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Seguridad y actividad del saquinavir en la infección por VIH
V S Kitchen1, C Skinner, K Ariyoshi
1Department of Genito-Urinary Medicine & Communicable Diseases, St Mary's Hospital Medical School, London, UK.
Lancet (London, England)
|April 15, 1995
Resumen
El saquinavir, un inhibidor de la proteínaza del VIH, fue evaluado en un estudio de dosificación. Las dosis más altas mostraron una tendencia hacia la reducción de la carga viral y la mejora de los recuentos de CD4 en pacientes VIH positivos.
Área de la Ciencia:
- Virología Virología.
- Inmunología Inmunología.
- Farmacología Farmacología.
Sus antecedentes:
- La infección por el virus de la inmunodeficiencia humana (VIH) es un problema de salud mundial.
- Las terapias antivirales efectivas son cruciales para el manejo del VIH.
- Los inhibidores de la proteínaza del VIH representan una clase de fármacos dirigidos a la replicación viral.
Objetivo del estudio:
- Para evaluar la actividad antiviral del saquinavir, un inhibidor de la HIV-proteinasa activo por vía oral.
- Para evaluar la tolerabilidad del saquinavir en pacientes VIH positivos que no habían recibido zidovudina.
- Para determinar la dosis óptima de saquinavir basada en la respuesta antiviral y la seguridad.
Principales métodos:
- Se llevó a cabo un estudio aleatorizado, doble ciego, de variación de dosis.
- Se incluyeron 49 pacientes VIH-positivos no tratados con zidovudina con recuentos de CD4 ≤500.
- Los pacientes recibieron saquinavir en dosis de 25, 75, 200 o 600 mg tres veces al día durante 16 semanas.
Principales resultados:
- El saquinavir fue bien tolerado y no se reportaron eventos adversos graves.
- Se observó una tendencia hacia una relación dosis-respuesta para el recuento de células CD4, favoreciendo la dosis de 600 mg.
- Las células mononucleares de la sangre periférica y la carga viral plasmática mostraron una tendencia hacia la reducción a dosis más altas de saquinavir.
Conclusiones:
- El saquinavir demuestra actividad antiviral en pacientes infectados por el VIH.
- La dosis de 600 mg mostró una tendencia prometedora para mejorar el recuento de CD4 y reducir la carga viral.
- El saquinavir es un inhibidor de la proteínaza del VIH bien tolerado para pacientes no tratados previamente.
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