Potential for simplification of HIV treatment with boosted protease inhibitor monotherapy.

BACKGROUND: Previous studies have evaluated the simplification of HIV treatment with ritonavir-boosted protease inhibitor monotherapy, demonstrating acceptable efficacy and advantages such as avoidance of the adverse effects of reverse transcriptase inhibitors. To achieve the best results, patients should be appropriately selected for this therapy. OBJECTIVE: The purpose of this study was to estimate the proportion of HIV patients suitable for boosted protease inhibitor monotherapy according to clinical trial criteria. Setting The study was conducted in the outpatient hospital pharmacy service of the Complejo Hospitalario de Navarra in northern Spain. METHOD: A retrospective analysis was performed on data from 635 adults on antiretroviral therapy. The eligibility criteria were: (1) >18 years of age; (2) prior triple-drug antiretroviral regimen; (3) durability of current treatment >18 months; (4) viral load <400 copies/mL over the 18 months before evaluation and <50 copies/mL over the last 6 months; (5) CD4 count ≥250 cells/µL; (6) CD4 count nadir >100 cells/µL; (7) no previous virological failure under prior protease inhibitor-based regimen; (8) absence of co-infection with hepatitis B virus; (9) absence of HIV-related neurological disease; and (10) adherence >95 %. The average cost of the current treatment was calculated for patients who met all criteria, as well as the potential economic impact of simplification to monotherapy. MAIN OUTCOME MEASURE: Number of patients meeting all criteria for simplification to monotherapy according to clinical trial standards. RESULTS: One hundred and three patients (16.5 %) met the clinical trial criteria for protease inhibitor monotherapy. One hundred and fifty patients (24 %) failed to fulfil only one of the conditions. Fifty-four percent of the patients who met all of the criteria had been treated for more than 10 years. The average saving per patient per year was 2,850-3,400. CONCLUSION: This treatment strategy represents a realistic, albeit minority, option. Fulfilment of the above conditions should be the basis for simplification to protease inhibitor monotherapy, though the final decision depends on clinical criteria and patient preferences assessed by the attending physician. Further studies are needed to confirm long-term safety and efficacy.

[Evaluation of the surveillance system for human immunodeficiency virus infections of Navarra, Spain, 1985-2003]. / Evaluación del sistema de información de Navarra sobre diagnósticos de infección por el VIH, 1985-2003.

BACKGROUND: Navarra has an information system of HIV diagnoses working since the beginning of the epidemic up to the present day. This study aims at describing and evaluating this system, focusing on its sensitivity. METHODS: The updated guidelines for evaluating public health surveillance systems from the CDC were used to describe the purpose and operation of the system and to analyse its attributes for the period 1985-2003. For the evaluation of the sensitivity the regional database of antiretrovirals distribution was used. RESULTS: The HIV surveillance system of Navarra is confidential and name-based, and includes all HIV-infection cases diagnosed each year. The information sources of the system are: (a) all the laboratories in the public health system that perform the western blot test, and (b) hospital discharge registries. The system covers the entire population of Navarre (584,734 inhabitants). It uses the HIV case definition proposed by the European Centre for the Epidemiological Monitoring of AIDS. The system is well-accepted by the community and by all the stakeholders, including those providing data. By the end of 2003 it included 2302 HIV cases, and 98.8% of all patients who had ever received antiretrovirals in Navarra. CONCLUSIONS: The HIV information system of Navarra is simple, useful, well-accepted and highly sensitive. The information about antiretroviral distribution was useful for this evaluation.

Evaluación del sistema de información de Navarra sobre diagnósticos de infección por el VIH, 1985-2003 / Evaluation of the surveillance system for Human Immunodeficiency Virus infections of Navarra, Spain, 1985-2003

Fundamento: Navarra cuenta con un sistema de información sobre los diagnósticos de infección por VIH que abarca desde el comienzo de la epidemia hasta la actualidad. El objetivo de este trabajo es describir y evaluar su funcionamiento y sus atributos, haciendo énfasis en el estudio de su sensibilidad. Métodos: Siguiendo las directrices para la Evaluación de Sistemas de Vigilancia en Salud Pública de los Centros para el Control y Prevención de Enfermedades de Atlanta, describimos el sistema de información sobre diagnósticos de infección por VIH de Navarra (el sistema) y analizamos sus atributos cualitativos y cuantitativos entre 1985 y 2003. Para valorar la sensibilidad se utilizó como referencia el registro de dispensación de antirretrovirales de los hospitales de Navarra. Resultados: El sistema de información sobre diagnósticos de infección por VIH de Navarra es nominal y confidencial, e incluye los casos nuevos diagnosticados cada año. Sus fuentes de información son todos los laboratorios que realizan la prueba de confirmación de Western blot en el sistema público, y el registro de altas hospitalarias de la Comunidad Autónoma. Cubre a toda la población de Navarra (584.734 habitantes), y utiliza la definición de caso de infección por VIH del Centro Europeo para la Vigilancia Epidemiológica del VIH y el sida. Es un sistema bien aceptado por la comunidad y por los responsables de suministrar los datos. Hasta diciembre de 2003 se habían incluido 2.302 casos, incluyendo al 98,8% de los pacientes que reciben o han recibido antirretrovirales en Navarra. Conclusiones: Este sistema de información es sencillo, útil, bien aceptado y altamente sensible. La información sobre uso de antirretrovirales ha sido de utilidad para su evaluación

Background: Navarra has an information system of HIV diagnoses working since the beginning of the epidemic up to the present day. This study aims at describing and evaluating this system, focusing on its sensitivity. Methods: The updated guidelines for evaluating public health surveillance systems from the CDC were used to describe the purpose and operation of the system and to analyse its attributes for the period 1985-2003. For the evaluation of the sensitivity the regional database of antiretrovirals distribution was used. Results: The HIV surveillance system of Navarra is confidential and name-based, and includes all HIV-infection cases diagnosed each year. The information sources of the system are: a) all the laboratories in the public health system that perform the western blot test, and b) hospital discharge registries. The system covers the entire population of Navarre (584,734 inhabitants). It uses the HIV case definition proposed by the European Centre for the Epidemiological Monitoring of AIDS. The system is well-accepted by the community and by all the stakeholders, including those providing data. By the end of 2003 it included 2,302 HIV cases, and 98.8% of all patients who had ever received antiretrovirals in Navarra. Conclusions: The HIV information system of Navarra is simple, useful, well-accepted and highly sensitive. The information about antiretroviral distribution was useful for this evaluation