Article information
Objetivo
Efectuar una puesta al día de las recomendaciones sobre el tratamiento antirretroviral (TAR) para los adultos infectados por el virus de la inmunodeficiencia humana (VIH).
MétodosEstas recomendaciones se han consensuado por un comité del Grupo de Estudio de Sida (GESIDA) y del Plan Nacional sobre el Sida (PNS). Para ello se han revisado los avances en la fisiopatología del VIH, 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 TAR.
ResultadosEn el momento actual, el TAR con combinaciones de al menos tres fármacos constituye el tratamiento de inicio de elección de la infección crónica por el VIH. Estas pautas deben incluir dos inhibidores de la transcriptasa inversa análogos de nucleósidos (ITIAN) más un no nucleósido (ITINN) o dos ITIAN más un inhibidor de la proteasa (IP). En los pacientes con una infección por VIH sintomática se recomienda iniciar TAR. En los pacientes asintomáticos el inicio de TAR se basará en la cifra de linfocitos CD4+/μl y en la carga viral plasmática (CVP): a) en pacientes con linfocitos CD4+ < 200 cél./μl se recomienda iniciar el TAR; b) en pacientes con linfocitos CD4+ entre 200 y 350 cél./μl en la mayoría de las ocasiones se debe recomendar el inicio de TAR; si bien se podría diferir cuando la cifra de linfocitos CD4+ se mantiene próxima a 350 cél./μl y la CVP es baja, y c) en los pacientes con linfocitos CD4+ > 350 cél./μl se puede diferir el inicio del TAR. El objetivo del TAR inicial es lograr una CVP indetectable. La adherencia al TAR tiene un papel fundamental en la duración de la respuesta antiviral. Las opciones terapéuticas en los fracasos del TAR son limitadas por la aparición de resistencias cruzadas. Los estudios genotípicos en estos casos son de utilidad. La toxicidad es un factor limitante del TAR, aunque los beneficios superan los posibles perjuicios. También se discuten los criterios de TAR de la infección aguda, embarazo y profilaxis postexposición, y el manejo de la coinfección por el VIH y los virus de la hepatitis C y B (VHC y VHB).
ConclusionesLa cifra de linfocitos CD4+ es el factor de referencia más importante para iniciar el TAR en pacientes asintomáticos. Por otra parte, el número considerable de fármacos disponibles, los métodos de monitorización más sensibles (CVP), y la posibilidad de determinar las resistencias hacen que las estrategias terapéuticas sean mucho más individualizadas.
Palabras clave:
Tratamiento antirretroviral
VIH
Sida
GESIDA
PNS
Recomendaciones
Resistencias
Prevención
Coinfección VIH y VHC o VHB
Objective
This consensus document is an update of antiretroviral therapy (ART) recommendations for adult patients infected with the human immunodeficiency virus (HIV).
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 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 of these situations.
ResultsART consisting of at least three drugs is currently the initial treatment of choice for chronic HIV infection. These regimens should include 2 NRTI + 1 NNRTI or 2 NRTI + 1 PI. 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 per μL 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. Because of the development of cross resistance, therapeutic options are limited when ART fails. Genotype studies are useful in these cases. Toxicity is a limiting factor in the use of ART, although the benefits outweigh the risks. In addition, the criteria for the use of ART are discussed in situations of acute infection, pregnancy, and post-exposure prophylaxis, and in the management of co-infection of HIV with HCV or HBV.
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 possibility to determine viral resistance is leading to a more individualized approach to therapy. Key words: Antiretroviral treatment. HIV. AIDS. GESIDA. Plan Nacional sobre el Sida. Recommendations. Resistance. Prevention. HIV and HCV or HBV co-infection.
Key words:
Antiretroviral treatment
HIV
AIDS
GESIDA
Plan Nacional sobre el Sida
Recommendations
Resistance
Prevention
HIV
HCV or HBV co-infection
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