Beneficio clínico y económico de 32 años de tratamiento antirretroviral de personas que viven con VIH en España: ¿ha sido una intervención eficiente? / Clinical and economic benefit of 32 years of antiretroviral treatment for people living with HIV in Spain: Has it been an efficient intervention?

Introducción: Aunque el tratamiento antirretroviral (TAR) del VIH/sida se introdujo en 1987, la mejora en la progresión de la enfermedad y reducción de la mortalidad poblacional no se observó sino hasta 1996, con la combinación de tres o más fármacos. El objetivo fue estimar el beneficio clínico y económico del TAR en España en el periodo de 32 años, comprendido entre 1987 y 2018. Métodos: Se realizó un análisis de coste-beneficio mediante la simulación de Monte Carlo de segundo orden, desde las perspectivas de la sociedad (caso base) y el Sistema Nacional de Salud (SNS). Los nuevos casos de VIH, sida y muertes relacionadas se obtuvieron de los registros SINIVIH y ONUSIDA, con proyecciones poblacionales sin TAR mediante suavizamiento exponencial triple. El gasto en TAR se obtuvo de informes del Plan Nacional del SIDA y estudios de mercado. Resultados: El SNS invirtió 6.185 millones de euros en 32 años. Durante este periodo se evitaron 323.651 muertes por sida, 500.129 casos de sida y 161.417 casos de VIH, con un ahorro total de 41.997 millones de euros. El beneficio neto (ahorros netos) se estima en 35.812 millones de euros (sociedad) y 1.032 millones de euros (SNS). Por cada euro invertido en TAR, se obtuvo un retorno de la inversión de 6,79 € y 1,16 €, respectivamente. Conclusión: La utilización de TAR durante 32 años ha evitado gran número de muertes y casos de sida y VIH, generando significativos ahorros económicos para el SNS. El TAR es una intervención eficiente para el SNS.(AU)

Introduction: Although antiretroviral therapy (ART) for HIV / AIDS was introduced in 1987, improvement in disease progression and reduction in mortality at a population level was not observed until 1996, with the combination of three or more drugs. The objective was to estimate the clinical and economic benefit of ART in Spain in the 32-year period between 1987 and 2018. Methods: A cost-benefit analysis was performed, using a second-order Monte Carlo simulation, from the societal (base case) and the National Health System (NHS) perspectives. New cases of HIV, AIDS and related deaths were obtained from the SINIVIH and UNAIDS registries, with population projections without ART using triple exponential smoothing. Expenditure on ART was obtained from the National AIDS Plan reports and market studies. Results: The NHS invested 6,185 million euros in 32 years. In that period, 323,651 AIDS-related deaths, 500,129 AIDS cases and 161,417 HIV cases were averted, with total savings of 41,997 million euros. The net benefit (net savings) is estimated at 35,812 million euros (societal) and 1,032 million euros (NHS). For every euro invested in ART, a return on investment of € 6.79 and € 1.16 was obtained, respectively. Conclusion: The use of ART over 32 years prevented a large number of deaths and cases of AIDS and HIV, providing significant economic savings for the NHS. ART is an efficient intervention for the NHS.(AU)

Clinical and economic benefit of 32 years of antiretroviral treatment for people living with HIV in Spain: Has it been an efficient intervention?

INTRODUCTION: Although antiretroviral therapy (ART) for HIV/AIDS was introduced in 1987, improvement in disease progression and reduction in mortality at a population level was not observed until 1996, with the combination of three or more drugs. The objective was to estimate the clinical and economic benefit of ART in Spain in the 32-year period between 1987 and 2018. METHODS: A cost-benefit analysis was performed, using a second-order Monte Carlo simulation, from the societal (base case) and the National Health System (NHS) perspectives. New cases of HIV, AIDS and related deaths were obtained from the SINIVIH and UNAIDS registries, with population projections without ART using triple exponential smoothing. Expenditure on ART was obtained from the National AIDS Plan reports and market studies. RESULTS: The NHS invested 6185 million euros in 32 years. In that period, 323,651 AIDS-related deaths, 500,129 AIDS cases and 161,417 HIV cases were averted, with total savings of 41,997 million euros. The net benefit (net savings) is estimated at 35,812 million euros (societal) and 1032 million euros (NHS). For every euro invested in ART, a return on investment of € 6.79 and € 1.16 was obtained, respectively. CONCLUSIONS: The use of ART over 32 years prevented a large number of deaths and cases of AIDS and HIV, providing significant economic savings for the NHS. ART is an efficient intervention for the NHS.

Clinical and economic benefit of 32 years of antiretroviral treatment for people living with HIV in Spain: Has it been an efficient intervention? / Beneficio clínico y económico de 32 años de tratamiento antirretroviral de personas que viven con VIH en España: ¿ha sido una intervención eficiente?

INTRODUCTION: Although antiretroviral therapy (ART) for HIV / AIDS was introduced in 1987, improvement in disease progression and reduction in mortality at a population level was not observed until 1996, with the combination of three or more drugs. The objective was to estimate the clinical and economic benefit of ART in Spain in the 32-year period between 1987 and 2018. METHODS: A cost-benefit analysis was performed, using a second-order Monte Carlo simulation, from the societal (base case) and the National Health System (NHS) perspectives. New cases of HIV, AIDS and related deaths were obtained from the SINIVIH and UNAIDS registries, with population projections without ART using triple exponential smoothing. Expenditure on ART was obtained from the National AIDS Plan reports and market studies. RESULTS: The NHS invested 6,185 million euros in 32 years. In that period, 323,651 AIDS-related deaths, 500,129 AIDS cases and 161,417 HIV cases were averted, with total savings of 41,997 million euros. The net benefit (net savings) is estimated at 35,812 million euros (societal) and 1,032 million euros (NHS). For every euro invested in ART, a return on investment of € 6.79 and € 1.16 was obtained, respectively. CONCLUSION: The use of ART over 32 years prevented a large number of deaths and cases of AIDS and HIV, providing significant economic savings for the NHS. ART is an efficient intervention for the NHS.

Executive summary: Pre-exposure prophylaxis for prevention of HIV infection in adults in Spain: July 2016 / Resumen ejecutivo: profilaxis pre-exposición en adultos para la prevención de la infección por VIH en España: Julio 2016

Administration of antiretroviral drugs to individuals exposed to, but not infected by, HIV has been shown to reduce the risk of transmission. The efficacy of pre-exposure prophylaxis (PrEP) makes it obligatory to include it in an integral program of prevention of HIV transmission, together with other measures, such as use of the condom, training, counseling, and appropriate treatment of infected individuals. In this document, the AIDS Study Group (GeSIDA) of the Spanish Society of Infectious Diseases and Clinical Microbiology (Sociedad Española de Enfermedades Infecciosas y Microbiología Clínica [SEIMC]) provides its views on this important subject. The available evidence on the usefulness of PrEP in the prevention of transmission of HIV is presented, and the components that should make up a PrEP program and whose development and implementation are feasible in Spain are set out (AU)

Se ha demostrado que la administración de fármacos antirretrovirales a personas expuestas y no infectadas por el VIH puede reducir el riesgo de transmisión. La eficacia de la profilaxis pre-exposición obliga a considerar su inclusión en un programa integral de prevención de la transmisión del VIH, junto con otras medidas como el uso del preservativo, la formación y el consejo asistido y el tratamiento adecuado de las personas infectadas. En este documento, el Grupo de Estudio de SIDA (GeSIDA) de la SEIMC aporta su visión sobre este importante tema. Se presenta la evidencia disponible acerca de la utilidad de la PrEP en la prevención de la transmisión del VIH y se enumeran los elementos que deberían integrar un programa de PrEP, cuyo desarrollo y puesta en marcha sea factible y viable en nuestro medio (AU)

Executive summary: Pre-exposure prophylaxis for prevention of HIV infection in adults in Spain: July 2016.

Administration of antiretroviral drugs to individuals exposed to, but not infected by, HIV has been shown to reduce the risk of transmission. The efficacy of pre-exposure prophylaxis (PrEP) makes it obligatory to include it in an integral program of prevention of HIV transmission, together with other measures, such as use of the condom, training, counseling, and appropriate treatment of infected individuals. In this document, the AIDS Study Group (GeSIDA) of the Spanish Society of Infectious Diseases and Clinical Microbiology (Sociedad Española de Enfermedades Infecciosas y Microbiología Clínica [SEIMC]) provides its views on this important subject. The available evidence on the usefulness of PrEP in the prevention of transmission of HIV is presented, and the components that should make up a PrEP program and whose development and implementation are feasible in Spain are set out.

HLA-B*57: 01 genotyping in the prevention of hypersensitivity to abacavir: 5 years of experience.

INTRODUCTION: Most of the cost-effectiveness analyses are based on estimations to make decisions on the future implementation of a test. However, the model should be verified with real data to prove that previous estimations have been successfully fulfilled. OBJECTIVE: To study the economic impact of the systematic HLA-B*57:01 genotyping in preventing hypersensitivity reactions (HSRs) in the patient population of a tertiary-care hospital treated with abacavir (ABC) using retrospective data of 5 years of experience. METHODS: A retrospective study was carried out with two cohorts including 780 and 473 patients before and after the implementation of the systematic HLA-B*57:01 genotyping before ABC treatment. Cost-effectiveness analysis was carried out by the parameter 'cost per HSR avoided'. The clinical utility of the test was verified by evaluating the differences in HSR incidence between both cohorts. Finally, a sensitivity analysis including all variables was carried out. RESULTS: In the population studied, systematic genotyping represents an additional cost of &OV0556;306 per HSR avoided. In the sensitivity analysis, pharmacological therapy cost is the major influencing factor found in the estimation of the 'cost per HSR avoided'. In terms of clinical utility, the incidence ratio was 0.040 (95% confidence interval 0.0009-0.2399) and statistically significant differences were found between both groups (P=1.40×10). CONCLUSION: Retrospective data from 5 years of experience have confirmed the cost-effectiveness of the systematic genotyping in candidate patients for ABC therapy, and have shown that cost-effectiveness is a dynamic parameter closely linked to allele prevalence and pharmacological therapy costs.

[Consensus statement on the clinical management of human immunodeficiency virus-associated neurocognitive disorders]. / Documento de consenso sobre el manejo clínico de los trastornos neurocognitivos asociados a la infección por el virus de la inmunodeficiencia humana (enero 2013).

OBJECTIVE: To develop a consensus document containing clinical recommendations for the management of human immunodeficiency virus (HIV)-associated neurocognitive disorder (HAND). METHODS: We assembled a panel of experts appointed by GeSIDA and the Secretariat of the National AIDS Plan (PNS), including internal medicine physicians with expertise in the field of HIV, neuropsychologists, neurologists and neuroradiologists. Scientific information was reviewed to October 2012 in publications and conference papers. In support of the recommendations using two levels of evidence: the strength of the recommendation in the opinion of the experts (A, B, C) and the level of empirical evidence (I, II, III), two levels based on the criteria of the Infectious Disease Society of America, already used in previous documents GeSIDA/SPNS. RESULTS: Multiple recommendations for the clinical management of these disorders are provided, including two graphics algorithms, considering both the diagnostic and possible therapeutic strategies. CONCLUSIONS: Neurocognitive disorders associated with HIV infection is currently highly prevalent, are associated with a decreased quality of life and daily activities, and given the possibility of occurrence of an increase in the coming years, there is a need to adequately manage these disorders, from a diagnostic as well as therapeutic point of view, and always from a multidisciplinary perspective.

Etravirina en pacientes ampliamente pretratados / Etravirine in highly treatment-experienced patients

Etravirina (ETR) se ha mostrado eficaz en pacientes multitratados con fallos virológicos previos y mutaciones de resistencia a varias familias de fármacos antirretrovirales. La mayor evidencia surge de los estudios DUET. Éstos son 2 ensayos clínicos multicéntricos idénticos, aleatorizados y doble ciego, que incluyeron alrededor de 1.200 pacientes, donde se observó una respuesta virológica e inmunológica superior a placebo y que se tradujo en una reducción en la incidencia de ingresos hospitalarios y de progresión a sida/muerte. Además, ETR fue muy bien tolerado en estos pacientes. El efecto adverso más frecuente fue el exantema que, generalmente, fue leve o moderado y únicamente obligó a suspender el tratamiento en el 2% de los pacientes. No hubo diferencias en cuanto a toxicidades gastrointestinales, hepáticas o lipídicas, comparado con la rama placebo. El desarrollo reciente de nuevos fármacos permite disponer hoy de pautas activas eficaces para pacientes multitratados. El estudio TRIO ha evaluado la eficacia y tolerabilidad de una de las pautas más utilizadas actualmente en la práctica habitual: ETR/raltegravir/darunavir/r, con excelentes resultados de respuesta virológica e inmunológica (el 86% de carga viral < 50 copias y CD4 +108 a las 48 semanas) y, al mismo tiempo, una muy buena tolerabilidad. ETR es eficaz y bien tolerada y es el primer inhibidor de la transcriptasa inversa no análogo de nucleósidos (ITINAN) que permite el uso secuencial de fármacos de esta familia, gracias a su elevada barrera genética comparando con los ITINAN de primera generación. Además, su larga vida media permite su administración una vez al día en caso de que los pacientes necesitaran una pauta qd

Etravirine (ETR) has demonstrated efficacy in patients with multiple prior treatments with prior virological failure and resistance mutations to various families of antiretroviral drugs. Most of the evidence concerning this drug has been drawn from the DUET studies, consisting of two multicenter, randomized, double-blind clinical trials with identical designs that included 1,200 patients. These trials showed that ETR obtained a superior virological and immunological response to placebo, reducing the incidence of hospital admissions and progression to AIDS/death. The most frequent adverse effect was rash, which was generally mild to moderate and required treatment discontinuation in only 2%. There were no differences in gastrointestinal, liver or lipid toxicities compared with the placebo arm. Because of the recent development of new drugs, effective regimens are now available for multi-treated patients. The TRIO study evaluated the efficacy and tolerability of one of the regimens most widely used today (ETR/raltegravir/darunavir/r) with excellent virological and immunological response (86% of viral load < 50 copies and CD4 +108 at 48 weeks) and excellent tolerance. ETR is effective and well tolerated and is the first non-nucleoside reverse transcriptase inhibitor (NNRTI) that allows the sequential use of drugs in this family, due to its high genetic barrier compared with firstgeneration NNRTI. Moreover, its long half-life allows once daily administration in patients requiring a QD régimen