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Resumen Este estudio se ha centrado en las actuaciones a nivel politico y administrativo que se han realizado en Espana en relacion con la implementacion de la profilaxis preexposicion (PrEP) al VIH. Se ha analizado todo tipo de iniciativas formales por parte de los actores politicos y administrativos implicados. Las fuentes utilizadas son las fuentes oficiales publicas. Hasta febrero de 2018, la PrEP no ha sido implementada. La decision depende de los niveles estatal y autonomico. El Ministerio de Sanidad y algunas Comunidades Autonomas trabajan en diversas intervenciones sin establecer un calendario de implementacion. Los partidos politicos por su parte han promovido escasas iniciativas relacionadas con la implementacion de la PrEP. En el terreno juridico, se han producido vaivenes legales relacionados con la extension de la patente. El papel de los organos intergubernamentales e interdepartamentales es vital para la implementacion de la PrEP.

Immigrant populations, especially those from endemic countries, living in the European Union (EU) suffer a disproportionate burden of HIV, delayed diagnosis and poorer access to antiretroviral treatment. While International Organisations are developing recommendations aimed at increasing the uptake of HIV testing, the feasibility and real outcomes of these measures remain unexplored. The aim of this review was, firstly to identify the recommendations of the main International Organisations (IO) on HIV testing in immigrants. Secondly, to describe the challenges for implementing and expanding HIV testing and counselling interventions targeting immigrants by interviewing key informants. The importance of HIV testing in immigrants is discussed, along with the appropriateness of universal HIV testing approaches vs most at risk targeted approaches. Also addressed is, pre- and post-HIV test counselling characteristics and community initiatives suitable to reach this population and, finally the legal issues regarding access to treatment for illegal immigrants.

Resumen Introduccion El objetivo de este trabajo es estudiar el impacto poblacional del TARGA e identificar los factores sociodemograficos que lo modifican, lo que resulta fundamental para orientar las intervenciones. Metodos Cohorte abierta y prospectiva de seroconvertores al VIH reclutados en el Centro Sanitario Sandoval (1986-2009) y seguidos en colaboracion con hospitales de referencia de la Comunidad de Madrid. Se calculo la incidencia acumulada de sida y muerte mediante decrementos multiples y se identificaron factores asociados mediante modelos predictivos de Fine & Gray. El periodo calendario ( Resultados Se identificaron 479 seroconvertores. El Hazard Ratio (HR) de progresion a sida fue de 0,215 (IC: 0,11-0,519; p Conclusion La introduccion del TARGA ha tenido gran impacto en el riesgo de progresion a sida y a muerte, pero este se ve influido por la edad de infeccion y por el nivel educativo, lo que senala la importancia de un abordaje global del paciente, y de implementar politicas que disminuyan las desigualdades sociales en salud.

Resumen Introduccion La efectividad del tratamiento antirretroviral de gran actividad (TARGA) en la reduccion del tiempo al primer evento definitorio de sida ha sido demostrada por diversos estudios observacionales, pero el efecto en eventos recurrentes de sida no es tan evidente. Material y metodos Se dispone de 1.938 sujetos seroconvertores al VIH de la cohorte GEMES. Se ha utilizado una extension del modelo de Cox para analizar el tiempo desde la seroconversion a cada evento sida, que tiene en cuenta el tiempo entre sucesivos eventos y que permite que el riesgo de referencia cambie con el numero de paciente con sida previos. El calendario se dividio en tres periodos coincidiendo con la disponibilidad de diferentes regimenes de terapia antirretroviral. Resultados Durante el seguimiento 1.524 (78,6%), 259(13,4%), 83 (4,3%) y 72 (3,7%) sujetos desarrollaron 0, 1, 2 y 3 o mas eventos definitorios de sida, respectivamente. Despues de ajustar por sexo, edad a la seroconversion y categoria de exposicion, el riesgo de sida para el periodo TARGA fue RR = 0,38 (IC del 95%, 0,30-0,48) en comparacion con el periodo 1992–1995.Teniendo en cuenta el numero de sujetos con sida previos, se observo un RR de 0,40 (IC del95%, 0,32-0,50) para el primer evento sida, RR = 0,27 (IC del 95%, 0,15-0,50) para el segundo y 0,41 (IC del 95%, 0,18-0,96) para el tercero. Considerando todos los eventos de sida, se obtiene un riesgo RR = 0,32 (IC del 95%, 0,125-0,40). Los usuarios de drogas por via parenteral tienen un riesgo mayor de desarrollar un primer episodio de sida que los homosexuales, RR = 2,14 (IC del 95%, 1,48-3,10). Conclusiones Los resultados obtenidos muestran un efecto protector de la terapia al primer sida, manteniendose el efecto para posteriores eventos. La inclusion en el analisis de todos los eventos recurrentes de sida permite obtener estimaciones del riesgo mas precisas.

This paper provides an overview of the main statistical methods used in the analysis of data from cohort studies and presents a detailed description of the way these methods are applied in HIV/AIDS research. First, we describe methods for analyzing events in person-time data. Second, we present survival methods for the analysis of time-to-event data. In this context, we illustrate the application of these methods to describe the AIDS incubation period and survival from HIV seroconversion, to determine the factors and biological markers associated with disease progression, and to evaluate effectiveness of therapy. The review ends by illustrating the statistical methods used for the analysis of markers measured repeatedly over time.

In this paper, we provide a definition of cohort studies and reviews the main types of cohort studies used in the context of HIV infection. We discuss how the main sources of selection biases in cohort studies are those derived from the lack of observation of the event that determines the origin and/or of the event of interest due to losses to follow-up or development of a competing event, and how this bias must be appropriately taken into account following specific epidemiological methods. Although cohort studies play an essential role in the study of HIV infection, they are logistically complex and require considerable resources. Therefore, strategic planning on the quality and quantity of the information collected must always be accompanied by a resource allocation plan.

Resumen Introduccion En Espana, la proporcion de inmigrantes en los servicios clinicos de infeccion por virus de la inmunodeficiencia humana (VIH) es creciente. El objetivo del presente articulo es describir las caracteristicas sociodemograficas, epidemiologicas y clinicas de una cohorte de personas con infeccion por VIH de la Red de Investigacion en Sida (CoRIS) segun su lugar de origen. Metodos CoRIS es una cohorte abierta, prospectiva y multicentrica de adultos con infeccion por VIH sin tratamiento antirretrovirico previo, que se atendieron en 19 hospitales de 9 Comunidades Autonomas espanolas entre enero de 2004 y octubre de 2006. Se describen las caracteristicas por region de origen y se comparan con los casos espanoles. Resultados Se incluyeron 2.507 pacientes: el 76,3% fueron varones, con una mediana de edad de 36 anos. Por el lugar de origen, el 71,5% fueron espanoles; el 16,0% fueron latinoamericanos; el 5,8% fueron de Africa Subsahariana; el 3,7% fueron de Europa occidental; el 1,7% fueron de Europa del este, y el 1,4% fueron de Africa del norte. En comparacion con los espanoles, hubo diferencias significativas en sexo, edad y categoria de transmision. La mediana de linfocitos CD4 al ingreso a la cohorte fue de 352×106/l, sin que hubiera diferencias segun el origen. La mediana de carga virica fue de 48,962 copias/ml, significativamente menor en el grupo de Africa subsahariana. Tras 11,4 meses de seguimiento, el 57,9% habia iniciado tratamiento, sin que hubiera diferencias por origen. La prevalencia de coinfeccion con hepatitis C fue del 29,9% en espanoles, del 7,3% en latinoamericanos, del 11,7% en los sujetos de Africa subsahariana y del 45,7% en los sujetos de Europa del este (p Conclusiones Casi un tercio de las personas con infeccion por VIH que se atendieron recientemente en Espana fueron extranjeros. Sus caracteristicas sociodemograficas, epidemiologicas y clinicas reflejan la epidemia en sus lugares de origen. Sin embargo, su situacion inmunologica cuando acceden al hospital y en el inicio del tratamiento no difiere de la de los pacientes espanoles.

Objetivo Describir la metodologia y los resultados basales de la cohorte de pacientes con infeccion por virus de la inmunodeficiencia humana (VIH) de la Red de Investigacion de Sida (CoRIS). Metodos Cohorte abierta, prospectiva, multicentrica, de pacientes mayores de 13 anos con diagnostico de VIH sin tratamiento antirretroviral previo. La seleccion se realizo entre enero de 2004 y octubre de 2005 en 17 hospitales de 8 comunidades autonomas. Se recogieron variables sociodemograficas, epidemiologicas, clinicas y analiticas, junto con muestras biologicas iniciales y de seguimiento. Resultados Se han incluido 1.591 pacientes, 24% mujeres, mediana de edad 36 anos, el 74% diagnosticados de VIH en 2004 o 2005. El 27% provenian de otros lugares de origen, destacando Latinoamerica (16%) y Africa subsahariana (5%). El 32% tenian estudios secundarios y el 16% universitarios. La categoria de transmision mas frecuente fue la de hombres homosexuales (37%), seguida por la heterosexual (36%); y solo el 21% tenian antecedente de consumo de drogas inyectadas. Al ingreso en la cohorte la mediana de CD4 era 317 celulas/μl, la de carga viral 52.300 copias/ml y el 18% tenian diagnostico de sida. Las enfermedades diagnosticas de sida mas frecuentes fueron: neumonia por Pneumocystis jiroveci (6,1%), candidiasis esofagica (3,3%) y tuberculosis extrapulmonar (3,0%) y pulmonar (2,7%). Se registraron 35 fallecimientos (2,2%). El 33% de los pacientes han aportado muestras basales al BioBanco. Conclusiones CoRIS proporciona informacion relevante del perfil epidemiologico reciente de la infeccion por el VIH en nuestro medio, en el que predomina la transmision sexual. Se demuestra la viabilidad de esta cohorte, recogiendo datos clinicos y epidemiologicos junto con muestras biologicas, lo que abre grandes posibilidades de investigacion.

The aim of this study was to investigate the incidence and risk factors for the development of AIDS-defining cancers (ADCs); and to investigate the effect of making different assumptions on the definition of incident cases.A multicentre cohort study was designed. Poisson regression was used to assess incidence and risk factors. To account for misclassification, incident cases were defined using lag-times of 0, 14 and 30 days after enrolment.A total of 6393 HIV-positive subjects were included in the study. The incidences of ADCs changed as the lag periods were varied from 0 to 30 days. Different risk factors emerged as the definition of incident cases was changed. For a lag time of 0, the risk of Kaposi sarcoma [KS] and non-Hodgkin lymphoma [NHL] increased at CD4 counts200/ml. HAART was associated with lower risk of NHL and KS. Men who had sex with men had a higher risk of KS. KS and NHL were not associated with viral load, gender, or hepatitis B or C. The results were similar for a lag-time of 14 and 30 days; however, hepatitis C was significantly associated with NHL.This analysis shows the importance of the definition of incident cases in cohort studies. Alternative definitions gave different incidence estimates, and may have implications for the analysis of risk factors.

Current information on cardiovascular risk (CVR) in HIV-infected patients in Spain is limited.An analysis was made of a prospective multicentre cohort of Spanish HIV-infected patients (CoRIS) between January-2010 and July-2011. CVR was evaluated using Framingham, REGICOR and SCORE equations.The study included 1019 patients (76% males, mean age 40 years) recruited from 13 hospitals belonging to 10 autonomous communities in Spain. Almost two-thirds (65.4%) of patients were on antiretroviral therapy (ART), 36.7% with non-nucleoside analogs, 24% with protease inhibitors (PIs) (52% with atazanavir/r or darunavir/r) and 4,6% with raltegravir. More than half (56.2%) of the patients had an HIV viral load50 copies/ml. Smoking prevalence was 46%, HDL cholesterol (HDL-C)40mg/dl 36.1%, total cholesterol (total-C)200mg/dl 27.8%, age45years 27.2%, metabolic syndrome 11.5%, hypertension 9.4%, cocaine use 7%, and diabetes 2.9%. ART was associated with higher total-C and LDL-C concentrations, although also higher HDL-C and lower total-C/HDL-C ratio; patients receiving PIs boosted with a high ritonavir dose showed higher total-C levels and higher total-C/HDL-C ratio. According to Framingham cardiovascular, and coronary, REGICOR, and SCORE equations, 15.2%, 6.4%, 4.2% and 3.9% of patients, respectively, were classified as having moderate or high CVR.In HIV-infected patients from CoRIS, prevalence of modifiable CVR factors is still high. Commonly used scores identify a relatively low number of patients with high CVR.

This article describes the development of the Cohort of the Spanish Research Network (CoRIS), its methodological and organizational aspects, the demographic and clinical characteristics of the subjects enrolled and quantifies the losses to follow-up and associated factors.Multicentre cohort of HIV-positive naïve subjects recruited in 28 sites of Spain from 2004-onwards. Missing and inconsistent data were submitted to internal quality controls and the datasets were externally audited. Multiple logistic regression models were used.As of October 2009, 5,514 subjects had been recruited, representing 11,708 person-years with a median follow-up time of 1.81 years. Most are men (78.8%), infected by sexual transmission (46.1% men who have sex with men and 35.2% heterosexual persons) and Spanish (69.7%). During follow-up 64.5% have started Antiretroviral Therapy (ART) and 201 deaths have occurred. New HIV diagnoses accounted for 80.7% of the sample. Some 52% of subjects had at least one baseline sample in the BioBank while naïve to ART. Losses to follow-up (18.9%) were more frequent in younger people, in injecting drug users, in persons of non-Spanish origin, in persons with primary or lower educational level, and in those with a CD4 count over 350 cells/mm(3) at time of recruitment.The implementation of CoRIS has been successful; the cohort has wide representation at national level, is actively recruiting new members and blood samples, and has excellent data quality. Losses to follow-up are of similar magnitude to other cohort studies, as are the factors associated with them.

The objective of this work is to study the impact of HAART at a population level and to identify socio-demographic factors that may affect it, which is essential for deciding interventions.An open, prospective cohort of HIV seroconverters recruited in the Centro Sanitario Sandoval (1986-2009), and followed up in collaboration with referral hospitals in the Comunidad Autónoma de Madrid. Cumulative incidence of AIDS and death was calculated by the multiple decrements method, and predictive FineGray models were developed to identify associated factors. A calendar period (1997; ≥ 1997) was introduced as a proxy of HAART availability.A total of 479 HIV seroconverters were identified. Hazard Ratio (HR) for progression to AIDS was 0.215 (95% CI: 0.11-0.519; P.01) for the period ≥ 1997. Risk increased with age at the time of seroconversion (for each year older HR=1.071; 95% CI: 1.038-1.105; P.01), but only prior to 1997. In the following period, only a high educational level showed to be a protective factor (HR=0.982; 95% CI: 0.936-1.031; P=.06). HR for progression to death was 0.134 (95% CI: 0.052-0.346; P.01) for the period after 1997, 0.383 (95% CI: 0.168-0.875; P=.02) in people with high educational level and 1.048 (95% CI: 1.014-1.084; P.01) for each year increase in age at seroconversion, both latter effects being homogeneous throughout the two periods.HAART has had a great impact on the risk of progression to AIDS and death, but this benefit appears to be influenced by age at HIV infection and educational level of the patient, which highlights the importance of a global approach to case management and of the implementation of policies that address social inequities in health.

Immigration to Spain has greatly increased since 1995. Currently, more than 4 million foreigners are resident in the country. The immigration process increases vulnerability. The most common route of HIV infection in the immigrant population and ethnic minorities is heterosexual transmission. The number of people living with HIV worldwide (39.5 million people in 2006) and the number of those dying from AIDS continues to increase. In 2006, there were an estimated 30,000 people living with HIV/AIDS in Spain. The number of cases of AIDS in immigrants has risen in the last few years. AIDS in immigrants from any country, and especially in those from sub-Saharan Africa, is associated with a greater frequency of tuberculosis disease. Knowledge of opportunistic pathogens with tropical distribution is required for a correct differential diagnosis. Throughout the European Union, the number of AIDS cases has progressively decreased since the introduction of highly effective anti- HIV treatment, but this decrease has been significantly lower in immigrants. The difference may be due to lower access to health systems caused by administrative, legal, cultural and linguistic barriers.

In this paper, we provide a definition of cohort studies and reviews the main types of cohort studies used in the context of HIV infection. We discuss how the main sources of selection biases in cohort studies are those derived from the lack of observation of the event that determines the origin and/or of the event of interest due to losses to follow-up or development of a competing event, and how this bias must be appropriately taken into account following specific epidemiological methods. Although cohort studies play an essential role in the study of HIV infection, they are logistically complex and require considerable resources. Therefore, strategic planning on the quality and quantity of the information collected must always be accompanied by a resource allocation plan.

This paper provides an overview of the main statistical methods used in the analysis of data from cohort studies and presents a detailed description of the way these methods are applied in HIV/AIDS research. First, we describe methods for analyzing events in person-time data. Second, we present survival methods for the analysis of time-to-event data. In this context, we illustrate the application of these methods to describe the AIDS incubation period and survival from HIV seroconversion, to determine the factors and biological markers associated with disease progression, and to evaluate effectiveness of therapy. The review ends by illustrating the statistical methods used for the analysis of markers measured repeatedly over time.

A growing number of immigrants are using the public health services for HIV in Spain. We describe the sociodemographic, epidemiological, and clinical characteristics of a cohort of naïve HIV-infected subjects (CoRIS cohort) according to their place of origin.CoRIS is an open, hospital-based cohort of naïve, HIV-infected persons attended in 19 hospitals from 9 of the 19 autonomous regions in Spain. We describe the characteristics of the cohort members by place of origin, and compare them with the Spanish cases identified from January 2004 to October 2006, using the chi-square and Fisher exact tests.Of 2507 patients, 76.3% were men and median age was 36 years. By origin, 71.5% were Spanish, 16.0% Latin Americans (LA), 5.8% sub-Saharan Africans (SSA), 3.7% Western Europeans (WE), 1.7% Eastern Europeans (EE) and 1.4% North Africans (NA). Compared to Spaniards, there were significant differences by origin in sex, age, and transmission category. Median CD4 count at cohort entry was 352 cell/microL, with no differences according to origin. Median viral load was 48 962 copies/mL and was significantly lower for SSA. Over 11.4 months of follow-up, 57.9% initiated HAART with no differences by origin. Hepatitis C prevalence was 29.9% in Spaniards, 7.3% in Latin Americans, 11.7% in SSA, and 45.7% in EE (P0.05). Overall, 13.4% were Mantoux-positive (28.6% in SSA and 30.8% in NA). Tuberculosis was more common among cases from EE (9.5%) and SSA (8.3%) compared to Spaniards (4.8%) (P0.05).Almost one third of naïve HIV-infected patients in CoRIS are foreign-born. Their sociodemographic, epidemiological and clinical characteristics reflect the epidemic in their places of origin. However, their immunological status at cohort entry and initiation of HAART is no different from that of Spaniards.

To describe the methodology and baseline results of the Spanish cohort of naïve HIV-infected patients included in the Research Network on HIV/AIDS (CoRIS).CoRIS is a multicenter, hospital-based prospective cohort of HIV sero-prevalent, retroviral-naïve subjects, over 13 years old, and seen at 17 hospitals in 8 of the 17 Autonomous Regions in Spain from January 2004 to October 2005. The socio-demographic characteristics, as well as epidemiological, clinical, laboratory and treatment data were recorded, and biological samples were collected at baseline and during follow-up.A total of 1,591 subjects have been included in CoRIS; 24% are women, median age at cohort entry is 36 years, and 74% were diagnosed during 2004 or 2005. Twenty-seven percent came from countries other than Spain, mainly Latin-America (16%) and sub-Saharan Africa (5%). Thirty-two percent had completed secondary education and 16% university studies. The most frequent categories of transmission were men having sex with men (37%) and heterosexual sex (36%); only 21% were injection drug users. At cohort entry, median CD4 count was 317 cells/mm 3 and median viral load was 52,300 copies/mL; 18% were diagnosed with AIDS. Main AIDS-defining illnesses were Pneumocystis jiroveci pneumonia (6.1%), esophageal candidiasis (3.3%) and tuberculosis (extrapulmonary, 3.0% and pulmonary 2.7%). There were 35 deaths (2.2%). Thirty-three percent of patients gave a baseline sample to the BioBank.CoRIS offers relevant information about the current epidemiological profile of HIV infection in Spain, where sexual transmission has become predominant. The type and amount of information obtained from clinical and epidemiological data collection together with biological samples demonstrate the viability of the project, which offers many possibilities for future research.