La farmacéutica estadounidense Pfizer anunció este viernes que su candidato antiviral oral contra el coronavirus Paxlovid redujo en un 89% la hospitalización y la muerte según el análisis intermedio de la fase de 2/3 de un estudio realizado con pacientes adultos con Covid-19 no hospitalizados que tienen un alto riesgo de progresar a enfermedad grave.
«El análisis intermedio programado mostró una reducción del 89% en el riesgo de hospitalización relacionada con Covid-19 o muerte por cualquier causa en comparación con el placebo en pacientes tratados dentro de los tres días posteriores al inicio de los síntomas», indicó la compañía en un comunicado.
En el estudio, el 0,8% de los pacientes que recibieron Paxlovid fueron hospitalizados hasta el día 28 después de la aleatorización (3/389 hospitalizados sin muertes), en comparación con el 7% de los pacientes que recibieron placebo y fueron hospitalizados o murieron (27/385 hospitalizados con 7 muertes posteriores).
«La significancia estadística de estos resultados fue alta. Se observaron reducciones similares en las hospitalizaciones o muertes relacionadas con Covid-19 en pacientes tratados dentro de los cinco días posteriores al inicio de los síntomas», indicó el comunicado.
En la población general del estudio hasta el día 28, no se informaron muertes en pacientes que recibieron Paxlovid en comparación con 10 (1,6%) muertes en personas que recibieron placebo.
Por recomendación de un Comité de Monitoreo de Datos independiente y en consulta con la Administración de Drogas y Alimentos de EEUU (FDA, el ente regulador), Pfizer dejará de inscribir pacientes en el estudio «debido a la abrumadora eficacia demostrada en estos resultados» y planea enviar los datos a la FDA para la autorización de uso de emergencia lo antes posible, informaron.
Paxlovid es una terapia antiviral para administrarse por vía oral de modo que pueda prescribirse al primer signo de infección o al primer conocimiento de una exposición; la droga está diseñada para bloquear la actividad de una enzima que el coronavirus necesita para replicarse.
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