Highly active antiretroviral therapy induced adverse drug reactions in Indian human immunodeficiency virus positive patients

• Autores: Radhakrishnan Rajesh, Sudha Vidyasagar, Krishnadas Nandakumar
• Localización: Pharmacy Practice (Granada), ISSN-e 1886-3655, Vol. 9, Nº. 1, 2011, págs. 48-55
• Idioma: inglés
• Enlaces
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• Resumen
  • español

    Objetivo: Evaluar la incidencia, gravedad, causalidad y preventabilidad de las reacciones adversas medicamentosas (RAM) e identificar los factores de riesgo de esas RAM en terapias de antiretrovirales altamente activos.

    Metodos: Se monitorizo intensamente a los pacientes incluidos a la busqueda de RAM. La predecibilidad se evaluo con base en la historia de exposiciones previas al medicamento o a la incidencia de RAM en la literatura. La preventabilidad se valoro usando los criterios de Schumock y Thornton y la gravedad se evaluo utilizando la escala modificada de Hartwig y Siegel. Se utilizaron regresiones logisticas multivariadas para identificar los factores de riesgo de RAM.

    Resultados: La monitorizacion retrospectiva de 130 pacientes mediante farmacovigilancia activa identifico 74 RAM de 57 pacientes. Anemia y hepatotoxicidad fueron las RAM mas comunmente observadas. El sistema comunmente afectado por las RAM fueron las celulas rojas sanguineas (21,4%).

    Las RAM fueron moderadas en el 77% de los casos. Las reacciones tipo A fueron las mas comunes. Un total del 10,8% de RAM fueron definitivamente prevenibles. La incidencia de RAM mas alta fue con la combinacion Zidovudina + Lamivudina + Nevirapina. Un 84% de las interrupciones de terapias antiretrovirales altamente activas fue debido a la toxicidad. Se observaron como factores de riesgo de RAM un CD4 en menos de 200 cel, el genero femenino y la tuberculosis.

    Conclusion: La incidencia de RAM en pacientes intensivamente monitorizados fue del 43,8%. La anemia en pacientes con VIH es u7n factor d e riesgo de influencia en la aparicion de RAM. Con el creciente uso de antiretrovirales en India, los clinicos deben centrar la atencion en la deteccion temprana y la prevencion de RAM de terapias antiretrovirales altamente activos.

  • English

    Objective: To assess the incidence, severity pattern, causality, predictability and preventability of adverse drug reactions (ADRs) and to identify risk factors for adverse drug reactions in highly active antiretroviral therapy.

    Methods: Enrolled patients were intensively monitored for ADRs to highly active antiretroviral therapy. Predictability was assessed based on history of previous exposure to the drug or literature incidence of ADRs. Preventability was assessed using Schumock and Thornton criteria and severity was assessed using modified Hartwig and Siegel scale. Multivariate logistic regressions were used to identify the risk factors for ADRs.

    Results: Monitoring of 130 retropositive patients by active pharmacovigilance identified 74 ADRs from 57 patients. Anemia and hepatotoxicity were the most commonly observed ADRs. The organ system commonly affected by ADR was red blood cell (21.4%).The ADRs were moderate in 77% of cases.

    Type A reactions (77%) were more common. A total of 10.8% ADRs were definitely preventable. The incidence rate of ADRs (65.9%) was highest with Zidovudine + Lamivudine + Nevirapine combination.

    A total of 84% interruptions to highly active antiretroviral therapy were due to toxicity. CD4 less than 200 cells/ìl, female gender and tuberculosis were observed as risk factors for ADRs.

    Conclusion: Incidence of ADRs in intensively monitored patients was found to be 43.8%. Anemia in HIV patients is an influential risk factor for occurrence of ADRs. With the increasing access to antiretroviral in India, clinicians must focus on early detection and prevention of ADRs to highly active antiretroviral therapy.