RESUMO O mieloma múltiplo é o segundo câncer hematológico mais comum; representa aproximadamente 10% de todas os cânceres hematológicos e 1%-2% de todos as neoplasias. Foi conduzido um estudo ecológico para descrever a morbidade, a mortalidade e a carga da doença no Brasil e suas 27 unidades federativas e avaliar tendências entre 1990-2019. Dados do estudo da Carga Global de Doenças foram avaliados para descrever medidas ajustadas por idade: incidência, prevalência, mortalidade, anos de vida ajustados pela incapacidade e seus componentes de acordo com sexo e Índice Sociodemográfico. As tendências foram estimadas usando regressão linear e expressas como Variação Percentual Anual Média (AAPC) e Intervalos de Confiança (IC) 95%. Tendências ascendentes das medidas foram observadas. A mortalidade aumentou em menor extensão comparada à incidência (AAPC=1,3%;IC95%=1,2-1,3 vs. AAPC=1,5%;IC95%=1,5-1,5 homens; AAPC=0,9%; IC95%=0,9-0,9 vs. AAPC=1,1%; IC95%=1,1-1,2 mulheres), resultando em tendências crescentes da prevalência para ambos os sexos. Todas as medidas foram mais altas nos quintis do índice sociodemográfico alto e médio-alto; tendências ascendentes mais altas foram encontradas em quintis do índice sociodemográfico mais baixos. Envelhecimento, nível de desenvolvimento, acesso ao diagnóstico e tratamento parecem explicar as medidas ascendentes do mieloma múltiplo no Brasil e suas diferenças entre as unidades federativas.

ABSTRACT Multiple myeloma is the second most common hematological cancer; it accounts for approximately 10% of all hematologic malignancies and 1%-2% of all cancer diagnoses. From 1990 to 2019, an ecological study was conducted to describe and evaluate trends in Brazil’s morbidity, mortality, and disease. The Global Burden of Disease data described age-standardized (+40 years) incidence, prevalence, mortality, disability-adjusted life years, and its components in Brazil and across its 27 federative units according to sex and Socio-demographic Index quintiles. Trends were estimated using linear regression and expressed as Average Annual Percentage Changes (AAPC) and 95% Confidence Intervals (CI). Ascending trends of the measures were found for both sexes in Brazil and its federative units. Mortality increased to a lesser extent than incidence (AAPC=1.3%; 95%CI=1.2-1.3 vs. AAPC=1.5%; 95%CI= 1.5-1.5 for men; AAPC=0.9%; 95%CI=0.9-0.9 vs. AAPC=1.1%; 95%CI=1.1-1.2 for women), resulting in higher rising trends in prevalence for both sexes. All the measures were significantly higher in high- and high-middle socio-demographic quintiles; however, higher ascending trends were found in lower socio-demographic quintiles. Aging, level of development, diagnosis, and treatment appear to explain Brazil’s ascending multiple myeloma rates and their differences among the federative units.

RESUMO O mieloma múltiplo é o segundo câncer hematológico mais comum; representa aproximadamente 10% de todas os cânceres hematológicos e 1%-2% de todos as neoplasias. Foi conduzido um estudo ecológico para descrever a morbidade, a mortalidade e a carga da doença no Brasil e suas 27 unidades federativas e avaliar tendências entre 1990-2019. Dados do estudo da Carga Global de Doenças foram avaliados para descrever medidas ajustadas por idade: incidência, prevalência, mortalidade, anos de vida ajustados pela incapacidade e seus componentes de acordo com sexo e Índice Sociodemográfico. As tendências foram estimadas usando regressão linear e expressas como Variação Percentual Anual Média (AAPC) e Intervalos de Confiança (IC) 95%. Tendências ascendentes das medidas foram observadas. A mortalidade aumentou em menor extensão comparada à incidência (AAPC=1,3%;IC95%=1,2-1,3 vs. AAPC=1,5%;IC95%=1,5-1,5 homens; AAPC=0,9%; IC95%=0,9-0,9 vs. AAPC=1,1%; IC95%=1,1-1,2 mulheres), resultando em tendências crescentes da prevalência para ambos os sexos. Todas as medidas foram mais altas nos quintis do índice sociodemográfico alto e médio-alto; tendências ascendentes mais altas foram encontradas em quintis do índice sociodemográfico mais baixos. Envelhecimento, nível de desenvolvimento, acesso ao diagnóstico e tratamento parecem explicar as medidas ascendentes do mieloma múltiplo no Brasil e suas diferenças entre as unidades federativas. comum 10 1%2% 12 1% 2% 1 2 1%-2 neoplasias morbidade 19902019. 19902019 1990 2019. 2019 1990-2019 idade Sociodemográfico AAPC (AAPC IC (IC 95 95% observadas AAPC=1,3%IC95%=1,21,3 AAPC13IC951213 AAPCIC AAPC=1,3% IC95%=1,2 1,3 3 IC95 (AAPC=1,3%;IC95%=1,2-1, vs AAPC=1,5%IC95%=1,51,5 AAPC15IC951515 AAPC=1,5% IC95%=1,5 1,5 5 AAPC=1,5%;IC95%=1,5-1, homens AAPC=0,9% AAPC09 0 9 IC95%=0,90,9 IC950909 IC95%=0,9 0,9 IC95%=0,9-0, AAPC=1,1% AAPC11 IC95%=1,11,2 IC951112 IC95%=1,1 1,2 IC95%=1,1-1, mulheres, mulheres , mulheres) sexos médioalto médio médio-alto baixos Envelhecimento desenvolvimento 1%2 1%- 1990201 199 201 1990-201 21 AAPC=1,3%IC95%=1,21, AAPC13IC95121 AAPC13 AAPC=1,3 IC9512 IC95%=1, 13 1, IC9 (AAPC=1,3%;IC95%=1,2-1 51 AAPC=1,5%IC95%=1,51, AAPC15IC95151 AAPC15 AAPC=1,5 IC9515 15 AAPC=1,5%;IC95%=1,5-1 AAPC=0,9 AAPC0 90 IC95%=0,90, IC95090 IC9509 IC95%=0, 09 0, IC95%=0,9-0 AAPC=1,1 AAPC1 11 IC95%=1,11, IC95111 IC9511 IC95%=1,1-1 199020 19 20 1990-20 AAPC=1,3%IC95%=1,21 AAPC13IC9512 AAPC=1, IC951 IC95%=1 (AAPC=1,3%;IC95%=1,2- AAPC=1,5%IC95%=1,51 AAPC15IC9515 AAPC=1,5%;IC95%=1,5- AAPC=0, IC95%=0,90 IC950 IC95%=0 IC95%=0,9- IC95%=1,11 IC95%=1,1- 19902 1990-2 AAPC=1,3%IC95%=1,2 AAPC13IC951 AAPC=1 IC95%= (AAPC=1,3%;IC95%=1,2 AAPC=1,5%IC95%=1,5 AAPC15IC951 AAPC=1,5%;IC95%=1,5 AAPC=0 1990- AAPC=1,3%IC95%=1, AAPC13IC95 AAPC= IC95% (AAPC=1,3%;IC95%=1, AAPC=1,5%IC95%=1, AAPC15IC95 AAPC=1,5%;IC95%=1, AAPC=1,3%IC95%=1 AAPC13IC9 (AAPC=1,3%;IC95%=1 AAPC=1,5%IC95%=1 AAPC15IC9 AAPC=1,5%;IC95%=1 AAPC=1,3%IC95%= AAPC13IC (AAPC=1,3%;IC95%= AAPC=1,5%IC95%= AAPC15IC AAPC=1,5%;IC95%= AAPC=1,3%IC95% (AAPC=1,3%;IC95% AAPC=1,5%IC95% AAPC=1,5%;IC95% AAPC=1,3%IC95 (AAPC=1,3%;IC95 AAPC=1,5%IC95 AAPC=1,5%;IC95 AAPC=1,3%IC9 (AAPC=1,3%;IC9 AAPC=1,5%IC9 AAPC=1,5%;IC9 AAPC=1,3%IC (AAPC=1,3%;IC AAPC=1,5%IC AAPC=1,5%;IC

ABSTRACT Multiple myeloma is the second most common hematological cancer; it accounts for approximately 10% of all hematologic malignancies and 1%-2% of all cancer diagnoses. From 1990 to 2019, an ecological study was conducted to describe and evaluate trends in Brazil’s morbidity, mortality, and disease. The Global Burden of Disease data described age-standardized (+40 years) incidence, prevalence, mortality, disability-adjusted life years, and its components in Brazil and across its 27 federative units according to sex and Socio-demographic Index quintiles. Trends were estimated using linear regression and expressed as Average Annual Percentage Changes (AAPC) and 95% Confidence Intervals (CI). Ascending trends of the measures were found for both sexes in Brazil and its federative units. Mortality increased to a lesser extent than incidence (AAPC=1.3%; 95%CI=1.2-1.3 vs. AAPC=1.5%; 95%CI= 1.5-1.5 for men; AAPC=0.9%; 95%CI=0.9-0.9 vs. AAPC=1.1%; 95%CI=1.1-1.2 for women), resulting in higher rising trends in prevalence for both sexes. All the measures were significantly higher in high- and high-middle socio-demographic quintiles; however, higher ascending trends were found in lower socio-demographic quintiles. Aging, level of development, diagnosis, and treatment appear to explain Brazil’s ascending multiple myeloma rates and their differences among the federative units. 10 1%2% 12 1% 2% 1 2 1%-2 diagnoses 199 2019 Brazils s morbidity mortality disease agestandardized age standardized +40 40 (+4 years disabilityadjusted disability adjusted Sociodemographic Socio demographic quintiles AAPC (AAPC 95 CI. CI . (CI) AAPC=1.3% AAPC13 3 (AAPC=1.3% 95%CI=1.21.3 95CI1213 95%CI=1.2 1.3 95%CI=1.2-1. vs AAPC=1.5% AAPC15 5 95CI 95%CI 1.51.5 1515 1.5 1.5-1. men AAPC=0.9% AAPC09 0 9 95%CI=0.90.9 95CI0909 95%CI=0.9 0.9 95%CI=0.9-0. AAPC=1.1% AAPC11 95%CI=1.11.2 95CI1112 95%CI=1.1 1.2 95%CI=1.1-1. women, women , women) high highmiddle middle sociodemographic socio however Aging development diagnosis 1%2 1%- 19 201 +4 4 (+ (CI AAPC=1.3 AAPC1 (AAPC=1.3 21 95%CI=1.21. 95CI121 95CI12 95%CI=1. 13 1. 95%CI=1.2-1 AAPC=1.5 51 1.51. 151 15 1.5-1 AAPC=0.9 AAPC0 90 95%CI=0.90. 95CI090 95CI09 95%CI=0. 09 0. 95%CI=0.9-0 AAPC=1.1 11 95%CI=1.11. 95CI111 95CI11 95%CI=1.1-1 20 + ( AAPC=1. (AAPC=1. 95%CI=1.21 95CI1 95%CI=1 95%CI=1.2- 1.51 1.5- AAPC=0. 95%CI=0.90 95CI0 95%CI=0 95%CI=0.9- 95%CI=1.11 95%CI=1.1- AAPC=1 (AAPC=1 AAPC=0 AAPC= (AAPC=

ABSTRACT Objective To compare viral suppression in treatment-naïve adults starting antiretroviral therapy with dolutegravir (50mg)- and efavirenz (600mg)-based regimens. Methods We analyzed secondary data from Brazilian health information systems of people living with human immunodeficiency virus who started antiretroviral therapy between 2015 and 2017 in Minas Gerais, Brazil. The outcome was viral suppression, defined as the achievement of the first viral load <50 copies/mL within 12 months after initiating antiretroviral therapy. This outcome was also compared with viral load <1,000 copies/mL and analyzed in two scenarios: intention-to-treat versus per-protocol. Time to viral suppression and adjusted odds ratio accompanied by 95% confidence intervals were estimated. Results Of the 2,599 participants enrolled, 77.5% were men, and the median age was 34 years. In the intention-to-treat analysis, viral suppression was 58.1% for efavirenz and 76.7% for dolutegravir. People living with HIV on dolutegravir-based regimen were more likely to achieve viral suppression (aOR: 2.44; 95%CI: 2.01-2.95) and had a shorter median time to viral suppression (p<0.0001). Antiretroviral therapy initiation within <120 days, baseline CD4⁺T-cells ≥200 cells/mm3, and viral load <100,000 copies/mL had higher odds of viral suppression. According to the per-protocol analysis, viral suppression ≥90% was observed by considering viral load <1,000 copies/mL. Conclusion Our study demonstrated that viral suppression improved after introducing dolutegravir, although the proportion of patients with viral load <50 copies/mL was lower than expected. Improved access to routine viral load examinations and continuous surveillance of the effectiveness of antiretroviral therapy should be considered. treatmentnaïve treatment naïve 50mg mg (50mg) 600mgbased mgbased 600mg based regimens 201 Gerais Brazil 50 <5 copiesmL copies mL 1 1000 000 <1,00 scenarios intentiontotreat intention treat perprotocol. perprotocol per protocol. protocol 95 estimated 2599 2 599 2,59 enrolled 775 77 5 77.5 men 3 years analysis 581 58 58.1 767 76 7 76.7 dolutegravirbased aOR (aOR 2.44 244 44 95%CI 95CI CI 2.012.95 201295 2.01 2.95 01 2.01-2.95 p<0.0001. p00001 p p<0.0001 . 0 0001 (p<0.0001) 120 <12 days CD4⁺Tcells CD4Tcells CDTcells CD4⁺T cells CD4 T CD 200 ≥20 cellsmm3 cellsmm mm3 mm cells/mm3 100000 100 <100,00 90 ≥90 expected considered (50mg 20 < 00 <1,0 9 259 59 2,5 77. 58. 76. 2.4 24 4 012 2.012.9 20129 2.0 295 2.9 2.01-2.9 p0000 p<0.000 (p<0.0001 <1 Tcells CD4T CDT ≥2 cells/mm 10000 10 <100,0 ≥9 <1, 25 2, 2. 2.012. 2012 29 2.01-2. p000 p<0.00 (p<0.000 ≥ <100, 2.012 2.01-2 p00 p<0.0 (p<0.00 <100 2.01- p0 p<0. (p<0.0 <10 p<0 (p<0. p< (p<0 (p< (p

ABSTRACT The incidence and clinical characteristics of NTM diseases in Brazil remain relatively unknown. The present study describes the diagnosis of NTM isolates, the clinical presentation and treatment outcomes. We analyzed NTM isolates in patients of a tertiary hospital in the Southeast region of Brazil, from January 2008 to July 2019. The ATS/IDSA criteria for diagnosis and treatment of these patients was applied. Mycobacterium kansasii were identified in 13/113 (11.5%) patients. In 59/113 (52.2%) patients who met the ATS criteria for disease, 29/59 (49.1%) received treatment, and 22/29 (75.8%) were cured. The major species identified was M. kansasii. The most frequent symptoms among the treated patients were dyspnea and cough, and the proportion of cured patients was high. unknown outcomes 200 2019 ATSIDSA IDSA applied 13113 13 113 13/11 11.5% 115 11 5 (11.5% 59113 59 59/11 52.2% 522 52 2 (52.2% disease 2959 29 29/5 49.1% 491 49 1 (49.1% 2229 22 22/2 75.8% 758 75 8 (75.8% M cough high 20 201 1311 13/1 11.5 (11.5 5911 59/1 52.2 (52.2 295 29/ 49.1 4 (49.1 222 22/ 75.8 7 (75.8 131 13/ 11. (11. 591 59/ 52. (52. 49. (49. 75. (75. (11 (52 (49 (75 (1 (5 (4 (7 (

Resumo Estudo de utilização de medicamento que descreve o controle da talidomida no Brasil e sua utilização em Minas Gerais. Questionário online foi enviado às unidades federativas do Brasil para coleta de dados de distribuição, dispensação, cadastro de usuários e eventos adversos da talidomida. Dados de distribuição (2011-2018) e dispensação (2015-2018) de Minas Gerais foram obtidos pelo sistema de gerenciamento da assistência farmacêutica. Análise de variância e teste de Tukey foram empregados para comparações dos dados. Das 16 unidades federativas participantes, 100% e 50% utilizavam sistema eletrônico para distribuição e dispensação, respectivamente, e cerca de 43% cadastravam usuários. Sistemas de notificação de eventos adversos eram escassos. Houve redução de 44% na distribuição em Minas Gerais no período. A dispensação manteve-se constante (média 0,0004 DDD/1000 hab./dia) e ocorreu principalmente para eritema nodoso hansênico e mieloma múltiplo. O uso off-label (2,2%) foi crescente. A maioria dos usuários era do sexo masculino (idade média 56 anos). Das mulheres, 30% estavam em idade fértil. A vigilância da talidomida é um desafio em saúde pública. Apesar da ampliação do uso e obrigatoriedade de controle, não há padronização em nível nacional e a notificação de eventos adversos é incipiente.

Abstract Drug utilization research to describe the control of thalidomide in Brazil and its use in Minas Gerais state. An online questionnaire was sent to the Brazilian federative units to collect data concerning distribution, dispensation, user registration, and thalidomide adverse events. Distribution (2011-2018) and dispensing (2015-2018) data in Minas Gerais were obtained through the pharmaceutical care management system. Analysis of variance and Tukey test were used for data comparisons. Of the 16 participating federative units, 100% and 50% used electronic distribution and dispensing systems, respectively, and about 43% registered users. Adverse event reporting systems were scarce. A 44% reduction was observed in the distribution in Minas Gerais for the period. Dispensing remained constant (mean 0.0004 DDD/1,000 inhabitants/day) and occurred mainly for erythema nodosum leprosum and multiple myeloma. Off-label use (2.2%) was increasing. Most users were male (mean age 56 years) and thirty percent of women were of childbearing age. Thalidomide surveillance is a public health challenge. Despite the increased use and mandatory control, there is no national standardization, and adverse event reporting is incipient.

Resumo Estudo de utilização de medicamento que descreve o controle da talidomida no Brasil e sua utilização em Minas Gerais. Questionário online foi enviado às unidades federativas do Brasil para coleta de dados de distribuição, dispensação, cadastro de usuários e eventos adversos da talidomida. Dados de distribuição (2011-2018) e dispensação (2015-2018) de Minas Gerais foram obtidos pelo sistema de gerenciamento da assistência farmacêutica. Análise de variância e teste de Tukey foram empregados para comparações dos dados. Das 16 unidades federativas participantes, 100% e 50% utilizavam sistema eletrônico para distribuição e dispensação, respectivamente, e cerca de 43% cadastravam usuários. Sistemas de notificação de eventos adversos eram escassos. Houve redução de 44% na distribuição em Minas Gerais no período. A dispensação manteve-se constante (média 0,0004 DDD/1000 hab./dia) e ocorreu principalmente para eritema nodoso hansênico e mieloma múltiplo. O uso off-label (2,2%) foi crescente. A maioria dos usuários era do sexo masculino (idade média 56 anos). Das mulheres, 30% estavam em idade fértil. A vigilância da talidomida é um desafio em saúde pública. Apesar da ampliação do uso e obrigatoriedade de controle, não há padronização em nível nacional e a notificação de eventos adversos é incipiente.

Abstract Drug utilization research to describe the control of thalidomide in Brazil and its use in Minas Gerais state. An online questionnaire was sent to the Brazilian federative units to collect data concerning distribution, dispensation, user registration, and thalidomide adverse events. Distribution (2011-2018) and dispensing (2015-2018) data in Minas Gerais were obtained through the pharmaceutical care management system. Analysis of variance and Tukey test were used for data comparisons. Of the 16 participating federative units, 100% and 50% used electronic distribution and dispensing systems, respectively, and about 43% registered users. Adverse event reporting systems were scarce. A 44% reduction was observed in the distribution in Minas Gerais for the period. Dispensing remained constant (mean 0.0004 DDD/1,000 inhabitants/day) and occurred mainly for erythema nodosum leprosum and multiple myeloma. Off-label use (2.2%) was increasing. Most users were male (mean age 56 years) and thirty percent of women were of childbearing age. Thalidomide surveillance is a public health challenge. Despite the increased use and mandatory control, there is no national standardization, and adverse event reporting is incipient.

RESUMO Objetivo Descrever a utilização de psicofármacos por servidores públicos com registro de absenteísmo por transtornos mentais, e analisar sua associação com a duração do afastamento do trabalho. Métodos Estudo transversal com servidores públicos em afastamento laboral por transtornos mentais, entre janeiro a dezembro de 2017. Variáveis demográficas, ocupacionais e clínicas foram obtidas a partir de dados secundários. Foram empregados testes não paramétricos para avaliar a correlação entre o uso de psicofármacos e o tempo de afastamento. A análise de cluster foi utilizada para verificar a associação entre as características ocupacionais e o perfil de adoecimento do servidor. Resultados Os antidepressivos foram os medicamentos mais utilizados (82,9%). Observaram-se diferenças nos valores centrais de dias de afastamentos por número de psicofármacos utilizados. Na análise de cluster , um dos conglomerados (servidores com idade e tempo de trabalhos intermediários – média 46 anos de idade e 15 anos de trabalho) destacou-se em relação à utilização de antidepressivos, gravidade do quadro depressivo, frequência e duração do afastamento. Conclusão O afastamento laboral por transtornos mentais esteve associado à maior utilização de psicofármacos. O grupo de servidores identificado pode ser alvo prioritário de ações de promoção, prevenção e recuperação da saúde na instituição.

ABSTRACT Objective To describe the use of psychotropic drugs among civil servants with registered absenteeism due to mental disorders, and to investigate associations with duration of leave of absence. Methods A cross-sectional study with civil servants on leave of absence due to mental disorders, between January and December 2017. Demographic, occupational and clinical variables were extracted from secondary data. Non-parametric tests were used to investigate correlations between use of psychotropic drugs and leave duration. Cluster analysis was used to investigate associations between occupational characteristics and illness profile. Results Antidepressants were the most commonly used drugs (82.9%). Central tendency values for days on leave differed according to the number of psychotropic drugs used. In cluster analysis, a particular cluster (servants of intermediate age group and work experience – mean of 46 years and 15 years, respectively) stood out regarding use of antidepressants, severity of depression and frequency and duration of leave of absence. Conclusion Leave of absence due to mental disorders was associated with higher rates of psychotropic drug use. The group of servants identified in this study may be a primary target for health promotion, prevention and recovery actions at the organization.

A recuperação imunológica reflete condições de saúde. Nosso objetivo foi estimar o tempo até a recuperação imunológica e fatores associados em pessoas vivendo com HIV (PVHIV) após de iniciar a terapia antirretroviral (TARV). Foi conduzida uma coorte histórica de PVHIV (> 18 anos) no Estado de Minas Gerais, Brasil, usando bancos de serviços públicos de saúde. Foram incluídos pacientes que iniciaram a TARV entre 2009 e 2018, com linfócitos T-CD4+ e carga viral registrados antes e depois do início da TARV. O desfecho foi a recuperação imunológica, definida como a primeira contagem de T-CD4+ > 500 cel/µL após o início da TARV. As variáveis explanatórias foram idade, sexo, local de residência, ano de início de TARV, carga viral basal, T-CD4+ na linha de base e carga viral e adesão à TARV no seguimento. Foi realizada uma análise descritiva com estimativa de incidência acumulada e taxa de incidência (pessoa-ano). O tempo mediano até a recuperação imunológica foi estimado pelo método Kaplan-Meier. Fatores associados à recuperação imune foram avaliados por meio de regressão de Cox. Entre as 26.430 PVHIV, 8.014 (30%) foram elegíveis. A maioria era do sexo masculino (67%), com média de idade = 38,7 anos, residência em regiões fora da região metropolitana, mediana de T-CD4+ baseline = 228 células/µL (< 200 células/µL = 43%) e mediana de carga viral baseline = 4,7 log10 cópias/mL (carga viral detectável = 99%). Tempo de seguimento = 15.872 pessoas-ano. A incidência acumulativa e a taxa de incidência foram foram 58% (IC95%: 57-58) (n = 4.678) e 29,47 casos/100 pessoas-ano, respectivamente. Tempo mediano até recuperação imune = 22,8 meses (IC95%: 21,9-24,0). Os fatores independentemente associados com recuperação imunológica foram sexo feminino, idade < 38 anos, T-CD4+ basal > 200 células/µL, carga viral detectável (linha de base), adesão à TARV e carga viral indetectável (no seguimento). O tempo até a recuperação imunológica ainda é longo e impactado pelo tratamento precoce e da adesão à TARV.

Immune recovery reflects health conditions. Our goal was to estimate the time it takes to achieve immune recovery and its associated factors, in people living with HIV (PLHIV), after antiretroviral therapy (ART) initiation. A historical cohort study was performed among PLHIV (> 18 years-old) in Minas Gerais State, Brazil, using data from healthcare databases. Patients initiating ART between 2009-2018, with T-CD4+ lymphocytes and viral load recorded before and after antiretroviral therapy were included. The outcome is achievement of immune recovery, defined as the first T-CD4+ > 500 cells/µL after ART initiation. Explanatory variables were age, gender, place of residence, year of ART initiation, baseline viral load and T-CD4+, viral load status, and adherence to ART at follow-up. Descriptive analysis, cumulative, and person-time incidences of immune recovery were estimated. Median-time to immune recovery was estimated using Kaplan-Meier method. Factors associated with immune recovery were assessed by Cox regression. Among 26,430 PLHIV, 8,014 (30%) were eligible. Most were male (67%), mean age 38.7 years, resided in non-central region, median-baseline T-CD4+ = 228 cells/µL (< 200 cells/µL = 43%) and viral load median-baseline = 4.7 log10 copies/mL (detectable viral load = 99%). Follow-up time = 15,872 person-years. Cumulative and incidence rate were 58% (95%CI: 57-58) (n = 4,678) and 29.47 cases/100 person-years, respectively. Median-time to immune recovery was of 22.8 months (95%CI: 21.9-24.0). Women living with HIV, younger than 38 years of age, with T-CD4+ baseline > 200 cells/µL, detectable viral load (baseline), antiretroviral therapy-adherence and undetectable viral load (follow-up) were independently associated with immune recovery. Time to immune recovery remains long and depends on early treatment and antiretroviral therapy-adherence.

La recuperación inmunológica refleja condiciones de salud. Nuestra meta fue estimar el tiempo y los factores asociados a la recuperación inmunológica en personas que viven con VIH (PVVIH), tras iniciar una terapia antirretroviral (TAR). Se realizó sobre una cohorte histórica entre PVVIH (> 18 años de edad) en Minas Gerais, Brasil, usando datos de las bases de datos del sistema de salud. Se incluyeron a pacientes que comenzaron una TAR entre 2009-2018, con T-CD4+ linfocitos y carga viral, registrada antes/después de TAR. El resultado fue el logro de recuperación inmunológica, definida como la primera T-CD4+ > 500 células/µL tras la iniciación TAR. Las variables explicatorias fueron: edad, género, lugar de residencia, año de iniciación TAR, base de referencia de carga viral, base de referencia de T-CD4+ y estatus de la carga viral y adherencia al TAR en el seguimiento. Se estimó: análisis descriptivo, acumulativo e incidencias persona-tiempo de recuperación inmunológica. La media de tiempo para la recuperación inmunológica se estimó usando el método Kaplan-Meier. Los factores asociados con la recuperación inmunológica se evaluaron mediante la regresión de Cox. Entre las 26.430 PVVIH, 8.014 (30%) fueron elegibles. La mayoría eran hombres (67%), media de edad = 38,7 años, residentes en una región no central, media de base de referencia T-CD4+ = 228 células/µL (< 200 células/µL = 43%) y carga viral media de base de referencia = 4,7 log10 copias/mL (carga viral detectable = 99%). El tiempo de seguimiento = 15.872 persona-años. La tasa acumulativa y de incidencia fue 58% (95%CI: 57-58) (n = 4.678) y 29,47 casos/100 persona-años, respectivamente. El tiempo de media para la recuperación inmunológica = 22,8 meses (95%CI: 21,9-24,0). Género femenino, PVVIH < 38 años de edad, T-CD4+ base de referencia > 200 células/µL, carga viral detectable (base de referencia), adherencia al TAR e carga viral indetectable (seguimiento) estuvieron independientemente asociadas con la recuperación inmunológica. El tiempo para la recuperación inmunológica sigue siendo largo y depende de un tratamiento temprano y de adherencia a la TAR.

A recuperação imunológica reflete condições de saúde. Nosso objetivo foi estimar o tempo até a recuperação imunológica e fatores associados em pessoas vivendo com HIV (PVHIV) após de iniciar a terapia antirretroviral (TARV). Foi conduzida uma coorte histórica de PVHIV (> 18 anos) no Estado de Minas Gerais, Brasil, usando bancos de serviços públicos de saúde. Foram incluídos pacientes que iniciaram a TARV entre 2009 e 2018, com linfócitos T-CD4+ e carga viral registrados antes e depois do início da TARV. O desfecho foi a recuperação imunológica, definida como a primeira contagem de T-CD4+ > 500 cel/µL após o início da TARV. As variáveis explanatórias foram idade, sexo, local de residência, ano de início de TARV, carga viral basal, T-CD4+ na linha de base e carga viral e adesão à TARV no seguimento. Foi realizada uma análise descritiva com estimativa de incidência acumulada e taxa de incidência (pessoa-ano). O tempo mediano até a recuperação imunológica foi estimado pelo método Kaplan-Meier. Fatores associados à recuperação imune foram avaliados por meio de regressão de Cox. Entre as 26.430 PVHIV, 8.014 (30%) foram elegíveis. A maioria era do sexo masculino (67%), com média de idade = 38,7 anos, residência em regiões fora da região metropolitana, mediana de T-CD4+ baseline = 228 células/µL (< 200 células/µL = 43%) e mediana de carga viral baseline = 4,7 log10 cópias/mL (carga viral detectável = 99%). Tempo de seguimento = 15.872 pessoas-ano. A incidência acumulativa e a taxa de incidência foram foram 58% (IC95%: 57-58) (n = 4.678) e 29,47 casos/100 pessoas-ano, respectivamente. Tempo mediano até recuperação imune = 22,8 meses (IC95%: 21,9-24,0). Os fatores independentemente associados com recuperação imunológica foram sexo feminino, idade < 38 anos, T-CD4+ basal > 200 células/µL, carga viral detectável (linha de base), adesão à TARV e carga viral indetectável (no seguimento). O tempo até a recuperação imunológica ainda é longo e impactado pelo tratamento precoce e da adesão à TARV.

Immune recovery reflects health conditions. Our goal was to estimate the time it takes to achieve immune recovery and its associated factors, in people living with HIV (PLHIV), after antiretroviral therapy (ART) initiation. A historical cohort study was performed among PLHIV (> 18 years-old) in Minas Gerais State, Brazil, using data from healthcare databases. Patients initiating ART between 2009-2018, with T-CD4+ lymphocytes and viral load recorded before and after antiretroviral therapy were included. The outcome is achievement of immune recovery, defined as the first T-CD4+ > 500 cells/µL after ART initiation. Explanatory variables were age, gender, place of residence, year of ART initiation, baseline viral load and T-CD4+, viral load status, and adherence to ART at follow-up. Descriptive analysis, cumulative, and person-time incidences of immune recovery were estimated. Median-time to immune recovery was estimated using Kaplan-Meier method. Factors associated with immune recovery were assessed by Cox regression. Among 26,430 PLHIV, 8,014 (30%) were eligible. Most were male (67%), mean age 38.7 years, resided in non-central region, median-baseline T-CD4+ = 228 cells/µL (< 200 cells/µL = 43%) and viral load median-baseline = 4.7 log10 copies/mL (detectable viral load = 99%). Follow-up time = 15,872 person-years. Cumulative and incidence rate were 58% (95%CI: 57-58) (n = 4,678) and 29.47 cases/100 person-years, respectively. Median-time to immune recovery was of 22.8 months (95%CI: 21.9-24.0). Women living with HIV, younger than 38 years of age, with T-CD4+ baseline > 200 cells/µL, detectable viral load (baseline), antiretroviral therapy-adherence and undetectable viral load (follow-up) were independently associated with immune recovery. Time to immune recovery remains long and depends on early treatment and antiretroviral therapy-adherence.

La recuperación inmunológica refleja condiciones de salud. Nuestra meta fue estimar el tiempo y los factores asociados a la recuperación inmunológica en personas que viven con VIH (PVVIH), tras iniciar una terapia antirretroviral (TAR). Se realizó sobre una cohorte histórica entre PVVIH (> 18 años de edad) en Minas Gerais, Brasil, usando datos de las bases de datos del sistema de salud. Se incluyeron a pacientes que comenzaron una TAR entre 2009-2018, con T-CD4+ linfocitos y carga viral, registrada antes/después de TAR. El resultado fue el logro de recuperación inmunológica, definida como la primera T-CD4+ > 500 células/µL tras la iniciación TAR. Las variables explicatorias fueron: edad, género, lugar de residencia, año de iniciación TAR, base de referencia de carga viral, base de referencia de T-CD4+ y estatus de la carga viral y adherencia al TAR en el seguimiento. Se estimó: análisis descriptivo, acumulativo e incidencias persona-tiempo de recuperación inmunológica. La media de tiempo para la recuperación inmunológica se estimó usando el método Kaplan-Meier. Los factores asociados con la recuperación inmunológica se evaluaron mediante la regresión de Cox. Entre las 26.430 PVVIH, 8.014 (30%) fueron elegibles. La mayoría eran hombres (67%), media de edad = 38,7 años, residentes en una región no central, media de base de referencia T-CD4+ = 228 células/µL (< 200 células/µL = 43%) y carga viral media de base de referencia = 4,7 log10 copias/mL (carga viral detectable = 99%). El tiempo de seguimiento = 15.872 persona-años. La tasa acumulativa y de incidencia fue 58% (95%CI: 57-58) (n = 4.678) y 29,47 casos/100 persona-años, respectivamente. El tiempo de media para la recuperación inmunológica = 22,8 meses (95%CI: 21,9-24,0). Género femenino, PVVIH < 38 años de edad, T-CD4+ base de referencia > 200 células/µL, carga viral detectable (base de referencia), adherencia al TAR e carga viral indetectable (seguimiento) estuvieron independientemente asociadas con la recuperación inmunológica. El tiempo para la recuperación inmunológica sigue siendo largo y depende de un tratamiento temprano y de adherencia a la TAR.

Abstract Introduction Life expectancy of people living with human immunodeficiency (PLHIV) has increased mainly due to the accessibility and effectiveness of antiretroviral therapy (ART). However, adverse effects from long-term use of antiretrovirals, and the physiological changes associated with aging, may compromise the quality of life of PLHIV, in addition to causing new demands on the healthcare system. Objectives Estimate the frequency of osteoporosis and osteopenia in patients on prolonged ART and to verify their associated factors. Methods A cross-sectional study was conducted in Belo Horizonte, Minas Gerais, Brazil, from August 2017 to June 2018, in a sample of PLHIV (age≥18 years) who started ART between 2001 and 2005. Data were collected through face-to-face interviews, physical evaluation, laboratory tests, and Dual-Energy X-Ray Absorptiometry Screening (DEXA). The outcome of interest was presence of bone alteration, defined as presence of osteopenia or osteoporosis in DEXA. The association between the explanatory variables and the event was assessed through odds ratio (OR) estimate, with 95% confidence interval (CI). Multiple logistic regression was performed to evaluate factors independently associated with bone alteration. Results Among 92 participants, 47.8% presented bone alteration (19.6% osteoporosis and 28.2% osteopenia). The variables that remained in the final logistic regression model were age ≥ 50 years (OR: 12.53; 95% CI: 4.37–35.90) and current alcohol use (OR: 2.63; 95% CI: 0.94–7.37). Conclusions This study showed a high frequency of bone changes, especially in PLHIV older than 50 years. This information is useful to stimulate the screening and timely intervention of this comorbidity of PLHIV on prolonged use of ART in order to prevent or minimize complications and new demands on the healthcare system.

Abstract INTRODUCTION The first Brazilian HIV treatment recommendation was put forward in 1996, resulting in 12 subsequent guidelines. Several changes were made regarding “when” and “how” to begin treatment. The latest guideline recommends immediate initiation of antiretroviral therapy (ART). This study aimed to describe the evolution of HIV treatment among people living with HIV (PLHIV) who initiated ART between 2004 and 2018 based on the national guideline recommendations concerning T-CD4+ and VL measurements. METHODS A cross-sectional analysis of data of PLHIV aged >18 years, in Minas Gerais who received ART between 2004 and 2018 was conducted. Clinical, therapeutic, and demographic information were obtained from national healthcare databases. The study was divided into four periods: 2004-2007, 2008-2012, 2013-2016, and 2017-2018. Descriptive analyses were performed. RESULTS A total of 60,618 PLHIV initiated ART (67% male and 48% aged 25-39 years), 36% of whom had CD4 counts at ART initiation and 51% documented VL after ART initiation. The median CD4 count ranged from 288 to 373 cells/µL. The median time to ART initiation decreased from 604 to 28 days and was lower among males (p <0.01). The median time from ART initiation to the first VL result decreased from 101 to 62 days over the study period, while the median VL after ART initiation ranged from 2.3 to 1.7 log10 copies/ml. CONCLUSIONS Although our results demonstrated that most recommendations were followed, there seemed to be little impact on CD4 counts and VL testing. This may result in an inadequate evaluation of ART effectiveness.

In Brazil, thalidomide is manufactured by a public laboratory, distributed by the Unified Health System (SUS), and regulated by the National Health Surveillance Agency (Anvisa). Despite the concerns regarding the adverse effects of thalidomide, few drug utilization studies have been conducted to describe processes and outcomes related to this drug. The aim of this study was to elucidate the issues related to the utilization and control of thalidomide, and patient safety within the scope of SUS. In this cross-sectional study, we evaluated the articulation between an outpatient dermatology service of a referral hospital in infectology, the manufacturer, and Anvisa. Four data sources were used: i) interviews with health professionals; ii) data from the Customer Service of the manufacturer, iii) data on adverse events reported to Anvisa, and iv) adverse events identified in outpatient service. Most health professionals interviewed knew the major thalidomide-related adverse effects. None of them ever reported adverse events to Anvisa or contacted the Customer Service. For over three years, there were 330 calls concerning thalidomide at Customer Service, 7% of which were related to adverse events. During a period of six years, Anvisa was notified of only 15 adverse events. Health professionals were aware of the adverse events associated with thalidomide, but not the necessity to report them. The low number of notifications recorded by Anvisa and the information obtained from Customer Service show that pharmacovigilance remains incipient. A pharmacovigilance system that integrates all the services associated with thalidomide is required to strengthen this activity within the SUS to improve patient safety.

RESUMO Objetivo Estimar a prevalência e os fatores associados ao uso de metilfenidato para neuroaprimoramento entre estudantes universitários. Métodos Amostra aleatória simples de discentes da Universidade Federal de Minas Gerais (n=438), convidados a responder um questionário online sobre o consumo de metilfenidato. A coleta ocorreu de setembro de 2014 a janeiro de 2015. A amostra foi descrita em termos de proporções, médias e desvio padrão. A análise multivariada foi realizada utilizando o algoritmo Classification and Regression Tree para classificação dos casos de uso do metilfenidato para neuroaprimoramento em grupos, com base nas variáveis de exposição. Resultados Dos 378 alunos incluídos, 5,8% (n=22) declararam ter feito uso de metilfenidato para neuroaprimoramento, sendo 41% (9/22) nas 4 semanas anteriores à pesquisa. A situação da moradia foi a variável mais associada ao uso de metilfenidato para neuroaprimoramento. Relataram o uso do metilfenidato para neuroaprimoramento e outros fins nas 4 semanas anteriores à pesquisa 11 estudantes, sendo que 27% não apresentaram prescrição médica para adquiri-lo. Conclusão O uso de metilfenidato para neuroaprimoramento ocorre no meio acadêmico brasileiro e deve ser considerado sério problema de saúde pública, principalmente diante dos riscos de danos e efeitos adversos associados ao seu uso.

ABSTRACT Objective To estimate the prevalence of and factors associated with the use of methylphenidate for cognitive enhancement among undergraduate students. Methods Simple random sample of students of the Universidade Federal de Minas Gerais (n=438), invited to answer an online questionnaire about the use of methylphenidate. Data collection occurred from September 2014 to January 2015. The sample was described by means of proportions, means and standard deviations. A multivariate analysis was performed using the Classification and Regression Tree algorithm to classify the cases of use of methylphenidate for cognitive enhancement in groups, based on the exposure variables. Results Out of 378 students included, 5.8% (n=22) reported using methylphenidate for cognitive enhancement; in that, 41% (9/22) in the 4 weeks prior to the survey. The housing situation was the variable most often associated with the use of methylphenidate for cognitive enhancement. Eleven students reported using methylphenidate for cognitive enhancement and other purposes 4 weeks prior to the survey, 27% of whom had no medical prescription to purchase it. Conclusion The use of methylphenidate for cognitive enhancement is frequent among Brazilian undergraduate students and should be considered a serious public health problem, especially due to risks of harm and adverse effects associated with its use.

Abstract INTRODUCTION: Rapid and accurate tuberculosis detection is critical for improving patient diagnosis and decreasing tuberculosis transmission. Molecular assays can significantly increase laboratory costs; therefore, the average time and economic impact should be evaluated before implementing a new technology. The aim of this study was to evaluate the cost and average turnaround time of smear microscopy and Xpert assay at a university hospital. METHODS: The turnaround time and cost of the laboratory diagnosis of tuberculosis were calculated based on the mean cost and activity based costing (ABC). RESULTS: The average turnaround time for smear microscopy was 16.6 hours while that for Xpert was 24.1 hours. The Xpert had a mean cost of USD 17.37 with an ABC of USD 10.86, while smear microscopy had a mean cost of USD 13.31 with an ABC of USD 6.01. The sensitivity of smear microscopy was 42.9% and its specificity was 99.1%, while the Xpert assay had a sensitivity of 100% and a specificity of 96.7%. CONCLUSIONS: The Xpert assay has high accuracy; however, the turnaround time and cost of smear microscopy were lower than those of Xpert.

Abstract INTRODUCTION: Thalidomide, used to treat erythema nodosum leprosum (ENL), is associated with severe adverse events (AEs) and is highly teratogenic. METHODS: A cross-sectional study was conducted on thalidomide-treated patients with ENL. AEs and selected variables were investigated through interviews and assessment of medical records. Odds ratios with 95% confidence intervals were estimated via logistic regression. RESULTS: Peripheral neuropathy symptoms and deep vein thrombosis (DVT) were the most common AEs reported. Although women of reproductive age used contraceptives, <50% of patients reported using condoms. Polypharmacy was associated with all endpoints, except DVT. CONCLUSIONS: Pharmacovigilance is crucial to prevent harmful thalidomide-associated AEs.