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Vol. 35. Issue 1.
Pages 14-22 (January 2011)
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Vol. 35. Issue 1.
Pages 14-22 (January 2011)
Original Article
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Indications for the use of next-generation antiretroviral drugs in current clinical practice
Indicación de uso de los antirretrovirales de última generación en la práctica clínica actual
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I. Castillo Romeraa,
Corresponding author
, A. Ais Larisgoitiaa, A.N. Trovato Lópeza, V. Escudero Villaplanaa, J.M. Bellón Canob, M. Sanjurjo Saéza
a Servicio de Farmacia, Hospital General Universitario Gregorio Marañón, Madrid, Spain
b Servicio de Medicina y Preventiva, Hospital General Universitario Gregorio Marañón, Madrid, Spain
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Abstract
Objective

To describe the indications for use, in medical practice, of next-generation antiretroviral drugs (NGA): darunavir, raltegravir, maraviroc and etravirine.

Method

An observational, transversal and descriptive study conducted in adult patients who have started to receive a NGA between May 2008 and April 2009. The variables associated with the use of NGA were defined as follows: a) Variables related to efficacy: resistance confirmed by geno/phenotype tests or potencial resistance as a result of extensive exposure to antiretroviral agents, and/or severe immunological deterioration (CD4 less than 200 cells/mcl). b) Variables related to safety: prior toxicity to classic antiretroviral drugs and/or comorbidity which compromises their use. c) Combined efficacy and safety variable (main variable): prioritizing the variables which were detected, the patients were classified into three groups: multiresistant geno/phenotype (multi-G/P), multiresistant as a result of treatment history and other situations. Data was obtained from electronic medical records, laboratory tests, and records of interviews and drugs dispensed by the Pharmacy Service.

Results

Seventy three patients, 40% of whom had an undetectable viral load and 38.4% who showed severe immunological deterioration, were included in the study. Multi-G/P occurred in 45% and multiresistance as a result of treatment history was found in 33% of patients. Patients classified as belonging to the “other situations”ategory were characterized by having a greater viral load and a poorer immunological status. In 90% of the patients without multi-G/P two or more variables associated with the use of NGA were detected.

Discussion

The medical reality of using NGA shows that they play a role in clinical situations which are very different, specific and difficult to manage.

Keywords:
Darunavir
Maraviroc
Etravirine
Raltegravir
Multiple drug resistance
Antiretroviral treatment
HIV infection
Resumen
Objetivo

Describir el perfil de utilización en la práctica asistencial de los antirretrovirales de última generación (AUG): darunavir, raltegravir, maraviroc y etravirina.

Método

Estudio observacional, transversal y descriptivo realizado en pacientes adultos que hubiesen iniciado tratamiento con algún AUG entre mayo de 2008 y abril de 2009. Se definieron las variables asociadas al uso de AUG: a) relacionadas con la eficacia: resistencias según pruebas geno/fenotípicas, o potenciales por amplia experiencia previa a antirretrovirales; y/o deterioro inmunológico grave (CD4 inferior a 200 células/mcl). b) Relacionadas con la seguridad: toxicidad previa a antirretrovirales clásicos, y/o comorbilidad que condiciona su uso. c) Variable combinada de eficacia y seguridad (variable principal): priorizando las variables detectadas se clasificaron a los pacientes como multirresistencia geno/fenotípica (multi-G/F), mutirresistencia según histórico de tratamiento, y otras situaciones. Los datos se obtuvieron de la historia clínica informatizada, las pruebas de laboratorio, y el registro de la entrevista y las dispensaciones del Servicio de Farmacia.

Resultados

Se incluyeron 73 pacientes de los que el 40% tenía carga viral indetectable y el 38,4% deterioro inmunológico grave. La multi-G/F ocurrió en el 45%, y la multirresistencia según histórico en el 33% de los pacientes. Los pacientes clasificados como «otras situaciones» se caracterizaron por tener mayor carga viral y peor situación inmunológica. De los pacientes que no presentaron multi-G/F en el 90% se detectaron dos o más variables asociadas al uso de AUG.

Discusión

La realidad asistencial del uso de los AUG muestra su papel en situaciones clínicas muy variadas, particulares y difíciles de manejar.

Palabras clave:
Darunavir
Maraviroc
Etravirina
Raltegravir
Resistencia multiple a medicamentos
Tratamiento antirretroviral
Infección por VIH
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