Resultados perinatales asociados a las gestantes infectadas por el virus de la inmunodeficiencia humana en el Complejo Hospitalario Universitario de Vigo / Perinatal outcomes in HIV-positive pregnant women in the Complejo Hospitalario Universitario de Vigo

Introducción: la infección por el virus de la imnunodeficiencia humana (VIH) tiene gran repercusión sobre la reproducción desde el momento de la concepción, por el riesgo de la transmisión sexual, hasta la posible infección del recién nacido. Por ello, es primordial combatir la transmisión vertical durante el embarazo en toda mujer gestante infectada por este virus. Objetivo: conocer la tasa de transmisión vertical, así como estudiar los resultados perinatales asociados a las gestantes infectadas por el VIH en el Complejo Hospitalario Universitario de Vigo. Material y métodos: se realizó un estudio descriptivo retrospectivo de la población gestante afectada por el VIH desde enero de 2000 hasta enero de 2014. Definimos para el estudio variables maternas, gestacionales, intraparto y neonatales. El tratamiento estadístico de los datos fue realizado con el programa SPSS20 para Windows. Resultados: la población estudiada fue de 100 gestantes seropositivas. El 50% presentó coinfección por el virus de la hepatitis C (VHC) y el 9% por el virus de la hepatitis B (VHB). El 98% de las pacientes recibió tratamiento antirretroviral durante el embarazo, el 97% profilaxis intraparto con zidovudina y el 98% de recién nacidos tratamiento antirretroviral desde el nacimiento. El 45% de los casos cumplió criterios para un parto vaginal. Finalmente, el 28% fueron partos eutócicos y el 4%, instrumentados; en el 13% restante se indicó cesárea urgente intraparto. La transmisión materno-fetal fue del 0%. Conclusión: protocolizar el manejo gestacional y neonatal en las pacientes seropositivas frente al VIH ha permitido obtener un importante descenso en su tasa de transmisión vertical (AU)

Introduction: Human Immunodeficiency Virus (HIV) infection has a major impact on reproduction that includes the risk of sexual transmission at conception and even possible infection of the newborn. Consequently, it is essential to combat vertical transmission during pregnancy in all HIV-infected pregnant women. Objective: The objective of this study was to determine the rate of vertical transmission and perinatal outcomes in HIV-infected pregnant women attended at the University Hospital of Vigo. Material and methods: A retrospective descriptive study was conducted in HIV- pregnant women from January 2000 to January 2014. Maternal, gestational, intrapartum and neonatal variables were defined for the study. The statistical analysis of the data was carried out with SPSS version 20 for Windows. Results: The study population consisted of 100 HIV-seropositive pregnant women. Fifty percent were coinfected with the hepatitis C virus (HCV) and 9% with the hepatitis B virus (HBV). Most (98%) of patients received antiretroviral therapy during pregnancy, 97% received intrapartum prophylaxis with zidovudine and 98% of newborns received antiretroviral treatment from birth. Forty-five percent of the patients met the criteria for vaginal delivery. Delivery was normal in 28% and instrumental in 4%, while intrapartum emergency caesarian section was required in the remaining 13%. Maternal-fetal transmission was 0%. Conclusion: Protocolizing gestational and neonatal management in HIV-seropositive patients significantly decreased the rate of vertical transmission (AU)

¿Son iguales todas las combinaciones de análogos? / Are all analogue combinations equal?

La impresionante mejora en el arsenal terapéutico ha hecho real la posibilidad de convivir crónicamente con el virus de la inmunodeficiencia humana. Nuestros pacientes, como nosotros, están envejeciendo y su esperanza de vida se aproxima a la de la población de referencia. Por ello se necesitan fármacos seguros, fáciles de tomar, con interacciones controlables y con el menor impacto posible sobre comorbilidades de gran prevalencia, como la aterosclerosis o la coinfección por virus hepatotropos. Fármacos que se adapten al estilo de vida del paciente sin afectarle en su calidad y libres, sobre todo, de efectos estigmatizantes como la lipoatrofia, que supone hoy una gran preocupación para la mayoría de los pacientes de reciente diagnóstico. La elección de la pareja análogos de nucleósidosinhibidores de la transcriptasa inversa (ANITI) al inicio del tratamiento antirretroviral (TAR) debe sustentarse en la evaluación cuidadosa de los ya muchos datos acumulados acerca de todos estos determinantes que ya están configurando una nueva era en el control de la infección. Así, en este escenario, los análogos timidínicos han sido relegados a un uso alternativo. Las combinaciones a dosis fijas de tenofovir (TDF) y emtricitabina (FTC) o abacavir (ABC) y lamivudina (3TC) son el «backbone» electivo al iniciar el TAR. Los datos comparativos directos aún son escasos, pero apuntan a una eficacia virológica similar, con algún dato de desventaja, muy preliminar del ABC/3TC. Aunque, tras excluir a los pacientes con riesgo de hipersensibilidad a ABC, ambos «combos» son muy bien tolerados, el TDF/FTC se asocia a un mejor perfil lipídico. Los recientes datos del DAD que muestran una inesperada asociación del ABC con el incremento del riesgo cardiovascular precisan estudios en profundidad

The huge improvement in the therapeutic arsenal for HIV infection has led to HIV becoming a chronic disease. Like us, our patients are aging and their life expectancy is close to that of the general population. Consequently, we need safe, easily administered drugs with interactions that can be controlled and the least possible impact on highly prevalent comorbidities such as atherosclerosis or coinfection with hepatotropic viruses. Drugs should fit the patient¿s lifestyle without affecting quality of life and, above all, be free of effects leading to stigma, such as lipoatrophy, a major concern for most recently diagnosed patients. The choice of the two nucleoside analogue reverse transcriptase inhibitors used at the start of antiretroviral therapy should be based on careful evaluation of the abundant data accumulated on all these determining factors which are heralding a new era in the control of HIV infection. Thus, in this scenario, thymidine analogues have been relegated to alternative use. Fixeddose combinations of tenofovir and emtricitabine (TDF/FTC) or abacavir and lamivudine (ABC/3TC) are the backbone of choice when initiating antiretroviral therapy. Direct comparative data are still scarce but suggest similar virological efficacy, with highly preliminary data suggesting some disadvantages associated with the use of ABC/3TC. After excluding patients at risk of hypersensitivity to ABC, both combinations are well tolerated, but TDF/FTC is associated with a better lipid profile. Recent data from the Data Collection on Adverse Events of Anti-HIV drugs (DAD) study show an unexpected association of ABC with increased cardiovascular risk and thus more detailed studies are required (AU)

¿Son iguales todas las combinaciones de análogos? / Are all analogue combinations equal?

La impresionante mejora en el arsenal terapéutico hahecho real la posibilidad de convivir crónicamente con elvirus de la inmunodeficiencia humana. Nuestrospacientes, como nosotros, están envejeciendo y suesperanza de vida se aproxima a la de la población dereferencia. Por ello se necesitan fármacos seguros, fácilesde tomar, con interacciones controlables y con el menorimpacto posible sobre comorbilidades de granprevalencia, como la aterosclerosis o la coinfección porvirus hepatotropos.Fármacos que se adapten al estilo de vida del paciente sinafectarle en su calidad y libres, sobre todo, de efectosestigmatizantes como la lipoatrofia, que supone hoy unagran preocupación para la mayoría de los pacientes dereciente diagnóstico.La elección de la pareja análogos de nucleósidosinhibidoresde la transcriptasa inversa (ANITI) al inicio deltratamiento antirretroviral (TAR) debe sustentarse en laevaluación cuidadosa de los ya muchos datosacumulados acerca de todos estos determinantes que yaestán configurando una nueva era en el control de lainfección.Así, en este escenario, los análogos timidínicos han sidorelegados a un uso alternativo. Las combinaciones a dosisfijas de tenofovir (TDF) y emtricitabina (FTC) o abacavir(ABC) y lamivudina (3TC) son el ®backbone» electivo aliniciar el TAR.Los datos comparativos directos aún son escasos, peroapuntan a una eficacia virológica similar, con algún datode desventaja, muy preliminar del ABC/3TC. Aunque, trasexcluir a los pacientes con riesgo de hipersensibilidad aABC, ambos ®combos» son muy bien tolerados, elTDF/FTC se asocia a un mejor perfil lipídico. Los recientesdatos del DAD que muestran una inesperada asociacióndel ABC con el incremento del riesgo cardiovascularprecisan estudios en profundidad(AU)

The huge improvement in the therapeutic arsenal for HIVinfection has led to HIV becoming a chronic disease. Likeus, our patients are aging and their life expectancy isclose to that of the general population. Consequently, weneed safe, easily administered drugs with interactionsthat can be controlled and the least possible impact onhighly prevalent comorbidities such as atherosclerosis orcoinfection with hepatotropic viruses. Drugs should fitthe patient’s lifestyle without affecting quality of life and,above all, be free of effects leading to stigma, such aslipoatrophy, a major concern for most recently diagnosedpatients. The choice of the two nucleoside analoguereverse transcriptase inhibitors used at the start ofantiretroviral therapy should be based on carefulevaluation of the abundant data accumulated on all thesedetermining factors which are heralding a new era in thecontrol of HIV infection. Thus, in this scenario, thymidineanalogues have been relegated to alternative use. Fixeddosecombinations of tenofovir and emtricitabine(TDF/FTC) or abacavir and lamivudine (ABC/3TC) are thebackbone of choice when initiating antiretroviral therapy.Direct comparative data are still scarce but suggestsimilar virological efficacy, with highly preliminary datasuggesting some disadvantages associated with the useof ABC/3TC. After excluding patients at risk ofhypersensitivity to ABC, both combinations are welltolerated, but TDF/FTC is associated with a better lipidprofile. Recent data from the Data Collection on AdverseEvents of Anti-HIV drugs (DAD) study show anunexpected association of ABC with increasedcardiovascular risk and thus more detailed studies arerequired(AU)

[Are all analogue combinations equal?]. / Son iguales todas las combinaciones de análogos?

The huge improvement in the therapeutic arsenal for HIV infection has led to HIV becoming a chronic disease. Like us, our patients are aging and their life expectancy is close to that of the general population. Consequently, we need safe, easily administered drugs with interactions that can be controlled and the least possible impact on highly prevalent comorbidities such as atherosclerosis or coinfection with hepatotropic viruses. Drugs should fit the patient's lifestyle without affecting quality of life and, above all, be free of effects leading to stigma, such as lipoatrophy, a major concern for most recently diagnosed patients. The choice of the two nucleoside analogue reverse transcriptase inhibitors used at the start of antiretroviral therapy should be based on careful evaluation of the abundant data accumulated on all these determining factors which are heralding a new era in the control of HIV infection. Thus, in this scenario, thymidine analogues have been relegated to alternative use. Fixeddose combinations of tenofovir and emtricitabine (TDF/FTC) or abacavir and lamivudine (ABC/3TC) are the backbone of choice when initiating antiretroviral therapy. Direct comparative data are still scarce but suggest similar virological efficacy, with highly preliminary data suggesting some disadvantages associated with the use of ABC/3TC. After excluding patients at risk of hypersensitivity to ABC, both combinations are well tolerated, but TDF/FTC is associated with a better lipid profile. Recent data from the Data Collection on Adverse Events of Anti-HIV drugs (DAD) study show an unexpected association of ABC with increased cardiovascular risk and thus more detailed studies are required.

[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)

[Retrospective epidemiological study on the durability of the treatment of HIV infection or AIDS in Spain]. / Estudio epidemiológico retrospectivo sobre la duración del tratamiento de la infección por el virus de la inmunodeficiencia humana en España.

BACKGROUND AND OBJECTIVE: To know the durability of consecutive regimens of antiretroviral treatment is important to design a long-term therapy, but there is not much information about this subject. PATIENTS AND METHOD: Retrospective epidemiological study of a sample of 401 patients who began antiretroviral treatment between January 1997 and April 2000 at ten Spanish hospitals. The duration of each consecutive antiretroviral regimen was calculated and the reasons for modification and discontinuation were described. RESULTS: In the 3 years and 3 months covered by the study, 48.6% of the patients received more than one regimen of therapy. Seventy five of the initial prescribed combinations included protease inhibitors. Median duration of consecutive lines of therapy was decreasing: 560, 360, 330 and 202 days for the first, second, third and fourth regimens, respectively. The main reason to modification was intolerance or toxicity (46.2, 49.1 and 47.1% for the first, second and third modification). A fifth of changes was originated by difficulties to follow the therapy. Virological failure was the reason for modification in 21.8, 24.5 and 26.5% of first, second and third changes. CONCLUSIONS: Duration of consecutive antiretroviral regimens progressively decreases. Intolerance or drug toxicity were the main reasons conditioning the change of treatment.