Please use this identifier to cite or link to this item: http://hdl.handle.net/10668/2345
Título : Low Efficacy of Pegylated Interferon plus Ribavirin plus Nitazoxanide for HCV Genotype 4 and HIV Coinfection.
Autor : Macías, Juan
López-Cortés, Luis F
Téllez, Francisco
Recio, Eva
Ojeda-Burgos, Guillermo
Ríos, Maria José
Rivero-Juárez, Antonio
Delgado, Marcial
Rivas, Jeremías
Pineda, Juan A
Filiación: [Macías,J; Recio,E; Pineda,JA] Unidad Clínica de Enfermedades Infecciosas y Microbiología, Hospital Universitario de Valme, Sevilla, Spain. [López-Cortés.LF; Rivas,J] Unidad Clínica de Enfermedades Infecciosas, Microbiología y Medicina Preventiva, Hospital Universitario Virgen del Rocío, Instituto de Biomedicina de Sevilla (IBiS), Sevilla, Spain. [Téllez,F] Unidad de Gestión Clínica de Enfermedades Infecciosas y Microbiología, Hospital de La Línea de la Concepción, AGS Campo de Gibraltar, Cádiz, Spain. [Ojeda-Burgos,G] Unidad de Gestión Clínica de Enfermedades Infecciosas, Hospital Virgen de la Victoria, Complejo Hospitalario de Málaga, Málaga, Spain. [Ríos,MJ] Unidad de Enfermedades Infecciosas, Hospital Universitario Virgen Macarena, Sevilla, Spain. [Rivero-Juárez,A] Unidad de Enfermedades Infecciosas, Hospital Universitario Reina Sofía, Instituto Maimónides de Investigación Biomédica de Córdoba (IMIBIC), Córdoba, Spain. [Delgado,M] Servicio de Enfermedades Infecciosas, Hospital Regional de Málaga, Malaga, Spain.
Palabras clave : Brazo
Coinfección
Intervalos de confianza
Genotipo
Infecciones por VIH
Hepacivirus
Humanos
Análisis de la intención de tratar
Interferon-alfa
Glicoles de polietileno
Ribavirina
Tiazoles
MeSH: Medical Subject Headings::Anatomy::Body Regions::Extremities::Upper Extremity::Arm
Medical Subject Headings::Diseases::Virus Diseases::Coinfection
Medical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Investigative Techniques::Epidemiologic Methods::Statistics as Topic::Confidence Intervals
Medical Subject Headings::Phenomena and Processes::Genetic Phenomena::Genotype
Medical Subject Headings::Diseases::Immune System Diseases::Immunologic Deficiency Syndromes::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::Health Care::Health Care Quality, Access, and Evaluation::Quality of Health Care::Health Care Evaluation Mechanisms::Epidemiologic Study Characteristics as Topic::Clinical Trials as Topic::Controlled Clinical Trials as Topic::Randomized Controlled Trials as Topic::Intention to Treat Analysis
Medical Subject Headings::Chemicals and Drugs::Biological Factors::Intercellular Signaling Peptides and Proteins::Interferons::Interferon Type I::Interferon-alpha
Medical Subject Headings::Chemicals and Drugs::Organic Chemicals::Alcohols::Glycols::Ethylene Glycols::Polyethylene Glycols
Medical Subject Headings::Chemicals and Drugs::Nucleic Acids, Nucleotides, and Nucleosides::Nucleosides::Ribonucleosides::Ribavirin
Medical Subject Headings::Chemicals and Drugs::Organic Chemicals::Sulfur Compounds::Thiazoles
Fecha de publicación : 7-Dec-2015
Editorial : Biomed Central
Cita Bibliográfica: Macías J, López-Cortés LF, Téllez F, Recio E, Ojeda-Burgos G, Ríos MJ, et al. Low Efficacy of Pegylated Interferon plus Ribavirin plus Nitazoxanide for HCV Genotype 4 and HIV Coinfection. PLoS One. 2015;10(12):e0143492.
Abstract: BACKGROUND Nitazoxanide (NTZ) plus pegylated interferon and ribavirin (Peg-IFN/RBV) improved the sustained virological response (SVR) achieved with Peg-IFN/RBV in hepatitis C virus genotype 4 (HCV-4)-monoinfected patients. There are no data currently on the efficacy of Peg-IFN/RBV plus NTZ for human immunodeficiency virus (HIV)/HCV-4 coinfection. Therefore, the objectives of this clinical trial were to assess the efficacy and to evaluate the safety of Peg-IFN/RBV plus NTZ in HIV/HCV-4-coinfected patients. PATIENTS AND METHODS This was an open-label, single arm, multicenter phase II pilot clinical trial (NCT01529073) enrolling HIV-infected individuals with HCV-4 chronic infection, naïve to HCV therapy. Patients were treated with NTZ 500 mg bid for 4 weeks, followed by NTZ 500 mg bid plus Peg-IFN alpha-2b 1.5 μg/kg/week plus weight-adjusted RBV during 48 weeks. Analyses were done by intention-to-treat (ITT, missing = failure). A historical cohort of HIV/HCV-4-infected patients treated with Peg-IFN alpha-2b and RBV at the same area was used as control. RESULTS Two (9.5%) of 21 patients included in the trial compared with 5 (21.7%) of 23 patients included in the historical cohort achieved SVR (SVR risk difference, -12.2%; 95% confidence interval, -33.2% to 8.8%; p = 0.416). Virological failure was due to lack of response in 13 (62%) individuals recruited in the trial. Two (9.5%) patients included in the trial and two (9.5%) individuals from the historical cohort discontinued permanently due to adverse events. CONCLUSIONS No increase in SVR was observed among HIV/HCV-4-coinfected patients receiving Peg-IFN/RBV plus NTZ compared with a historical cohort treated with Peg-IFN/RBV. Interruptions due to adverse events of Peg-IFN/RBV plus NTZ were similar to those of dual therapy.
Descripción : Journal Article; Research Support, Non-U.S. Gov't; TRIAL REGISTRATION ClinicalTrials.gov NCT01529073.
URI: http://hdl.handle.net/10668/2345
Versión del editor : http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0143492
DOI: 10.1371/journal.pone.0143492
ISSN : 1932-6203 (Online)
Appears in Collections:01- Artículos - AGS Sur de Sevilla
01- Artículos - IMIBIC. Instituto Maimónides de Investigación Biomédica de Córdoba
01- Artículos - Hospital Reina Sofía
01- Artículos - Hospital Virgen Macarena
01- Artículos - Hospital Virgen de la Victoria
01- Artículos - IBIS. Instituto de Biomedicina de Sevilla
01- Artículos - Hospital Virgen del Rocío
01- Artículos - Hospital Regional de Málaga
01- Artículos - AGS Campo de Gibraltar

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