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Article ; Online: sFlt-1/PlGF ratio for the prediction of delivery within 48 hours and adverse outcomes in expectantly managed early-onset preeclampsia.

Simón, Elisa / Permuy, Celia / Sacristán, Laura / Zamoro-Lorenci, María José / Villalaín, Cecilia / Galindo, Alberto / Herraiz, Ignacio

Pregnancy hypertension

2020 Volume 22, Page(s) 17–23

Abstract: Objective: To analyze if sFlt-1/PlGF ratio is more useful than other parameters at diagnosis of early-onset (<34 weeks) preeclampsia (PE) in the prediction of delivery within 48 h and adverse maternal and perinatal outcomes.: Method: Observational ... ...

Abstract	Objective: To analyze if sFlt-1/PlGF ratio is more useful than other parameters at diagnosis of early-onset (<34 weeks) preeclampsia (PE) in the prediction of delivery within 48 h and adverse maternal and perinatal outcomes. Method: Observational retrospective study of a cohort of 76 singleton pregnancies with early-onset PE and expectant management. The predictive value of sFlt-1/PlGF ratio, blood pressure, proteinuria, creatinine, liver enzymes and platelets at diagnosis for delivery < 48 h and adverse outcomes was determined. Results: Maternal and perinatal adverse outcomes occurred in 25/76 (32.9%) cases and 13/69 (18.8%) livebirths, respectively. Areas under the curve (AUC) for sFlt-1/PlGF ratio were 0.59 (95%CI 0.42-0.75) and 0.75 (95%CI 0.62-0.88) for maternal and perinatal complications, respectively. Mean (standard deviation) time to delivery for a sFlt-1/PlGF ratio > 655 vs. ≤ 655 was of 4.4 (7.5) vs. 12.1 (9.3) days, p < 0.01. Relative risk for delivery within 48 h for a sFlt-1/PlGF ratio > 655 was 5.3 (95% confidence interval 2.7-10.6), p < 0.01. Conclusions: sFlt-1/PlGF ratio > 655 at diagnosis was associated with a 5-fold increased risk of delivery in ≤ 48 h. None of the parameters were good predictors of adverse maternal or perinatal outcomes.
MeSH term(s)	Adult ; Biomarkers/blood ; Female ; Gestational Age ; Humans ; Placenta Growth Factor/blood ; Pre-Eclampsia/blood ; Predictive Value of Tests ; Pregnancy ; Premature Birth/diagnosis ; Prospective Studies ; Vascular Endothelial Growth Factor Receptor-1/blood ; Watchful Waiting/methods
Chemical Substances	Biomarkers ; PGF protein, human ; Placenta Growth Factor (144589-93-5) ; FLT1 protein, human (EC 2.7.10.1) ; Vascular Endothelial Growth Factor Receptor-1 (EC 2.7.10.1)
Language	English
Publishing date	2020-07-15
Publishing country	Netherlands
Document type	Journal Article ; Observational Study
ZDB-ID	2584464-7
ISSN	2210-7797 ; 2210-7789
ISSN (online)	2210-7797
ISSN	2210-7789
DOI	10.1016/j.preghy.2020.07.007
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Article: The Impact of Antibiotic Prophylaxis on a Retrospective Cohort of Hospitalized Patients with COVID-19 Treated with a Combination of Steroids and Tocilizumab.

Membrillo de Novales, Francisco Javier / Ramírez-Olivencia, Germán / Mata Forte, Maj Tatiana / Zamora Cintas, María Isabel / Simón Sacristán, Maj María / Sánchez de Castro, María / Estébanez Muñoz, Miriam

Antibiotics (Basel, Switzerland)

2023 Volume 12, Issue 10

Abstract: Objectives: In the context of COVID-19, patients with a severe or critical illness may be more susceptible to developing secondary bacterial infections. This study aims to investigate the relationship between the use of prophylactic antibiotic therapy ... ...

Abstract	Objectives: In the context of COVID-19, patients with a severe or critical illness may be more susceptible to developing secondary bacterial infections. This study aims to investigate the relationship between the use of prophylactic antibiotic therapy and the occurrence of bacterial or fungal isolates following the administration of tocilizumab in hospitalized COVID-19 patients who had previously received steroids during the first and second waves of the pandemic in Spain. Methods: This retrospective observational study included 70 patients hospitalized with COVID-19 who received tocilizumab and steroids between January and December 2020. Data on demographics, comorbidities, laboratory tests, microbiologic results, treatment, and outcomes were collected from electronic health records. The patients were divided into two groups based on the use of antibiotic prophylaxis, and the incidence of bacterial and fungal colonizations/infections was analyzed. Results: Among the included patients, 45 patients received antibiotic prophylaxis. No significant clinical differences were observed between the patients based on prophylaxis use regarding the number of clinically diagnosed infections, ICU admissions, or mortality rates. However, the patients who received antibiotic prophylaxis showed a higher incidence of colonization by multidrug-resistant bacteria compared to that of the subgroup that did not receive prophylaxis. The most commonly isolated microorganisms were
Language	English
Publishing date	2023-10-06
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2681345-2
ISSN	2079-6382
ISSN	2079-6382
DOI	10.3390/antibiotics12101515
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Article ; Online: Coinfections among hospitalized patients with covid-19 in the first pandemic wave.

Zamora-Cintas, María Isabel / López, Diana Jiménez / Blanco, Ana Collazos / Rodriguez, Tamara Martín / Segarra, Javier Mombiedro / Novales, Javier Membrillo / Ferriol, María Francisca Ramos / Maestre, Maria Mateo / Sacristán, María Simón

Diagnostic microbiology and infectious disease

2021 Volume 101, Issue 3, Page(s) 115416

Abstract: Background: COVID19 is the novel respiratory illness caused by SARS-CoV-2. The presence of other potentially pathogenic microorganisms could worsen the prognosis of these patients.: Aim: The study aims to describe coinfections in COVID-19 patients ... ...

Abstract	Background: COVID19 is the novel respiratory illness caused by SARS-CoV-2. The presence of other potentially pathogenic microorganisms could worsen the prognosis of these patients. Aim: The study aims to describe coinfections in COVID-19 patients and contrast it between standard ward and critical care patients at Hospital Central de la Defensa Gómez Ulla (HCDGU). Methods: A retrospective study was carried out of patients with COVID-19 confirmed with RTPCR admitted to the HCDGU from March 5, 2020 to May 7 of 2020. Findings: Of a total of 703 patients with COVID-19, 75(10.7%) had other microbiologically confirmed infections: 9% (58/648) in standard ward patients and 31.5%(17/54) in critical care patients. In total 86 samples of the 75 patients presented some microorganism; clinically relevant bacteraemias, 50%, respiratory cultures, 32.6% and pneumococcal positive antigens, 17.4%. Conclusions: We found a low frequency of microorganism coinfection in COVID-19 patients, however in critical care these coinfections increased considerably.
MeSH term(s)	Aged ; Bacteremia/complications ; Bacteremia/microbiology ; Bacteria/classification ; Bacteria/isolation & purification ; Bacterial Infections/complications ; COVID-19/complications ; Coinfection/diagnosis ; Female ; Humans ; Inpatients ; Male ; Middle Aged ; Retrospective Studies ; SARS-CoV-2
Language	English
Publishing date	2021-05-07
Publishing country	United States
Document type	Journal Article
ZDB-ID	604920-5
ISSN	1879-0070 ; 0732-8893
ISSN (online)	1879-0070
ISSN	0732-8893
DOI	10.1016/j.diagmicrobio.2021.115416
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Article ; Online: Comparison of various serological assays for novel SARS-COV-2.

Sacristan, María Simón / Collazos-Blanco, Ana / Cintas, Maria Isabel Zamora / García, Alicia Serrano / de Villavicencio, Carmen Ybarra / Maestre, María Mateo

European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology

2020 Volume 40, Issue 5, Page(s) 963–968

Abstract: Coronavirus disease-19 (COVID19), the novel respiratory illness caused by severe acute respiratory syndrome coronavirus (SARS-CoV-2), is associated with severe morbidity and mortality. The aim of our study was to compare different immunoassays. We ... ...

Abstract	Coronavirus disease-19 (COVID19), the novel respiratory illness caused by severe acute respiratory syndrome coronavirus (SARS-CoV-2), is associated with severe morbidity and mortality. The aim of our study was to compare different immunoassays. We evaluated three immunochromatographic test (The StrongStep®SARS-CoV-2 IgG/IgM kit, AllTest COV-19 IgG/IgM kit, and Wondfo® SARS-CoV-2 Antibody) and two chemiluminescence immunoassays (CMIA) (Covid-19 VIRCLIA® IgM+IgA/IgG monotest and the Abbott SARS-CoV-2 IgG assay) in COVID-19 patients. The assays were performed using serum samples of three group patients, i.e., healthy controls, patients with SARS-CoV-2 PCR positive, and patients with SARS-CoV-2 PCR negative clinically diagnosed of COVID-19 infection. The detection percentages of IgG with the StrongStep® SARS-CoV-2 IgG/IgM kit and AllTest COV-19 IgG/IgM kit were similar in both groups (83.3% and 80.6%, respectively in group 2, p = 0.766) and (42.9% and 50.0%, respectively in group 3, p = 0.706). There were some differences on IgM detection between StrongStep® SARS-CoV-2 IgG/IgM kit and AllTest COV-19 IgG/IgM kit (11.1% and 30.6%, respectively in group 2, p = 0.042 and 0.0% and 28.6%, respectively in group 3, p = 0.031). The positive rate of IgG in group 2 is higher compared to group 3 with the two immunoassays tested. We observe the same positive rates of IgG with the two CMIA. Our study shows excellent performance of CMIA compared to immunochromatographic test and confirms its potential use in the diagnosis of the new SARS-CoV-2.
MeSH term(s)	Antibodies, Viral/blood ; COVID-19/blood ; COVID-19/diagnosis ; COVID-19 Nucleic Acid Testing ; COVID-19 Serological Testing/methods ; Humans ; Immunoassay/methods ; Immunoglobulin G/blood ; Immunoglobulin M/blood ; SARS-CoV-2/immunology ; SARS-CoV-2/isolation & purification ; Sensitivity and Specificity
Chemical Substances	Antibodies, Viral ; Immunoglobulin G ; Immunoglobulin M
Language	English
Publishing date	2020-11-25
Publishing country	Germany
Document type	Comparative Study ; Journal Article
ZDB-ID	603155-9
ISSN	1435-4373 ; 0934-9723 ; 0722-2211
ISSN (online)	1435-4373
ISSN	0934-9723 ; 0722-2211
DOI	10.1007/s10096-020-04091-4
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Zs.A 1732: Show issues

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Article ; Online: SARS-COV-2 Infection and Specific Antibody Detection on Health Care Workers from a Military Hospital in Madrid, Spain.

Simón Sacristán, María / Ybarra de Villavicencio, Carmen / Collazos Blanco, Ana / Mayo Montero, María Elga / Ariñez Fernández, María Del Carmen / Suárez Prieto, Adolfo / Zamora Cintas, María Isabel / Mateo Maestre, María

Current microbiology

2021 Volume 78, Issue 8, Page(s) 2910–2915

Abstract: This study aims to assess the COVID-19 seroprevalence in HCW at the Hospital Central de la Defensa Gómez Ulla (HCDGU) (Madrid). From 27 April to 10 June 2020 nasopharyngeal swab and serum samples from employees were processed in order to evaluate their ... ...

Abstract	This study aims to assess the COVID-19 seroprevalence in HCW at the Hospital Central de la Defensa Gómez Ulla (HCDGU) (Madrid). From 27 April to 10 June 2020 nasopharyngeal swab and serum samples from employees were processed in order to evaluate their seroprevalence and infective situation. Employees were classified according to their exposure to SARS-CoV-2 infection as high, moderate, and low exposure groups (level 1, level 2, and level 3, respectively). A specific real-time polymerase chain reaction (RT-PCR) was run to diagnose each patient, whereas the qualitative detection of IgG antibodies to SARS-CoV-2 was performed by means of an immunoassay. In total, 2781 HCW were screened. From this sample, 30 employees (1.1%) were infected with SARS-CoV-2 and 450 (16.2%) were positive to SARS-CoV-2-IgG antibodies. The seroprevalence was higher in the high exposure group.The seroprevalence of antibodies against SARS-CoV-2 among employees without any COVID-19 training was higher than in those who received COVID-19 training (14.5% vs 18.6%, P = 0.035). The seroprevalence in military and civilian personnel in level 1 was 18.2% and 20.0%, respectively (P = 0.4616), while in level 2 it was 6.0% and 16.0% (P = 0.0008) and in level 3 it was 16.7% and 10.2% (P = 0.0315). The results from the present study have shown that the high exposure group and HCW not receiving specific training against COVID-19 showed higher seroprevalence. Furthermore, the military employees from this hospital presented low percentage of seroprevalence.
MeSH term(s)	Antibodies, Viral ; COVID-19 ; Health Personnel ; Hospitals, Military ; Humans ; SARS-CoV-2 ; Seroepidemiologic Studies ; Spain ; United States
Chemical Substances	Antibodies, Viral
Language	English
Publishing date	2021-06-22
Publishing country	United States
Document type	Journal Article
ZDB-ID	134238-1
ISSN	1432-0991 ; 0343-8651
ISSN (online)	1432-0991
ISSN	0343-8651
DOI	10.1007/s00284-021-02541-6
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Zs.A 1446: Show issues

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Article: SARS-COV-2 Infection and Specific Antibody Detection on Health Care Workers from a Military Hospital in Madrid, Spain

Simón Sacristán, María / Ybarra de Villavicencio, Carmen / Collazos Blanco, Ana / Mayo Montero, María Elga / Ariñez Fernández, María del Carmen / Suárez Prieto, Adolfo / Zamora Cintas, María Isabel / Mateo Maestre, María

Current microbiology. 2021 Aug., v. 78, no. 8

2021

Abstract	This study aims to assess the COVID-19 seroprevalence in HCW at the Hospital Central de la Defensa Gómez Ulla (HCDGU) (Madrid). From 27 April to 10 June 2020 nasopharyngeal swab and serum samples from employees were processed in order to evaluate their seroprevalence and infective situation. Employees were classified according to their exposure to SARS-CoV-2 infection as high, moderate, and low exposure groups (level 1, level 2, and level 3, respectively). A specific real-time polymerase chain reaction (RT-PCR) was run to diagnose each patient, whereas the qualitative detection of IgG antibodies to SARS-CoV-2 was performed by means of an immunoassay. In total, 2781 HCW were screened. From this sample, 30 employees (1.1%) were infected with SARS-CoV-2 and 450 (16.2%) were positive to SARS-CoV-2-IgG antibodies. The seroprevalence was higher in the high exposure group.The seroprevalence of antibodies against SARS-CoV-2 among employees without any COVID-19 training was higher than in those who received COVID-19 training (14.5% vs 18.6%, P = 0.035). The seroprevalence in military and civilian personnel in level 1 was 18.2% and 20.0%, respectively (P = 0.4616), while in level 2 it was 6.0% and 16.0% (P = 0.0008) and in level 3 it was 16.7% and 10.2% (P = 0.0315). The results from the present study have shown that the high exposure group and HCW not receiving specific training against COVID-19 showed higher seroprevalence. Furthermore, the military employees from this hospital presented low percentage of seroprevalence.
Keywords	COVID-19 infection ; Severe acute respiratory syndrome coronavirus 2 ; antibody detection ; blood serum ; health services ; hospitals ; human resources ; immunoassays ; microbiology ; patients ; quantitative polymerase chain reaction ; seroprevalence ; Spain
Language	English
Dates of publication	2021-08
Size	p. 2910-2915.
Publishing place	Springer US
Document type	Article
ZDB-ID	134238-1
ISSN	1432-0991 ; 0343-8651
ISSN (online)	1432-0991
ISSN	0343-8651
DOI	10.1007/s00284-021-02541-6
Database	NAL-Catalogue (AGRICOLA)

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Article: Global Emergence of Resistance to Fluconazole and Voriconazole in

Trevijano-Contador, Nuria / Torres-Cano, Alba / Carballo-González, Cristina / Puig-Asensio, Mireia / Martín-Gómez, María Teresa / Jiménez-Martínez, Emilio / Romero, Daniel / Nuvials, Francesc Xavier / Olmos-Arenas, Roberto / Moretó-Castellsagué, María Clara / Fernández-Delgado, Lucía / Rodríguez-Sevilla, Graciela / Aguilar-Sánchez, María-Mercedes / Ayats-Ardite, Josefina / Ardanuy-Tisaire, Carmen / Sanchez-Romero, Isabel / Muñoz-Algarra, María / Merino-Amador, Paloma / González-Romo, Fernando /

Megías-Lobón, Gregoria / García-Campos, Jose Angel / Mantecón-Vallejo, María Ángeles / Alcoceba, Eva / Escribano, Pilar / Guinea, Jesús / Durán-Valle, Maria Teresa / Fraile-Torres, Arturo Manuel / Roiz-Mesones, María Pía / Lara-Plaza, Isabel / de Ayala, Ana Pérez / Simón-Sacristán, María / Collazos-Blanco, Ana / Nebreda-Mayoral, Teresa / March-Roselló, Gabriel / Alcázar-Fuoli, Laura / Zaragoza, Oscar

Open forum infectious diseases

2022 Volume 9, Issue 11, Page(s) ofac605

Abstract: Background: Candida parapsilosis: Methods: Yeast were identified by molecular biology, and antifungal susceptibility testing was performed using the European Committee on Antimicrobial Susceptibility Testing protocol. The : Results: We examined ... ...

Abstract	Background: Candida parapsilosis Methods: Yeast were identified by molecular biology, and antifungal susceptibility testing was performed using the European Committee on Antimicrobial Susceptibility Testing protocol. The Results: We examined the susceptibility profile of 1315 Conclusions: Our data suggest that concurrently with the coronavirus disease 2019 pandemic, a selection of fluconazole-resistant
Language	English
Publishing date	2022-11-07
Publishing country	United States
Document type	Journal Article
ZDB-ID	2757767-3
ISSN	2328-8957
ISSN	2328-8957
DOI	10.1093/ofid/ofac605
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Article ; Online: A multiplex antigen microarray for simultaneous IgG and IgM detection against SARS-CoV-2 reveals higher seroprevalence than reported.

Ruano-Gallego, David / García-Villadangos, Miriam / Moreno-Paz, Mercedes / Gómez-Elvira, Javier / Postigo, Marina / Simón-Sacristán, María / Reyburn, Hugh T / Carolis, Carlo / Rodrigo, Natalia / Codeseira, Yaiza B / Rueda, Paloma / Zúñiga, Sonia / Enjuanes, Luis / Parro, Victor

Microbial biotechnology

2021 Volume 14, Issue 3, Page(s) 1228–1236

Abstract: The surge of SARS-CoV-2 has challenged health systems worldwide and efficient tests to detect viral particles, as well as antibodies generated against them, are needed. Specificity, sensitivity, promptness or scalability are the main parameters to ... ...

Abstract	The surge of SARS-CoV-2 has challenged health systems worldwide and efficient tests to detect viral particles, as well as antibodies generated against them, are needed. Specificity, sensitivity, promptness or scalability are the main parameters to estimate the final performance, but rarely all of them match in a single test. We have developed SCOVAM, a protein microarray with several viral antigens (spike, nucleocapsid, main protease Nsp5) as capturing probes in a fluorescence immunoassay for COVID-19 serological testing. SCOVAM depicts IgG and IgM antibody responses against each of these proteins of 22 individuals in a single microscope slide. It detects specific IgM (0.094 μg ml
MeSH term(s)	Antibodies, Viral ; COVID-19/therapy ; COVID-19 Serological Testing ; Humans ; Immunization, Passive ; Immunoglobulin G ; Immunoglobulin M ; SARS-CoV-2 ; Sensitivity and Specificity ; Seroepidemiologic Studies ; Spike Glycoprotein, Coronavirus ; COVID-19 Serotherapy
Chemical Substances	Antibodies, Viral ; Immunoglobulin G ; Immunoglobulin M ; Spike Glycoprotein, Coronavirus
Language	English
Publishing date	2021-04-29
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2406063-X
ISSN	1751-7915 ; 1751-7915
ISSN (online)	1751-7915
ISSN	1751-7915
DOI	10.1111/1751-7915.13801
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Article ; Online: Global emergence of resistance to fluconazole and voriconazole in Candida parapsilosis in tertiary hospitals in Spain during the COVID-19 pandemic

Zaragoza, Oscar / Alcazar-Fuoli, Laura / Trevijano-Contador, Nuria / Torres-Cano, Alba / Carballo-Gonzalez, Cristina / Puig-Asensio, Mireia / Martin-Gomez, Maria Teresa / Jimenez-Martinez, Emilio / Romero, Daniel / Xavier Nuvials, Francesc / Olmos-Arenas, Roberto / Moreto-Castellsague, Maria Clara / Fernandez-Delgado, Lucia / Rodriguez-Sevilla, Graciela / Aguilar-Sanchez, Maria Mercedes / Ayats-Ardite, Josefina / Ardanuy-Tisaire, Carmen / Sanchez-Romero, Isabel / Munoz-Algarra, Maria /

Merino-Amador, Paloma / Gonzalez-Romo, Fernando / Megias-Lobon, Gregoria / Garcia Campos, Jose Angel / Mantecon-Vallejo, Maria angeles / Duran-Valle, Maria Teresa / Fraile-Torres, Arturo / Roiz-Mesones, Maria Pia / Lara-Plaza, Isabel / Perez de Ayala, Ana / Simon-Sacristan, Maria / Collazos-Blanco, Ana / Nebreda-Mayoral, Teresa / March-Rosello, Gabriel

medRxiv

Abstract: Background: Candida parapsilosis is a frequent cause of candidemia worldwide. Its incidence is associated with the use of medical implants, such as central venous catheters or parenteral nutrition. This species has reduced susceptibility to echinocandins ...

Abstract	Background: Candida parapsilosis is a frequent cause of candidemia worldwide. Its incidence is associated with the use of medical implants, such as central venous catheters or parenteral nutrition. This species has reduced susceptibility to echinocandins and is susceptible to polyenes and azoles. Multiple outbreaks caused by fluconazole non-susceptible strains have been reported recently. A similar trend has been observed among the C. parapsilosis isolates received in the last two years at the Spanish Mycology Reference Laboratory. Methods: Yeast were identified by molecular biology and antifungal susceptibility testing was performed using EUCAST protocol. ERG11 gene was sequenced to identify resistance mechanisms, and typification was carried out by microsatellite analysis. Results: We examined the susceptibility profile of the C. parapsilosis isolates available at our Reference Laboratory since 2000 (around 1,300 strains). During the last two years, the number of isolates with acquired resistance to fluconazole and voriconazole has increased in at least eight different Spanish hospitals. Typification of the isolates revealed that some prevalent clones had spread through several hospitals of the same geographical region. One of these clones was found in hospitals from the region of Catalonia, another in hospitals from Madrid and Burgos, and two other different genotypes from Santander. Conclusions: Our data suggests that the epidemiological situation caused by the COVID-19 pandemic might have induced a selection of fluconazole-resistant C. parapsilosis isolates that were already present at the hospitals. Further measures must be taken to avoid the establishment of clinical outbreaks that could threaten the life of infected patients.
Keywords	covid19
Language	English
Publishing date	2022-06-06
Publisher	Cold Spring Harbor Laboratory Press
Document type	Article ; Online
DOI	10.1101/2022.06.06.22275514
Database	COVID19

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Article ; Online: Effectiveness, safety and clinical outcomes of direct-acting antiviral therapy in HCV genotype 1 infection: Results from a Spanish real-world cohort.

Calleja, Jose Luis / Crespo, Javier / Rincón, Diego / Ruiz-Antorán, Belén / Fernandez, Inmaculada / Perelló, Christie / Gea, Francisco / Lens, Sabela / García-Samaniego, Javier / Sacristán, Begoña / García-Eliz, María / Llerena, Susana / Pascasio, Juan Manuel / Turnes, Juan / Torras, Xavier / Morillas, Rosa Maria / Llaneras, Jordi / Serra, Miguel A / Diago, Moises /

Rodriguez, Conrado Fernández / Ampuero, Javier / Jorquera, Francisco / Simon, Miguel A / Arenas, Juan / Navascues, Carmen Alvarez / Bañares, Rafael / Muñoz, Raquel / Albillos, Agustin / Mariño, Zoe

Journal of hepatology

2017 Volume 66, Issue 6, Page(s) 1138–1148

Abstract: Background & aims: Clinical trials evaluating second-generation direct-acting antiviral agents (DAAs) have shown excellent rates of sustained virologic response (SVR) and good safety profiles in patients with chronic hepatitis C virus (HCV) genotype 1 ... ...

Abstract	Background & aims: Clinical trials evaluating second-generation direct-acting antiviral agents (DAAs) have shown excellent rates of sustained virologic response (SVR) and good safety profiles in patients with chronic hepatitis C virus (HCV) genotype 1 infection. We aimed to investigate the effectiveness and safety of two oral DAA combination regimens, ombitasvir/paritaprevir/ritonavir plus dasabuvir (OMV/PTV/r+DSV) and ledipasvir/sofosbuvir (LDV/SOF), in a real-world clinical practice. Methods: Data from HCV genotype 1 patients treated with either OMV/PTV/r+DSV±ribavirin (RBV) (n=1567) or LDV/SOF±RBV (n=1758) in 35 centers across Spain between April 1, 2015 and February 28, 2016 were recorded in a large national database. Demographic, clinical and virological data were analyzed. Details of serious adverse events (SAEs) were recorded. Results: The two cohorts were not matched with respect to baseline characteristics and could not be compared directly. The SVR12 rate was 96.8% with OMV/PTVr/DSV±RBV and 95.8% with LDV/SOF±RBV. No significant differences were observed in SVR according to HCV subgenotype (p=0.321 [OMV/PTV/r+DSV±RBV] and p=0.174 [LDV/SOF]) or degree of fibrosis (c0.548 [OMV/PTV/r/DSV±RBV] and p=0.085 [LDV/SOF]). Only baseline albumin level was significantly associated with failure to achieve SVR (p<0.05) on multivariate analysis. Rates of SAEs and SAE-associated treatment discontinuation were 5.4% and 1.7%, in the OMV/PTV/r+DSV subcohort and 5.5% and 1.5% in the LDV/SOF subcohort, respectively. Hepatocellular carcinoma (HCC) recurred in 30% of patients with a complete response to therapy for previous HCC. Incident HCC was reported in 0.93%. Conclusions: In this large cohort of patients managed in the real-world setting in Spain, OMV/PTV/r+DSV and LDV/SOF achieved high rates of SVR12, comparable to those observed in randomized controlled trials, with similarly good safety profiles. Lay summary: In clinical trials, second-generation direct-acting antiviral agents (DAAs) have been shown to cure over 90% of patients chronically infected with the genotype 1 hepatitis C virus and have been better tolerated than previous treatment regimens. However, patients enrolled in clinical trials do not reflect the real patient population encountered in routine practice. The current study, which includes almost 4,000 patients, demonstrates comparable rates of cure with two increasingly used DAA combinations as those observed in the clinical trial environment, confirming that clinical trial findings with DAAs translate into the real-world setting, where patient populations are more diverse and complex.
MeSH term(s)	Adult ; Aged ; Aged, 80 and over ; Anilides/administration & dosage ; Antiviral Agents/administration & dosage ; Antiviral Agents/adverse effects ; Antiviral Agents/therapeutic use ; Benzimidazoles/administration & dosage ; Carbamates/administration & dosage ; Carcinoma, Hepatocellular/etiology ; Cohort Studies ; Drug Therapy, Combination ; Female ; Fluorenes/administration & dosage ; Genotype ; Glomerular Filtration Rate ; Hepacivirus/genetics ; Hepatitis C, Chronic/drug therapy ; Hepatitis C, Chronic/physiopathology ; Hepatitis C, Chronic/virology ; Humans ; Liver Neoplasms/etiology ; Macrocyclic Compounds/administration & dosage ; Male ; Middle Aged ; Neoplasm Recurrence, Local/etiology ; Retrospective Studies ; Ribavirin/administration & dosage ; Ritonavir/administration & dosage ; Sofosbuvir ; Spain ; Sulfonamides/administration & dosage ; Sustained Virologic Response ; Treatment Outcome ; Uracil/administration & dosage ; Uracil/analogs & derivatives ; Uridine Monophosphate/administration & dosage ; Uridine Monophosphate/analogs & derivatives ; Young Adult
Chemical Substances	Anilides ; Antiviral Agents ; Benzimidazoles ; Carbamates ; Fluorenes ; Macrocyclic Compounds ; Sulfonamides ; ledipasvir, sofosbuvir drug combination ; ombitasvir (2302768XJ8) ; Ribavirin (49717AWG6K) ; Uracil (56HH86ZVCT) ; dasabuvir (DE54EQW8T1) ; Uridine Monophosphate (E2OU15WN0N) ; Ritonavir (O3J8G9O825) ; paritaprevir (OU2YM37K86) ; Sofosbuvir (WJ6CA3ZU8B)
Language	English
Publishing date	2017-02-09
Publishing country	Netherlands
Document type	Journal Article ; Multicenter Study
ZDB-ID	605953-3
ISSN	1600-0641 ; 0168-8278
ISSN (online)	1600-0641
ISSN	0168-8278
DOI	10.1016/j.jhep.2017.01.028
Database	MEDical Literature Analysis and Retrieval System OnLINE

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