Switching to Dolutegravir/lamivudine or Bictegravir/Emtricitabine/Tenofovir alafenamide. A comparative real-world study.

BACKGROUND: This real-world study compared the safety and effectiveness of Dolutegravir/lamivudine (D/L) and Bictegravir/Emtricitabine/Tenefovir alafenamide (B/F/T) switch therapy regimens for people living with HIV (PLWH). METHODS: The retrospective study conducted from April 2019 to November 2022, included PLWH with < 50 copies/mL of HIV-RNA prior to recruitment who initiated either D/L or B/F/T switching therapy. The primary objective was to evaluate treatment discontinuation rates; safety and virologic outcomes were also evaluated. RESULTS: 690 PLWH were included, 358 in the D/L and 332 in the B/F/T, and a median follow-up of 728 and 1013 days, respectively. The discontinuation proportions were 8.7% (31 participants, incidence rate of 4.44 per 100 PYFU in the D/L group and 15.3% (51 participants, incidence rate of 6.25 per 100 PYFU) in the B/F/T group. The adjusted hazard ratio for B/F/T discontinuation compared to D/L was 1.20 (95% CI: 0.71;2.0; p = 0.494). Virologic failure (VL > 200 copies/mL in two consecutive measurements) occurred in 1.1% and 0.9% of patients in the D/L and B/F/T groups, respectively. Notably, one patient in D/L group with severe non-adherence and virologic failure developed resistance mutations. CONCLUSIONS: Switching to either B/T/F or D/L treatment for PLWH was effective and well tolerated in this real-world study. Treatment discontinuation rates did not significantly differ between the two regimens.

Development and Validation of a Risk Score for Predicting Non-Adherence to Antiretroviral Therapy.

Several patient-related factors that influence adherence to antiretroviral therapy (ART) have been described. However, studies that propose a practical and simple tool to predict nonadherence after ART initiation are still scarce. In this study, we develop and validate a score to predict the risk of nonadherence in people starting ART. The model/score was developed and validated using a cohort of people living with HIV starting ART at the Hospital del Mar, Barcelona, between 2012 and 2015 (derivation cohort) and between 2016 and 2018 (validation cohort),. Adherence was evaluated every 2 months using both pharmacy refills and patient self-reports. Nonadherence was defined as taking <90% of the prescribed dose and/or ART interruption for more than 1 week. Predictive factors for nonadherence were identified by logistic regression. Beta coefficients were used to develop a predictive score. Optimal cutoffs were identified using the bootstrapping methodology, and performance was evaluated with the C statistic. Our study is based on 574 patients: 349 in the derivation cohort and 225 in the validation cohort. A total of 104 patients (29.8%) of the derivation cohort were nonadherent. Nonadherence predictors were patient prejudgment; previous medical appointment failures; cultural and/or idiomatic barriers; heavy alcohol use; substance abuse; unstable housing; and severe mental illness. The cutoff point (receiver operating characteristic curve) for nonadherence was 26.3 (sensitivity 0.87 and specificity 0.86). The C statistic (95% confidence interval) was 0.91 (0.87-0.94). These results were consistent with those predicted by the score in the validation cohort. This easy-to-use, highly sensitive, and specific tool could be easily used to identify patients at highest risk for nonadherence, thus allowing resource optimization and achieving optimal treatment goals.

Impact of the COVID-19 pandemic: Community and hospital shared pharmaceutical care model. Satisfaction and acceptability of patients with HIV infection on antiretroviral treatment / Impacto de la pandemia COVID-19: Modelo de atención farmacéutica compartida comunitaria y hospitalaria. Satisfacción y aceptabilidad depacientes con infección VIH en tratamiento antirretroviral

Background. The health crisis due to the COVID-19 pandemic is a challenge in the dispensing of outpatient hospital medication (OHM). Models of Antiretroviral Therapy (ART) based on community pharmacy support (ARTCP) have proven to be successful. The aim was to evaluate the degree of satisfaction, acceptability and limitations of the implementation of ARTCP, in the context of a pandemic, in our environment. Methods. Descriptive cross-sectional study carried out in a Barcelona hospital, during the months of July-November 2020. A telephone survey was carried out via a questionnaire on the quality dimensions of the model (degree of satisfaction, acceptability) and associated inconveniences. Data collected: demographics, antiretroviral treatment (ART), concomitant medication, drug interactions (DDIs), CD4 lymphocyte count and plasma viraemia. Data analysis included descriptive statistics. Results. A total of 533 (78.0%) HIV patients receiving ART were included. 71.9% (383/533) of these patients were very satisfied and 76.2% preferred attending the community pharmacy rather than the hospital. The mean satisfaction rating was 9.3 (DS: 1.4). The benefits reported were: 1) proximity to home (406: 76.1%); 2) lower risk of contagion of COVID-19 (318: 59.7%); 3) shorter waiting time (201: 37.1%); 4) time flexibility (104: 19.5%); 5) reduction of financial expenses (35: 6.57%). A total of 11 (2%) patients reported no benefit. Only 22.9% reported disadvantages associated with ARTCP: 1) lack of privacy (65: 12.2%); 2) lack of coordinationorganization (57: 10.7%). Conclusion. The COVID-19 pandemic has had an impact on the provision of pharmaceutical care for HIV patients. The ARTPC model has proved efficient, with patients reporting a high degree of satisfaction. (AU)

Introducción. La crisis sanitaria por la pandemia COVID-19 plantea un desafío en la dispensación de la medicación hospitalaria de dispensación ambulatoria (MHDA). Los modelos de terapia antirretroviral basados en el apoyo de la farmacia comunitaria (TARFC) han demostrado tener éxito. El objetivo del estudio fue evaluar el grado de satisfacción, aceptabilidad y limitaciones de la implementación del TARFC, en contexto de pandemia, en nuestro entorno. Métodos. Estudio descriptivo transversal realizado en un hospital de Barcelona, durante los meses de julio-noviembre del 2020. Se realizó una encuesta telefónica, mediante un cuestionario sobre dimensiones de calidad del modelo (grado de satisfacción, aceptabilidad) e inconvenientes asociados. Se recogieron datos: demográficos, tratamiento antirretroviral (TAR), medicación concomitante, interacciones farmacológicas (DDIs), recuento de linfocitos CD4 y viremia plasmática. El análisis de datos incluyó estadística descriptiva. Resultados. Se incluyeron 533 pacientes VIH adherentes al TAR. El 71,9% (383/533) de pacientes estaban muy satisfechos y el 76,2% preferían acudir a la farmacia comunitaria frente a la hospitalaria. La calificación de satisfacción media fue de 9,3 (DS: 1,4). Los beneficios reportados fueron: 1) cercanía al domicilio (406: 76,1%); 2) menor riesgo de contagio de COVID-19 (318: 59,7%) 3) menor tiempo de espera (201: 37,1%); 4) flexibilidad horaria (104: 19,5%); 5) reducción de gastos económicos (35: 6,57%). Un total de 11 (2%) pacientes no reportaron ningún beneficio. Únicamente el 22,9% reportaron desventajas asociadas al TARFC: 1) falta de privacidad (65:12,2%); 2) falta de coordinación-organización (57: 10,7%) Conclusión. La pandemia de COVID-19 tiene un impacto en la prestación de atención farmacéutica al VIH. El modelo TARFC ha resultado eficiente con un elevado grado de satisfacción por parte de los pacientes. (AU)

Bone density, microarchitecture, and tissue quality after 1 year of treatment with tenofovir disoproxil fumarate.

OBJECIVE: Bone mineral density (BMD) measured by dual-energy X-ray absorptiometry (DXA) is used to assess bone health in HIV patients. DXA measures the amount of mineral, but not other key aspects of bone strength such as bone microarchitecture or bone quality. Trabecular bone score (TBS) and in-vivo microindentation directly measure trabecular microarchitecture and bone tissue quality, respectively. The aim of this study is to measure bone strength properties using these techniques. RESULTS: Forty naive HIV patients who were going to start antiretroviral therapy (ART), a single pill treatment with elvitegravir/cobicistat, tenofovir disoproxil fumarate (TDF), emtricitavine (FTC) were included. A significant reduction in BMD at spine (-3.25%, P < 0.001) and in femoral neck (-3.82%, P = 0.016) between baseline and 48 weeks of treatment were found. Bone microarchitecture score at the spine, as measured by TBS, also significantly decreased from 1.357 (0.09) to 1.322 (0.09) (-2.5%, P = 0.011) between baseline to 48 weeks of treatment. Microindentation (BMSi) values were significantly higher than at baseline [89.04 (4.2) versus 86.07 (6.1); 3.49%, P < 0.001] after 48 weeks of TDF-based ART treatment, indicating improved bone material properties CONCLUSION:: A significant decrease in BMD and TBS were observed after 1 year of TDF therapy. However, tissue quality significantly improved after 1 year of treatment, suggesting a recovery of bone material properties following the control of the infection despite the significant reduction of BMD. These techniques provide additional and necessary information to DXA about bone health in treated HIV patients, and because of its convenience and feasibility they could be routinely apply to assess bone in clinical practice.

The role of oncogenic human papillomavirus determination for diagnosis of high-grade anal intraepithelial neoplasia in HIV-infected MSM.

OBJECTIVE: To assess the oncogenic human papillomavirus (HPV) determination and the cotesting HPV and anal cytology value to detect high-grade anal intraepithelial neoplasia (HGAIN) in a cohort of HIV-MSM. DESIGN AND METHODS: Prospective study of HIV-infected MSM who underwent screening for anal dysplasia. Screening program includes anal cytology, HPV testing, and high-resolution anoscopy (HRA) at each visit. Histological samples were obtained if suspicious lesions were revealed by HRA. Sensitivity and specificity of the different tests were calculated by using histological results of HRA-guided biopsy as the reference test for HGAIN diagnosis. RESULTS: From May 2009 to August 2016, 692 HIV-infected MSM underwent 1827 anal cytologies, 1841 HRA examinations, and 1607 HPV testing. At first screening visit, anal cytology results were abnormal in 418 (60.4%) of 692 patients, and oncogenic HPV genotypes were found in 482 (79.5%) of 606 patients. Anal cytology showed a sensitivity of 89.2% [95% confidence interval (CI); 80.7-94.2] and a specificity of 44.2% (95% CI; 40.2-48.2) to detect HGAIN. Oncogenic HPV testing had 90.4% sensitivity (95% CI; 82-86.8) and 24.4% specificity (95% CI; 20.8-28.3). Cotesting showed a 97.4% sensitivity (95% CI; 91-99.3) and 14% specificity (95% CI; 11.2-17.3). In patients with atypical squamous cells of uncertain significance on cytology, oncogenic HPV testing had 91.3% sensitivity and 28.3% specificity to detect HGAIN. CONCLUSION: Abnormal cytology and oncogenic HPV determination showed similar sensitivity for detecting HGAIN. The two tests used together improved the sensitivity but with lowered specificity. In our opinion, HPV testing does not improve HGAIN detection and should not replace anal cytology as a standard screening test for HIV-infected MSM.

Impact of probiotic Saccharomyces boulardii on the gut microbiome composition in HIV-treated patients: A double-blind, randomised, placebo-controlled trial.

Dysbalance in gut microbiota has been linked to increased microbial translocation, leading to chronic inflammation in HIV-patients, even under effective HAART. Moreover, microbial translocation is associated with insufficient reconstitution of CD4+T cells, and contributes to the pathogenesis of immunologic non-response. In a double-blind, randomised, placebo-controlled trial, we recently showed that, compared to placebo, 12 weeks treatment with probiotic Saccharomyces boulardii significantly reduced plasma levels of bacterial translocation (Lipopolysaccharide-binding protein or LBP) and systemic inflammation (IL-6) in 44 HIV virologically suppressed patients, half of whom (n = 22) had immunologic non-response to antiretroviral therapy (<270 CD4+Tcells/µL despite long-term suppressed viral load). The aim of the present study was to investigate if this beneficial effect of the probiotic Saccharomyces boulardii is due to modified gut microbiome composition, with a decrease of some species associated with higher systemic levels of microbial translocation and inflammation. In this study, we used 16S rDNA gene amplification and parallel sequencing to analyze the probiotic impact on the composition of the gut microbiome (faecal samples) in these 44 patients randomized to receive oral supplementation with probiotic or placebo for 12 weeks. Compared to the placebo group, in individuals treated with probiotic we observed lower concentrations of some gut species, such as those of the Clostridiaceae family, which were correlated with systemic levels of bacterial translocation and inflammation markers. In a sub-study of these patients, we observed significantly higher parameters of microbial translocation (LBP, soluble CD14) and systemic inflammation in immunologic non-responders than in immunologic responders, which was correlated with a relative abundance of specific gut bacterial groups (Lachnospiraceae genus and Proteobacteria). Thus, in this work, we propose a new therapeutic strategy using the probiotic yeast S. boulardii to modify gut microbiome composition. Identifying pro-inflammatory species in the gut microbiome could also be a useful new marker of poor immune response and a new therapeutic target.

Bone Density, Microarchitecture, and Tissue Quality After Long-Term Treatment With Tenofovir/Emtricitabine or Abacavir/Lamivudine.

OBJECTIVES: HIV infection has been associated with reduced bone mineral density (BMD). Antiretroviral therapy (ART) has a deleterious effect on BMD, but its effect on bone fragility is not clear. The objective of this study is to analyze the BMD, microarchitecture, and tissue quality of bone in patients receiving long-term tenofovir- or abacavir-based ART. DESIGN: We conducted a cross-sectional study in patients with HIV undergoing tenofovir or abacavir ART for more than 5 years. METHODS: We measured BMD using dual X-ray absorptiometry ,bone michroarchitecture using trabecular bone score (TBS), and bone tissue quality using microindentation. TBS is a dual X-ray absorptiometry-based software that is more highly correlated with bone fragility than BMD. Microindentation (BMSi) directly assesses bone quality at the tissue level. RESULTS: A total of 63 patients were included in this study, with 36 belonging to the TDF-FTC group and 27 to the ABC-3TC group. Patients receiving TDF-FTC treatment showed lower BMD values than those in the ABC-3TC group. We found no differences in TBS or microindentation between the 2 groups. However, after adjusting for sex, age, body mass index, and 25[OH]vitD we found lower BMSi and thus poorer bone properties in the TDF-FTC group than in the ABC-3TC group [beta coefficient -3.594 (confidence interval: 95% -0.12 to -7.61); P = 0.043]. CONCLUSIONS: Long-term treatment with TDF-FTC leads to impaired bone health, not only in terms of BMD but also in terms of bone quality, another determinant of overall bone strength. To complement BMD-based predictions, these other techniques may also be used to identify patients with excess fracture risk.

Risk factors of high-grade anal intraepithelial neoplasia recurrence in HIV-infected MSM.

OBJECTIVE: To assess risk factors of high-grade anal intraepithelial neoplasia (HGAIN) recurrence in a cohort of HIV-infected MSM. DESIGN AND METHODS: Consecutive HIV-infected 100 MSM with a history of successfully treated intra-anal HGAIN with electrocautery were followed with anal cytology, human papillomavirus (HPV) determination, and high-resolution anoscopy (HRA) at 3-6-month intervals. HGAIN recurrence was analyzed using Kaplan-Meier analysis. Risk factors of recurrence were assessed using Cox proportional hazards regression. The value of different tests for detecting recurrence was also assessed. RESULTS: After a mean follow-up of 17.6 months, 39 of the 100 patients [39%, 95% confidence interval (CI): 29-49] developed recurrent HGAIN, 24 at the previously treated site, and 15 at a different site. The probability of recurrence was 23.5% at 12 months (95% CI: 13.9-33.1) and 53.3% at 24 months (95% CI: 34.3-72.7). Risk factors of recurrence were presence of hepatitis C antibodies (hazard ratio 2.79; 95% CI: 1.04-7.53), nadir CD4 cell count less than 200 cells/µl (hazard ratio 2.61; 95% CI: 1.06-6.44), and HGAIN lesions affecting at least two octants of anal circumference (hazard ratio 8.27; 95% CI: 1.1-62). Infection by at least two HPV oncogenic strains increased the risk of recurrence (hazard ratio 2.3; 95% CI: 0.98-5.42). HRA, anal cytology, and oncogenic HPV determination test showed a sensitivity of 100, 79.4, and 86.7%, and a specificity of 57.7, 36.6, and 34.7%, respectively, for detecting HGAIN recurrence. CONCLUSION: The risk of HGAIN recurrence in HIV-infected MSM is high. Regular posttreatment follow-up of these patients is mandatory, and performing direct HRA appears to be the best strategy.

The Framingham function overestimates the risk of ischemic heart disease in HIV-infected patients from Barcelona.

BACKGROUND: Cardiovascular risk (CVR) assessment helps to identify patients at high CVR. The Framingham CVR score (FRS) is the most widely used methods but may overestimate risk in regions with low incidence of cardiovascular disease. The objective was to compare the 10-year performance of the original and the adapted REGICOR - Framingham CVR functions in HIV-infected individuals. METHODS: We carried out a longitudinal study of HIV-infected patients with CVR evaluation in a hospital in Barcelona between 2003 and 2013. STATISTICS: Risk probability was calculated using the FRAMINGHAM function and REGICOR adaptation to the Spanish population, and individuals were categorized in three groups (low, 0 < 5%; moderate, 5-10%; and high, >10%). For each risk group, the number of events over 10 years was calculated using the Kaplan-Meier method, and the expected number of events was calculated by multiplying the frequency of participants in the group by the mean of the probabilities from the risk function. We used the X(2) goodness-of-fit test to assess agreement between observed and expected. RESULTS: Six hundred and forty-one patients were followed up for a median of 10.2 years, and 20 ischemic heart events (IHE) were observed. The mean (95% CI) number of IHEs per 1000 person-years was 3.7 (2.06-5.27). The estimates from the Framingham and REGICOR functions were 40 and 14 IHEs, respectively. The estimate from the original Framingham function differed significantly from the observed incidence (p < 0.001), whereas that from the REGICOR-adapted function did not (p = 0.15). In terms of the number of cardiovascular events (38 events observed), the REGICOR function significantly underestimated risk (p = 0.01), whereas the estimate from the Framingham function was similar to observed (p:0.93). CONCLUSIONS: The FRS significantly overestimates risk of IHE events in our HIV-infected patients, while the REGICOR function is a better predictor of these events. In terms of cardiovascular events, the REGICOR function significantly underestimates risk, whereas the FRS is a better estimator. We recommend using CVR scales and adjusting them to the origin of the population being studied.

Brief Report: HIV Infection Is Associated With Worse Bone Material Properties, Independently of Bone Mineral Density.

Low bone mineral density (BMD) in HIV-infected individuals has been documented in an increasing number of studies. However, it is not clear whether it is the infection itself or the treatment that causes bone impairment. Microindentation measures bone material strength (Bone Material Strength index) directly. We recruited 85 patients, 50 infected with HIV and 35 controls. Median Bone Material Strength index was 84.5 (interquartile range 83-87) in HIV-infected patients and 90 (88.5-93) in controls (P < 0.001). No significant differences in BMD between cases and controls at any of the sites examined (total hip, femoral neck, and lumbar spine). HIV infection is associated with bone damage, independently of BMD.

Risk of progression to high-grade anal intraepithelial neoplasia in HIV-infected MSM.

OBJECTIVE: To assess the value of several factors to predict the risk of progression to high-grade anal intraepithelial neoplasia (HGAIN) in a cohort of HIV-infected MSM. DESIGN: Longitudinal study of 556 HIV-infected MSM who underwent screening for anal dysplasia (include anal cytology and high-resolution anoscopy at each visit). METHODS: Progression rate to HGAIN was estimated by Kaplan-Meier analysis. Predictors of progression were assessed by Cox-proportional hazards regression. RESULTS: Sixty-eight incidents HGAIN cases over 649 person-years of follow-up were diagnosed, resulting in a progression rate of 10.5 cases/100 person-years [95% confidence interval (CI), 8.1-13.3). The cumulative incidence of HGAIN was 7.2% at 12 months (95% CI, 4.3-10.1) and 16.2% at 24 months (95% CI, 11.7-20.7). Independent risk factors for progression were as follows: abnormal cytology [hazard ratio (HR), 2.5 (95% CI, 1.2-4.9) if low-grade squamous intraepithelial lesion, HR 2.76 (95% CI, 1.4-5.3) if atypical squamous cells of uncertain significance and HR 7.73 (95% CI, 2.3-25.4) if high-grade squamous intraepithelial lesion], abnormal high-resolution anoscopy (HR 3.57; 95% CI, 2-6.4) and infection by 16 or 18 human papillomavirus (HR 1.63; 95% CI, 1-2.6). To be receiving HAART (HR 0.4; 95% CI, 0.2-0.7) and have stable sexual couple (HR 0.62; 95% CI, 0.4-0.9) were protective factors. Patients with favorable predictors had an incident rate of 2.86 cases/100 person-years (95% CI, 3.5-10.3). CONCLUSION: The rate of progression to HGAIN varies according to different predictors that should be considered when assessing the particular risk of each patient. Patients with low risk of progression could be screened at longer intervals. BRIEF SUMMARY: We describe the risk of progression to HGAIN in a cohort of 556 HIV-infected MSM. The incidence rate of HGAIN varies widely according to different predictors. These factors should be considered when assessing the particular risk of each patient.

Effect of probiotics (Saccharomyces boulardii) on microbial translocation and inflammation in HIV-treated patients: a double-blind, randomized, placebo-controlled trial.

BACKGROUND: Microbial translocation has been associated with an increase in immune activation and inflammation in HIV infection despite effective highly active antiretroviral therapy. It has been shown that some probiotics have a beneficial effect by reducing intestinal permeability and, consequently, microbial translocation. OBJECTIVES: To assess changes in microbial translocation and inflammation after treatment with probiotics (Saccharomyces boulardii) in HIV-1-infected patients with virologic suppression. METHODS: A double-blind, randomized, placebo-controlled trial was conducted in 44 nonconsecutive HIV-1-infected patients with viral load of <20 copies per milliliter for at least 2 years. Patients were randomized to oral supplementation with probiotics or placebo during 12 weeks. Markers of microbial translocation (lipopolysaccharide-binding protein [LBP] and soluble CD14), inflammation (interleukin 6 [IL-6], tumor necrosis factor alpha, interferon gamma, high-sensitivity C-reactive protein), and immunological and clinical data were determined before and after the intervention and 3 months after treatment discontinuation. Quantitative variables were compared using the Mann-Whitney U test, and categorical variables were compared using the Fisher exact test. RESULTS: After 12 weeks of treatment, differences between the probiotic arm and the placebo arm were observed in LBP values (-0.30 vs +0.70 pg/mL) and IL-6 (-0.60 vs +0.78 pg/mL). These differences were also noted at 3 months after treatment withdrawal. Qualitative analysis was performed, defining a variable as "decreased" or "increased" from baseline LBP. A significant decrease of LBP at 12 weeks of treatment was observed (57.9% patients in the probiotic group vs 6.2% in the placebo group, P = 0.002). CONCLUSIONS: Treatment with S. boulardii decreases microbial translocation (LBP) and inflammation parameters (IL-6) in HIV-1-infected patients with long-term virologic suppression.

Prevalence and Factors Associated with Vitamin D Deficiency and Hyperparathyroidism in HIV-Infected Patients Treated in Barcelona.

Vitamin D deficiency is an important problem in patients with chronic conditions including those with human immunodeficiency virus (HIV) infection. The aim of this cross-sectional study was to identify the prevalence and factors associated with vitamin D deficiency and hyperparathyroidism in HIV patients attended in Barcelona. Cholecalciferol (25OH vitamin D3) and PTH levels were measured. Vitamin D insufficiency was defined as 25(OH) D < 20 ng/mL and deficiency as <12 ng/mL. Hyperparathyroidism was defined as PTH levels >65 pg/mL. Cases with chronic kidney failure, liver disease, treatments or conditions potentially affecting bone metabolism were excluded. Among the 566 patients included, 56.4% were exposed to tenofovir. Vitamin D insufficiency was found in 71.2% and 39.6% of those had deficiency. PTH was measured in 228 subjects, and 86 of them (37.7%) showed high levels. Adjusted predictors of vitamin D deficiency were nonwhite race and psychiatric comorbidity, while lipoatrophy was a protective factor. Independent risk factors of hyperparathyroidism were vitamin D < 12 ng/mL (OR: 2.14, CI 95%: 1.19-3.82, P: 0.01) and tenofovir exposure (OR: 3.55, CI 95%: 1.62-7.7, P: 0.002). High prevalence of vitamin deficiency and hyperparathyroidism was found in an area with high annual solar exposure.

Epidemiological characteristics and predictors of late presentation of HIV infection in Barcelona (Spain) during the period 2001-2009.

BACKGROUND: Early diagnosis of HIV infection can prevent morbidity and mortality as well as reduce HIV transmission. The aim of the present study was to assess prevalence, describe trends and identify factors associated with late presentation of HIV infection in Barcelona (Spain) during the period 2001-09. METHODS: Demographic and epidemiological characteristics of cases reported to the Barcelona HIV surveillance system were analysed. Late presentation was defined for individuals with a CD4 count below 350 cells/ml upon HIV diagnosis or diagnosis of AIDS within 3 months of HIV diagnosis. Multivariate logistic regression were used to identify predictors of late presentation. RESULTS: Of the 2,938 newly diagnosed HIV-infected individuals, 2,507 (85,3%) had either a CD4 cell count or an AIDS diagnosis available. A total of 1,139 (55.6%) of the 2,507 studied cases over these nine years were late presenters varying from 48% among men who have sex with men to 70% among heterosexual men. The proportion of late presentation was 62.7% in 2001-2003, 51.9% in 2004-2005, 52.6% in 2006-2007 and 52.1% in 2008-2009. A decrease over time only was observed between 2001-2003 and 2004-2005 (p = 0.001) but remained constant thereafter (p = 0.9). Independent risk factors for late presentation were older age at diagnosis (p < 0.0001), use of injected drugs by men (p < 0.0001), being a heterosexual men (p < 0.0001), and being born in South America (p < 0.0001) or sub-Saharan Africa (p = 0.002). CONCLUSION: Late presentation of HIV is still too frequent in all transmission groups in spite of a strong commitment with HIV prevention in our city. It is necessary to develop interventions that increase HIV testing and facilitate earlier entry into HIV care.

Influence of HAART on the clinical course of HIV-1-infected patients with progressive multifocal leukoencephalopathy: results of an observational multicenter study.

BACKGROUND: The aim of this study was to analyze the incidence of new cases, survival of HIV-1-infected patients with progressive multifocal leukoencephalopathy (PML), and the characteristics of PML-associated immune reconstitution inflammatory syndrome (IRIS). METHODS: Multicenter observational cohort study of all HIV-1-infected patients newly diagnosed of PML in 7 hospitals in Barcelona (Spain) from 2002 to 2006. The annual incidence of PML was calculated. Survival was estimated using the Kaplan-Meier method. IRIS was defined as new onset or rapid worsening of PML shortly after initiation of highly active antiretroviral therapy together with a decline in HIV-1 viral load and rising of CD4 lymphocytes. RESULTS: Sixty-one new cases of PML were diagnosed. The mean survival time was 15 months [95% confidence interval (CI), 11 to 19]. The Kaplan-Meier estimates of the probability of survival were 47.7% (95% CI, 35 to 59) at 6 months, 38.6% (95% CI, 25 to 51) at 12 months, 35.1% (95% CI, 22 to 48) at 24 months, and 25.1% (95% CI, 10 to 40) at 36 months. IRIS was diagnosed in 14 (23%) cases. Mortality was similar in patients with and without IRIS. CONCLUSIONS: PML continues to be one of the deadliest opportunistic infections in acquired immunodeficiency syndrome patients. The development of PML-associated IRIS has no influence on prognosis.

Global cardiovascular risk in patients with HIV infection: concordance and differences in estimates according to three risk equations (Framingham, SCORE, and PROCAM).

To compare cardiovascular risk stratification according to Framingham, PROCAM (Prospective Cardiovascular Münster), and SCORE (Systematic Coronary Risk Evaluation) equations in patients with HIV infection, a cross-sectional study of a well-characterized cohort of 760 HIV-infected adults managed at the outpatient Infectious Disease Unit in 2003 was conducted. Cardiovascular risk score was examined and patients were classified as having low, moderate, or high risk using Framingham and PROCAM (<10%, 10%-20%, and <20%, respectively) and SCORE (<3%, 3%-4%, and >/=5%, respectively) equations. The prevalence of patients with low, moderate and high cardiovascular risk was 76.6%, 15.1%, and 8.3% by the Framingham, respectively, 90.1%, 4.9%, and 5% by the PROCAM, respectively, and 88.6%, 3%, and 8.4% by SCORE, respectively. Concordance between these three risk functions was significant, but globally moderate (Framingham and PROCAM, kappa 0.36, p < 0.0001; Framingham and SCORE, kappa 0.32, p < 0.0001; PROCAM and SCORE, kappa 0.46, p < 0.0001). The Framingham equation categorized a higher proportion of HIV-infected male patients with moderate cardiovascular risk and a lower proportion of those with low risk (p < 0.0001) compared with PROCAM and SCORE. The present study showed a high prevalence of HIV-infected patients at low cardiovascular risk regardless of the assessed coronary risk system used. However, compared with PROCAM and SCORE, Framingham risk equation in HIV-infected patients identified a higher number of male patients with moderate cardiovascular risk.

Molecular and epidemiological characteristics of blood-borne virus infections among recent immigrants in Spain.

The increased immigration from developing regions to Western countries raises public health concerns related to blood-borne viruses. The prevalence of human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), and human T-lymphotropic virus (HTLV) infections among recent immigrants attending several Spanish diagnostic centers in years 2002 and 2003 was examined. Genetic characterization of viral subtypes and its relationship with distinct at-risk populations was carried out. A total of 1,303 immigrants were identified. They originated in Latin America (46.9%), Sub-Saharan Africa (23.7%), Eastern Europe (9.4%), and the Maghreb (9.2%). Seroprevalence rates were as follows: HIV-1 4.2%, HBV 4.1%, HCV 2.9%, and HTLV-1 0.8%. All patients with HIV-1 non-B subtypes, HBV genotypes E and A3, and HCV genotype 4 were sub-Saharan Africans, and had been infected mainly through heterosexual contacts. In contrast, Latin American homo/bisexual men carried HIV-1 subtype B most likely acquired after their arrival to Spain. In conclusion, while Sub-Saharan Africans carry wide diverse genetic variants of blood-borne viruses, the absence of high-risk practices in most cases could limit the spread of these variants. In contrast, Latin Americans with high-risk sexual practices may be a particularly vulnerable collective to acquire blood-borne viruses in the receptor country.

[Effectiveness and tolerance of atorvastatin for antiretroviral therapy-secondary dyslipemia]. / Eficacia y tolerancia de la atorvastatina en el tratamiento de la dislipemia secundaria a tratamiento antirretroviral.

BACKGROUND AND OBJECTIVE: We investigated atorvastatin effectiveness and tolerance in HIV patients with hypercholesterolemia related to antiretroviral treatment. PATIENTS AND METHOD: Prospective study that included HIV+ patients under antiretroviral treatment who displayed secondary dyslipemia and medical treatment criteria (according to NCEP-III). These patients were given 10 mg/day atorvastatin and hygienic-dietetic measures. If the therapeutic objectives were not achieved, the dose of atorvastatin was increased to 20 mg/day. Patients were followed up for 6 months. RESULTS: 32 patients were included. In 5 cases it was necessary to increase the dose from 10 mg atorvastatin to 20 mg. The therapeutic objective was obtained in 62% cases, with a good clinical tolerance. Only one adverse effect was noticed, which forced the removal of the drug. CONCLUSION: In our study atorvastatin was effective for the treatment of dyslipemia in HIV patients, and it was safe and well tolerated.

Eficacia y tolerancia de la atorvastatina en el tratamiento de la dislipemia secundaria a tratamiento antirretroviral / Effectiveness and tolerance of atorvastatin for antiretroviral therapy-secondary dyslipemia

Fundamento y objetivo: Conocer la utilidad clínica del tratamiento hipolipemiante con atorvastatina en pacientes infectados por el virus de la inmunodeficiencia humana (VIH) con hipercolesterolemia asociada al tratamiento antirretroviral, así como su tolerabilidad. Pacientes y método: Estudio observacional, prospectivo y no controlado que incluye a pacientes infectados por el VIH en tratamiento antirretroviral que presentan dislipemia secundaria con criterios de tratamiento médico según el National Cholesterol Education Program Adult Treatment Panel III (NCEP-ATP III). La intervención terapéutica realizada fue atorvastatina a dosis de 10 mg/día y medidas higiénico-dietéticas. Si a los 3 meses de tratamiento no se alcanzaba los objetivos terapéuticos, se aumentaba la dosis de atorvastatina a 20 mg/día. Se realizó un seguimiento clínico y analítico durante 6 meses. Resultados: Se incluyó a 32 pacientes. En 5 casos se precisó aumentar la dosis de 10 a 20 mg de atorvastatina al día. En un 62% de los casos se consiguió el objetivo terapéutico con buena tolerancia clínica. Se observó un efecto adverso que obligó a retirar el fármaco. Conclusión: En este estudio, la atorvastatina ha resultado ser eficaz y bien tolerada para el tratamiento de la dislipemia en la población infectada por el VIH+

Background and objective: We investigated atorvastatin effectiveness and tolerance in HIV patients with hypercholesterolemia related to antiretroviral treatment. Patients and method: Prospective study that included HIV+ patients under antiretroviral treatment who displayed secondary dyslipemia and medical treatment criteria (according to NCEP-III). These patients were given 10 mg/day atorvastatin and hygienic-dietetic measures. If the therapeutic objectives were not achieved, the dose of atorvastatin was increased to 20 mg/day. Patients were followed up for 6 months. Results: 32 patients were included. In 5 cases it was necessary to increase the dose from 10 mg atorvastatin to 20 mg. The therapeutic objective was obtained in 62% cases, with a good clinical tolerance. Only one adverse effect was noticed, which forced the removal of the drug. Conclusion: In our study atorvastatin was effective for the treatment of dyslipemia in HIV patients, and it was safe and well tolerated