<?xml version="1.0" encoding="ISO-8859-1"?><article xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:xlink="http://www.w3.org/1999/xlink" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance">
<front>
<journal-meta>
<journal-id>1130-6343</journal-id>
<journal-title><![CDATA[Farmacia Hospitalaria]]></journal-title>
<abbrev-journal-title><![CDATA[Farm Hosp.]]></abbrev-journal-title>
<issn>1130-6343</issn>
<publisher>
<publisher-name><![CDATA[Grupo Aula Médica]]></publisher-name>
</publisher>
</journal-meta>
<article-meta>
<article-id>S1130-63432022000400002</article-id>
<article-id pub-id-type="doi">10.7399/fh.11845</article-id>
<title-group>
<article-title xml:lang="es"><![CDATA[Contribución de cabotegravir + rilpivirina de acción prolongada al tratamiento de la infección por VIH-1]]></article-title>
<article-title xml:lang="en"><![CDATA[Contribution of cabotegravir + rilpivirine long-acting for the treatment of HIV-1 infection]]></article-title>
</title-group>
<contrib-group>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Calleja-Hernández]]></surname>
<given-names><![CDATA[Miguel Ángel]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Martinez-Sesmero]]></surname>
<given-names><![CDATA[José Manuel]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Vallejo-Aparicio]]></surname>
<given-names><![CDATA[Laura Amanda]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Hernández-Novoa]]></surname>
<given-names><![CDATA[Beatriz]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Badia]]></surname>
<given-names><![CDATA[Xavier]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
</contrib-group>
<aff id="Af1">
<institution><![CDATA[,Hospital Virgen Macarena Servicio de Farmacia ]]></institution>
<addr-line><![CDATA[Sevilla ]]></addr-line>
<country>España</country>
</aff>
<aff id="Af2">
<institution><![CDATA[,Hospital Universitario Clínico San Carlos Servicio de Farmacia ]]></institution>
<addr-line><![CDATA[Madrid ]]></addr-line>
<country>España</country>
</aff>
<aff id="Af3">
<institution><![CDATA[,GSK Departamento de Acceso al Mercado ]]></institution>
<addr-line><![CDATA[Tres Cantos Madrid]]></addr-line>
<country>España</country>
</aff>
<aff id="Af4">
<institution><![CDATA[,ViiV Healthcare España Medical Affairs Manager ]]></institution>
<addr-line><![CDATA[Tres Cantos Madrid]]></addr-line>
<country>España</country>
</aff>
<aff id="Af5">
<institution><![CDATA[,Omakase Consulting S.L.  ]]></institution>
<addr-line><![CDATA[Barcelona ]]></addr-line>
<country>España</country>
</aff>
<pub-date pub-type="pub">
<day>00</day>
<month>08</month>
<year>2022</year>
</pub-date>
<pub-date pub-type="epub">
<day>00</day>
<month>08</month>
<year>2022</year>
</pub-date>
<volume>46</volume>
<numero>4</numero>
<fpage>208</fpage>
<lpage>214</lpage>
<copyright-statement/>
<copyright-year/>
<self-uri xlink:href="http://scielo.isciii.es/scielo.php?script=sci_arttext&amp;pid=S1130-63432022000400002&amp;lng=en&amp;nrm=iso"></self-uri><self-uri xlink:href="http://scielo.isciii.es/scielo.php?script=sci_abstract&amp;pid=S1130-63432022000400002&amp;lng=en&amp;nrm=iso"></self-uri><self-uri xlink:href="http://scielo.isciii.es/scielo.php?script=sci_pdf&amp;pid=S1130-63432022000400002&amp;lng=en&amp;nrm=iso"></self-uri><abstract abstract-type="short" xml:lang="es"><p><![CDATA[Resumen  Objetivo: Determinar la contribución de valor de cabotegravir + rilpivirina, el primer tratamiento antirretroviral inyectable de acción prolongada, utilizando metodología de análisis de decisión multicriterio.  Método: El estudio se desarrolló en dos fases: una prueba piloto y una fase de extensión, con un grupo multidisciplinar más grande. Se seleccionaron siete regímenes de comprimido único orales diarios recomendados en las guías GeSIDA como comparadores. Se utilizó el marco EVIDEM, compuesto por 12 criterios cuantitativos y 5 contextuales. Los criterios cuantitativos se analizaron calculando la media y desviación estándar, y los cualitativos se analizaron mediante el porcentaje de expertos que consideraron el impacto positivo, neutro o negativo para el Sistema Nacional de Salud.  Resultados: Un total de 35 expertos participaron en el estudio. La infección por virus de la inmunodeficiencia humana 1 se consideró grave (media ± desviación estándar: 3,0 ± 1,0), con un tamaño de población afectada (2,7 ± 1,2) y unas necesidades no cubiertas (2,8 ± 1,0) moderadas. Las diferencias fueron mínimas en los criterios comparativos de eficacia/efectividad (0,1 ± 0,5), seguridad/tolerabilidad (&#8211;0,5 ± 0,7) y coste: coste del tratamiento (0,5 ± 2,0), otros costes médicos (0,2 ± 1,8) y costes no-médicos/indirectos (0,5 ± 1,6). Los expertos observaron una mejora con cabotegravir + rilpivirina de acción prolongada en los resultados reportados por los pacientes (2,7 ± 1,4). El beneficio terapéutico (3,5 ± 1,2) se consideró moderado-alto. La evidencia de cabotegravir + rilpivirina de acción prolongada fue considerada robusta (4,3 ± 0,8), con elevado consenso sobre su futura recomendación en las guías (3,2 ± 1,0). En los criterios contextuales, el impacto fue positivo en los criterios de prioridades de acceso (91%), objetivo común (63%) y contexto político (60%). El impacto fue neutro en la capacidad del sistema (40%) y los costes de oportunidad (51%). El resultado promedio de la contribución del valor global de cabotegravir + rilpivirina de acción prolongada fue de 0,34 (escala de &#8211;1 a +1), siendo el criterio de resultados reportados por el paciente el que proporcionó la mayor contribución de valor (0,04).  Conclusiones: Cabotegravir + rilpivirina de acción prolongada aporta un valor añadido en el manejo del virus de la inmunodeficiencia humana 1 en España en comparación con los regímenes de comprimido único utilizados actualmente. Los expertos valoraron positivamente los resultados reportados por los pacientes y el beneficio terapéutico de cabotegravir + rilpivirina de acción prolongada, considerando que el beneficio esperado en la adherencia y los problemas relacionados con el estigma produciría una mejora en la calidad de vida de las personas con virus de la inmunodeficiencia humana 1.]]></p></abstract>
<abstract abstract-type="short" xml:lang="en"><p><![CDATA[Abstract  Objective: To determine the value contribution of cabotegravir + rilpivirine, the first injectable every two months long-acting antiretroviral regimen, using multi-criteria decision analysis.  Method: The study was developed in two phases. After a small pilot, a field work study with a larger number of multidisciplinary experts was carried out. Seven single-tablet regimens, currently recommended by the GeSIDA guidelines, were selected as comparators. EVIDEM methodology was followed, with a framework composed by 12 quantitative and 5 contextual criteria. Mean and standard deviations were calculated for quantitative criteria (1 to 5 scale; comparative criteria &#8211;5 to +5), whereas qualitative criteria were analyzed as percentages of experts that considered a positive, neutral or negative impact for the National Health System.  Results: 35 experts participated in the study. Human immunodeficiency virus-1 infection was considered severe (mean ± standard deviation: 3.0 ± 1.0), with moderate size of affected population (2.7 ± 1.2) and unmet needs (2.8 ± 1.0). Minimal differences were found in comparative efficacy/effectiveness (0.1 ± 0.5), safety/tolerability (&#8211;0.5 ± 0.7), and cost criteria: cost of the intervention (0.5 ± 2.0), other medical costs (0.2 ± 1.8) and non-medical/indirect costs (0.5 ± 1.6). Experts perceived an improvement with cabotegravir + rilpivirine long-acting, compared to current daily oral single-tablet regimens, in patient-reported outcomes (2.7 ± 1.4). Therapeutic benefit of the long-acting regimen was considered moderate-to-high (3.5 ± 1.2). Experts considered the evidence provided by cabotegravir + rilpivirine long-actingrobust (4.3 ± 0.8), with elevated consensus on its future recommendation in guidelines (3.2 ± 1.0). In contextual criteria, most experts considered positive the impact on population priorities and access (91%), common goal and specific interests (63%) and political, historical, and cultural context criteria (60%). Impact was neutral in system capacity and appropriate use (40%), and opportunity costs and affordability criteria (51%). Result of the weighted global value contribution of cabotegravir + rilpivirine long-acting was 0.34 (&#8211;1 to +1 scale), with Patient Reported Outcomes comparative criterion bringing the highest added value.  Conclusions: Cabotegravir + rilpivirine long-acting provides added value contribution to human immunodeficiency virus-1 management in Spain compared to daily oral single-tablet regimens. Patient Reported Outcomes and therapeutic benefit of cabotegravir + rilpivirine long-acting were highly valued by experts, as the expected benefit in adherence and stigma-related issues would improve overall quality of life for people living with human immunodeficiency virus-1.]]></p></abstract>
<kwd-group>
<kwd lng="es"><![CDATA[VIH]]></kwd>
<kwd lng="es"><![CDATA[Agentes anti-VIH]]></kwd>
<kwd lng="es"><![CDATA[VIH-1/efectos del tratamiento]]></kwd>
<kwd lng="es"><![CDATA[Cabotegravir]]></kwd>
<kwd lng="es"><![CDATA[Rilpivirina]]></kwd>
<kwd lng="es"><![CDATA[Técnicas de apoyo a la toma de decisiones]]></kwd>
<kwd lng="en"><![CDATA[HIV]]></kwd>
<kwd lng="en"><![CDATA[Anti-HIV Agents]]></kwd>
<kwd lng="en"><![CDATA[HIV-1/drug effects]]></kwd>
<kwd lng="en"><![CDATA[Cabotegravir]]></kwd>
<kwd lng="en"><![CDATA[Rilpivirine]]></kwd>
<kwd lng="en"><![CDATA[Decision Support Techniques]]></kwd>
</kwd-group>
</article-meta>
</front><back>
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