Posicionamiento de etravirina en la terapia antirretroviral de combinación
Role of etravirine in combination antiretroviral therapy
Pere Domingo
Unidad de Enfermedades Infecciosas, Hospital de la Santa Creu i Sant Pau, Universitat Autònoma de Barcelona, Barcelona, España
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"documento" => "article" "crossmark" => 0 "subdocumento" => "fla" "cita" => "Enferm Infecc Microbiol Clin. 2009;27 Supl 2:40-5" "abierto" => array:3 [ "ES" => false "ES2" => false "LATM" => false ] "gratuito" => false "lecturas" => array:2 [ "total" => 1643 "formatos" => array:3 [ "EPUB" => 9 "HTML" => 1195 "PDF" => 439 ] ] "es" => array:10 [ "idiomaDefecto" => true "titulo" => "Etravirina en poblaciones especiales" "tienePdf" => "es" "tieneTextoCompleto" => 0 "tieneResumen" => array:2 [ 0 => "es" 1 => "en" ] "paginas" => array:1 [ 0 => array:2 [ "paginaInicial" => "40" "paginaFinal" => "45" ] ] "titulosAlternativos" => array:1 [ "en" => array:1 [ "titulo" => "Etravirine in special populations" ] ] "contieneResumen" => array:2 [ "es" => true "en" => true ] "contienePdf" => array:1 [ "es" => true ] "autores" => array:1 [ 0 => array:2 [ "autoresLista" => "Ignacio De Los Santos Gil" "autores" => array:1 [ 0 => array:2 [ "nombre" => "Ignacio De Los" "apellidos" => "Santos Gil" ] ] ] ] ] "idiomaDefecto" => "es" "EPUB" => "https://multimedia.elsevier.es/PublicationsMultimediaV1/item/epub/S0213005X09732185?idApp=UINPBA00004N" "url" => "/0213005X/00000027000000S2/v1_201305090145/S0213005X09732185/v1_201305090145/es/main.assets" ] "es" => array:12 [ "idiomaDefecto" => true "titulo" => "Posicionamiento de etravirina en la terapia antirretroviral de combinación" "tieneTextoCompleto" => 0 "paginas" => array:1 [ 0 => array:2 [ "paginaInicial" => "46" "paginaFinal" => "51" ] ] "autores" => array:1 [ 0 => array:3 [ "autoresLista" => "Pere Domingo" "autores" => array:1 [ 0 => array:3 [ "nombre" => "Pere" "apellidos" => "Domingo" "email" => array:2 [ 0 => "pdomingo@santpau.cat" 1 => "pere.domingo@uab.cat" ] ] ] "afiliaciones" => array:1 [ 0 => array:1 [ "entidad" => "Unidad de Enfermedades Infecciosas, Hospital de la Santa Creu i Sant Pau, Universitat Autònoma de Barcelona, Barcelona, España" ] ] ] ] "titulosAlternativos" => array:1 [ "en" => array:1 [ "titulo" => "Role of etravirine in combination antiretroviral therapy" ] ] "pdfFichero" => "main.pdf" "tienePdf" => true "PalabrasClave" => array:2 [ "es" => array:1 [ 0 => array:4 [ "clase" => "keyword" "titulo" => "Palabras clave" "identificador" => "xpalclavsec137949" "palabras" => array:9 [ 0 => "Etravirina" 1 => "No análogos de nucleósido" 2 => "Efavirenz" 3 => "Nevirapina" 4 => "Eficacia virológica" 5 => "Seguridad" 6 => "Interacciones" 7 => "Indicaciones" 8 => "Embarazo" ] ] ] "en" => array:1 [ 0 => array:4 [ "clase" => "keyword" "titulo" => "Key words" "identificador" => "xpalclavsec137950" "palabras" => array:9 [ 0 => "Etravirine" 1 => "Non-nucleoside analogues" 2 => "Efavirenz" 3 => "Nevirapine" 4 => "Virological efficacy" 5 => "Safety" 6 => "Drug-drug interactions" 7 => "Indication" 8 => "Pregnancy" ] ] ] ] "tieneResumen" => true "resumen" => array:2 [ "es" => array:2 [ "titulo" => "Resumen" "resumen" => "<p class="elsevierStyleSimplePara elsevierViewall">Etravirina (ETR) es un nuevo fármaco antirretroviral que pertenece a la familia de los inhibidores de la transcriptasa inversa no análogos de los nucleósidos (ITINAN) y que ha sido recientemente autorizado por las agencias reguladoras para el tratamiento de pacientes con experiencia previa a antirretrovirales, con evidencia de replicación viral activa y que albergan cepas de virus de la inmunodeficiencia humana 1 multirresistentes. En este contexto, en Europa se ha autorizado su uso en combinación con inhibidores de proteasa potenciados e inhibidores de la transcriptasa inversa análogos de nucleósidos. Dicha indicación se ha establecido basándose en los resultados de los estudios DUET, estudios aleatorizados y doble ciego, en los que los pacientes que se aleatorizaron a ETR evidenciaron una respuesta estadísticamente superior en cuanto a eficacia virológica, recuperación inmunológica y calidad de vida relacionada con la salud. Desde el punto de vista de la seguridad, ETR mostró en dichos estudios ser tan bien tolerada como el placebo, con una única excepción, la aparición de exantema. Éste fue más frecuente que en el grupo placebo, generalmente leve a moderado, y obligó a interrumpir el tratamiento con ETR sólo en un 2% de los pacientes.</p><p class="elsevierStyleSimplePara elsevierViewall">Sin embargo, las características de ETR, es decir, su potencia virológica, su excelente perfil de seguridad, su perfil de resistencias, sus propiedades farmacocinéticas y su perfil de interacciones farmacológicas permiten entrever que su utilidad no se halla restringida al perfil de pacientes aprobado por las agencias reguladoras. No obstante, en la mayoría de estos supuestos no hay evidencias formales de su uso, aunque algunos de ellos están en fase de ensayo clínico. Así pues, hay en marcha un estudio en pacientes <span class="elsevierStyleItalic">naïve</span> (SENSE) con administración en toma única diaria con el objetivo de demostrar mejor tolerabilidad sobre el sistema nervioso central que efavirenz. En otros supuestos, su perfil de tolerabilidad hepática, neuropsiquiátrica, e incluso cutánea sugieren que ETR puede constituir una buena alternativa cuando haya toxicidad, o peligro de la misma, causada por los ITINAN de primera generación. Cuando hay fracaso virológico a un régimen de inicio con ITINAN de primera generación, el perfil diferencial de resistencias de ETR puede permitir construir una combinación de rescate basada en ETR. Su ausencia de teratogenicidad la hace potencialmente útil en pacientes embarazadas o en mujeres que hayan expresado deseo gestacional. Finalmente, su benigno perfil de interacciones medicamentosas debe permitir una mejor utilización en pacientes que se hallen sometidos a comedicación, y ello puede ser especialmente importante en áreas con elevada prevalencia de tratamiento con metadona puesto que no hay interacción significativa entre ambos fármacos.</p><p class="elsevierStyleSimplePara elsevierViewall">ETR se halla aprobada para uso en rescate avanzado. Sin embargo, sus características permiten suponer que hay una serie de indicaciones potenciales basadas en su potencia antiviral, perfil diferencial de resistencias, seguridad y tolerabilidad y perfil de interacciones medicamentosas.</p>" ] "en" => array:2 [ "titulo" => "Abstract" "resumen" => "<p class="elsevierStyleSimplePara elsevierViewall">Etravirine (ETR) is a new antiretroviral drug of the non-nucleoside reverse transcriptase inhibitor (NNRTI) family that has recently been approved by the regulatory agencies for the treatment of patients with prior experience with antiretrovirals, evidence of active viral replication, and who harbor multidrug resistant HIV-1 strains. In this context, in Europe, the use of this drug has been authorized combined with boosted protease inhibitors and nucleoside reverse transcriptase inhibitors. This approval was based on the results of the randomized double-blind DUET studies, in which the ETR arm was statistically superior to the placebo arms in terms of virological efficacy, immunological recovery, clinical progression and health- related quality of life. These studies showed that ETR was as well-tolerated as placebo, except for the appearance of rash, which was more common in the ETR arm. However, rash was usually mild or moderate and caused discontinuation of ETR in only 2% of the patients.</p><p class="elsevierStyleSimplePara elsevierViewall">The characteristics of ETR, i.e., potency, benign safety profile, resistance profile, pharmacokinetic characteristics, and drug interactions suggest that the use of this drug may go beyond its currently approved indications. Nevertheless, the evidence supporting these alternative uses is still scarce, although a randomized, double-blind, placebo controlled trial (SENSE) is under way in treatment-naïve patients. In this trial ETR will be administered once daily and the principal objective is to show that ETR has better tolerability in the central nervous system (CNS) than efavirenz. Moreover, the tolerability profile in the CNS, liver, and even skin suggest that ETR may be a good option when there are toxicity problems, or a risk of toxicity, with first-generation NNRTIs. When there is virological failure with an initial first-generation NNRTI-based regimen, the differential resistance profile of ETR may allow this drug to be used to construct a rescue combination. ETR is not teratogenic and can therefore be safely used in pregnant or fertile women. Finally, ETR has an excellent drug-drug interaction profile, which may be useful in patients administered other medications. This interaction profile may be especially important in areas with a high prevalence of methadone treatment, as both drugs can be coadministered safely.</p><p class="elsevierStyleSimplePara elsevierViewall">ETR has received approval as advanced rescue therapy. However, the characteristics of this drug suggest that it may be useful in a series of potential indications, due to its antiviral potency, differential resistance profile, safety, tolerability and drug-drug interaction profile.</p>" ] ] "bibliografia" => array:2 [ "titulo" => "Bibliografía" "seccion" => array:1 [ 0 => array:1 [ "bibliografiaReferencia" => array:52 [ 0 => array:3 [ "identificador" => "bib1" "etiqueta" => "1." "referencia" => array:1 [ 0 => array:1 [ "referenciaCompleta" => "Panel on Antiretroviral Guidelines for Adults and Adolescents Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents. Department of Health and Human Services. November 3, 2008; 1-139 [consultado 1-9-2009]. 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| año/Mes | Html | Total | |
|---|---|---|---|
| 2024 Octubre | 14 | 5 | 19 |
| 2024 Septiembre | 24 | 4 | 28 |
| 2024 Agosto | 12 | 2 | 14 |
| 2024 Julio | 9 | 3 | 12 |
| 2024 Junio | 4 | 3 | 7 |
| 2024 Mayo | 12 | 2 | 14 |
| 2024 Abril | 6 | 4 | 10 |
| 2024 Marzo | 11 | 2 | 13 |
| 2024 Febrero | 16 | 1 | 17 |
| 2024 Enero | 16 | 1 | 17 |
| 2023 Diciembre | 12 | 4 | 16 |
| 2023 Noviembre | 21 | 2 | 23 |
| 2023 Octubre | 20 | 2 | 22 |
| 2023 Septiembre | 12 | 0 | 12 |
| 2023 Agosto | 11 | 4 | 15 |
| 2023 Julio | 8 | 5 | 13 |
| 2023 Junio | 8 | 0 | 8 |
| 2023 Mayo | 24 | 1 | 25 |
| 2023 Abril | 13 | 1 | 14 |
| 2023 Marzo | 13 | 4 | 17 |
| 2023 Febrero | 10 | 3 | 13 |
| 2023 Enero | 5 | 4 | 9 |
| 2022 Diciembre | 11 | 2 | 13 |
| 2022 Noviembre | 19 | 3 | 22 |
| 2022 Octubre | 10 | 5 | 15 |
| 2022 Septiembre | 11 | 6 | 17 |
| 2022 Agosto | 11 | 7 | 18 |
| 2022 Julio | 18 | 7 | 25 |
| 2022 Junio | 13 | 7 | 20 |
| 2022 Mayo | 12 | 7 | 19 |
| 2022 Abril | 14 | 11 | 25 |
| 2022 Marzo | 28 | 6 | 34 |
| 2022 Febrero | 23 | 5 | 28 |
| 2022 Enero | 62 | 11 | 73 |
| 2021 Diciembre | 17 | 10 | 27 |
| 2021 Noviembre | 16 | 6 | 22 |
| 2021 Octubre | 11 | 12 | 23 |
| 2021 Septiembre | 24 | 5 | 29 |
| 2021 Agosto | 13 | 7 | 20 |
| 2021 Julio | 35 | 3 | 38 |
| 2021 Junio | 9 | 6 | 15 |
| 2021 Mayo | 38 | 14 | 52 |
| 2021 Abril | 63 | 19 | 82 |
| 2021 Marzo | 15 | 9 | 24 |
| 2021 Febrero | 6 | 10 | 16 |
| 2021 Enero | 7 | 11 | 18 |
| 2020 Diciembre | 8 | 11 | 19 |
| 2020 Noviembre | 8 | 6 | 14 |
| 2020 Octubre | 7 | 2 | 9 |
| 2020 Septiembre | 10 | 8 | 18 |
| 2020 Agosto | 12 | 7 | 19 |
| 2020 Julio | 6 | 1 | 7 |
| 2020 Junio | 23 | 7 | 30 |
| 2020 Mayo | 12 | 4 | 16 |
| 2020 Abril | 4 | 4 | 8 |
| 2020 Marzo | 13 | 1 | 14 |
| 2020 Febrero | 21 | 2 | 23 |
| 2020 Enero | 14 | 5 | 19 |
| 2019 Diciembre | 8 | 2 | 10 |
| 2019 Noviembre | 1 | 8 | 9 |
| 2019 Octubre | 16 | 8 | 24 |
| 2019 Septiembre | 11 | 6 | 17 |
| 2019 Agosto | 9 | 4 | 13 |
| 2019 Julio | 20 | 10 | 30 |
| 2019 Junio | 19 | 57 | 76 |
| 2019 Mayo | 19 | 86 | 105 |
| 2019 Abril | 26 | 57 | 83 |
| 2019 Marzo | 17 | 6 | 23 |
| 2019 Febrero | 8 | 4 | 12 |
| 2019 Enero | 9 | 5 | 14 |
| 2018 Diciembre | 9 | 4 | 13 |
| 2018 Noviembre | 3 | 4 | 7 |
| 2018 Octubre | 8 | 5 | 13 |
| 2018 Septiembre | 10 | 1 | 11 |
| 2018 Agosto | 11 | 1 | 12 |
| 2018 Julio | 8 | 3 | 11 |
| 2018 Junio | 3 | 1 | 4 |
| 2018 Mayo | 3 | 1 | 4 |
| 2018 Abril | 6 | 3 | 9 |
| 2018 Marzo | 10 | 2 | 12 |
| 2018 Febrero | 3 | 2 | 5 |
| 2018 Enero | 4 | 3 | 7 |
| 2017 Diciembre | 3 | 7 | 10 |
| 2017 Noviembre | 9 | 6 | 15 |
| 2017 Octubre | 11 | 10 | 21 |
| 2017 Septiembre | 5 | 7 | 12 |
| 2017 Agosto | 10 | 17 | 27 |
| 2017 Julio | 10 | 5 | 15 |
| 2017 Junio | 13 | 29 | 42 |
| 2017 Mayo | 21 | 0 | 21 |
| 2017 Abril | 12 | 17 | 29 |
| 2017 Marzo | 46 | 20 | 66 |
| 2017 Febrero | 20 | 5 | 25 |
| 2017 Enero | 16 | 3 | 19 |
| 2016 Diciembre | 13 | 6 | 19 |
| 2016 Noviembre | 24 | 9 | 33 |
| 2016 Octubre | 49 | 2 | 51 |
| 2016 Septiembre | 47 | 5 | 52 |
| 2016 Agosto | 29 | 1 | 30 |
| 2016 Julio | 13 | 1 | 14 |
| 2016 Junio | 10 | 10 | 20 |
| 2016 Mayo | 18 | 8 | 26 |
| 2016 Abril | 20 | 2 | 22 |
| 2016 Marzo | 24 | 4 | 28 |
| 2016 Febrero | 11 | 9 | 20 |
| 2016 Enero | 8 | 8 | 16 |
| 2015 Diciembre | 2 | 8 | 10 |
| 2015 Noviembre | 19 | 4 | 23 |
| 2015 Octubre | 22 | 7 | 29 |
| 2015 Septiembre | 5 | 5 | 10 |
| 2015 Agosto | 6 | 5 | 11 |
| 2015 Julio | 8 | 5 | 13 |
| 2015 Junio | 8 | 2 | 10 |
| 2015 Mayo | 8 | 7 | 15 |
| 2015 Abril | 7 | 6 | 13 |
| 2015 Marzo | 10 | 10 | 20 |
| 2015 Febrero | 22 | 8 | 30 |
| 2015 Enero | 22 | 6 | 28 |
| 2014 Diciembre | 14 | 4 | 18 |
| 2014 Noviembre | 19 | 3 | 22 |
| 2014 Octubre | 22 | 3 | 25 |
| 2014 Septiembre | 27 | 4 | 31 |
| 2014 Agosto | 21 | 3 | 24 |
| 2014 Julio | 23 | 5 | 28 |
| 2014 Junio | 16 | 5 | 21 |
| 2014 Mayo | 11 | 3 | 14 |
| 2014 Abril | 7 | 3 | 10 |
| 2014 Marzo | 13 | 1 | 14 |
| 2014 Febrero | 13 | 1 | 14 |
| 2014 Enero | 16 | 1 | 17 |
| 2013 Diciembre | 12 | 6 | 18 |
| 2013 Noviembre | 16 | 3 | 19 |
| 2013 Octubre | 12 | 3 | 15 |
| 2013 Septiembre | 14 | 3 | 17 |
| 2013 Agosto | 12 | 2 | 14 |
| 2013 Julio | 8 | 1 | 9 |
| 2009 Diciembre | 400 | 0 | 400 |
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