Please use this identifier to cite or link to this item: http://hdl.handle.net/10668/2349
Título : Hepatic Safety of Rilpivirine/Emtricitabine/Tenofovir Disoproxil Fumarate Fixed-Dose Single-Tablet Regimen in HIV-Infected Patients with Active Hepatitis C Virus Infection: The hEPAtic Study.
Autor : Neukam, Karin
Espinosa, Nuria
Collado, Antonio
Delgado-Fernández, Marcial
Jiménez-Aguilar, Patricia
Rivero-Juárez, Antonio
Hontañón-Antoñana, Victor
Gómez-Berrocal, Ana
Ruiz-Morales, Josefa
Merino, Dolores
Carrero, Ana
Téllez, Francisco
Ríos, María José
Hernández-Quero, José
de Lagarde-Sebastián, María
Pérez-Camacho, Inés
Vera-Méndez, Francisco
Macías, Juan
Pineda, Juan A
Filiación: [Neukam,K; Macías,J; Pineda,JA] Unit of Infectious Diseases and Microbiology, Hospital Universitario de Valme, Seville, Spain. [Espinosa,N] Service of Infectious Diseases, Hospital Universitario Virgen del Rocío, Seville, Spain. [Collado,A] Unit of Infectious Diseases, Hospital Torrecárdenas, Almeria, Spain. [Delgado-Fernández,M] Unit of Infectious Diseases, Hospital Regional de Málaga. Malaga, Spain. [Jiménez-Aguilar,P] Unit of Infectious Diseases, Hospital Universitario Puerto Real, Puerto Real, Spain. [Rivero-Juárez,A] Unit of Infectious Diseases, Hospital Universitario Reina Sofía, Instituto de Investigación Biomédica de Córdoba(IMIBIC), Cordoba, Spain. [Hontañón-Antoñana,V] HIV Unit, Service of Internal Medicine, Hospital Universitario La Paz/IdiPAZ, Madrid, Spain. [Gómez-Berrocal,A] Service of Internal/Infectious Medicine, Hospital Universitario de la Princesa, Madrid, Spain. [Ruiz-Morales,J] Unit of Infectious Diseases, Hospital Universitario Virgen de la Victoria, Malaga, Spain. [Merino,D] Unit of Infectious Diseases, Complejo Hospitalario de Huelva, Huelva, Spain. [Carrero,A] Unit of Infectious Diseases/HIV, Hospital General Universitario Gregorio Marañón, Madrid, Spain. [Téllez,F] Unit of Infectious Diseases, Hospital La Línea, AGS Campo de Gibraltar, La Linea de la Concepcion, Spain. [Ríos,MJ] Unit of Infectious Diseases, Hospital Virgen Macarena, Seville, Spain. [Hernández-Quero,J] Unit of Infectious Diseases, Hospital Universitario San Cecilio, Granada, Spain. [de Lagarde-Sebastián,M] HIV Unit, Hospital Universitario 12 de Octubre, Madrid, Spain. [Pérez-Camacho,I] Tropical Medicine Unit, Hospital Poniente, El Ejido, Spain. [Vera-Méndez,F] Infectious Medicine Section, Hospital Universitario Santa Lucia, Cartagena, Spain.
Grupo de Investigación: the hEPAtic Study Group
Palabras clave : Bilirrubina
Protocolos clínicos
Coinfección
Infecciones por VIH
Hepacivirus
Cirrosis hepática
Estudios retrospectivos
Transaminasas
MeSH: Medical Subject Headings::Chemicals and Drugs::Heterocyclic Compounds::Heterocyclic Compounds, 1-Ring::Azoles::Pyrroles::Tetrapyrroles::Bile Pigments::Bilirubin
Medical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Therapeutics::Clinical Protocols
Medical Subject Headings::Diseases::Bacterial Infections and Mycoses::Infection::Coinfection
Medical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Investigative Techniques::Epidemiologic Methods::Epidemiologic Research Design::Control Groups
Medical Subject Headings::Health Care::Health Care Quality, Access, and Evaluation::Quality of Health Care::Health Care Evaluation Mechanisms::Epidemiologic Study Characteristics as Topic::Epidemiologic Studies::Cohort Studies::Follow-Up Studies
Medical Subject Headings::Diseases::Virus Diseases::RNA Virus Infections::Retroviridae Infections::Lentivirus Infections::HIV Infections
Medical Subject Headings::Organisms::Viruses::Hepatitis Viruses::Hepacivirus
Medical Subject Headings::Organisms::Eukaryota::Animals::Chordata::Vertebrates::Mammals::Primates::Haplorhini::Catarrhini::Hominidae::Humans
Medical Subject Headings::Diseases::Digestive System Diseases::Liver Diseases::Liver Cirrhosis
Medical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Investigative Techniques::Epidemiologic Methods::Epidemiologic Study Characteristics as Topic::Epidemiologic Studies::Case-Control Studies::Retrospective Studies
Medical Subject Headings::Geographicals::Geographic Locations::Europe::Spain
Medical Subject Headings::Chemicals and Drugs::Pharmaceutical Preparations::Dosage Forms::Tablets
Medical Subject Headings::Chemicals and Drugs::Enzymes and Coenzymes::Enzymes::Transferases::Nitrogenous Group Transferases::Transaminases
Fecha de publicación : 19-May-2016
Editorial : Public Library of Science
Cita Bibliográfica: Neukam K, Espinosa N, Collado A, Delgado-Fernández M, Jiménez-Aguilar P, Rivero-Juárez A, et al. Hepatic Safety of Rilpivirine/Emtricitabine/Tenofovir Disoproxil Fumarate Fixed-Dose Single-Tablet Regimen in HIV-Infected Patients with Active Hepatitis C Virus Infection: The hEPAtic Study. PLoS ONE. 2016; 11(5):e0155842
Abstract: OBJECTIVES The aim of this study was to evaluate the frequency of transaminase elevations (TE) and total bilirubin elevations (TBE) during the first year of therapy with a single tablet regimen including RPV/FTC/TDF (EPA) in HIV/hepatitis C virus (HCV)-coinfected subjects in clinical practice. METHODS In a retrospective analysis, HIV/HCV-coinfected subjects who started EPA at 17 centres throughout Spain were included as cases. Subjects who started an antiretroviral therapy (ART) other than EPA during the study period at the same hospitals were randomly selected as controls in a 1:2 ratio. Primary outcome variables were grade (G) 3-4 TE and G4 TBE. RESULTS Of the 519 subjects included, 173 individuals started EPA. Nine (5.2%) subjects of the EPA group and 49 (14.2%) controls were naïve to ART. The median (Q1-Q3) follow-up was 11.2 (9.7-13.9) months. TE was observed in 2 [1.2%; 95% confidence interval (CI): 0.14%-4.1%] subjects receiving EPA and 11 (3.2%; 95%CI: 1.6%-5.6%) controls (p = 0.136), all events were G3. No patient discontinued ART due to TE. One (0.6%; 95%CI: 0.01%-3.1%) subject on EPA and 8 (2.3%; 95%CI: 1%-4.5%) subjects in the control group developed TBE (p = 0.141), without developing any other hepatic event during follow-up. Three (2.3%) subjects with cirrhosis versus 10 (3.1%) without cirrhosis showed G3-4 TE (p = 0.451). CONCLUSION The frequency of severe liver toxicity in HIV/HCV-coinfected subjects receiving EPA under real-life conditions is very low, TE were generally mild and did not lead to drug discontinuation. All these data suggest that EPA can be safely used in this particular subpopulation.
Descripción : Journal Article;
URI: http://hdl.handle.net/10668/2349
Versión del editor : http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0155842
DOI: 10.1371/journal.pone.0155842
ISSN : 1932-6203 (Online)
Appears in Collections:01- Artículos - AGS Sur de Sevilla
01- Artículos - Complejo Hospitalario Universitario de Granada
01- Artículos - APES Hospital de Poniente
01- Artículos - AGS Campo de Gibraltar
01- Artículos - Complejo Hospitalario Universitario de Huelva
01- Artículos - Hospital Virgen de la Victoria
01- Artículos - IMIBIC. Instituto Maimónides de Investigación Biomédica de Córdoba
01- Artículos - Hospital Reina Sofía
01- Artículos - Hospital de Puerto Real
01- Artículos - Hospital Regional de Málaga
01- Artículos - Complejo Hospitalario Torrecárdenas
01- Artículos - Hospital Virgen del Rocío
01- Artículos - Hospital Virgen Macarena

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