Información del artículo
Objetivo
Efectuar una actualización de las recomendaciones sobre el tratamiento antiretroviral (TARV) de los adultos infectados por el VIH-1.
MétodosEstas recomendaciones se han consensuado por un panel del Grupo de Estudio de Sida y del Plan Nacional sobre el Sida. Se han revisado los avances en la fisiopatología del VIH-1, los resultados de eficacia y seguridad de ensayos clínicos, estudios de cohortes y de farmacocinética, publicados en revistas biomédicas o presentados en congresos en los últimos años. Se han definido tres niveles de evidencia según la procedencia de los datos: estudios aleatorizados (nivel A), de cohortes o de caso-control (nivel B), u opinión de expertos (nivel C). En cada una de las situaciones se ha establecido recomendar, considerar o no recomendar el TARV.
ResultadosActualmente, el TARV con combinaciones de tres fármacos constituye el tratamiento de inicio de elección de la infección crónica por el VIH-1. Estas pautas deben incluir 2 análogos de nucleósido o nucleótido (AN)+1 no análogo (NN) o 2 AN+ 1 inhibidor de la proteasa (IP) potenciado con ritonavir. En los pacientes con infección por VIH-1 sintomática se recomienda iniciar el TARV. En los pacientes asintomáticos el inicio de TARV se basará en la cifra de linfocitos CD4+/μl y en la carga viral plasmática (CVP): 1) en pacientes con linfocitos CD4+<200 células/μl se recomienda iniciar el TARV; 2) en pacientes con linfocitos CD4+ entre 200 y 350 células/μl en la mayoría de las ocasiones se debe recomendar el tratamiento, si bien se podría diferir cuando la cifra de linfocitos CD4+ se mantiene próxima a 350 células/μl y la CVP es baja; 3) en los pacientes con linfocitos CD4+>350 células/μl se puede diferir el inicio del TARV. El objetivo del TARV es lograr una carga viral plasmática indetectable. Las opciones terapéuticas en los fracasos del TARV se ven limitadas por la aparición de resistencias cruzadas. Los estudios genotípicos en estos casos son de utilidad. Se puede encontrar más información sobre los estudios analizados, las recomendaciones del panel sobre adherencia, toxicidad, tratamiento de la embarazada, pacientes coinfectados por VHB o VHC o sobre la profilaxis postexposición en la página web www.gesida.seimc.org.
ConclusionesLa cifra de linfocitos CD4+ es el factor de referencia más importante para iniciar el TARV en pacientes asintomáticos. Por otra parte, el número considerable de fármacos disponibles, los métodos más sensibles de monitorización de la CVP y la posibilidad de determinar las resistencias hacen que las estrategias terapéuticas deban ser cada vez más, mucho más individualizadas.
Palabras clave:
Tratamiento antirretroviral
Sida
Infección por VIH
GESIDA
PNS (Plan Nacional sobre el Sida)
Resistencia a antirretrovirales
Guía
Objective
This consensus document is an update of antiretroviral therapy (ART) recommendations for adult patients infected with the human immunodeficiency virus (HIV-1).
MethodsTo formulate these recommendations, a panel composed of members of the Grupo de Estudio de Sida (GESIDA; AIDS Study Group) and the Plan Nacional sobre el Sida (PNS; Spanish AIDS Plan) reviewed the advances in the current understanding of the pathophysiology of HIV, the safety and efficacy findings from clinical trials, and the results from cohort and pharmacokinetic studies published in biomedical journals or presented at scientific meetings over the last years. Three levels of evidence were defined according to the source of the data: randomized studies (level A), cohort or case-control studies (level B), and expert opinion (level C). The decision to recommend, consider or not recommend ART was established in each situation.
ResultsCurrently, the treatment of choice for chronic HIV infection is the combination of three drugs of two different classes, including 2 nucleosides or nucleotide analogs (NRTI) plus 1 non-nucleoside (NNRTI) or 1 boosted protease inhibitor (PI/r). Initiation of ART is recommended in patients with symptomatic HIV infection. In asymptomatic patients, initiation of ART is recommended on the basis of CD4+ lymphocyte counts and plasma viral load, as follows: 1) therapy should be started in patients with CD4+ counts of<;200 cells/μl; 2) therapy should be started in most patients with CD4+ counts of 200-350 cells/μl, although it can be delayed when CD4+ count persists at around 350 cells/μL and viral load is low, and 3) initiation of therapy can be delayed in patients with CD4+ counts of>350 cells/μL. The initial objective of ART is to achieve an undetectable viral load. Adherence to therapy plays an essential role in maintaining the antiviral response. Therapeutic options are limited with the development of cross resistance and ART failure. Genotype studies are useful in these cases. More information regarding the studies analyzed and the panel recommendations for adherence, toxicity, treatment during pregnancy, patients with hepatitis B or C virus co-infection, and post-exposure prophylaxis can be accessed at www.gesida.seimc.org
ConclusionsCD4+ lymphocyte count is the most important reference factor for initiating ART in asymptomatic patients. The large number of available drugs, the increased sensitivity of tests to monitor viral load, and the ability to determine viral resistance is leading to a more individualized approach to therapy.
Key words:
Antiretroviral treatment
AIDS
HIV infection
GESIDA
PNS (Plan Nacional sobre el Sida)
Antiretroviral resistance
Guidelines
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