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.

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)

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.

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.

First-line antiretroviral therapy with efavirenz or lopinavir/ritonavir plus two nucleoside analogues: the SUSKA study, a non-randomized comparison from the VACH cohort.

BACKGROUND: Efavirenz and lopinavir/ritonavir are both recommended antiretroviral agents for combination first-line therapy, although information on direct comparisons between them is scarce. A retrospective longitudinal study from the VACH cohort comparing both regimens was performed. METHODS: Efficacy was examined comparing time to virological failure, CD4 recovery and clinical progression. Tolerability was examined comparing time to treatment discontinuation for any reason and for toxicity. Survival analysis was conducted using the Kaplan-Meier method, and standard and weighted Cox regression models. RESULTS: A total of 1550 antiretroviral-naive patients starting a two-nucleoside reverse transcriptase inhibitor regimen plus either efavirenz (n = 1159) or lopinavir/ritonavir (n = 391) were included in the study. At baseline, patients starting lopinavir/ritonavir had higher HIV-1 RNA and lower CD4+ cell counts. There was no difference in the adjusted hazards of virological failure [efavirenz versus lopinavir/ritonavir hazard ratio (HR) = 0.93, 95% confidence interval (CI): 0.77-1.12, P = 0.43], CD4 recovery (HR = 1.11, 95% CI: 0.95-1.30, P = 0.19) and clinical progression (HR = 0.71, 95% CI: 0.39-1.31, P = 0.27). There was an increased risk of discontinuation for any reason or for toxicity for lopinavir/ritonavir (HR = 2.10, 95% CI: 1.40-3.15, P = 0.0003). CD4 recovery with both drugs was also similar in the lowest CD4 strata. A higher risk of early hypertriglyceridaemia was associated with lopinavir/ritonavir-based regimens. CONCLUSIONS: Our study suggests similar virological efficacy for efavirenz- or lopinavir/ritonavir-based first-line antiretroviral regimens, but an increased risk of discontinuation because of toxicity in case of lopinavir/ritonavir-based therapy. Immunological outcome appeared similar with both regimens.

[Delayed diagnosis of HIV infection in the Spanish VACH cohort [1997-2002]]. / Diagnóstico tardío de la infección por el virus de la inmunodeficiencia humana en la Cohorte VACH (1997-2002).

OBJECTIVE: To study the prevalence of delayed diagnosis of HIV infection and associated factors. METHODS: A cross sectional study of patients included in the Spanish VACH cohort who had been diagnosed with HIV infection between 1997 and 2002 was performed. Delayed diagnosis was defined as patients diagnosed with HIV infection and AIDS simultaneously or within the first month after the first positive serologic test, or those with a first CD4+ cell count below 200/ml. The epidemiological characteristics of these patients were compared with those of the remaining patients RESULTS: Of 2,820 new cases of HIV infection, delayed diagnosis was found in 506 (18%). These patients differed from the remaining patients in their lower mean age and higher HIV viral load, as well as in their distribution by sex (higher proportion of males), occupational status, history of incarceration in prison, and HIV-risk transmission group. The median survival during follow-up was significantly lower among AIDS patients with a delayed diagnosis. CONCLUSIONS: Delayed diagnosis remains a cause for concern in our environment, due to its magnitude and its association with mortality. Some epidemiological characteristics provide clues to guide future programs directed at increasing information and improving prevention.

Diagnóstico tardío de la infección por el virus de la inmunodeficiencia humana en la Cohorte VACH (1997-2002) / Delayed diagnosis of HIV infection in the Spanish VACH cohort [1997-2002]

Objetivo: Estudiar la prevalencia del diagnóstico tardío (DT) de la infección por el virus de la inmunodeficiencia humana (VIH) y sus factores asociados. Métodos: Estudio transversal sobre los pacientes incluidos en la cohorte VACH cuya infección por el VIH hubiese sido diagnosticada entre 1997 y 2002. Consideramos DT los casos diagnosticados de sida concomitantemente o dentro del primer mes desde la primera serología positiva, o con recuento de CD4+ < 200/ml. Comparamos sus características epidemiológicas con las de los demás pacientes. Resultados: De 2.820 nuevos casos de infección por el VIH, 506 (18%) tuvieron DT. Éstos difirieron del resto en su menor edad media, mayor carga viral y en su distribución por sexos (mayor proporción de hombres), situación laboral, antecedentes penitenciarios y grupo de riesgo. La mediana de supervivencia durante el seguimiento fue menor en el grupo de DT. Conclusiones: El DT continúa siendo un problema preocupante por su magnitud y asociación con la mortalidad. Algunas características epidemiológicas proporcionan indicios para orientar futuros programas de información y prevención

Objective: To study the prevalence of delayed diagnosis of HIV infection and associated factors. Methods: A cross sectional study of patients included in the Spanish VACH cohort who had been diagnosed with HIV infection between 1997 and 2002 was performed. Delayed diagnosis was defined as patients diagnosed with HIV infection and AIDS simultaneously or within the first month after the first positive serologic test, or those with a first CD4+ cell count below 200/ml. The epidemiological characteristics of these patients were compared with those of the remaining patients Results: Of 2,820 new cases of HIV infection, delayed diagnosis was found in 506 (18%). These patients differed from the remaining patients in their lower mean age and higher HIV viral load, as well as in their distribution by sex (higher proportion of males), occupational status, history of incarceration in prison, and HIV-risk transmission group. The median survival during follow-up was significantly lower among AIDS patients with a delayed diagnosis. Conclusions: Delayed diagnosis remains a cause for concern in our environment, due to its magnitude and its association with mortality. Some epidemiological characteristics provide clues to guide future programs directed at increasing information and improving prevention

[Changing trends in HIV epidemics: recent diagnoses in the Spanish VACH cohort (2000-2002)]. / Patrón epidemiológico de la infección por el VIH en 15 hospitales españoles: casos de nuevo diagnóstico incluidos en la cohorte VACH en 2001 y 2002.

BACKGROUND: Studying the changing trends of HIV epidemics is a useful means of evaluating the results of current preventive plans as well as of defining future needs and objectives. METHODS: We performed a cross-sectional study of the newly-diagnosed cases of HIV infection included in the Spanish VACH cohort. New HIV cases were defined as those diagnosed between January 2001 and December 2002. Their epidemiologic characteristics were compared with those of patients included in the same cohort who had been diagnosed between January 1998 and December 2000. RESULTS: We studied 603 new cases (27% women). In 146 (24.4%) HIV infection had been acquired by sharing material for intravenous drug use (IVDU), 171 (28,6%) were men who had had sex with other men (MSM) and 247 (41.3%) acknowledged some risk for heterosexual HIV transmission. The median age was 36 years (range: 18-80). Only 1.5% of the patients were younger than 20 years while 32.1% were older than 40 years. This percentage was significantly higher than that corresponding to 1998-2000 (27.5%; p < 0,05). HIV infection was diagnosed simultaneously with an AIDS-defining condition in 13.3% of patients and an AIDS-defining disease was diagnosed in the first month after HIV-diagnosis in another 40 patients (6.6%). CONCLUSIONS: We confirm the trends observed in previous studies: a growing proportion of newly diagnosed cases among women, a decreasing proportion of IVDU, a growth of MSM, and a trend toward diagnosis at a later age.

Patrón epidemiológico de la infección por el VIH en 15 hospitales españoles: casos de nuevo diagnóstico incluidos en la cohorte VACH en 2001 y 2002 / Changing trends in HIV epidemics: recent diagnoses in the Spanish VACH cohort (2000-2002)

ANTECEDENTES. El estudio de los cambios en las tendencias de la epidemia del virus de la inmunodeficiencia humana(VIH) constituye un método útil para evaluar los resultados de los planes preventivos actuales, así como para definir futuras necesidades y objetivos de los próximos. MÉTODOS. Estudio descriptivo transversal de los casos nuevos incluidos en la cohorte VACH. Definimos “caso nuevo” a los sujetos cuyo diagnóstico de infección por el VIH se realizó entre enero de 2001 y diciembre de 2002. Comparamos sus características epidemiológicas con las de los sujetos incluidos en la misma cohorte diagnosticados de infección por el VIH entre enero de 1998 y diciembre de 2000. RESULTADOS. Estudiamos 603 nuevos casos (27% mujeres).En 146 (24,4%) el riesgo de transmisión había sido el uso de drogas (usuarios de drogas por vía parenteral, UDVP),171 (28,6%) eran hombres que tuvieron relaciones sexuales con otros hombres (HSH) y 247 (41,3%) reconocían alguna exposición heterosexual de riesgo. La mediana de edad fue 36 años (límites: 16-80). Solamente 1,5% tenían menos de 20 años y 32,1% superaban 40 años. Este porcentaje fue significativamente superior al correspondiente al trienio 98-00 (27,5%; p < 0,05). La infección por VIH se diagnosticó simultáneamente con alguna complicación definitoria de sida en 13,3% casos y otros 40 pacientes (6,6%) la desarrollaron durante el primer mes tras el diagnóstico. CONCLUSIONES. Confirmamos las tendencias observadas en estudios previos: crecimiento de la proporción de mujeres con diagnóstico reciente de VIH, progresiva disminución de la proporción de UDVP y aumento de HSH y tendencia al diagnóstico en edades más avanzadas (AU)

BACKGROUND. Studying the changing trends of HIV epidemics is a useful means of evaluating the results of current preventive plans as well as of defining future needs and objectives. METHODS. We performed a cross-sectional study of the newly-diagnosed cases of HIV infection included in the Spanish VACH cohort. New HIV cases were defined as those diagnosed between January 2001 and December 2002. Their epidemiologic characteristics were compared with those of patients included in the same cohort who had been diagnosed between January 1998 and December 2000. RESULTS. We studied 603 new cases (27% women). In 146 (24.4%) HIV infection had been acquired by sharing material for intravenous drug use (IVDU), 171 (28,6%) were men who had had sex with other men (MSM) and 247 (41.3%) acknowledged some risk for heterosexual HIV transmission. The median age was 36 years (range: 18-80).Only 1.5% of the patients were younger than 20 years while 32.1% were older than 40 years. This percentage was significantly higher than that corresponding to 1998-2000 (27.5%; p < 0,05). HIV infection was diagnosed simultaneously with an AIDS-defining condition in 13.3% of patients and an AIDS-defining disease was diagnosed in the first month after HIV-diagnosis in another 40 patients (6.6%). CONCLUSIONS. We confirm the trends observed in previous studies: a growing proportion of newly diagnosed cases among women, a decreasing proportion of IVDU, a growth of MSM, and a trend toward diagnosis at a later age (AU)

Hepatitis C virus and human immunodeficiency virus coinfection in Spain.

OBJECTIVE AND METHODS: In a cross-sectional study, based on a cohort composed of HIV-infected patients of fifteen tertiary level institutions of Spain, the main data of the entire cohort are described, characteristics of patients with or without hepatitis C coinfection are compared, and the possible association of hepatitis C virus coinfection with socioeconomic, HIV-related, and hepatitis B-related variables is assessed. RESULTS: A total of 4,709 patients are studied. Median of age is 37 years, 78.3% are male. HIV risk behaviours are: parenteral drug use in 63.8% of patients, heterosexual in 22.3%, and homosexual in 10.8%. Serology of hepatitis C is positive in 69.2% of participants. The following variables are associated with increased prevalence of hepatitis C coinfection, both in univariate and in multivariate analysis: HIV risk behaviour, positive anti-HBs, longer time elapsed since HIV infection diagnosis, younger age, lower social status, lower CD4 cell count increase between nadir and last available result, and lower educational level (all P<0.001). Patients with heterosexual behaviour are more frequently coinfected than patients with homosexual behaviour (P<0.001). CONCLUSION: This study highlights that, in Spain, more than two thirds of patients with HIV infection are coinfected with hepatitis C virus.

Diagnóstico de toxoplasmosis cerebral en un paciente inmunocompetente / Diagnosis of cerebral toxoplasmosis in an immunocompetent patient

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