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Vol. 20. Núm. 6.
Páginas 244-303 (Junio 2002)
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Vol. 20. Núm. 6.
Páginas 244-303 (Junio 2002)
DOI: 10.1016/S0213-005X(02)72804-8
Acceso a texto completo
Recomendaciones de GESIDA/Plan Nacional sobre el Sida respecto al tratamiento antirretroviral en pacientes adultos infectados por el virus de la inmunodeficiencia humana en el año 2002
Visitas
5256
Rafael Rubio1,1, Juan Berenguer2,2, José M. Miró3, Antonio Antela4, José Antonio Iribarren5, Juan González6, Luis Guerra7, Santiago Moreno4, Julio Arrizabalaga5, Buenaventura Clotet8, José M. Gatell3, Fernando Laguna9, Esteban Martínez3, Francisco Parras7, Juan Miguel Santamaría10, Montserrat Tuset3, Pompeyo Viciana11
1 Hospital 12 Octubre (Madrid)
2 Hospital Gregorio Marañón (Madrid)
3 Hospital Clínic-IDIBAPS (Barcelona)
4 Hospital Ramón y Cajal (Madrid)
5 Hospital Donostia (San Sebastián)
6 Hospital La Paz (Madrid)
7 Secretaria de Plan Nacional sobre el SIDA. Ministerio de Sanidad (Madrid)
8 Hospital Germans Trias i Pujol (Badalona)
9 Centro de Investigación Clínica. Instituto de Salud Carlos III (Madrid)
10 Hospital de Basurto (Bilbao)
11 Hospital Virgen del Rocío (Sevilla). España
por el Grupo de Estudio de Sida (Gesida) y por el Consejo Asesor Clínico (Cac) del Plan Nacional sobre el Sida (Pns) del Ministerio de Sanidad y Consumo (Msc)
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Estadísticas
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).

Métodos

Estas 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.

Resultados

En el momento actual, el TAR con combinaciones de al menos 3 fármacos constituye el tratamiento de elección de la infección crónica por el VIH. En los pacientes con una infección por VIH sintomática se recomienda iniciar el 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; c) en los pacientes con linfocitos CD4+> 350 cél./μl se puede diferir el inicio del TAR. El objetivo del TAR es lograr una CVP indetectable. La adherencia al TAR tiene un papel en la durabilidad 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. 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 las hepatitis B y C (VHC y VHB).

Conclusiones

En la actualidad existe una actitud más conservadora para iniciar el TAR que en recomendaciones previas. La 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 antiretroviral
VIH
Sida
Gesida
Plan Nacional sobre el SIDA
Recomendaciones
Resistencias
Prevención
Coinfección VIH y VHC o VHB
Objective

To provide an update of recommendation on antiretroviral treatment (ART) in HIV-infected adults.

Methods

These recommendations have been agreed by consensus by a committee of the spanish AIDS Study Group (GESIDA) and the National AIDS Plan. To do so, advances in the physiopathology of AIDS and the results on efficacy and safety in clinical trials, cohort and pharmacokinetics studies published in biomedical journals or presented at congresses in the last few years have been reviewed. Three levels of evidence have been defined according to the data source: randomized studies (level A), case-control or cohort studies (level B) and expert opinion (level C). Whether to recommend, consider, or not to recommend ART has been established for each situation.

Results

Currently, ART with combinations of at least three drugs constitutes the treatment of choice in chronic HIV infection. In patients with symptomatic HIV infection, initiation of ART is recommended. In asymptomatic patients initiation of ART should be based on the CD4+/μL lymphocyte count and on the plasma viral load (PVL): a) in patients with CD4+ lymphocytes < 200 cells/μL, initiation of ART is recommended; b) in patients with CD4+ lymphocytes between 200 and 300 cells/μL, initiation of ART should, in most cases, be recommended; however, it could be delayed when the CD4+ lymphocyte count remains close to 350 cells/μL and the PVL is low, and c) in patients with CD4+ lymphocytes > 350 cells/μL, initiation of ART can be delayed. The aim of ART is to achieve an undetectable PVL. Adherence to ART plays a role in the durability of the antiviral response. Because of the development of cross-resistance, the therapeutic options in treatment failure are limited. In these cases, genotypic analysis is useful. Toxicity limits ART. The criteria for ART in acute infection, pregnancy and postexposure prophylaxis and in the management of coinfection with HIV and hepatitis C and B virus are controversial.

Conclusions

The current approach to initiating ART is more conservative than in previous recommendations. In asymptomatic patients, the CD4+ lymphocyte count is the most important reference factor for initiating ART. Because of the considerable number of drugs available, more sensitive monitoring methods (PVL) and the possibility of determining resistance, therapeutic strategies have become much more individualized.

Key words:
Antiretroviral treatment
HIV
AIDS
GESIDA
National AIDS Plan
Recommendations
Resistance
Coinfection
HIV
hepatitis C
B virus
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