Predictive factors of renal impairment in HIV-infected patients on antiretroviral therapy: Results from the VACH longitudinal cohort study / Factores predictivos de insuficiencia renal en pacientes infectados por el VIH que reciben tratamiento antirretroviral: resultados del estudio de cohortes longitudinal VACH

BACKGROUND: The use of combination antiretroviral therapy has led to dramatic improvements in the life expectancy of HIV-infected persons. As result, the HIV population is aging and increasingly facing illnesses typically seen in the elderly, such as chronic kidney disease (CKD). METHODS: A retrospective longitudinal study was conducted using data from years 2010 and 2014 in all HIV-infected persons enrolled at the Spanish VACH cohort. We analyzed the prevalence and the predictive factors for developing CKD (estimated glomerular filtration rate, eGFR< 60 mL/min/1.73 m2). RESULTS: The CKD prevalence at baseline was 456/8968, 5.1% [4.6-5.6%]. Of 8512 HIV-positive individuals examined without CKD at baseline (73.7% male, median age 44 years-old), 2.15% developed CKD (eGFR < 60 mL/min/1.73m2). The odds ratios [95%CI] for the independent predictive factors identified were gender (male) 0.54 [0.39-0.75], age (per year) 1.08 [1.07-1.10], AIDS diagnosis 1.40 [1.03-1.91], protease inhibitor-based regimens 1.49 [1.10-2.02], hypertension 1.37 [0.94-1.99], diabetes 1.84 [1.33-2.55] and history of cardiovascular events 1.66 [0.96-2.86]. CONCLUSION: The prevalence and risk factors for CKD and its progression are high in the VACH cohort. Thus, preventive measures such as control of hypertension, diabetes and obesity, as well as efforts for avoiding exposure to nephrotoxic drugs, including some antiretrovirals, are warranted in this aging HIV population

ANTECEDENTES: El uso de tratamiento antirretroviral combinado ha dado lugar a mejoras sustanciales en la esperanza de vida de las personas infectadas por el virus de la inmunodeficiencia humana (VIH). Como resultado, la población con VIH está envejeciendo y haciendo frente cada vez más a enfermedades normalmente observadas en las personas de edad avanzada, como la nefropatía crónica (NC). MÉTODOS: Se ha realizado un estudio longitudinal retrospectivo usando datos de los años 2010 y 2014 en todas las personas infectadas por el VIH incluidas en la cohorte VACH española. Se ha analizado la prevalencia y los factores predisponentes para el desarrollo de NC (filtración glomerular estimada [FGe]:< 60 ml/min/1,73m2). RESULTADOS: La prevalencia de NC al inicio fue de 456/8.968; 5,1% (4,6-5,6%). De las 8.512 personas infectadas por el VIH evaluadas sin NC al inicio (73,7 varones, mediana de edad: 44 años), el 2,15% desarrolló NC (FGe < 60 ml/min/1,73m2). Los cocientes de posibilidades (IC del 95%) de los factores predictivos independientes identificados fueron 0,54 (0,39-0,75) para el sexo (varón); 1,08 (1,07-1,10) para la edad (por año); 1,40 (1,03-1,91) para el diagnóstico de sida; 1,49 (1,10-2,02) para los tratamientos basados en inhibidores de la proteasa; 1,37 (0,94-1,99) para la hipertensión; 1,84 (1,33-2,55) para la diabetes y 1,66 (0,96-2,86) para los antecedentes de acontecimientos cardiovasculares. CONCLUSIÓN: La prevalencia y los factores de riesgo para la NC y su progresión son elevados en la cohorte VACH. Por lo tanto, está justificada la aplicación de medidas preventivas (como el control de la hipertensión, la diabetes y la obesidad), así como la aplicación de esfuerzos para evitar la exposición a fármacos nefrotóxicos (incluidos algunos antirretrovirales) en esta población con VIH que envejece

Rate of cardiovascular, renal and bone disease and their major risks factors in HIV-infected individuals on antiretroviral therapy in Spain / Prevalencia de enfermedad cardiovascular, renal y ósea, y sus principales factores de riesgo en personas infectadas por el VIH que reciben tratamiento antirretroviral en España

BACKGROUND: The life expectancy of HIV-infected individuals has dramatically improved with potent antiretroviral therapies. However, organ-specific toxicities of some antiretrovirals and persistent inflammation and immune activation due to residual virus replication account for a high burden of age-associated comorbidities in the HIV population. METHODS: The prevalence of overt cardiovascular, renal and bone diseases as well as their major risk factors were cross-sectionally examined during the year 2014 in the VACH cohort, a large nationwide population of HIV-infected individuals in Spain. RESULTS: A total of 10,897 HIV-infected patients were examined. Seventy-one point four percent were male and the mean age was 48 years. Mean time since HIV diagnosis was 15.8 years and mean time on antiretroviral therapy was 13.1 years. The proportion of patients with undetectable viral load was 87.1%, whereas 65.7% had CD4 counts>500 cells/mm3. Overall, cardiovascular, renal and bone disease were recorded in 4.7%, 5.9% and 2.8%, respectively. The prevalence of major risk factors was as follows: smoking 51.3%, alcohol abuse 7.8%, overweight/obesity 42.2%, diabetes 19.9%, dyslipidaemia 72.6%, hypertension 25.6%, and osteoporosis 11.1%. In the subset of patients older than 55 years-old (18%), all figures for overt disease and their major risk factors were significantly greater. CONCLUSION: Major age-related medical conditions and most of their risk factors are highly prevalent in HIV-infected individuals on long-term antiretroviral therapy in Spain. Preventive actions, including careful selection of antiretroviral agents, should be prioritized in the ageing HIV population

INTRODUCCIÓN: La esperanza de vida de las personas infectadas por el VIH ha mejorado con la terapia antirretroviral. Sin embargo, la toxicidad de algunos antirretrovirales, la inflamación persistente y la activación inmune explican la alta carga de comorbilidades asociadas con el envejecimiento en la población con VIH. MÉTODOS: La prevalencia de enfermedad cardiovascular, renal y ósea, así como sus principales factores de riesgo, se analizó en una cohorte de individuos infectados por el VIH en un estudio realizado en España durante el año 2014. RESULTADOS: Se examinaron un total de 10.897 pacientes infectados por VIH. Varones el 74,1%, edad media 48 años. El tiempo medio transcurrido desde el diagnóstico del VIH fue de 15,8 años y el tiempo medio de tratamiento antirretroviral fue de 13,1 años. La proporción de pacientes con carga viral indetectable fue del 87,1%, mientras que el 65,7% tenían recuentos de CD4 > 500 células/mm3. La enfermedad cardiovascular, renal y ósea se encontró en el 4,7, 5,9 y 2,8%, respectivamente. La prevalencia de los principales factores de riesgo fue: fumar 51,3%, abuso de alcohol 7,8%, sobrepeso/obesidad 42,2%, diabetes 19,9%, dislipidemia 72,6%, hipertensión 25,6% y osteoporosis 11,1%. En el grupo de pacientes mayores de 55 años (18%), la prevalencia de comorbilidades y sus principales factores de riesgo fue significativamente mayor. CONCLUSIÓN: Las principales comorbilidades relacionadas con la edad y la mayoría de los factores de riesgo asociados son muy prevalentes en las personas infectadas por el VIH que reciben tratamiento antirretroviral en España. Las acciones preventivas, incluida la selección cuidadosa de agentes antirretrovirales, deben ser priorizadas en la población con VIH que está envejeciendo

Predictive factors of renal impairment in HIV-infected patients on antiretroviral therapy: Results from the VACH longitudinal cohort study.

BACKGROUND: The use of combination antiretroviral therapy has led to dramatic improvements in the life expectancy of HIV-infected persons. As result, the HIV population is aging and increasingly facing illnesses typically seen in the elderly, such as chronic kidney disease (CKD). METHODS: A retrospective longitudinal study was conducted using data from years 2010 and 2014 in all HIV-infected persons enrolled at the Spanish VACH cohort. We analyzed the prevalence and the predictive factors for developing CKD (estimated glomerular filtration rate, eGFR<60mL/min/1.73m2). RESULTS: The CKD prevalence at baseline was 456/8968, 5.1% [4.6-5.6%]. Of 8512 HIV-positive individuals examined without CKD at baseline (73.7% male, median age 44 years-old), 2.15% developed CKD (eGFR<60mL/min/1.73m2). The odds ratios [95%CI] for the independent predictive factors identified were gender (male) 0.54 [0.39-0.75], age (per year) 1.08 [1.07-1.10], AIDS diagnosis 1.40 [1.03-1.91], protease inhibitor-based regimens 1.49 [1.10-2.02], hypertension 1.37 [0.94-1.99], diabetes 1.84 [1.33-2.55] and history of cardiovascular events 1.66 [0.96-2.86]. CONCLUSION: The prevalence and risk factors for CKD and its progression are high in the VACH cohort. Thus, preventive measures such as control of hypertension, diabetes and obesity, as well as efforts for avoiding exposure to nephrotoxic drugs, including some antiretrovirals, are warranted in this aging HIV population.

Rate of cardiovascular, renal and bone disease and their major risks factors in HIV-infected individuals on antiretroviral therapy in Spain.

BACKGROUND: The life expectancy of HIV-infected individuals has dramatically improved with potent antiretroviral therapies. However, organ-specific toxicities of some antiretrovirals and persistent inflammation and immune activation due to residual virus replication account for a high burden of age-associated comorbidities in the HIV population. METHODS: The prevalence of overt cardiovascular, renal and bone diseases as well as their major risk factors were cross-sectionally examined during the year 2014 in the VACH cohort, a large nationwide population of HIV-infected individuals in Spain. RESULTS: A total of 10,897 HIV-infected patients were examined. Seventy-one point four percent were male and the mean age was 48 years. Mean time since HIV diagnosis was 15.8 years and mean time on antiretroviral therapy was 13.1 years. The proportion of patients with undetectable viral load was 87.1%, whereas 65.7% had CD4 counts>500 cells/mm3. Overall, cardiovascular, renal and bone disease were recorded in 4.7%, 5.9% and 2.8%, respectively. The prevalence of major risk factors was as follows: smoking 51.3%, alcohol abuse 7.8%, overweight/obesity 42.2%, diabetes 19.9%, dyslipidaemia 72.6%, hypertension 25.6%, and osteoporosis 11.1%. In the subset of patients older than 55 years-old (18%), all figures for overt disease and their major risk factors were significantly greater. CONCLUSION: Major age-related medical conditions and most of their risk factors are highly prevalent in HIV-infected individuals on long-term antiretroviral therapy in Spain. Preventive actions, including careful selection of antiretroviral agents, should be prioritized in the ageing HIV population.

Correction: Abacavir/Lamivudine plus Rilpivirine Is an Effective and Safe Strategy for HIV-1 Suppressed Patients: 48 Week Results of the SIMRIKI Retrospective Study.

[This corrects the article DOI: 10.1371/journal.pone.0164455.].

Abacavir/Lamivudine plus Rilpivirine Is an Effective and Safe Strategy for HIV-1 Suppressed Patients: 48 Week Results of the SIMRIKI Retrospective Study.

OBJECTIVES: Based on data from clinical practice, we evaluated the effectiveness and safety of switching to abacavir/lamivudine plus rilpivirine (ABC/3TC+RPV) treatment in virologically suppressed HIV-1-infected patients. METHODS: We performed a multicenter, non-controlled, retrospective study of HIV-1-infected patients who switched treatment to ABC/3TC+RPV. Patients had an HIV-RNA <50 copies/mL for at least 24 weeks prior to changing treatments. The primary objective was HIV-1 RNA <50 copies/mL at week 48. Effectiveness was analyzed by intention-to-treat (ITT), missing = failure and on-treatment (OT) analyses. The secondary objectives analyzed were adverse effects changes in renal, hepatic or lipid profiles, changes in CD4+ cell count and treatment discontinuations. RESULTS: Of the 205 patients included, 75.6% were men and the median age was 49. At baseline, before switching to ABC/3TC+RPV, median time since HIV diagnosis was 13.1 years, median time with undetectable HIV-1 RNA was 6.2 years and median time of previous antiretroviral regimen was 3.1 years (48.3% patients were taking efavirenz and ABC/3TC was the most frequent backbone coformulation in 69.7% of patients). The main reasons for switching were drug toxicity/poor tolerability (60.5%) and simplification (20%). At week 48, the primary objective was achieved by 187 out of 205 (91.2%) patients by ITT analysis, and 187 out of 192 (97.4%) patients by OT analysis. The CD4+ lymphocyte count and CD4+ percentage increased significantly from baseline to week 48 by a median of 48 cells/µL (-50 to 189) and 1.2% (-1.3% to 4.1%), respectively, P<0.001. Thirty-eight adverse events (AE) were detected in 32 patients. Of these, 25 had no clear association with treatment. Three patients interrupted therapy due to AE. We observed a decrease in all lipid parameters, P<0.001, and a slight improvement in the glomerular filtration rate, P<0.01. Therapy was considered to have failed in 18 patients owing to virological failure (5 [2.4%]), toxicity/poor tolerability (4 [2%]), clinical decision (3 [1.5%]), loss to follow-up (3 [1.5%]), death (1 [0.5%]), and no clinical data (2 [1%]). CONCLUSIONS: The results of this study confirms that ABC/3TC+RPV is an effective, safe, and cost-effective option for the treatment of patients with virologically stable HIV-1 infection.

Dual treatment with atazanavir-ritonavir plus lamivudine versus triple treatment with atazanavir-ritonavir plus two nucleos(t)ides in virologically stable patients with HIV-1 (SALT): 48 week results from a randomised, open-label, non-inferiority trial.

BACKGROUND: Problems associated with lifelong antiretroviral therapy, such as need for strict adherence, drug-related toxic effects, difficulties with treatment schedules, and cost, mean that simplification strategies should be sought. We aimed to explore the efficacy and safety of dual treatment with atazanavir-ritonavir plus lamivudine as an option to switch to from standard combination antiretroviral therapy in patients with an HIV-1 infection who are virologically suppressed. METHODS: In this randomised, open-label, non-inferiority trial, we recruited patients aged 18 years and older with chronic HIV-1 infection and no previous treatment failure or resistance, and with HIV-1 RNA of less than 50 copies per mL for at least 6 months, negative hepatitis B virus surface antigen, and good general health, from 30 hospitals in Spain. Exclusion criteria were switch in antiretroviral therapy during the previous 4 months, previous virological failure, pregnancy or breastfeeding, Gilbert's syndrome, use of contraindicated drugs, grade 4 laboratory abnormalities, and previous intolerance to any of the study drugs. We randomly assigned patients (1:1; stratified by active hepatitis C virus infection and previous treatment; computer-generated random number sequence) to dual treatment with oral atazanavir (300 mg once daily) and ritonavir (100 mg once daily) plus lamivudine (300 mg once daily) or triple treatment with oral atazanavir (300 mg once daily) and ritonavir (100 mg once daily) plus two nucleos(t)ide reverse transcriptase inhibitors at the discretion of the investigators. The primary endpoint was virological response, defined as HIV-1 RNA of less than 50 copies per mL at week 48, in the per-protocol population, with a non-inferiority margin of 12%. We included patients who received at least one dose of the study drug in the safety analysis. This study is registered at ClinicalTrials.gov, number NCT01307488. FINDINGS: Between Sept 29, 2011, and May 2, 2013, we randomly assigned 286 patients (143 [50%] to each group). At week 48 in the per-protocol population, 112 (84%) of 133 patients had virological response in the dual-treatment group versus 105 (78%) of 135 in the triple-treatment group (difference 6% [95% CI -5 to 16%), showing non-inferiority at the prespecified level. 14 (5%) patients developed severe adverse events (dual treatment six [4%]; triple treatment eight [6%]), none of which we deemed related to the study drug. Grade 3-4 adverse events were similar between groups (dual treatment 77 [55%] of 140; triple treatment 78 [55%] of 141). Treatment discontinuations were less frequent in the dual-treatment group (three [2%]) than in the triple-treatment group (ten [7%]; p=0·047). INTERPRETATION: In our trial, dual treatment was effective, safe, and non-inferior to triple treatment in patients with an HIV-1 infection who are virologically suppressed who switch antiretroviral therapy because of toxic effects, intolerance, or simplification. This combination has the potential to suppress some of the long-term toxic effects associated with nucleos(t)ide reverse transcriptase inhibitors, preserve future treatment options, and reduce the cost of antiretroviral therapy. FUNDING: Bristol Myers-Squibb and Fundación SEIMC-GESIDA.

Risk factors and outcomes for late presentation for HIV-positive persons in Europe: results from the Collaboration of Observational HIV Epidemiological Research Europe Study (COHERE).

BACKGROUND: Few studies have monitored late presentation (LP) of HIV infection over the European continent, including Eastern Europe. Study objectives were to explore the impact of LP on AIDS and mortality. METHODS AND FINDINGS: LP was defined in Collaboration of Observational HIV Epidemiological Research Europe (COHERE) as HIV diagnosis with a CD4 count <350/mm(3) or an AIDS diagnosis within 6 months of HIV diagnosis among persons presenting for care between 1 January 2000 and 30 June 2011. Logistic regression was used to identify factors associated with LP and Poisson regression to explore the impact on AIDS/death. 84,524 individuals from 23 cohorts in 35 countries contributed data; 45,488 were LP (53.8%). LP was highest in heterosexual males (66.1%), Southern European countries (57.0%), and persons originating from Africa (65.1%). LP decreased from 57.3% in 2000 to 51.7% in 2010/2011 (adjusted odds ratio [aOR] 0.96; 95% CI 0.95-0.97). LP decreased over time in both Central and Northern Europe among homosexual men, and male and female heterosexuals, but increased over time for female heterosexuals and male intravenous drug users (IDUs) from Southern Europe and in male and female IDUs from Eastern Europe. 8,187 AIDS/deaths occurred during 327,003 person-years of follow-up. In the first year after HIV diagnosis, LP was associated with over a 13-fold increased incidence of AIDS/death in Southern Europe (adjusted incidence rate ratio [aIRR] 13.02; 95% CI 8.19-20.70) and over a 6-fold increased rate in Eastern Europe (aIRR 6.64; 95% CI 3.55-12.43). CONCLUSIONS: LP has decreased over time across Europe, but remains a significant issue in the region in all HIV exposure groups. LP increased in male IDUs and female heterosexuals from Southern Europe and IDUs in Eastern Europe. LP was associated with an increased rate of AIDS/deaths, particularly in the first year after HIV diagnosis, with significant variation across Europe. Earlier and more widespread testing, timely referrals after testing positive, and improved retention in care strategies are required to further reduce the incidence of LP.

Risk of liver decompensation among HIV/hepatitis C virus-coinfected individuals with advanced fibrosis: implications for the timing of therapy.

BACKGROUND: Most human immunodeficiency virus (HIV)/hepatitis C virus (HCV)-infected patients who are currently receiving boceprevir or telaprevir-based therapy against HCV show cirrhosis. However, the risk of liver decompensation (DC) among HIV/HCV-coinfected patients with stage 3 fibrosis in the short term could be high enough to not allow delays. We aimed at assessing the risk of DC among HIV/HCV-coinfected individuals with advanced fibrosis (F3-F4). METHODS: Eight hundred ninety-two HIV/HCV-coinfected patients, naive or without sustained virologic response to HCV therapy, were included in this cohort. Fibrosis was staged by biopsy in 317 patients and by liver stiffness measurement (LSM) in 575 individuals. Precirrhosis was defined as an LSM of 9.5-14.6 kilopascals (kPa), and cirrhosis as an LSM of ≥14.6 kPa. RESULTS: For patients with biopsy, the probability of remaining free of DC for F3 vs F4 was 99% (95% confidence interval [CI], 95%-100%) vs 96% (95% CI, 91%-98%) at 1 year, and 98% (95% CI, 94%-100%) vs 87% (95% CI, 81%-92%) at 3 years. The only factor independently associated with DC was fibrosis stage (F4 vs F3, subhazard ratio [SHR], 2.1; 95% CI, 1.07-4.1; P = .032). For patients with LSM, the probability of remaining free of DC for precirrhosis vs cirrhosis was 99% (95% CI, 96%-100%) vs 93% (95% CI, 89%-96%) at 1 year, and 97% (95% CI, 94%-99%) vs 83% (95% CI, 77%-87%) at 3 years. Factors independently associated with DC were platelet count (<100 × 10(3) vs ≥100 × 10(3): SHR, 1.86; 95% CI, 1.01-3.42; P = .046) and LSM (cirrhosis vs precirrhosis: SHR, 5.67; 95% CI, 2.27-14.1; P < .0001). CONCLUSIONS: As in patients with cirrhosis, immediate therapy against HCV is warranted for patients with precirrhosis and HIV coinfection, as they are at risk of DC soon after the diagnosis of advanced fibrosis.

Response to combined antiretroviral therapy according to gender and origin in a cohort of naïve HIV-infected patients: GESIDA-5808 study.

BACKGROUND: We analyzed differences in response to combined antiretroviral therapy (cART) according to sex and geographic origin in a retrospective comparative study of Spanish-born and immigrant patients initiating cART. METHODS: The primary endpoint was time to treatment failure (TTF), defined as virological failure, death, opportunistic infection, interruption of cART, or loss to follow-up. Late diagnosis was defined as a CD4+ cell count ≤ 200 cells/mm3 and/or AIDS at initiation of cART. Survival was analyzed using Kaplan-Meier analysis and Cox regression. RESULTS: We followed 1,090 patients, of whom 318 were women (45.6% immigrant women [IW]). At initiation of treatment, women had a higher CD4+ count than men (217 vs 190 cells/mm3), a lower viral load (4.7 vs 5 log), and fewer were late starters (49% vs 59%). The adjusted risk of TTF between women and men was not significantly different (hazard ratio [HR], 1.10; 95% CI, 0.79-1.53). TTF was shorter among IW than Spanish-born women (124 weeks [95% CI, 64-183] vs 151 [95% CI, 127-174]) and loss to follow-up was double that of Spanish-born women (25.5% vs 11.6%). CONCLUSIONS: Although response to cART was similar for both sexes, men started treatment later. IW were more frequently lost to follow-up and switched treatment. Measures to improve medical follow-up after initiation of cART should be promoted among this minority group.

Dyslipidaemia in HIV-infected women on antiretroviral therapy. Analysis of 922 patients from the Spanish VACH cohort.

BACKGROUND: Information concerning lipid disturbances in HIV-infected women on antiretroviral therapy (ART) is scarce. The objective of the study is to describe the lipid profile in a large cohort of HIV-infected women on contemporary ART and analyse differences between regimes and patient's characteristics. METHODS: Observational, multicentre, cross-sectional study from the Spanish VACH Cohort. 922 women on stable ART without lipid-lowering treatment were included. RESULTS: Median age was 42 years, median CD4 lymphocyte count was 544 cells/mm3, and 85.6% presented undetectable HIV-1 viral load. Median total cholesterol (TC) was 189 mg/dL (interquartile range, IQR, 165-221), HDL cholesterol 53 mg/dL (IQR, 44-64), LDL cholesterol 108 mg/dL (IQR, 86-134), and triglycerides 116 mg/dL (IQR, 85-163). Mean accumulated time on ART was 116 months; 47.4% were on NNRTI-based regimes, 44.7% on PI, and 6.7% on only-NRTI therapy. 43.8% were also hepatitis C (HCV) coinfected. Patients on PI treatment presented higher TC/HDL ratio than those on NNRTI (p < 0.001). Significantly higher HDL values were observed in NNRTI-treated patients. HCV-coinfected patients presented lower TC/HDL ratio than the non HCV-coinfected. In multivariate analysis, factors independently associated with TC/HDL ratio were age, triglyceride levels and HCV co-infection. PI treatment presented a non-significant association with higher TC/HDL ratio. CONCLUSIONS: In HIV-infected women, the NNRTI-based ART is associated with a better lipid profile than the PI-based. Factors unrelated to ART selection may also exert an independent, significant influence on lipids; in particular, age, and triglyceride levels are associated with an increased TC/HDL ratio while HCV co-infection is associated with a reduced TC/HDL ratio.

Do HIV-Infected Immigrants Initiating HAART have Poorer Treatment-Related Outcomes than Autochthonous Patients in Spain? Results of the GESIDA 5808 Study.

OBJECTIVE: currently, 12% of the Spanish population is foreign-born, and a third of newly diagnosed HIV-infected patients are immigrants. We determined whether being an immigrant was associated with a poorer response to antiretroviral treatment. METHODS: historical multicenter cohort study of naïve patients starting HAART. The primary endpoint was time to treatment failure (TTF) defined as virological failure (VF), death, opportunistic disease, treatment discontinuation (D/C), or missing patient. Secondary endpoints were TTF expressed as observed data (TFO; censoring missing patients) and time to virological failure (TVF; censoring missing patients and D/C not due to VF). A multivariate analysis was performed to control for confounders. RESULTS: a total of 1090 treatment-naïve HIV-infected patients (387 immigrants and 703 autochthonous) from 33 hospitals were included. Most immigrants were from Sub-Saharan Africa (28.3%) or South-Central America/Caribbean (31%). Immigrants were significantly younger (34 y vs. 39 y), more frequently female (37.5% vs. 24.6%), with less HCV coinfection than autochthonous patients (7% vs. 31.3%). There were no differences in baseline viral load (4.95 Log(10) vs. 4.98 Log(10)), CD4 lymphocyte count (193.5/µL vs. 201.5/µL), late initiation of HAART (56.4% vs. 56.0%), or antiretrovirals used. Cox-regression analysis (HR; 95%CI) did not show differences in TTF (0.89; 0.66-1.20), TFO (0.95; 0.66-1.36), or TVF (1.00; 0.57-1.78) between immigrants and autochthonous patients. Losses to follow-up were more frequent among immigrants (17.8% vs. 12.1; p=0.009). Sub-Saharan African patients and immigrant females had a significantly shorter TTF. CONCLUSIONS: the response to HAART among immigrant patients was similar to that of autochthonous patients, although they had a higher rate of losses to follow-up. Sub-Saharan Africans and immigrant females may need particular measures to avoid barriers hindering antiviral efficacy.

Indicadores de calidad asistencial de GESIDA para la atención de personas infectadas por el VIH/sida / No disponible

Los sistemas de garantía de calidad asistencial tienen una cierta tradición en España y mucho mayor en los países anglosajones, pero en el campo de la infección VIH es escasa su implantación. Aunque ello podía ser comprensible al inicio de la epidemia por la incertidumbre que rodeaba a la enfermedad, desde hace varios años existe suficiente solidez científica en muchos aspectos de su abordaje, concretada en numerosas guías de tratamiento y práctica clínica. Esto ha inducido a GESIDA a realizar los presentes indicadores de calidad asistencial para la atención de personas infectadas por el VIH/sida. Un comité de profesionales, con la asesoría del Instituto Universitario Avedis Donabedian, redactó un primer borrador, posteriormente evaluado por un equipo de asesores externos y expuesto en la página web de la Sociedad. Las sugerencias fueron en parte incorporadas al texto final, resultando un total de 66 indicadores (estructura: 5; proceso: 45; resultados: 16) en las siguientes áreas: Condiciones estructurales, Diagnóstico y evaluación, Seguimiento e intervenciones de prevención, Seguimiento de pacientes en tratamiento, Aspectos específicos en la mujer, Comorbilidades, Hospitalización, Índices de mortalidad, Formación e investigación. En cada indicador se especifican los apartados que garantizan su validez y fiabilidad: justificación, dimensión, fórmula, explicación de términos, población, tipo, fuente de datos, estándar y comentarios. Finalmente, se seleccionaron 22 indicadores considerados como relevantes y que GESIDA entiende que todas las unidades VIH deberían monitorizar para conocer en todo momento sus resultados en esos aspectos de la práctica asistencial y así poder introducir medidas de mejora

Spain has some tradition of quality assurance systems, although less than in Anglo-Saxon countries. However, there is scarce implantation of these systems in the field of HIV infection. While this scarcity could be explained by the uncertainty surrounding the disease at the beginning of the epidemic, for several years there has been solid scientific evidence on many features of the approach to this disease, established in the various treatment and clinical practice guidelines. Consequently, the AIDS Study Group [Grupo de Estudio del Sida (GESIDA)] designed the present quality of care indicators for persons with HIV/AIDS. The first draft was developed by a committee of health professionals, with the guidance of the Avedis Donebadian University Institute. This draft was then evaluated by a team of external reviewers and posted on the Web page of the Society's web page. Some of the suggestions were included in the final document, with 66 indicators (structure: 5, process: 45, results: 16) in the following areas: structural conditions, diagnosis and evaluation, follow-up and preventive interventions, follow-up of patients under treatment, specific aspects in women, comorbidities, hospitalization, mortality rates, training and research. In each indicator, the sections guaranteeing the indicators' validity and reliability are specified: justification of the indicator as a measure of quality, the healthcare dimension evaluated, mathematical formula, explanation of terms, population, type of indicator (structure, process result), data source, the standard to be achieved and commentaries on the validity of the indicator. Finally, 22 indicators deemed relevant were chosen. GESIDA believes that these indicators should be constantly monitored in all HIV units to identify their results at all times and thus be able to introduce improvement measures

Characteristics and outcome of HIV infection in gypsies in the Spanish VACH Cohort

Objective To study the characteristics of HIV infection in the gypsy (Roma) population in Spain, as compared with those of the Caucasian, non-gypsy majority. Design Cross-sectional, historical cohort study from the Spanish VACH Cohort. Methods Patients attending VACH clinics between 1 June 2004 and 30 November 2004 were classified according to their racial and ethnic origin as “gypsies”, Caucasian non-gypsy Spanish natives (CNGN), and “other” (the last being excluded from this study). Their sociodemographic and clinico-epidemiological characteristics were compared, as well as the Kaplan–Meier curves of time to AIDS, or death, or disease progression (either of the 2 outcomes).Results4819 (48%) of 10,032 cases included in the VACH database were eligible: 210 (4.2%) were gypsies and 4252 (84.8%) were CNGN. Differences were observed in age, household, academic, inmate, marital, and employment history. Injecting drug use had been the most frequent mechanism of transmission in both groups, but to a greater extent among gypsies (72% versus 50%; P<0.000). Sex distribution, CD4 cell counts, and viral loads at the first visit were similar in the 2 groups, as was the percentage of patients with previous AIDS, percentage receiving antiretrovirals, and percentage subsequently starting antiretroviral therapy. Up to 1 April 2005, 416 new AIDS cases and 85 deaths were recorded. The percentage of these outcomes did not differ between groups, but log-rank test showed a shorter time to AIDS and disease progression among gypsies. Conclusions The sociodemographic characteristics of gypsies, the largest minority in the VACH Cohort, show differences relative to those of CNGN. HIV-related outcomes suggest that gypsies have a poorer prognosis (AU)

Objetivo estudiar las características de la infección por el VIH en gitanos en España, en comparación con las de la mayoría caucásica no gitana (CNG).Métodos estudio transversal y de cohortes históricas en la Cohorte VACH. Clasificamos a los pacientes que acudieron a las clínicas participantes en VACH entre el 1 de junio de 2004 y el 30 de noviembre de 2004 de acuerdo a su raza y etnia, como «gitanos», «nativos españoles CNG» u «otros» (estos, excluidos de este estudio). Comparamos sus características sociodemográficas y clinicoepidemiológicas, así como sus curvas de Kaplan–Meier del tiempo hasta sida, muerte o progresión de la enfermedad (cualquiera de ambos).Resultados4819 (48%) de 10.032 casos recogidos en la base de datos de VACH fueron incluidos en el estudio: 210 (4,2%) eran gitanos y 4.252 (84,8%) eran nativos CNG. Observamos diferencias en sus distribuciones por edad, domicilio, estudios, antecedentes penales, situación laboral y marital. La inyección de drogas había sido el mecanismo de transmisión del VIH más frecuente en los dos grupos, pero más marcadamente en los gitanos (72% frente a 50%; p<0,000). La distribución por sexos, los recuentos de linfocitos CD4 y las cargas virales en la primera visita fueron similares en ambos grupos, así como las proporciones de pacientes con sida previo y las de quienes estaban ya en, o iniciaron entonces, tratamiento antirretroviral. Hasta el 1 de abril de 2005 se registraron 416 nuevos casos de sida y 85 muertes. La proporción de ambos resultados fue similar en ambos grupos, pero la prueba del rango logarítmico demostró una evolución más rápida a sida y a progresión de la (..) (AU)

La epidemiología de la infección por el virus de la inmunodeficiencia humana a través de estudios de cohortes: una mirada hacia el pasado con intención de influir en el futuro / Epidemiology of HIV infection through cohort studies: A look on the past in order to influence on the future

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Characteristics and outcome of HIV infection in gypsies in the Spanish VACH Cohort.

OBJECTIVE: To study the characteristics of HIV infection in the gypsy (Roma) population in Spain, as compared with those of the Caucasian, non-gypsy majority. DESIGN: Cross-sectional, historical cohort study from the Spanish VACH Cohort. METHODS: Patients attending VACH clinics between 1 June 2004 and 30 November 2004 were classified according to their racial and ethnic origin as "gypsies", Caucasian non-gypsy Spanish natives (CNGN), and "other" (the last being excluded from this study). Their sociodemographic and clinico-epidemiological characteristics were compared, as well as the Kaplan-Meier curves of time to AIDS, or death, or disease progression (either of the 2 outcomes). RESULTS: 4819 (48%) of 10,032 cases included in the VACH database were eligible: 210 (4.2%) were gypsies and 4252 (84.8%) were CNGN. Differences were observed in age, household, academic, inmate, marital, and employment history. Injecting drug use had been the most frequent mechanism of transmission in both groups, but to a greater extent among gypsies (72% versus 50%; P<0.000). Sex distribution, CD4 cell counts, and viral loads at the first visit were similar in the 2 groups, as was the percentage of patients with previous AIDS, percentage receiving antiretrovirals, and percentage subsequently starting antiretroviral therapy. Up to 1 April 2005, 416 new AIDS cases and 85 deaths were recorded. The percentage of these outcomes did not differ between groups, but log-rank test showed a shorter time to AIDS and disease progression among gypsies. CONCLUSIONS: The sociodemographic characteristics of gypsies, the largest minority in the VACH Cohort, show differences relative to those of CNGN. HIV-related outcomes suggest that gypsies have a poorer prognosis.

[GESIDA quality care indicators for the care of persons infected by HIV/AIDS]. / Indicadores de calidad asistencial de GESIDA para la atención de personas infectadas por el VIH/sida.

Spain has some tradition of quality assurance systems, although less than in Anglo-Saxon countries. However, there is scarce implantation of these systems in the field of HIV infection. While this scarcity could be explained by the uncertainty surrounding the disease at the beginning of the epidemic, for several years there has been solid scientific evidence on many features of the approach to this disease, established in the various treatment and clinical practice guidelines. Consequently, the AIDS Study Group [Grupo de Estudio del Sida (GESIDA)] designed the present quality of care indicators for persons with HIV/AIDS. The first draft was developed by a committee of health professionals, with the guidance of the Avedis Donebadian University Institute. This draft was then evaluated by a team of external reviewers and posted on the Web page of the Society's web page. Some of the suggestions were included in the final document, with 66 indicators (structure: 5, process: 45, results: 16) in the following areas: structural conditions, diagnosis and evaluation, follow-up and preventive interventions, follow-up of patients under treatment, specific aspects in women, comorbidities, hospitalization, mortality rates, training and research. In each indicator, the sections guaranteeing the indicators' validity and reliability are specified: justification of the indicator as a measure of quality, the healthcare dimension evaluated, mathematical formula, explanation of terms, population, type of indicator (structure, process result), data source, the standard to be achieved and commentaries on the validity of the indicator. Finally, 22 indicators deemed relevant were chosen. GESIDA believes that these indicators should be constantly monitored in all HIV units to identify their results at all times and thus be able to introduce improvement measures.

Bacterial meningitis in HIV-1-infected patients in the era of highly active antiretroviral therapy.

BACKGROUND: The burden that spontaneous bacterial meningitis (SBM) currently represents among HIV-1-infected patients is poorly known. METHODS: We prospectively evaluated 32 episodes of SBM in HIV-1-infected patients from the VACH (VIH-Aplicación de Control Hospitalario) Cohort and compared findings with those of 267 episodes in uninfected persons, matched by age and year of infection. A group of 13,187 HIV-1-infected patients from the VACH Cohort were used to identify predictors for acquiring SBM. RESULTS: Between 1997 and 2006, we found 32 episodes of SBM among HIV-1-infected patients for an annual incidence rate of 62.0 cases per 100,000 population compared with 3.2 (3.0 to 3.4) per 100,000 population for uninfected patients (P < 0.001). The last CD4 >or=200/mm count was the only predictor for developing SBM. Compared with uninfected, HIV-1-infected patients with SBM had a greater prevalence of primary extrameningeal infection, especially pneumonia (P = 0.02), bacteremia (P = 0.02), focal neurologic signs (P = 0.005), seizures (P = 0.06), a lower cerebrospinal fluid to blood glucose ratio (P = 0.02), and a lower prevalence of nuchal rigidity (P = 0.005). Streptococcus pneumoniae was the most frequent etiologic agent among HIV-1-infected patients. HIV-1-infected patients had neurologic complications more frequently (P = 0.02), a higher overall case fatality rate (P = 0.004), and greater incidence of neurologic sequelae (P = 0.001). CONCLUSIONS: Even in the highly active antiretroviral therapy era, the risk of developing SBM is 19 times higher among HIV-1-infected patients than among uninfected ones. It tends to present in severely immunosuppressed patients not previously vaccinated and off antiretroviral therapy, with a concomitant extrameningeal infection, bacteremia, and focal neurologic signs, and is caused by S. pneumoniae. SBM in HIV-1-infected patients carries a worse prognosis than in uninfected ones both in terms of lethality and sequelae.

Effectiveness and safety of didanosine, lamivudine and efavirenz versus zidovudine, lamivudine and efavirenz for the initial treatment of HIV-infected patients from the Spanish VACH cohort.

BACKGROUND: Preliminary data suggest that a once-daily combination of lamivudine, didanosine and efavirenz is an effective alternative regimen for antiretroviral-naive HIV-1-infected patients. However, data from randomized trials comparing this combination versus standard first-line regimens are not available yet. In an observational study, we analyse the efficacy and tolerability of didanosine plus lamivudine and efavirenz versus zidovudine plus lamivudine and efavirenz in a cohort of therapy naive patients. METHODS: We performed an observational study on prospectively collected data from patients participating in a multicentre Spanish treatment-naive cohort (VACH cohort). Efficacy was assessed comparing time to therapeutic failure and CD4 cell recovery. Safety was analysed comparing the proportion of patients who discontinued therapy for toxicity or any other reason. RESULTS: Overall, 219 patients treated with once-daily didanosine/lamivudine/efavirenz and 409 patients receiving twice-daily zidovudine/lamivudine (Combivir) plus efavirenz were evaluated. By intent-to treat analysis (non-completers and therapeutic change=failure), time to treatment failure was similar in both groups of treatment: 40.0 months (95% CI 23.3-56.8 months) among patients on didanosine/lamivudine/efavirenz and 33.3 months (95% CI 25.6-41.1 months) in patients treated with zidovudine/lamivudine/efavirenz (P=0.253). The risk of failure due to treatment change was almost double among patients treated with zidovudine/lamivudine/efavirenz compared with those who received didanosine/lamivudine/efavirenz. CONCLUSIONS: Our data suggest that didanosine/lamivudine/efavirenz is a combination with an efficacy comparable to zidovudine/lamivudine/efavirenz as first-line therapy for HIV infection. The risk of treatment change was significantly higher among patients treated with zidovudine/lamivudine/efavirenz than in those starting therapy with didanosine/lamivudine/efavirenz.