Switch to bictegravir/emtricitabine/tenofovir alafenamide from dolutegravir-based therapy.

OBJECTIVE: To evaluate the efficacy and safety of 96 weeks of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) treatment in participants switching from dolutegravir (DTG)-based therapy. DESIGN: Studies 1489 (NCT02607930) and 1490 (NCT02607956) were phase 3 randomized, double-blind, active-controlled, first-line therapy trials in people with HIV-1. After 144 weeks of DTG-based or B/F/TAF treatment, participants could enter a 96-week open-label extension (OLE) of B/F/TAF. METHODS: A pooled analysis evaluated viral suppression (HIV-1 RNA <50 copies/ml) and changes in CD4 + cell count at OLE Weeks 48 and 96, treatment-emergent resistance, safety, and tolerability after switch from a DTG-based regimen to B/F/TAF. Outcomes by prior treatment were summarized using descriptive statistics and compared by two-sided Wilcoxon rank sum test. RESULTS: At OLE Week 96, participants who switched to B/F/TAF ( N  = 519) maintained high levels of virologic suppression (99.5 and 99.1% in those switching from DTG/abacavir/lamivudine and DTG+F/TAF, respectively) and CD4 + cell count, with no treatment-emergent resistance to B/F/TAF. Twenty-one participants experienced drug-related adverse events after switching, with diarrhea, weight gain, and headache occurring most commonly. There were no cases of proximal renal tubulopathy, drug-related Grade 4 adverse events, or serious adverse events. Two participants discontinued B/F/TAF due to treatment-related adverse events. Participants who switched from DTG/abacavir/lamivudine experienced statistically significant greater weight gain than those who switched from DTG+F/TAF; however, median weight change from the blinded phase baseline to OLE Week 96 was numerically similar across treatment groups. CONCLUSION: This medium-term analysis demonstrates the safety and efficacy of switching to B/F/TAF from a DTG-containing regimen in people with HIV-1.

A Risk Assessment Tool for Predicting Fragility Fractures in People with HIV: Derivation and Internal Validation of the FRESIA Model.

People with HIV have a higher risk of fracture than the general population. Because of the low performance of the existing prediction tools, there is controversy surrounding fracture risk estimation in this population. The aim of the study was to develop a model for predicting the long-term risk of fragility fractures in people with HIV. We included 11,899 individuals aged ≥30 years from the Spanish HIV/AIDS research network cohort. We identified incident fragility fractures from medical records, defined as nontraumatic or those occurring after a casual fall, at major osteoporotic sites (hip, clinical spine, forearm, proximal humerus). Our model accounted for the competing risk of death and included 12 candidate predictors to estimate the time to first fragility fracture. We assessed the discrimination and calibration of the model and compared it with the FRAX tool. The incidence rate of fragility fractures was 4.34 (95% CI 3.61 to 5.22) per 1000 person-years. The final prediction model included age, chronic kidney disease, and chronic obstructive pulmonary disease as significant predictors. The model accurately predicted the 5- and 10-year risk of fragility fractures, with an area under the receiving operator characteristic curve of 0.768 (95% CI 0.722 to 0.814) and agreement between the observed and expected probabilities. Furthermore, it demonstrated better discrimination and calibration than the FRAX tool, improving the classification of over 35% of individuals with fragility fractures compared to FRAX. Our prediction model demonstrated accuracy in predicting the long-term risk of fragility fractures. It can assist in making personalized intervention decisions for individuals with HIV and could potentially replace the current tools recommended for fracture risk assessment in this population. © 2023 The Authors. Journal of Bone and Mineral Research published by Wiley Periodicals LLC on behalf of American Society for Bone and Mineral Research (ASBMR).

Conventional versus extended-pulsed fidaxomicin dosing in patients at high risk of recurrence of Clostridioides difficile infection: a propensity score analysis.

INTRODUCTION: The main challenge in the treatment of Clostridioides difficile infection (CDI) is to reduce recurrence rates. Fidaxomicin improves the recurrence rate of CDI compared with vancomycin. Extended-pulsed dosing of fidaxomicin was associated with lower recurrence rates in one clinical trial but has never been directly compared with conventional fidaxomicin dosing. METHODS: To compare the recurrence rate of fidaxomicin conventional dosing (FCD) and fidaxomicin in extended-pulsed dosing (FEPD) in conditions of clinical practice at a single institution. We performed propensity score matching taking the variables age, severity and previous episode as confounders to evaluate patients with a similar recurrence risk. RESULTS: In total, 254 episodes of CDI treated with fidaxomicin were evaluated: 170 (66.9%) received FCD, and 84 (33.1%) received FEPD. More patients who received FCD were hospitalized for CDI, had severe CDI and had a diagnosis based on toxin detection. In contrast, the proportion of patients receiving proton pump inhibitors was higher in those receiving FEPD. The crude recurrence rates in FCD- and FEPD-treated patients were 20.0% and 10.7%, respectively (OR:0.48; 95% CI 0.22-1.05; P = 0.068). We did not find any differences in CDI recurrence rate in patients receiving FEPD versus FCD (OR = 0.74; 95% CI 0.27-2.04) by propensity score analysis. CONCLUSIONS: Although the recurrence rate with FEPD was numerically lower than that observed with FCD, we have not been able to show that the recurrence rate of CDI is different depending on the dosage regimen of fidaxomicin. Clinical trials or large observational studies comparing the two dosing regimens of fidaxomicin are needed.

Understanding Sexualized Drug Use: Substances, Reasons, Consequences, and Self-Perceptions among Men Who Have Sex with Other Men in Spain.

Sexualized drug use (SDU) has been identified as a health risk factor among gay, bisexual, and other men who have sex with men (GBMSM). This study aimed to analyze the associations between SDU frequency and a broad set of substances, motives, consequences, and self-perceptions. Sampling was conducted through an online survey. The final sample consisted of 185 GBMSM aged between 18 and 78 years old (mean age = 38.38, SD = 11.52) who engaged in SDU. We analyzed the frequency of SDU in terms of practicing it "once," "moderately" ("once a month or less" or "a few times a month"), or "frequently" (from "once a week" to "daily") during the previous 18 months. A questionnaire was administered through which sociodemographic variables, substances, reasons, consequences, and self-perceptions of SDU practice were analyzed. Participants who did so frequently were significantly more likely to use mephedrone, methamphetamine, and GHB/GBL than those who performed SDU less often (large effect sizes). In addition, habitual SDU was associated with motivations to achieve pleasurable emotions and sensations and manage negative feelings. Health implications, such as blackout moments, were also significantly related to frequent SDUs. Finally, those who practiced frequent SDU perceived it as a severe problem and wanted to control it. These data indicate the importance of raising awareness of chemsex as a public health problem among GBMSM. Specific identification, education, and prevention programs need to be strengthened to reduce the incidence of the most undesirable implications of SDU among GBMSM.

Mental Health Symptoms Associated with Sexualized Drug Use (Chemsex) among Men Who Have Sex with Men: A Systematic Review.

BACKGROUND: Sexualized drug use (SDU), also known as chemsex, refers to the use of psychoactive substances for sexual purposes among men who have sex with men (MSM), which has been associated with mental health symptoms. The objective of this review is to systematically review the available evidence on mental health outcomes in MSM who use sexualized drugs. METHODS: To prepare this systematic review, search strategies were developed and applied to the Web of Science, Science Direct, PubMed, and Scopus databases. A total of 117 articles were found, of which 12 were selected for the final review. RESULTS: Those MSM who practiced SDU were more likely to experience from depression, anxiety, or a substance dependence, although these results were not found in all the studies analyzed. Among those who practiced the administration of intravenous drugs (referred to as slamsex), the mental health symptoms were more severe. CONCLUSIONS: This systematic review contributes to a fuller understanding of the mental health symptoms present in MSM who consume drugs for sexual purposes. Greater uniformity in data collection instruments is required, as well as the need to conduct a more in-depth assessment of the psychosocial adjustment of people who practice chemsex.

Personality and adherence to antiretroviral therapy in HIV-infected adult patients.

OBJECTIVE: Antiretroviral therapy (ART) has been able to transform HIV infection into a chronic disease. However, ART adherence remains an important barrier and personality traits have been postulated as a factor to be considered. This study aims to identify personality traits that can affect ART adherence, taking into account other potentially influencing factors. METHODS: Case-control study. Controls and cases were classified using the percentage ART dispensation as recorded in the Hospital Pharmacy database. Controls were defined as people living with HIV/AIDS (PLWHA) with percentage ART dispensation during the last year >95% and cases were defined as PLWHA with percentage ART dispensation during the last year <90%. Sociodemographic, clinical parameters of HIV infection, psychopathological and neuropsychological factors were collected. Personality was assessed using the NEO PI-R Personality Inventory, questionnaire based on the Five Factor Model of Personality. Statistical analysis was performed using logistic regression (SPSS v.22). RESULTS: 125 PLWHA were included: 79 controls and 46 cases. After adjusting for confounding variables, logistic regression analysis showed that poor adherence was associated with Neuroticism (OR 1.2, 95%CI: 1.021-1.385) and Impulsivity (N5) (OR 1.5, 95%CI: 1.066-2.163). In contrast, each additional point in Order (C2) (OR 0.8, 95%CI: 0.679-0.992) or Values (O6) (OR 0.8, 95%CI: 0.710-0.974) were associated with good ART adherence. CONCLUSIONS: Personality is a variable to be considered in ART adherence. Implementation of the personality in the assessment of PLWHA helps identify those individuals potentially more likely to exhibit poorer ART adherence.

COVID-19 and geographical area of origin.

OBJECTIVES: To describe and compare the main clinical characteristics and outcome measures in hospitalized patients with confirmed coronavirus disease 2019 (COVID-19) according to geographical area of origin. METHODS: A retrospective analysis of patients hospitalized with confirmed COVID-19 at a referral centre in Madrid, Spain, during March-May 2020 was performed. Recorded variables (age, gender, intensive care unit (ICU) admission, outcome), and geographical area of origin were compared for Europeans and non-Europeans (Latin Americans, Asians and Africans). RESULTS: In total, 2345 patients with confirmed COVID-19 hospitalized during the study period were included in the study. Of these, 1956 (83.4%) were European and 389 (16.6%) were non-European (of whom over 90%, 354/389, were Latin American). Non-Europeans were significantly younger than Europeans (mean 54 (SD 13.5) versus 70.4 (SD 15.1) years, p < 0.001); the majority were male (1420/2345, 60.6%), with no significant differences in gender between Europeans and non-Europeans (1197/1956 (61.2%) male in the European group versus 223/389 (57.3%) male in the non-European group, p 0.15). In-hospital mortality overall was higher in Europeans (443/1956, 22.7%) than in non-Europeans (40/389, 10.3%) (p < 0.001), but there were no significant differences when adjusted for age/gender (OR 1.27, 95% CI 0.86-1.88). Non-Europeans were more frequently admitted to ICU (71/389, 18.3%) compared with Europeans (187/1956, 9.6%) (p < 0.001) and a difference in ICU admission rate was also found when adjusted for age/gender (OR 1.43, 95% CI 1.03-1.98). CONCLUSIONS: No significant differences in mortality were observed between Europeans and non-Europeans (mainly Latin Americans), but an increase in ICU admission rate was found in non-Europeans.

What Should Be Known by a Urologist About the Medical Management of COVID-19's Patients?

PURPOSE OF REVIEW: The alarming number of confirmed COVID-19 cases put a strain on the healthcare systems, which had to reallocate human and technical resources to respond to the emergency. Many urologists became integrated into multidisciplinary teams, dealing with this respiratory illness and its unknown management. It aims to summarize the epidemiological, clinical, diagnostical, and therapeutical characteristics of COVID-19, from a practical perspective, to ease COVID-19 management to non-physician staff. RECENT FINDINGS: We performed a narrative review of the literature regarding COVID-19, updated to May 8th, 2020, at PubMed and COVID resource platforms of the main scientific editorials. COVID-19, characterized by fever, myalgias, dyspnea, and dry cough, varies widely from asymptomatic infection to death. Arrhythmias and thrombotic events are prevalent. Lymphopenia and inflammatory reactant elevation on laboratory, as well as bilateral and peripheral ground-glass opacities or consolidations on X-Ray, are usually found in its assessment. Little is known about SARS-CoV-2 immunology. To date, no therapy has demonstrated efficacy in COVID-19. Of-level or compassionate-use therapies are prescribed in the context of clinical trials. We should become familiar with specific adverse events and pharmacological interactions. The COVID-19 pandemic has paralyzed the urological activity, and its long-term consequences are unpredictable. Despite not being used to deal with respiratory diseases, the urologists become easily qualified to manage COVID-19 by following protocols and being integrated into multidisciplinary teams, helping to overcome the pandemic.

Organisational and financial consequences of the early discharge of patients treated for acute bacterial skin and skin structure infection and osteomyelitis in infectious disease departments in Greece, Italy and Spain: a scenario analysis.

OBJECTIVE: The aim of the analysis is to assess the organisational and economic consequences of adopting an early discharge strategy for the treatment of acute bacterial skin and skin structure infection (ABSSSI) and osteomyelitis within infectious disease departments. SETTING: Infectious disease departments in Greece, Italy and Spain. PARTICIPANTS: No patients were involved in the analysis performed. INTERVENTIONS: An analytic framework was developed to consider two alternative scenarios: standard hospitalisation care or an early discharge strategy for patients hospitalised due to ABSSSI and osteomyelitis, from the perspective of the National Health Services of Greece, Italy and Spain. The variables considered were: the number of annual hospitalisations eligible for early discharge, the antibiotic treatments considered (ie, oral antibiotics and intravenous long-acting antibiotics), diagnosis-related group (DRG) reimbursements, number of days of hospitalisation, incidence and costs of hospital-acquired infections, additional follow-up visits and intravenous administrations. Data were based on published literature and expert opinions. PRIMARY AND SECONDARY OUTCOME MEASURES: Number of days of hospitalisation avoided and direct medical costs avoided. RESULTS: The total number of days of hospitalisation avoided on a yearly basis would be between 2216 and 5595 in Greece (-8/-21 hospital beds), between 15 848 and 38 444 in Italy (-57/-135 hospital beds) and between 7529 and 23 520 in Spain (-27/-85 hospital beds). From an economic perspective, the impact of the early discharge scenario is a reduction between €45 036 and €149 552 in Greece, a reduction between €182 132 and €437 990 in Italy and a reduction between €292 284 and €884 035 in Spain. CONCLUSIONS: The early discharge strategy presented would have a positive organisational impact on National Health Services, leading to potential savings in beds, and to a reduction of hospital-acquired infections and costs.

Analysis of the dysregulation between regulatory B and T cells (Breg and Treg) in human immunodeficiency virus (HIV)-infected patients.

This study examines the relationship between regulatory B (Breg) and T (Treg) compartments, which play crucial roles in the maintenance of immune homeostasis in the context of HIV. Using flow cytometry, the phenotypes of different Breg and Treg subsets from HIV-infected and healthy individuals were analyzed, along with the suppressive capacity of Breg. Peripheral blood samples of thirteen HIV+ treatment-naïve individuals, fourteen treated-HIV+ individuals with undetectable viral load and twelve healthy individuals were analyzed. The absolute counts of Breg and Treg subsets were decreased in HIV+ treatment-naïve individuals in comparison to treated-HIV+ and healthy individuals. Interestingly, correlations between Breg subsets (CD24hiCD27+ and PD-L1+ B cells) and IL-10-producing Breg observed in healthy individuals were lost in HIV+ treatment-naïve individuals. However, a correlation between frequencies of CD24hiCD38hi or TIM-1+-Breg subsets and Treg was observed in HIV+ treatment-naïve individuals and not in healthy individuals. Therefore, we hypothesized that various Breg subsets might have different functions during B and T-cell homeostasis during HIV-1 infection. In parallel, stimulated Breg from HIV-infected treatment-naïve individuals presented a decreased ability to suppress CD4+ T-cell proliferation in comparison to the stimulated Breg from treated-HIV+ or healthy individuals. We demonstrate a dysregulation between Breg and Treg subsets in HIV-infected individuals, which might participate in the hyper-activation and exhaustion of the immune system that occurs in such patients.

Healthcare and economic impact. / Atención sanitaria e impacto económico.

This chapter reviews the current model of HIV patient care and its economic impact. There are clinical and geographical differences in the care HIV patients receive and a need to develop new models of comprehen-sive HIV care has been identified. HIV infection in Spain is an important and expensive public health problem. The main costs are due to an-tiretroviral therapy, indirect costs and the cost of admission, consultation and diagnostic testing. A strong correlation between severity and cost has been identified. Patients diagnosed late have a poorer clinical course, increased mortality and require more medical and therapeutic resources. Early detection of the disease significantly improves the clinical outcomes of patients. The increased number of patients receiving treatment and their progressive ageing will increase costs of HIV healthcare in the coming years.

CD72/CD100 and PD-1/PD-L1 markers are increased on T and B cells in HIV-1+ viremic individuals, and CD72/CD100 axis is correlated with T-cell exhaustion.

In our work, we analyzed the role of the CD100/CD72 and PD-1/PD-L1 axes in immune response dysfunction in human immunodeficiency virus (HIV)-1 infection in which high expressions of PD-1 and PD-L1 were associated with an immunosuppressive state via limitation of the HIV-1-specific T-cell responses. CD100 was demonstrated to play a relevant role in immune responses in various pathological processes and may be responsible for immune dysregulation during HIV-1 infection. We investigated the function of CD72/CD100, and PD-1/PDL-1 axes on T and B cells in HIV-infected individuals and in healthy individuals. We analyzed the frequencies and fluorescence intensities of these four markers on CD4+, CD8+ T and B cells. Marker expressions were increased during active HIV-1 infection. CD100 frequency on T cells was positively associated with the expression of PD-1 and PD-L1 on T cells from HIV-infected treatment-naïve individuals. In addition, the frequency of CD72-expressing T cells was associated with interferon gamma (IFN-γ) production in HIV-infected treatment-naïve individuals. Our data suggest that the CD72/CD100 and PD-1/PD-L1 axes may jointly participate in dysregulation of immunity during HIV-1 infection and could partially explain the immune systems' hyper-activation and exhaustion.

Cost-utility analysis of the fixed-dose combination of dolutegravir/abacavir/lamivudine as initial treatment of HIV+ patients in Spain.

OBJECTIVE: Fixed-dose combinations of antiretroviral drugs have meant an important step forward in simplifying treatment and improving compliance and has led to an increased effectiveness of therapy, a viral load decrease and improving the quality of life of patients. The single-table formulation of dolutegravir with abacavir and lamivudine (DTG/ABC/3TC) is a highly efficacious and well-tolerated once-daily regimen for HIV-infected patients. The objective of the study was to assess the incremental cost-utility ratio of the fixed-dose combination of (DTG/ABC/3TC) versus the combinations emtricitabine/tenofovir/efavirenz (FTC/TDF/EFV), and darunavir/r (DRV/r) or raltegravir (RAL) with emtricitabine/tenofovir (FTC/TDF) or abacavir/lamivudine (ABC/3TC) as initial antiretroviral therapy in patients infected with HIV-1 from the perspective of the Spanish National Health System. METHOD: The ARAMIS model, which uses a microsimulation approach to simulate the individual changes in each patient from the start of treatment to death through a Markov chain of descriptive health states of the disease, was adapted to Spain. The alternatives used for comparison were the fixed-dose combination of emtricitabine/tenofovir/efavirenz (FTC/TDF/EFV), and the fixed- dose combinations of emtricitabine/tenofovir (FTC/TDF) or abacavir/lamivudine (ABC/3TC) with darunavir/r (DRV/r) or raltegravir (RAL). The probability of achieving virological suppression by the treatments included in the model was obtained from clinical trials SINGLE, SPRING-2 and FLAMINGO and the costs were expressed in € (2015). The model use the perspective of the Spanish National Health System, with a lifetime horizon and a discount rate of 3% was applied to cost and effectiveness. RESULTS: Treatment initiation with DTG/ABC/3TC was dominant when it was compared with treatment initiation with all the comparators: vs. FTC/TDF/EFV (-67 210.71€/QALY), vs. DRV/r + FTC/TDF or ABC/3TC (-1 787 341.44€/QALY), and vs. RAL + FTC/TDF or ABC/3TC (-1 005 117.13€/QALY). All the sensitivity analyses performed showed the consistency of these findings. CONCLUSIONS: With the premises considered, treatment initiation with DTG/ABC/3TC STR appears to be the most cost-effective option in ARTnaïve HIV infected patients from the Spanish Health System perspective.

Objetivo: Las combinaciones a dosis fijas de medicamentos antirretrovirales han significado un importante paso adelante en la simplificación del tratamiento y la mejora del cumplimiento, así como hacia una mayor eficacia de la terapia, una disminución de la carga viral y una mejora de la calidad de vida de los pacientes. La formulación de un comprimido único una vez al día con dosis fijas de dolutegravir, abacavir y lamivudina (DTG/ABC/3TC) para pacientes infectados con VIH es un régimen altamente eficaz y bien tolerado. El objetivo del estudio fue evaluar la relación coste- utilidad incremental de la combinación de dosis fija de (DTG/ABC/3TC) versus las combinaciones de emtricitabina/tenofovir/efavirenz (TDF/FTC/EFV) y darunavir/r (DRV/r) o raltegravir (RAL) con emtricitabina/tenofovir (FTC/TDF) o abacavir/lamivudina (ABC/3TC) como tratamiento antirretroviral inicial en pacientes infectados con VIH-1 desde la perspectiva del Sistema Nacional de Salud Español.Método: Se adaptó en España el modelo ARAMIS. Este utiliza un enfoque de microsimulación para emular los cambios individuales en cada paciente desde el inicio del tratamiento hasta su muerte mediante una cadena de Markov de estados de salud descriptivos de la enfermedad. Las alternativas empleadas para la comparación fueron la combinación de dosis fijas de emtricitabina/tenofovir/efavirenz (TDF/FTC/EFV) y las combinaciones de dosis fijas de emtricitabina/tenofovir (FTC/TDF) o abacavir/lamivudina (ABC/3TC) con darunavir/r (DRV/r) o raltegravir (RAL). La probabilidad de lograr la supresión virológica mediante los tratamientos incluidos en el modelo se ha obtenido de ensayos clínicos individuales, SPRING2 y FLAMINGO, y los costes fueron expresados en € (2015). El uso del modelo de la perspectiva del Sistema Nacional de Salud español, con un horizonte de vida útil y una tasa de descuento del 3% se, aplicó a coste y efectividad.Resultados: El inicio de tratamiento con DTG/ABC/3TC fue dominante cuando se comparó con el inicio del tratamiento con el resto de comparadores: frente a TDF/FTC/EFV (-67.210,710 € / AVAC) vs DRV/r FTC/TDF o ABC/3TC (-1,787,341.44 € / AVAC) y vs RAL FTC/TDF o ABC/3TC (-1,005,117.13 € / AVAC). Todos los análisis de sensibilidad realizados demostraron la consistencia de estos hallazgos.Conclusiones: Con las premisas consideradas, el inicio del tratamiento con la combinación a dosis fijas de DTG/ABC/3TC parece ser la opción más rentable para el tratamiento de pacientes infectados con el VIH desde la perspectiva del Sistema Nacional de Salud español.

Pre-exposure prophylaxis (PrEP) against HIV: efficacy, safety and uncertainties.

Despite the global stabilization of the number of new HIV infections in recent years, there has been an increase in new infections among men who have sex with men. This fact indicates the lack of effectiveness of the measures and prevention campaigns established so far for this group.  It is therefore necessary to implement alternative preventive measures for them. Pre-exposure pharmacological prophylaxis (PrEP) is one of the best evaluated options and has had high protection rates in both clinical and real-life trials. The strategy has also shown an adequate profile in terms of safety, tolerance, adverse effects and cost-effectiveness in the studies carried out to assess this important topic.

En los últimos años se ha objetivado un incremento de las nuevas infecciones por el VIH en el grupo de hombres que tienen sexo con hombres, lo que indica la ausencia de eficacia de las campañas y medidas preventivas instauradas en dicho grupo.Es necesario, por tanto, implementar medidas preventivas alternativas, siendo la profilaxis farmacológica pre-exposición (PrEP) una de las opciones mejor evaluadas tanto en ensayos clínicos como en la vida real, habiéndose demostrado tasas de protección superiores al 80% cuando se administra en los casos indicados y con buen cumplimiento terapeútico.La estrategia ha demostrado, además, un perfil adecuado en seguridad,tolerancia y efectos adversos, siendo además coste-efectiva según losestudios realizados para valorar este importante aspecto.

Prevalence of hepatitis C antibodies in the population aged 16-80 years in the Community of Madrid 2008-2009.

Together with AIDS, the burden of hepatitis C virus (HCV) in Spain heads the list of communicable diseases in terms of impact on public health. The aim of this study was to estimate the prevalence of HCV antibodies in the Community of Madrid, assess changes in recent years and analyse associated risk factors. Descriptive cross-sectional study of a target population consisting of Community of Madrid residents aged 16-80 years old. Two-stage cluster sampling was performed, with stratification by socioeconomic status and percentage immigrant population. The sampling frame consisted of public blood extraction centers attached to the Madrid Health Service. Seroprevalence of HCV antibodies, prevalence ratios by age groups in comparison with 1999 survey data and prevalence association with risk factors were assessed using a logistic regression model. Prevalence of HCV antibodies for the age group 16-80 years was 1.8% (95% CI: 1.3-2.5). The age group with the highest prevalence was 41-60 years. In comparison with the 1999 survey, prevalence fell for the age groups 21-30 and 31-40 years and increased for the age group 41-60. Statistically significant associations were found for age, education, history of hepatitis C and consultation regarding liver problems. Seroprevalence of HCV antibodies in the Community of Madrid is similar to that shown in other regions of Spain. It is increasing in older age groups as the population at risk ages. Incidence of hepatitis C may be decreasing considering the decrease in the seroprevalence in the population younger than 40 related to the previous serosurvey.

Patient-Reported Outcomes After a Switch to a Single-Tablet Regimen of Rilpivirine, Emtricitabine, and Tenofovir DF in HIV-1-Positive, Virologically Suppressed Individuals: Additional Findings From a Randomized, Open-Label, 48-Week Trial.

BACKGROUND: Patient-reported outcomes (PROs) can provide important information about treatment tolerability in HIV-1-infected patients. OBJECTIVE: The aim of this study was to evaluate PROs following switching from a boosted protease inhibitor-based regimen to the single-tablet regimen (STR) of rilpivirine/emtricitabine/tenofovir disoproxil fumarate (RPV/FTC/TDF) in the 48-week open-label Switching Boosted PI to Rilpivirine in Combination with Truvada as a Single-Tablet Regimen (SPIRIT) trial. METHODS: In the open-label SPIRIT trial, patients were randomized to receive an STR of RPV/FTC/TDF (n = 317) for 48 weeks or stay on their baseline regimen of a ritonavir-boosted protease inhibitor and two nucleoside/nucleotide analog reverse transcriptase inhibitors (PI + RTV + 2NRTIs, n = 159) for 24 weeks before switching to RPV/FTC/TDF for another 24 weeks. PRO assessments included the HIV Treatment Satisfaction Questionnaire (TSQ) and the HIV Symptom Index Questionnaire (SIQ). RESULTS: At week 24, the mean HIV TSQ improvement from baseline was significantly greater in the RPV/FTC/TDF group than the PI + RTV + 2NRTIs group (p < 0.001). On the HIV SIQ, the percentage of patients reporting a shift from 'symptom' to 'no symptom' was significantly greater with RPV/FTC/TDF treatment compared with PI + RTV + 2NRTIs for all items (all p ≤ 0.01), with total within-group occurrence of 13/20 symptoms significantly decreasing from baseline for RPV/FTC/TDF patients. In the delayed switch group, significantly fewer patients reported diarrhea and sleep problems at week 48 vs. week 24. CONCLUSIONS: These data suggest that switching to the STR RPV/FTC/TDF from a PI-based multi-pill regimen is associated with greater patient-reported treatment satisfaction and improved tolerability in HIV-1-infected, virologically suppressed individuals.

Hepatitis B virus infection and vaccine-induced immunity in Madrid (Spain).

OBJECTIVE: To estimate the prevalence of hepatitis B virus (HBV) infection and vaccine-induced immunity in the region of Madrid, and to analyze their evolution over time. METHODS: An observational, analytical, cross-sectional study was carried out in the population aged 16-80 years between 2008 and 2009. This was the last of four seroprevalence surveys in the region of Madrid. The prevalence of HBV infection and vaccine-induced immunity was estimated using multivariate logistic models and were compared with the prevalences in the 1989, 1993 and 1999 surveys. RESULTS: In the population aged 16-80 years, the prevalence of HBV infection was 11.0% (95% CI: 9.8-12.3) and that of chronic infection was 0.7% (95% CI: 0.5-1.1). The prevalence of vaccine-induced immunity in the population aged 16-20 years was 73.0% (95% CI: 70.0-76.0). Compared with previous surveys, there was a decrease in the prevalence of HBV infection. CONCLUSIONS: Based on the prevalence of chronic infection (<1%), Madrid is a region with low HBV endemicity. Preventive strategies against HBV should especially target the immigrant population.

Prevalence of vitamin D deficiency and its related risk factor in a Spanish cohort of adult HIV-infected patients: effects of antiretroviral therapy.

We analyzed serum 25(OH) cholecalciferol [25(OH)D] levels and factors related to deficiency (<20 ng/ml) or insufficiency (<30 ng/ml) in a cohort of Spanish HIV-infected patients and compared them with an age- and latitude-matched population from another study. We prospectively assessed 25(OH)D deficiency/insufficiency in a cohort of 352 HIV patients during 2009-2010. Predisposing factors were recorded and their relationship to low levels was assessed by logistic regression; a nutritional survey examined intake, nutritional status, and sunlight exposure in a subgroup of 92 patients. We studied the correlation of 25(OH)D with parathyroid hormone (PTH) and alkaline phosphatase. Age-, sex-, and race/ethnicity-adjusted vitamin D deficiency (<20 ng/ml) was 44.0% (95% CI, 38.8-49.4%) and insufficiency (<30 ng/ml) was 71.6% (95% CI, 66.9-76.3). Deficiency was 16.4% more prevalent in our sample than in non-HIV-infected Spaniards. Lower sunlight exposure was the only factor related to lower levels in the lifestyle and nutritional survey (p=0.045). In multiple logistic regression, higher body mass index (BMI), black race/ethnicity, lower seasonal sunlight exposure, men who have sex with men (MSM), and heterosexual transmission categories, efavirenz exposure and lack of HIV viral suppression were independently associated with deficiency/insufficiency. These variables predicted 79% of cases [AUC=0.872 (95% CI, 0.83-0.91)]. Patients receiving protease inhibitors (PIs) [OR 4.0 (95% CI, 1.3-12.3); p=0.014] or NNRTI [OR 3.6 (95% CI, 1.7-11.2); p=0.025] had higher odds of increased PTH levels; this was significant only in 25(OH)D-deficient patients (p=0.004). As in less insolated areas, the prevalence of vitamin D deficiency/insufficiency was high in HIV-infected patients in Spain; among treated patients, levels were higher with PIs than with efavirenz.

[Teaching of infectious diseases in medical degree studies]. / La docencia de la patología infecciosa en los estudios de grado de medicina.

The teaching of the infectious diseases in the Bachelor of Medicine degree consists of activities aimed at providing the student with levels of competence in this area (knowledge, abilities, attitudes) appropriate for a general physician, and to give them a solid base to achieve the skills and abilities for becoming a specialist in this area. Currently, the location, the amount and quality of infectious diseases studies in the Bachelor of Medicine degree are very disparate between the different Spanish Medical Schools. The incorporation into the European Higher Education Area, with the necessary adaptation of curricula, will enable the contents and the teaching objectives in this field to be better defined. The latest document from the Medical Schools Deans Conference clearly identifies the studies of the infectious diseases into the Medical Diseases module and in the area of human clinical training. In our opinion, infectious diseases must be considered as a major subject, preferably in the second semester of the fifth year, and having a minimum of 6 and a maximum of 9 ECTS, theoretical and practical, distributed equally among attendance, part-attendance and self-teaching credits. Infectious diseases pathology must be horizontally integrated with most of the other subjects in the clinical module and vertically integrated with the subject of microbiology. The coordination and most of the teaching of the credits in the infectious diseases subject must be done by specialists with clinical activity in infectious diseases.

[Cost of nucleoside analogue reverse transcriptase inhibitor-related toxicity in HIV-1-infected patients]. / Costes de la toxicidad asociada a los análogos de nucleósidos inhibidores de la transcriptasa inversa en pacientes con infección por el VIH-1.

OBJECTIVE: To estimate the impact of toxicity related to nucleoside analogue reverse transcriptase inhibitors (NRTI) on the total cost of medical care in HIV-1-infected patients. METHODS: . A pharmacoeconomic model was developed from the data obtained by a prospective, observational, multicenter study performed in Spain (Recover). The study patients had developed one NRTI-associated adverse event (AE) that justified discontinuation of treatment with the drug. All costs derived from NRTI-associated AEs in the HAART regimens of HIV-1-infected patients over a period of one year were assessed. The cost assessment (2005 values) included direct medical costs (drugs and AE management) and indirect costs (loss of productivity). The healthcare resources used in AE management were estimated by an expert panel of clinicians. RESULTS: The use and cost of resources rose with increasing severity of all the AE. The average total cost per patient was estimated to be 4012 euro, which included 1789 euro in drug costs (NRTI associated with therapy discontinuation due to AE), and 2223 euro in direct and indirect costs of AE management (45% and 55% of total cost, respectively). Seventy-three per cent of AE-associated costs per patient came from lipoatrophy (560 euro), lipodystropy (535 euro) and peripheral neuropathy (533 euro). CONCLUSION: Management of NRTI-related toxicities is more costly than NRTI acquisition and produces a significant increase in the overall healthcare expenditure for HIV-1-infected patients. This fact should be taken into account when designing the most efficient antiretroviral treatment strategies.