, David Vinuesa, Coral García-Vallecillos, Leopoldo Muñoz-Medina, Sergio Sequera, Rosario Javier, Miguel Ángel López-Ruz, Svetlana Sadyrbaeva-Dolgova, and Juan Pasquau

Subjects
2DR, dolutegravir, rilpivirine, treatment-experienced PLHIV, Microbiology, QR1-502
Abstract

Two-drug regimens (2DRs) are emerging in clinical practice guidelines as treatment option for both naive and treatment-experienced people living with HIV (PLHIV). Objectives: To determine the real-life effectiveness of 2DR with 25 mg RPV plus 50 mg DTG in a single-tablet regimen (RPV/DTGSTR) and its impact on viral and immune status, lipid profile, and inflammatory markers. Methods: This observational study included 291 treatment-experienced PLHIV, starting 2DR with RPV/DTGSTR between 29 January 2019 and 2 February 2022, who were followed up for at least six months. Participants gave verbal informed consent for the switch in antiretroviral therapy (ART) to RPV/DTGSTR. Results: The mean age of the 291 participants was 51.3 years; 77.7% were male; and 42.9% were in the AIDS stage with a CD4 nadir of 283.5 ± 204.6 cells/uL. The median time since HIV diagnosis was 19.7 years (IQR: 10.6–27). Before 2DR, patients received a median of five ART lines (IQR: 3–7) for 22.2 years (IQR: 14–26), with 34.4% (n = 100) receiving a three-drug regimen (3DR), 31.3% (n = 91) receiving monotherapy, and 34.4% (n = 100) receiving 2DR. The median time on RPV/DTGSTR was 14 months (IQR: 9.5–21); 1.4% were lost to the follow-up. Effectiveness was 96.2% by intention-to-treat (ITT) analysis, 97.5% by modified ITT, and 99.3% by per-protocol analysis. Virological failure was observed in 0.69%, blips in 3.5%, and switch to another ART in 1.4%. The mean lipid profile improved, with reductions in TC/HDLc ratio (3.9 ± 0.9 vs. 3.6 ± 0.9; p = 0.0001), LDLc (118.3 ± 32.2 mg/dL vs. 106.2 ± 29.8 mg/dL, p = 0.0001), TG (130.9 ± 73.9 mg/dL vs. 115.9 ± 68.5 mg/dL, p = 0.0001), and CD4/CD8 ratio increase (0.99 ± 0.58 vs. 1.01 ± 0.54; p = 0.0001). The cost-effectiveness of 2DR with RPV/DTGSTR was similar to that of DTG/3TC and superior to those of BIC/TAF/FTC and DRV/c/TAF/FTC, with higher virological suppression and lower annual costs. Conclusions: The switch to RPV plus DTG in STR is a cost-effective, long-lasting, and robust strategy for PLHIV, with a very long experience of treatment, which improves the lipid profile without affecting inflammatory markers.

Published
2022
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5. DALBACEN cohort: dalbavancin as consolidation therapy in patients with endocarditis and/or bloodstream infection produced by gram-positive cocci

Author

Carmen Hidalgo-Tenorio, David Vinuesa, Antonio Plata, Pilar Martin Dávila, Simona Iftimie, Sergio Sequera, Belén Loeches, Luis Eduardo Lopez-Cortés, Mari Carmen Fariñas, Concepción Fernández-Roldan, Rosario Javier-Martinez, Patricia Muñoz, Maria del Mar Arenas-Miras, Francisco Javier Martínez-Marcos, Jose Maria Miró, Carmen Herrero, Elena Bereciartua, Samantha E. De Jesus, and Juan Pasquau

Subjects
Endocarditis, Bloodstream infection, Dalbavancin, Therapeutics. Pharmacology, RM1-950, Infectious and parasitic diseases, RC109-216, Microbiology, QR1-502
Abstract

Abstract Objectives To analyse the effectiveness of dalbavancin (DBV) in clinical practice as consolidation therapy in patients with bloodstream infection (BSI) and/or infective endocarditis (IE) produced by gram-positive cocci (GPC), as well as its safety and pharmacoeconomic impact. Methods A multicentre, observational and retrospective study was conducted of hospitalised patients with IE and/or BSI produced by GPC who received at least one dose of DBV. Clinical response was assessed during hospitalization, at 3 months and at 1 year. Results Eighty-three patients with median age of 73 years were enrolled; 73.5% were male; 59.04% had BSI and 49.04% IE (44.04% prosthetic valve IE, 32.4% native IE, 23.5% pacemaker lead). The most frequently isolated microorganism was Staphylococcus aureus in BSI (49%) and coagulase-negative staphylococci in IE (44.1%). All patients with IE were clinically cured in hospital; at 12 months, there was 2.9% loss to follow-up, 8.8% mortality unrelated to IE, and 2.9% therapeutic failure rate. The percentage effectiveness of DBV to treat IE was 96.7%. The clinical cure rate for BSI was 100% during hospital stay and at 3 months; there were no recurrences or deaths during the follow-up. No patient discontinued treatment for adverse events. The saving in hospital stay was 636 days for BSI (315,424.20€) and 557 days for IE (283,187.45€). Conclusions DBV is an effective consolidation antibiotic therapy in clinically stabilized patients with IE and/or BSI. It proved to be a cost-effective treatment, reducing the hospital stay, thanks to the pharmacokinetic/pharmacodynamic profile of this drug.

Published
2019
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6. Real-world outcomes of COVID-19 treatment with remdesivir in a Spanish hospital

Author

Covid Virgen de las Nieves Team, Carmen Hidalgo-Tenorio, Coral García-Vallecillos, and Sergio Sequera-Arquelladas

Subjects
Male, medicine.medical_specialty, Remdesivir, Observational Study, Antiviral Agents, Statistics, Nonparametric, Interquartile range, Lower respiratory tract infection, Internal medicine, Outcome Assessment, Health Care, medicine, Humans, Prospective cohort study, Oxygen saturation (medicine), Aged, Retrospective Studies, Alanine, real-world data, SARS-CoV-2, business.industry, Mortality rate, COVID-19, Retrospective cohort study, General Medicine, Odds ratio, Middle Aged, medicine.disease, Adenosine Monophosphate, COVID-19 Drug Treatment, Hospitalization, Respiratory failure, Spain, Female, business, Research Article
Abstract

Remdesivir is the only antiviral approved for lower respiratory tract infection produced by SARS-CoV-2. The main objective of this study was to determine the mortality rate, readmissions, mean hospital stay, need for higher levels of oxygen support, and adverse effect-induced abandonment rate in hospitalized patients diagnosed with COVID-19 and treated with remdesivir (RDSV). The secondary objective was to determine mortality-related risk factors in these patients. The study included a prospective cohort of patients admitted to a third level Spanish hospital between July 5, 2020 and February 3, 2021 for COVID-19 diagnosed by SARS-CoV-2 polymerase chain reaction and/or antigen test and treated with RDSV. Remdesivir was received by 185 patients (69.7% males) with a mean age of 62.5 years, median Charlson index of 3 (interquartile range [IQR]: 1–4), and median ambient air oxygen saturation of 91% (IQR: 90–93); 61.6% of patients had hyper-inflammatory syndrome at admission. Median time with symptoms before RDSV treatment was 5 days (IQR: 3–6) and the median hospital stay was 10 days (IQR: 7–15); 19 patients (10.3%) died after a median stay of 13.5 days (IQR: 9.7–24 days), 58 patients (12.9%) were admitted to ICU, 58 (31.4%) needed higher levels of oxygen support, 0.5% abandoned the treatment due to adverse effects, and there were no readmissions. The only mortality-related factor was the need for higher levels of oxygen support (odds ratio 12.02; 95% confidence interval 2.25–64.2). All studied patients were admitted to hospital with a diagnosis of COVID-19 and in respiratory failure, needing initial low-flow oxygen support, and all received RDSV within 1 week of symptom onset. The percent mortality was lower in these patients than was observed in all patients with severe COVID-19 admitted to our center (10.3% vs 20.3%, respectively). Despite receiving RDSV, 1 in 3 patients needed higher levels of oxygen support, the sole mortality-related factor.

Published
2021

7. Impact of the COVID-19 pandemic on the diagnosis, management and prognosis of infective endocarditis

Author

Laura Escolà-Vergé, Guillermo Cuervo, Arístides de Alarcón, Dolores Sousa, Laura Varela Barca, Nuria Fernández-Hidalgo, Encarnación Gutiérrez-Carretero, Rafael Luque-Márquez, Blanca Anaya Baz, Luis Eduardo López-Cortés, Zaira Palacios Baena, María Victoria García López, Guillermo Ojeda Burgos, Antonio Pláta Ciézar, José María Reguera Iglesias, Ricardo Vivancos Delgado, Carmen Hidalgo-Tenorio, Sergio Sequera, null Ch, María Carmen Fariñas, Claudia González-Rico, José Francisco Gutiérrez-Díez, Gonzalo Cabezón, Javier López, Alberto San Román, Benito Almirante, Rubén Fernández, Maria Teresa Gonzàlez-Alujas, Olga Maisterra, Gerard Oristrell, María Nazarena Pizzi, Pau Rello, Remedios Ríos, Albert Roque, Antonia Sambola, Toni Soriano, Immaculada Grau, Sara Grillo, Lourdes Mateu Pruñonosa, Maria Lluïsa Pedro-Botet Montoya, Nuria Vallejo Camazón, Marta Hernández-Meneses, Jose M. Miro, Eduard Quintana, Antonio José Barros, Mercè Gurgui, Alba Rivera, María Laura Castelo Corral, Efrén Sánchez Vidal, María Teresa Pérez-Rodríguez, Adrián Sousa, Milagros Suárez, Maria Àngels Ribas Fernández, Laura Vidal Bonet, Lara García-Álvarez, José A. Oteo, Adrián Jerónimo Baza, Carmen Olmos, Isidre Vilacosta, Laura Domínguez-Pérez, Francisco López-Medrano, Javier T. Solera Rallo, José Luis Moya Mur, Enrique Navas Elorza, Andrea Kallmeyer Mayor, Ana María Pello, Luis Nieto Roca, María Aguilera García, Carmen de las Cuevas Torres, Carmen Sáez Béjar, Daniel de Castro Campos, Fernando Domínguez, Antonio Ramos-Martínez, Patricia Muñoz García, María Olmedo Samperio, Maricela Valerio Minero, Elisa García Vázquez, Alicia Hernández Torres, Encarnación Moral Escudero, Miguel Ángel Goenaga Sánchez, Xavier Kortajarena Urkola, Karlos Reviejo Jaka, Elena Bereciartua, Josune Goikoetxea, Regino Rodríguez, Martín Reyes Acevedo, and Universidad de Cantabria

Subjects
Microbiology (medical), Pais vasco, Male, medicine.medical_specialty, 2019-20 coronavirus outbreak, Coronavirus disease 2019 (COVID-19), Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), MEDLINE, Surveys and Questionnaires, Pandemic, medicine, Humans, Prospective Studies, Registries, Intensive care medicine, Letter to the Editor, Referral and Consultation, Aged, Retrospective Studies, Endocarditis, business.industry, COVID-19, Disease Management, General Medicine, Endocarditis, Bacterial, Middle Aged, Thoracic Surgical Procedures, medicine.disease, Prognosis, Organizational Innovation, Infectious Diseases, Spain, Infective endocarditis, Diagnosis management, Female, business
Published
2021

8. Safety and Tolerability of More than Six Days of Tedizolid Treatment

Author

Miguel Salavert Lletí, Mireia Mensa Vendrell, Laura Ruiz, Ester López Suñé, Josep Mensa Pueyo, Sergio Sequera Arquelladas, Maria Rosa Oltra Sempere, José Ramón Yuste Ara, Juan Pasquau Liaño, Valentina Isernia, Leonor Moreno Nuñez, Eva Calabuig Muñoz, Alex Soriano Viladomiu, María Tasias Pitarch, Maria-Luisa Pedro-Botet Montoya, Genís Castells Lao, and Esteban Alberto Reynaga Sosa

Subjects
safety, tedizolid, medicine.medical_specialty, Anemia, Tetrazoles, Clinical Therapeutics, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Interquartile range, Internal medicine, medicine, Humans, Pharmacology (medical), 030212 general & internal medicine, tolerability, Adverse effect, Oxazoles, Oxazolidinones, Retrospective Studies, Pharmacology, 0303 health sciences, 030306 microbiology, business.industry, Retrospective cohort study, Skin Diseases, Bacterial, medicine.disease, adverse events, Organophosphates, Anti-Bacterial Agents, Clinical trial, Infectious Diseases, chemistry, Tolerability, Linezolid, Tedizolid, business
Abstract

Tedizolid has demonstrated its efficacy and safety in clinical trials; however, data concerning its tolerability in long-term treatments are scarce. The aim of the study was to assess the indications and to describe the long-term safety profile of tedizolid. A multicentric retrospective study of patients who received tedizolid for more than 6 days was conducted. Adverse events (AEs) were identified from patients' medical records and laboratory data. The World Health Organization causality categories were used to discern AEs that were probably associated with tedizolid. Eighty-one patients, treated with tedizolid 200 mg once daily for a median (interquartile range [IQR]) duration of 28 (14 to 59) days, were included; 36 (44.4%) had previously received linezolid. The most common reasons for selecting tedizolid were to avoid linezolid potential toxicities or interactions (53.1%) or due to previous linezolid-related toxicities (27.2%). The most common indications were off-label, including prosthetic joint infections, osteomyelitis, and respiratory infections (77.8%). Overall, 9/81 patients (11.1%) experienced a probably associated AE. Two patients (2.5%) developed gastrointestinal disorders, 1 (1.2%) developed anemia, and 6 developed thrombocytopenia (7.4%) after a median (IQR) duration of treatment of 26.5 (17 to 58.5) days. Four (5%) patients discontinued tedizolid due to AEs. Among 23 patients with chronic renal failure (CRF), the rate of myelotoxicity was 17.4%, and only 8.7% had to stop tedizolid; 20 out of 22 with previous linezolid-associated toxicity had no AE. Long-term tedizolid treatments had good tolerance with rates of gastrointestinal AE and hematological toxicity lower than those reported with linezolid, particularly in patients with CRF and in those with a history of linezolid-associated toxicity.

Published
2020

9. DOLAMA study. Effectiveness, safety and pharmacoeconoSequera, Sergio mic analysis of dual therapy with dolutegravir and lamivudine in virologically suppressed HIV-1 patients

Author

Carmen Gálvez, Sergio Sequera, Coral García, Carmen Hidalgo-Tenorio, Samantha Eisabeth De Jesús, Juan Pasquau, Elisa Fernández, Jesús Basulto Santos, Luis Eduardo López Cortés, Franciso Téllez, Alicia Gutiérrez, and Mohamed Omar

Subjects
Oncology, Adult, Male, DOLAMA, medicine.medical_specialty, Dual therapy, Anti-HIV Agents, Pyridones, Cost-Benefit Analysis, Human immunodeficiency virus (HIV), HIV Infections, medicine.disease_cause, Piperazines, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Pharmacotherapy, Internal medicine, Oxazines, medicine, Fees, Pharmaceutical, Humans, 030212 general & internal medicine, Economics, Pharmaceutical, Retrospective Studies, business.industry, Lamivudine, Retrospective cohort study, General Medicine, Middle Aged, Viral Load, CD4 Lymphocyte Count, chemistry, Dolutegravir, 030220 oncology & carcinogenesis, Rilpivirine, HIV-1, Drug Therapy, Combination, Female, business, Viral load, Heterocyclic Compounds, 3-Ring, medicine.drug
Abstract

Dolutegravir (DTG) has shown effectiveness in combination with rilpivirine in with experience of antiretroviral therapy (ART) and with 3TC in naïve patients (GEMINI trial). The main objectives of this real-life study were to analyze the effectiveness and safety of 3TC plus DTG in virologically suppressed HIV-1 patients and to conduct a pharmacoeconomic analysis. We conducted an observational, retrospective and multicenter study of HIV+ patients pretreated for at least 6 months with ART that was then simplified to 3TC + DTG for any reason. We gathered data on viral loads (VLs) during exposure to the DT, calculating the rate with VL < 50 copies/mL at week 48, and on associated adverse effects. The 177 HIV+ patients were collected, 77.4% male, with average age of 48.5 years and mean count of 252.2cell/μL CD4+ nadir lymphocytes; 96.6% had VL < 50 copies/mL and 674 cells/μL CD4+ lymphocytes. Median time since HIV diagnosis was 15 years, and median ART duration was 13 years, and 34.5% of patients were on mono- or dual-therapy before the switch. At week 48, 82.4% of patients had VL < 50 cop/μL using an intention-to-treat (ITT) analysis, 89.6% according to mITT, and 96.7% according to Per-Protocol analysis. 3.3% patients had virological failure (VF). These effectiveness data and costs were compared with those for 2 reference triple therapies (DTG/ABC/3TC and EVG/cobi/FTC/TAF) in a cost minimization analysis, showing cost savings with administration of DTG+3TC (2741 €/year vs DTG/ABC/3TC and 4164 €/year vs EVG/cobi/FTC/TAF) and in a cost-effectiveness analysis, finding the DT to be the most cost-effective approach (ICER = −548 vs DTG/ABC/3TC and ICER = −4,627€ vs EVG/cobi/FTC/TAF) The combination of 3TC with DTG appears to be a safe and effective option for the simplification of ART in pretreated and virologically stable HIV-positive patients, being cost-effective and offering the same effectiveness as the triple therapy it replaces.

Published
2019

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