Emicizumab prophylaxis for people with hemophilia A: Waste estimation and the Brazilian perspective.

Costs of hemophilia A treatment are increasing. Waste of clotting products should be avoided. To estimate the first-year waste of emicizumab prophylaxis for people with hemophilia A and inhibitors (PwHAi) who failed immune tolerance induction (ITI), in Brazil. We evaluated the manufacturer and the Brazilian Ministry of Health (MoH) protocol-recommended regimens in a budget impact model. The loading dose consisted of 3.0 mg/kg/Q1W for 4 weeks, for both recommendations. The manufacturer maintenance regimens comprised 1.5 mg/kg/Q1W, 3.0 mg/kg/Q2W, and 6.0 mg/kg/Q4W. The MoH protocol maintenance regimen encompassed a hybrid Q1W/Q2W administration, depending on the body weight. The Q4W regimen was not recommended by the MoH protocol. Analyses were performed to estimate waste given its expense based on the World Health Organization body weight range (percentiles [P] 15, 50, and 85). The first-year emicizumab waste was estimated individually and for the disclosed PwHAi who failed ITI (n = 114). The highest emicizumab waste was estimated for the lowest body weights and the Q1W regimen. The Q4W regimen resulted in the lowest emicizumab waste, followed by the MoH protocol regimen. The total reconstituted costs estimated for the PwHAi who failed ITI according to the hybrid MoH protocol ranged from US$32,858,777 (P15) to US$47,186,858 (P85), with emicizumab waste ranging from 7.9 % (US$2,594,515) to 3.7 % (US$1,738,750), respectively. Lost resources due to current protocols for emicizumab prophylaxis for PwHAi who failed ITI in Brazil are considerable. Waste was more pronounced due to lower body weight and shorter administration intervals.

Health-related quality of life among HIV-infected patients initiating treatment in Brazil in the single-tablet regimen era.

Health-related quality of life (HRQoL) is a multidimensional concept involving an individual's self-perception about how a disease or treatment impacts their daily life. In this study, we evaluated the HRQoL and factors associated with this outcome in 366 patients initiating combination Antiretroviral Therapy (cART) in Belo Horizonte, Brazil.We measured HRQoL using the EuroQoL-5D 3 level (EQ-5D) and the HIV instrument of the World Health Organization (WHOQOL-HIV BREF) and identified factors associated with HRQoL using multilevel linear regression. Participants had been on cART treatment a median of 65.5 days at the time the instruments were completed. The median HRQoL of patients on the single-tablet regimen containing efavirenz/ tenofovir/ lamivudine and the multi-tablet regimen containing dolutegravir and tenofovir/ lamivudine were high, with no significant difference between groups. Factors consistently associated with lower HRQoL were being single (unmarried), having a lower educational level, recent cigarette smoking, recent signs and symptoms of anxiety or depression, comorbid disease and the occurrence of adverse drug reactions. We observed high levels of HRQoL in cART-treated people and no differences between dolutegravir and efavirenz-based regimens. This study provides inputs to future economic analysis and identifies opportunities to increase the HRQoL of patients by targeting modifiable factors.

(Un)Equitable distribution of health resources and the judicialization of healthcare: 10 years of experience in Brazil.

BACKGROUND: Equity has been acknowledged as a required principle for the fulfilment of the universal right to health once it seeks to tackle avoidable and unfair inequalities among individuals. In Brazil, a country marked by iniquities, this principle was adopted in the Brazilian National Health System (SUS) organization. But the phenomenon known as judicialization of healthcare, anchored in the argument of universality of the right, has been consolidated as a health policy parallel to the SUS. The analysis of these lawsuits distribution according to their beneficiaries' socio-economic profile can contribute to the verification of the judicialization's potential for reducing inequalities, thus becoming an auxiliary activity in the fulfilment of the universal and egalitarian right to health. This study aimed to assess what socioeconomic factors are associated to municipalities that had larger numbers of beneficiaries from lawsuits in health in the state of Minas Gerais, Brazil, from 1999 to 2009. METHODS: It is a descriptive quantitative study of the residence municipalities of beneficiaries registered in database regarding all deferred lawsuits against the state of Minas Gerais from 1999 to 2009. The verification of cities' socio-economic profile was performed based on information of the Brazilian Institute of Geography and Statistics' 2010 Demographic Census and on indexes derived from it. The variables studied for each municipality were: number of beneficiaries; resident population; Social Vulnerability Index (IVS); and Municipal Human Development Index (IDHm). Descriptive and statistical analysis were used to verify factors associated with a larger number of beneficiaries in a municipality. RESULTS: Out of 853 municipalities in Minas Gerais, 399 were registered as residence of at least one of the 6.906 beneficiaries of studied lawsuits. The residence non-information index was 11,5%. The minimum number of identified beneficiaries living in a municipality was 1 (one) while the maximum was 1920. The binary logistic regression revealed that high and very high IDHm (OR = 3045; IC = 1773-5228), IVS below 0.323 (OR = 2044; IC = 1099- 3800) and population size above 14.661 inhabitants (OR = 6162; IC = 3733-10,171) are statistically associated to a greater number of beneficiaries of lawsuits in health within a municipality. CONCLUSIONS: The judicialization of health care in Minas Gerais, from 1999 to 2009, didn't reach the most vulnerable municipalities. On the contrary, it favored a concentration of health resources in municipalities with better socioeconomic profiles. The register of all beneficiaries' municipalities of residence as well as individual socioeconomic data can contribute to a more conclusive analysis. Nevertheless, in general, the results of this study suggest that the judicial health policy conducted from 1999 to 2009 was not an auxiliary tool for the fulfilment of an equitable right to health in Minas Gerais.

Treatment of ankylosing spondylitis with TNF blockers: a meta-analysis.

Biological agents directed against tumor necrosis factor (TNF) represent therapeutic options for patients with ankylosing spondylitis with high disease activity despite use of non-steroidal anti-inflammatory drugs. To evaluate the efficacy and safety of the anti-TNF agents infliximab, etanercept, adalimumab, golimumab, and certolizumab for the treatment of ankylosing spondylitis, we performed a systematic review of randomized clinical trials on adult patients with ankylosing spondylitis using articles culled from the EMBASE, MEDLINE, Cochrane Controlled Trials Register and LILACS databases (September/2012), manual literature search, and the gray literature. Study selections and data collection were performed by two independent reviewers, with disagreements solved by a third reviewer. The following outcomes were evaluated: ASAS 20 response, disease activity, physical function, vertebral mobility, adverse events, and withdraws. The meta-analysis was performed using the Review Manager(®) 5.1 software by applying the random effects model. Eighteen studies were included in this review. No study of certolizumab was included. Patients treated with anti-TNF agents were more likely to display an ASAS 20 response after 12/14 weeks (RR 2.21; 95 % CI 1.91; 2.56) and 24 weeks (RR 2.68; 95 % CI 2.06; 3.48) compared with controls, which was also true for several other efficacy outcomes. Meta-analysis of safety outcomes and withdraws did not indicate statistically significant differences between treatment and control groups after 12 or 30 weeks. Adalimumab, infliximab, etanercept, and golimumab can effectively reduce the signs and symptoms of the axial component of ankylosing spondylitis. Safety outcomes deserve further study, especially with respect to long-term follow-ups.

Efficacy/effectiveness and safety of emicizumab prophylaxis of people with hemophilia A: a systematic review and meta-analysis.

BACKGROUND: Emicizumab is a monoclonal antibody approved for prophylaxis against bleeds for people with hemophilia A (PwHA). A systematic review was conducted evaluating the efficacy/effectiveness and the safety of emicizumab as prophylaxis for PwHA compared to prophylaxis with factor VIII (FVIII) or bypassing agents (BPA), respectively in patients without and with inhibitors. RESEARCH DESIGN AND METHODS: Database-directed search strategies were performed in Aug/26/2022 and updated in Mar/16/2023. Studies evaluating the prophylaxis with emicizumab versus prophylaxis with FVIII or BPA in PwHA without or with inhibitors, respectively, were selected by two independent reviewers. Data were extracted by two independent reviewers. Annualized bleeding rates for total treated bleeding events (ABR-all) were evaluated by meta-analysis. The quality of studies and certainty of evidence were assessed. RESULTS: A total of 11 studies were included. The standard mean differences for ABR-all were -0.6 (95%CI -1.0 to -0.2, p-value = 0.0002), among PwHA without inhibitors, and -1.7 (95%CI -2.4 to -0.9, p-value <0.00001), among PwHA with inhibitors. However, there was moderate heterogeneity in both meta-analyses. The most frequent adverse event was injection site reaction. CONCLUSIONS: Emicizumab prophylaxis was superior in reducing the ABR-all when compared with prophylaxis with FVIII or BPA.

Economic Evaluation of Immune Tolerance Induction in Children With Severe Hemophilia A and High-Responding Inhibitors: A Cost-Effectiveness Analysis of Prophylaxis With Emicizumab.

OBJECTIVE: This study aimed to measure the cost-effectiveness of prophylaxis with emicizumab in PsHAhri on ITI in Brazil. METHODS: A cost-effectiveness modeling analysis was used to estimate the costs per PsHAhri on ITI and the number of prevented bleedings from undertaking one intervention (prophylaxis with BpA) over another (prophylaxis with emicizumab), based on the Brazilian Ministry of Health perspective. Costs of ITI with recombinant FVIII, prophylaxis with BpA or emicizumab, and treated bleeding episodes with BpA costs were evaluated for PsHAhri who had ITI success or failure. This study was conducted with the perspective of the Brazilian Ministry of Health (payer). RESULTS: During ITI, prophylaxis with BpA cost US $924 666/PsHAhri/ITI, whereas prophylaxis with emicizumab cost US $488 785/PsHAhri/ITI. During ITI, there was an average of 9.32 bleeding episodes/PsHAhri/ITI when BpA were used as prophylaxis and 0.67 bleeding/PsHAhri/ITI when emicizumab was used. By univariate deterministic sensitivity analysis, emicizumab remained dominant whichever variable was modified. CONCLUSION: In this study, prophylaxis with emicizumab during ITI is a dominant option compared with prophylaxis with BpA during ITI.

Quality of life of patients in renal replacement therapy in Brazil: comparison of treatment modalities.

PURPOSE: This study aimed to analyze and compare the quality of life of renal replacement therapy patients undergoing hemodialysis, peritoneal dialysis and those with renal transplantation in Brazil. In addition, we aimed to verify factors associated with patients' quality of life and the relationship between quality of life and treatment modality, socioeconomic and demographic conditions as well as aspects related to the disease and health services. METHODS: A representative sample of the dialysis units and transplant centers was obtained. Structured questionnaires were used to interview 3,036 patients in one of three treatment modalities: hemodialysis, peritoneal dialysis and renal transplant. Information was collected about socioeconomic and demographic characteristics and quality of life measures. RESULTS: There were significant differences between renal transplants and both forms of dialysis for all dimensions of the SF-36. Hemodialysis patients showed better results in the dimensions of functional capacity, physical aspects and social aspects, compared to peritoneal dialysis patients. Renal transplant patients had the best mean score in the physical component of quality of life. There were no significant differences among treatment groups regarding the mental component of quality of life. The physical and mental components were associated with comorbidities and age; however, older patients had better mental quality of life but worse physical quality of life. Patients in a higher socioeconomic class and patients that were not hospitalized also reported better quality of life. Unmarried and male patients presented better physical quality of life. The dialysis units and transplant centers influenced the patients' quality of life. CONCLUSIONS: Renal transplant patients have the best quality of life of the three treatment modalities. It is necessary to increase access to renal transplants.

Economic evaluation of adalimumab versus etanercept for psoriatic arthritis in a Brazilian real-world model.

BACKGROUND: TNF inhibitors are costly drugs supplied generally on health systems or private insurances. Performance analysis is essential to verify the results achieved by health technologies in these systems. The objective of the study was to compare the two most used biological drugs for the treatment of psoriatic arthritis (PsA) in Brazil. METHODS: A cost-utility analysis was built using a Markov model, with a five-year time horizon, a discount rate of 5%, and from the perspective of the Unified Health System. Deterministic and probabilistic sensitivity analyses were performed. RESULTS: Etanercept was the most cost-effective drug. Adalimumab became the most cost-effective drug in one of the four analysis scenarios with a willingness to pay from one gross domestic product per capita. The deterministic sensitivity analysis identified that the cost parameters had the greatest impact on the most effective drug. The probabilistic sensitivity analysis indicated that etanercept is the drug most likely to be cost-effective. CONCLUSION: The difference between the drugs in terms of utility was minimal and the costs were the main factor that impacted the cost-utility ratio, which points to the benefits of price renegotiation for the efficient allocation of resources in the health system.

Conventional Synthetic Disease-Modifying Anti-rheumatic Drugs for Psoriatic Arthritis: Findings and Implications From a Patient Centered Longitudinal Study in Brazil.

Background: Conventional synthetic disease-modifying antirheumatic drugs are the first-line treatment to inhibit the progression of psoriatic arthritis. Despite their widespread clinical use, few studies have been conducted to compare these drugs for psoriatic arthritis. Methods: a longitudinal study was carried out based on a centered patient national database in Brazil. Market share of drugs, medication persistence, drug costs, and cost per response were evaluated. Results: a total of 1,999 individuals with psoriatic arthritis were included. Methotrexate was the most used drug (44.4%), followed by leflunomide (40.6%), ciclosporin (8.2%), and sulfasalazine (6.8%). Methotrexate and leflunomide had a greater market share than ciclosporin and sulfasalazine over years. Medication persistence was higher for leflunomide (58.9 and 28.2%), followed by methotrexate (51.6 and 25.4%) at six and 12 months, respectively. Leflunomide was deemed the most expensive drug, with an average annual cost of $317.25, followed by sulfasalazine ($106.47), ciclosporin ($97.64), and methotrexate ($40.23). Methotrexate was the drug being the lowest cost per response. Conclusion: Methotrexate had the best cost per response ratio, owing to its lower cost and a slightly lower proportion of persistent patients when compared to leflunomide. Leflunomide had a slightly higher medication persistence than methotrexate, but it was the most expensive drug.

Functionality assessment in patients with rheumatic diseases undergoing treatment in the Public Health System.

OBJECTIVE: To evaluate the therapeutic response (functionality) and its associated factors in patients on biological drugs on the Public Health System for treatment of rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis. METHODS: An open prospective cohort was carried out from 2011 to 2019, in Belo Horizonte (MG). Functionality was assessed using the Health Assessment Questionnaire Disability-Index at baseline, and after 6 and 12 months of follow-up. Factors associated with poor functionality were identified through logistic regression. RESULTS: The median Health Assessment Questionnaire Disability-Index at baseline was 1.5 (interquartile range of 0.8-1.9), with poor functionality observed in patients with rheumatoid arthritis. Improved functionality was seen at 6 months of treatment for the three diseases. The predictors of poor functionality at 6 months for psoriatic arthritis and ankylosing spondylitis were female sex, low education levels, and high disease activity; and for rheumatoid arthritis and psoriatic arthritis were female sex, advanced age, and high disease activity. In 12 months, the three diseases had predictors of worse functionality: female sex, low education, and high disease activity. CONCLUSION: There was a significant improvement in functionality during the follow-up, with better response at 6 months of treatment. Poor functionality was observed in older, female patients, with low education and high disease activity.

First-line biologic therapy with tumor necrosis factor inhibitors for psoriatic arthritis: a prospective observational study.

BACKGROUND: Psoriatic arthritis (PsA) is a chronic inflammatory disease that affects multiple joints. It is associated with psoriasis and treated with synthetic and biologic drugs. OBJECTIVE: The objective of this study was to assess the outcomes of patients who received biologic therapy with tumor necrosis factor (TNF) inhibitors in terms of effectiveness, safety, functionality, and quality of life. DESIGN AND SETTING: A prospective observational study was performed at a single center in Belo Horizonte, Brazil. METHODS: Patients with PsA who received their first TNF inhibitor treatment were followed up for 12 months. Disease activity was measured using the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and Clinical Disease Activity Index (CDAI). Functionality was measured using the Health Questionnaire Assessment (HAQ), and quality of life was evaluated using the European Quality of Life Five Dimensions (EQ-5D). Multiple linear regression was used to identify predictors of the clinical response at 12 months. RESULTS: A total of 143 patients treated with adalimumab or etanercept were evaluated. Most of the clinical measures were significantly improved at 12 months. However, 31%-51% of the patients did not achieve good clinical control. No differences were observed between adalimumab and etanercept, except for poor functionality at 12 months among patients treated with etanercept. The main predictors of a worse clinical response were female sex, etanercept use, poor functionality, or lower quality of life at baseline. The main adverse reactions were alopecia, headache, injection site reaction, sinusitis, flu, dyslipidemia, and infections. CONCLUSION: TNF inhibitor therapy was effective and safe. However, despite improvements in clinical measures, most patients did not achieve satisfactory control of the disease.

Chronic hepatitis B treatment: the cost-effectiveness of interferon compared to lamivudine.

OBJECTIVE: To perform a cost-effectiveness evaluation from the perspective of the Brazilian National Health System of alternatives strategies (i.e., conventional interferon, pegylated interferon, and lamivudine) for the treatment of patients with chronic hepatitis B who present elevated aminotransferase levels and no evidence of cirrhosis at the beginning of treatment. METHODS: A Markov model was developed for chronic hepatitis B (hepatitis B antigen e [HBeAg] positive and negative) with 40 years' time horizon. Costs and benefits were discounted at 5%. Annual rates of disease progression, costs due to complications, and the efficacy of medicines were obtained from the literature. One-way and probabilistic sensitivity analysis evaluated uncertainties. RESULTS: For HBeAg positive patients, peginterferon (48 weeks) resulted in an increase of 0.21 discounted life-years gained compared to interferon (24 weeks). The incremental cost-effectiveness ratio (ICER) converted to US dollars using the 2009 purchasing power parity conversion factor was US$100,752.24 per life-year gained. For HBeAg negative patients, it was observed that interferon (48 weeks) compared with long-term lamivudine presented an increase of 0.45 discounted life-years gained and ICER of US$15,766.90 per life-year gained. In the sensitivity analysis, the ICER was more sensitive to variation in the probability of transition from chronic hepatitis B to compensated cirrhosis, discount rate, and medicine prices. Cost-effectiveness acceptability curve for HBeAg positive (pegylated interferon vs. conventional interferon) and negative (conventional interferon vs. lamivudine) showed that conventional interferon was cost-effective until three times the gross domestic product per capita. CONCLUSIONS: For patients with chronic hepatitis B with elevated aminotransferase levels in the pretreatment and no cirrhosis who were HBeAg positive, pegylated interferon (48 weeks) provided more life-years gained when compared to conventional interferon (24 weeks), and the ICER surpasses the country's buying power, which makes conventional interferon the chosen alternative. For HBeAg negative patients, conventional interferon (48 weeks) compared to lamivudine provided more life-years gained at a favorable ICER.

[Expenses of the Brazilian Ministry of Health for high-cost drugs: a demographic and clinical analysis]. / Gastos do Ministério da Saúde do Brasil com medicamentos de alto custo: uma análise centrada no paciente.

OBJECTIVE: To describe the expenses of the Ministry of Health of Brazil with users of High-Cost Drug Program that began treatment between 2000-2004, according to their demographic and clinical characteristics. METHODS: We made a probabilistic-deterministic linkage of national databases of drugs and mortality, resulting in a historical cohort of patients using high-cost medications in 2000-2004. The per capita spending on medicines were stratified by a follow-up period and described according to demographic, clinical and type of drug used. RESULTS: The total population atended by the program was 611,419, being 63.5% female, average age 46 years. 41.9% of patients living in the Southeast and 29.7% in the Northeast of Brazil. 24.5% of patients began treatment in 2000, 12.4% in 2001, with increasing trend until 2004. The most prevalent diagnosis referred to the genitourinary system diseases and the most common use of chemical groups were antianemic preparations. 40,941 deaths were detected (6.7% of total). The total expenditure per capita was R$4.794,34. Higher spending per capita was observed in males, aged 47, who lived in the Southeast of Brazil and began treatment in 2000, had diagnoses of infectious and parasitic diseases and used blood substitutes and perfusions solutions. CONCLUSION: The understanding of the expenses involved subsidizes restructuring actions and scheduling drug programs, also provides information for therapeutic groups which are priorities for analysis.

Cost-utility analysis of the anti-TNF therapy for rheumatoid arthritis in a real-world based model.

BACKGROUND: Spending on drugs provided by the Brazilian Public Health System (BPHS) for the treatment of rheumatoid arthritis (RA) increased substantially with the beginning of the supply of biological disease-modifying anti-rheumatic drugs (bDMARD). This study aims to perform a cost-utility analysis of the most used biological drugs for the treatment of RA in Brazil. METHODS: a Markov model was used to carry out the cost-utility analysis. The data were obtained from a prospective cohort of RA patients using adalimumab, etanercept, and golimumab in Brazil. The BPHS perspective was adopted and the time horizon was five years. Deterministic and probabilistic sensitivity analyses were performed to evaluate the uncertainty. RESULTS: golimumab was the most cost-effective drug. Etanercept was dominated by golimumab. Adalimumab presented an incremental cost-utility ratio (ICUR) of $95,095.37 compared to golimumab in five years of follow-up. These results were confirmed by sensitivity analyses. CONCLUSION: the utility among adalimumab, etanercept, and golimumab was similar and the cost was the component that most impacted the economic model. Therefore, depending on the agreed price with the drug manufacturers, the incremental cost-utility ratio may vary among them.

Real-world effectiveness of olanzapine and risperidone in the treatment of schizophrenia in Brazil over a 16-year follow-up period; findings and implications.

Introduction: Antipsychotics are widely prescribed for patients with schizophrenia. The Brazilian public health system provides these patients free of charge to patients and it is pertinent to evaluate their benefits.Objective: To evaluate the effectiveness of olanzapine and risperidone in the treatment of patients with schizophrenia in the real-world and assessing risk factors for their discontinuation through a national non-concurrent cohort with 16 years of follow-up.Methods: Three SUS administrative databases were integrated by deterministic-probabilistic linkage. After patients were matched (1:1) for psychiatric hospitalization, year of receiving the antipsychotic, sex, and age, considering either olanzapine or risperidone at study entry. Kaplan-Meier was used to estimate the cumulative probabilities of discontinuation of treatment and associated factors were identified. Sensitivity analyses were performed.Results: 3416 pairs of patients were included. Olanzapine had a longer time until discontinuation of treatment (p = 0.021), and risperidone had a higher risk of discontinuation (p = 0.021). Among patients persistent for at least 24 months, there was no statistically significant difference.Conclusion: Olanzapine demonstrated superior real-world effectiveness over risperidone, in terms of survival and psychiatric hospitalization. This superiority was not sustained in all analyses.

Sixteen Years of Heart Transplant in an Open Cohort in Brazil: Analysis of Graft Survival of Patients using Immunosuppressants. / Dezesseis Anos de Transplante Cardíaco em Coorte Aberta no Brasil: Análise de Sobrevivência de Pacientes em Uso de Imunossupressores.

BACKGROUND: Heart transplant is the main therapeutic alternative for advanced heart failure patients. Several risk factors affect these patients' survival; however, few studies about the topic are available in Brazil. OBJECTIVES: To review the survival rates of heart transplant patients in the Brazilian Public Health System (Sistema Único de Saúde - SUS) between 2000 and 2015. METHODS: This is a non-concurrent, open cohort study, involving cardiac transplant patients in Brazil. The cumulative survival probability was estimated by the Kaplan-Meier curve, and the curve comparison was done using the Log-Rank test. The Cox model was used to calculate the Hazard-Ratio (HR). Analyses were conducted at the 95% confidence level. RESULTS: The heart transplant survival rate median in Brazil, during the period, was 8.3 years. Each additional year in the recipient's age, the occurrence of infections, and the performance of the surgical procedure in the South Region were associated with a higher risk of graft loss. A higher use ratio of immunosuppressants mycophenolate and azathioprine acted as a protection factor. CONCLUSIONS: The analyses conducted provide the first information about the median survival time in heart transplant patients in Brazil. The difference noticed among the geographical regions may be related to the different treatment protocols adopted in the country, especially in the early 2000s. The rate of mycophenolate and azathioprine use as a protection factor suggests that, despite the absence of differences among therapeutic strategies, use of these drugs may favor survival of certain patients. The study provides robust epidemiological data, which are relevant for public health.

FUNDAMENTO: O transplante cardíaco é a principal alternativa terapêutica para pacientes com insuficiência cardíaca avançada. Diversos fatores de risco influenciam a sobrevivência desses pacientes, entretanto, poucos estudos acerca do tema estão disponíveis no Brasil. OBJETIVOS: Analisar a sobrevivência de pacientes transplantados cardíacos pelo Sistema Único de Saúde no Brasil entre 2000-2015. MÉTODOS: Trata-se de uma coorte não concorrente, aberta, de pacientes transplantados cardíacos no Brasil. A probabilidade acumulada de sobrevivência foi estimada por Kaplan-Meier e a comparação entre as curvas realizada pelo Teste de Log-Rank. O modelo de Cox foi utilizado para calcular o Hazard-Ratio (HR). As análises foram realizadas ao nível de 95% de confiança. RESULTADOS: A mediana de sobrevivência do transplante cardíaco no Brasil no período foi 8,3 anos. Cada ano adicional na idade do receptor, a ocorrência de infecções e a realização do procedimento cirúrgico na região Sul relacionaram-se ao maior risco de perda do enxerto. Maior proporção de uso dos imunossupressores micofenolato e azatioprina atuou como fator protetor. CONCLUSÕES: As análises realizadas fornecem a primeira informação quanto ao tempo de sobrevivência mediana do transplante cardíaco no Brasil. A diferença observada entre as regiões pode estar relacionada aos diferentes protocolos de tratamento adotados no país, principalmente no início dos anos 2000. A proporção de uso de micofenolato e azatioprina como fator protetor sugere que, apesar de não haver diferença entre as estratégias terapêuticas, o uso desses medicamentos pode favorecer a sobrevida de determinados pacientes. O estudo apresenta dados epidemiológicos robustos e importantes para a saúde pública.

Individual and treatment setting predictors of HIV/AIDS knowledge among psychiatric patients and their implications in a national multisite study in Brazil.

The objective of this study is to measure HIV/AIDS knowledge among patients with mental illness in Brazil and to examine individual and treatment setting predictors of knowledge. We conducted a cross-sectional national multicenter study among 2,475 patients in 26 randomly selected mental health institutions throughout Brazil. We used Item Response Theory to standardize knowledge scores and multilevel multiple linear regression to determine the effect of individual and treatment setting characteristics on standardized knowledge score. Schizophrenia was the main diagnosis (48%) of participants. Mean knowledge score was 6.78 (range 1-10). Treatment setting characteristics were not associated with knowledge scores. Higher HIV/AIDS knowledge scores were significantly associated with a history of sexually transmitted disease (STD), previous HIV testing and consistent condom use; lower HIV/AIDS knowledge scores were significantly associated with specific sociodemographic, psychiatric, and HIV risk-perception factors. Psychiatric patients in Brazil lag behind the general population with knowledge scores comparable to those of nearly a decade ago. The mental health system in Brazil and elsewhere must consider strategies beyond dispensing information, for preventing HIV/AIDS transmission in the psychiatric population.

Use of medicines by adults in primary care: Survey on health services in Minas Gerais, Brazil. / Uso de medicamentos por adultos na atenção primária: inquérito em serviços de saúde de Minas Gerais, Brasil.

INTRODUCTION: Inappropriate use and increase of health care spending reinforce the need to extend our knowledge about the quality of medication use. OBJECTIVES: To describe and evaluate the profile of medication use in a representative sample of adult users of primary care services in the Unified Health System (SUS) of Minas Gerais. METHOD: Cross-sectional study, with 1,159 interviewees in 104 municipalities and 253 health care services. Data on sociodemographic characteristics, health conditions and use of medicines were collected, and these variables were stratified by age group. Univariate and multivariate analyses, using logistic regression, were conducted to identify predictors of self-medication. We set a significance level of 5% for all tests. RESULTS: The prevalence of medication use was 81.8%, with an average of 2.67 medicines per user, which increased with age. The most used drugs were losartan, hydrochlorothiazide and simvastatin, which differed between age groups. Significant self-medication was observed not only in young adults but also in the elderly. The predictors of self-medication were: being a young adult, having a higher level of education, not having chronic diseases, having worse self-perception of health and not adhering to prescription drugs. Young and elderly adults showed characteristics that made them more vulnerable in relation to the rational use of medicines. CONCLUSION: This study can contribute to improving primary care, where it identified problems related to the extent of medication use, especially among young adults and the elderly in Minas Gerais.

Effectiveness of Maintenance Immunosuppression Therapies in a Matched-Pair Analysis Cohort of 16 Years of Renal Transplant in the Brazilian National Health System.

The maintenance of patients with renal transplant typically involves two or more drugs to prevent rejection and prolong graft survival. The calcineurin inhibitors (CNI) are the most commonly recommended medicines in combinations with others. While immunosuppressive treatment regimens are well established, there is insufficient long-term effectiveness data to help guide future management decisions. The study analyzes the effectiveness of treatment regimens containing CNI after renal transplantation during 16 years of follow-up with real-world data from the Brazilian National Health System (SUS). This was a retrospective study of 2318 SUS patients after renal transplantion. Patients were propensity score-matched (1:1) by sex, age, type and year of transplantation. Kaplan-Meier analysis was used to estimate the cumulative probabilities of survival. A Cox proportional hazard model was used to evaluate factors associated with progression to graft loss. Multivariable analysis, adjusted for diabetes mellitus and race/color, showed a greater risk of graft loss for patients using tacrolimus plus mycophenolate compared to patients treated with cyclosporine plus azathioprine. In conclusion, this Brazilian real-world study, with a long follow-up period using matched analysis for relevant clinical features and the representativeness of the sample, demonstrated improved long-term effectiveness for therapeutic regimens containing cyclosporine plus azathioprine. Consequently, we recommend that protocols and clinical guidelines for renal transplantation should consider the cyclosporine plus azathioprine regimen as a potential first line option, along with others.