[Consensus statement on metabolic disorders and cardiovascular risks in patients with human immunodeficiency virus]. / Documento de consenso sobre alteraciones metabólicas y riesgo cardiovascular en pacientes con infección por el virus de la inmunodeficiencia humana.

OBJECTIVE: This consensus document is an update of metabolic disorders and cardiovascular risk (CVR) guidelines for HIV-infected patients. METHODS: This document has been approved by an expert panel of GEAM, SPNS and GESIDA after reviewing the results of efficacy and safety of clinical trials, cohort and pharmacokinetic studies published in biomedical journals (PubMed and Embase) or presented in medical scientific meetings. Recommendation strength and the evidence in which they are supported are based on the GRADE system. RESULTS: A healthy lifestyle is recommended, no smoking and at least 30min of aerobic exercise daily. In diabetic patients the same treatment as non-HIV infected patients is recommended. HIV patients with dyslipidemia should be considered as high CVR, thus its therapeutic objective is an LDL less than 100mg/dL. The antihypertensive of ACE inhibitors and ARAII families are better tolerated and have a lower risk of interactions. In HIV-patients with diabetes or metabolic syndrome and elevated transaminases with no defined etiology, the recommended is to rule out a hepatic steatosis Recommendations for action in hormone alterations are also updated. CONCLUSIONS: These new guidelines update previous recommendations regarding all those metabolic disorders involved in CVR. Hormone changes and their management and the impact of metabolic disorders on the liver are also included.

Executive summary of the consensus document on metabolic disorders and cardiovascular risk in patients with HIV infection.

The importance of the metabolic disorders and their impact on patients with HIV infection requires an individualized study and continuous updating. HIV patients have the same cardiovascular risk factors as the general population. The HIV infection per se increases the cardiovascular risk, and metabolic disorders caused by some antiretroviral drugs are added risk factors. For this reason, the choice of drugs with a good metabolic profile is essential. The most common metabolic disorders of HIV infected-patients (insulin resistance, diabetes, hyperlipidemia or osteopenia), as well as other factors of cardiovascular risk, such as hypertension, should also be dealt with according to guidelines similar to the general population, as well as insisting on steps to healthier lifestyles. The aim of this document is to provide a query tool for all professionals who treat HIV-patients and who may present or display any metabolic disorders listed in this document.

[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.

Perfil lipídico de atazanavir / Lipid profile of atazanavir

En la actualidad se sabe que la exposición al tratamiento antirretroviral, particularmente a los inhibidores de proteasa clásicos, se asocia con un incremento del riesgo de presentar enfermedad cardiovascular, aunque la interrupción del tratamiento antirretroviral puede ocasionar un riesgo aún mayor. Se han emitido recomendaciones sobre la intervención ante la dislipidemia y el riesgo cardiovascular en personas seropositivas. Estas recomendaciones se semejan a las de la población general, pero incluyen el carácter particular de considerar incluir un tratamiento antirretroviral benigno con los lípidos en la medida de lo posible. Atazanavir presenta unas características diferentes de las de otros inhibidores de la proteasa en cuanto a sus efectos sobre el tejido adiposo y el metabolismo en general. Atazanavir no se ha asociado con los aumentos de las concentraciones de colesterol total, colesterol unido a lipoproteínas de baja densidad (cLDL) o triglicéridos que han presentado otros inhibidores de la proteasa en pautas de inicio, rescate o simplificación. Los resultados de los estudios in vitro y clínicos son claros y contundentes. Estas características le confieren un papel singular muy atractivo a la hora de decidir el tratamiento antirretroviral más adecuado para una proporción de pacientes infectados por el virus de la inmunodeficiencia humana (VIH) en los que la reducción del riesgo cardiovascular constituya una prioridad

It is currently known that exposure to antiretroviral treatment, particularly to the classic protease inhibitors, is associated with an increased risk of suffering from cardiovascular disease, although stopping antiretroviral treatment can cause an even greater risk. Recommendations have been made on how to deal with dyslipaemia and cardiovascular risk in seropositive patients. These recommendations are similar to those for the general population, but include the particular feature of considering including benign treatment with lipids wherever possible. Atazanavir has different characteristics from other protease inhibitors as regards its effects on adipose tissue and metabolism in general. Atazanavir is not associated with increases in total cholesterol, LDL-cholesterol or triglycerides as with other PI in initial, rescue or simplification therapy. The results of in vitro studies and clinical studies are clear and convincing. These characteristics give it a particular role that is very attractive when deciding the most suitable antiretroviral treatment for a proportion of HIV-infected patients in whom the reduction in cardiovascular risk is seen as a priority

[Lipid profile of atazanavir]. / Perfil lipídico de atazanavir.

It is currently known that exposure to antiretroviral treatment, particularly to the classic protease inhibitors, is associated with an increased risk of suffering from cardiovascular disease, although stopping antiretroviral treatment can cause an even greater risk. Recommendations have been made on how to deal with dyslipaemia and cardiovascular risk in seropositive patients. These recommendations are similar to those for the general population, but include the particular feature of considering including benign treatment with lipids wherever possible. Atazanavir has different characteristics from other protease inhibitors as regards its effects on adipose tissue and metabolism in general. Atazanavir is not associated with increases in total cholesterol, LDL-cholesterol or triglycerides as with other PI in initial, rescue or simplification therapy. The results of in vitro studies and clinical studies are clear and convincing. These characteristics give it a particular role that is very attractive when deciding the most suitable antiretroviral treatment for a proportion of HIV-infected patients in whom the reduction in cardiovascular risk is seen as a priority.

[Cost of nucleoside analogue reverse transcriptase inhibitor-related toxicity in HIV-1-infected patients]. / Costes de la toxicidad asociada a los análogos de nucleósidos inhibidores de la transcriptasa inversa en pacientes con infección por el VIH-1.

OBJECTIVE: To estimate the impact of toxicity related to nucleoside analogue reverse transcriptase inhibitors (NRTI) on the total cost of medical care in HIV-1-infected patients. METHODS: . A pharmacoeconomic model was developed from the data obtained by a prospective, observational, multicenter study performed in Spain (Recover). The study patients had developed one NRTI-associated adverse event (AE) that justified discontinuation of treatment with the drug. All costs derived from NRTI-associated AEs in the HAART regimens of HIV-1-infected patients over a period of one year were assessed. The cost assessment (2005 values) included direct medical costs (drugs and AE management) and indirect costs (loss of productivity). The healthcare resources used in AE management were estimated by an expert panel of clinicians. RESULTS: The use and cost of resources rose with increasing severity of all the AE. The average total cost per patient was estimated to be 4012 euro, which included 1789 euro in drug costs (NRTI associated with therapy discontinuation due to AE), and 2223 euro in direct and indirect costs of AE management (45% and 55% of total cost, respectively). Seventy-three per cent of AE-associated costs per patient came from lipoatrophy (560 euro), lipodystropy (535 euro) and peripheral neuropathy (533 euro). CONCLUSION: Management of NRTI-related toxicities is more costly than NRTI acquisition and produces a significant increase in the overall healthcare expenditure for HIV-1-infected patients. This fact should be taken into account when designing the most efficient antiretroviral treatment strategies.

Costes de la toxicidad asociada a los análogos de nucleósidos inhibidores de la transcriptasa inversa en pacientes con infección por el VIH-1 / Cost of nucleoside analogue reverse transcriptase inhibitor-related toxicity in HIV-1-infected patients

Objetivo. Estimar el impacto de la toxicidad asociada a los inhibidores de la transcriptasa inversa análogos de nucleósidos (ITIAN) en el coste total del tratamiento de pacientes con infección por el virus de la inmunodeficiencia humana tipo 1 (VIH-1). Métodos. Se ha diseñado un modelo farmacoeconómico a partir de datos obtenidos de un estudio prospectivo, multicéntrico, observacional realizado en España (Estudio Recover). Los pacientes del estudio habían desarrollado un acontecimiento adverso (AA) asociado a un ITIAN que motivaba su suspensión. En el análisis se incluyen todos los costes derivados de la toxicidad inducida por los ITIAN en los tratamientos antirretrovirales durante un año. Los costes (valores del año 2005) incluidos han sido: médicos directos (fármacos y manejo de AA) e indirectos (pérdidas de productividad). La estimación de los recursos relacionados con el manejo de los AA se ha realizado a través de un panel de consenso de expertos clínicos. Resultados. El incremento en el uso y coste de recursos sanitarios se correlaciona con la gravedad de todos los AA evaluados. El coste promedio total estimado por paciente ha sido de 4.012 €: 1.789 € por costes farmacológicos (ITIAN asociados con la discontinuación de la terapia por AA) y 2.223 € por costes directos e indirectos del manejo de los AA (45 y 55%, respectivamente, de los costes totales). El 73% de los costes por paciente asociados a AA se deben a la lipoatrofia (560 €), lipodistrofia mixta (535 €) y neuropatía periférica (533 €). Conclusión. En pacientes que desarrollan toxicidades asociadas a ITIAN, el coste económico de su manejo es superior al coste de adquisición de los ITIAN y produce un incremento significativo en los costes totales del tratamiento de la infección por VIH-1. El coste del manejo de estas toxicidades debería tenerse en cuenta en el diseño de estrategias de tratamiento antirretroviral más eficientes (AU)

Objective. To estimate the impact of toxicity related to nucleoside analogue reverse transcriptase inhibitors (NRTI) on the total cost of medical care in HIV-1-infected patients. Methods. A pharmacoeconomic model was developed from the data obtained by a prospective, observational, multicenter study performed in Spain (Recover). The study patients had developed one NRTI-associated adverse event (AE) that justified discontinuation of treatment with the drug. All costs derived from NRTI-associated AEs in the HAART regimens of HIV-1-infected patients over a period of one year were assessed. The cost assessment (2005 values) included direct medical costs (drugs and AE management) and indirect costs (loss of productivity). The healthcare resources used in AE management were estimated by an expert panel of clinicians. Results. The use and cost of resources rose with increasing severity of all the AE. The average total cost per patient was estimated to be 4012 €, which included 1789 € in drug costs (NRTI associated with therapy discontinuation due to AE), and 2223 € in direct and indirect costs of AE management (45% and 55% of total cost, respectively). Seventy-three per cent of AE-associated costs per patient came from lipoatrophy (560 €), lipodystrophy (535 €) and peripheral neuropathy (533 €). Conclusion. Management of NRTI-related toxicities is more costly than NRTI acquisition and produces a significant increase in the overall healthcare expenditure for HIV-1-infected patients. This fact should be taken into account when designing the most efficient antiretroviral treatment strategies (AU)