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BackgroundThe COVID-19 pandemic notably impacted tuberculosis notification and detection in Brazil. We estimated the number of unnotified tuberculosis cases by group population over the first two years (2020-2021) of the pandemic.MethodsWe extracted tuberculosis case notifications from routine national surveillance records and population from Ministry of Health. We estimated trends for case notification during pre-pandemic period (2015–2019), stratified by sex, age group, and State with a mixed-effects model. We calculated the unnotified cases during 2020-2021 as the difference between expected, and reported values.ResultsWe estimated 11647 (95% uncertain interval [95%UI]: 829,22466) unnotified cases for 2020; and, 6170 (95%UI: -4629,16968) for 2021; amounting 17817 unnotified cases over the two years. Of the estimated expected tuberculosis cases in 2020 and 2021, 11.2% were not notified. Across sex and age, men aged 30-59 years had the highest number of unnotified cases, and men aged 0-14 years had the highest proportion of unnotified cases. Case underreporting was significant for 13 (of the 27 States) in 2020, and for four in 2021.ConclusionsTuberculosis cases notification decreased substantially during the COVID-19 pandemic in Brazil. Our analysis helped identify the most affected populations to plan strategies to mitigate the effects of the pandemic on tuberculosis control.Research in contextEvidence before this studyA systematic review was conducted to retrieve studies that aimed the impact of the COVID-19 pandemic on tuberculosis detection in PubMed with the following terms: “(TB or tuberculosis) and (incidence or case or notification or burden) and (COVID-19 or pandemic)” from January 2020 to May 2022, returning 189 records. Out of these studies, we analyzed 17 that reported a decrease in tuberculosis notification during the pandemic years, and most of them with data only from the first year of the pandemic. Two studies were carried out with Brazilian data. One of them focused on the number of tuberculosis consultations at the benning of the pandemic, and the other was a government bulletin describing tuberculosis notification. As far as we know, no study has examined the tuberculosis case notification in Brazil during the two years of the pandemic, by group population. Furthermore, none of them had predicted the expected cases considering local trends in both the incidence of tuberculosis and its main determinants.Added value of this studyUsing tuberculosis case reports from routine national surveillance registries, we estimated case notification trends during the pre-pandemic period (2015–2019), stratified by sex, age group, and State and calculated the unnotified cases during 2020-2021. Brazil lost 11647 (95% uncertain interval [95%UI]: 829,22466) tuberculosis cases in 2020; and, 6170 (95%UI: - 4629,16968) in 2021, which represents 11.2% of underreporting in both years. Across sex and age, men aged 30 to 59 years had the highest number of unnotified cases, and men aged 0 to 14 years had the highest proportion of unnotified cases. Case underreporting was significant for 13 (of the 27 States) in 2020, and for four in 2021.Implications of all the available evidenceThe COVID-19 pandemic had a catastrophic effect in tuberculosis notification in Brazil during 2020 and 2021. This resulted in a setback in progress made over decades in tuberculosis control, and highlight the threat posed by tuberculosis transmission. Several lessons learned from response to COVID-19 provide an opportunity to improve the notification of respiratory diseases.

Vulnerable populations, such as migrants and refugees, have an increased risk of tuberculosis disease, especially in the first years after arrival in the host country. The presence of migrants and refugees in Brazil exponentially grew over the period between 2011 and 2020, and approximately 1.3 million migrants from the Global South were estimated to be residing in Brazil, most of whom from Venezuela and Haiti. Tuberculosis control programs for migrants can be divided into pre- and post-migration screening strategies. Pre-migration screening aims to identify cases of tuberculosis infection (TBI) and can be carried out in the country of origin (pre-entry) or in the destination country (at entry). Pre-migration screening can also detect migrants at an increased risk of developing tuberculosis in the future. High-risk migrants are then followed up in post-migration screening. In Brazil, migrants are considered a priority group for the active search for tuberculosis cases. However, there is no recommendation or plan regarding screening for TBI in migrants and refugees. Ensuring prevention, diagnosis, and treatment for TBI and tuberculosis disease in migrant populations is an important aspect of tuberculosis control and elimination. In this review article, we address epidemiological aspects and access to health care for migrants in Brazil. In addition, the migration medical screening for tuberculosis was reviewed.

Over the past 15 years, and despite many difficulties, significant progress has been made to advance child and adolescent tuberculosis (TB) care. Despite increasing availability of safe and effective treatment and prevention options, TB remains a global health priority as a major cause of child and adolescent morbidity and mortality—over one and a half million children and adolescents develop TB each year. A history of the global public health perspective on child and adolescent TB is followed by 12 narratives detailing challenges and progress in 19 TB endemic low and middle-income countries. Overarching challenges include: under-detection and under-reporting of child and adolescent TB; poor implementation and reporting of contact investigation and TB preventive treatment services; the need for health systems strengthening to deliver effective, decentralized services; and lack of integration between TB programs and child health services. The COVID-19 pandemic has had a significant negative impact on case detection and treatment outcomes. Child and adolescent TB working groups can address country-specific challenges to close the policy–practice gaps by developing and supporting decentral ized models of care, strengthening clinical and laboratory diagnosis, including of multidrug-resistant TB, providing recommended options for treatment of disease and infection, and forging strong collaborations across relevant health sectors.

BackgroundIncarcerated individuals in Brazil are at high-risk of tuberculosis (TB), but their access to World Health Organization recommended diagnostics is poorly understood.MethodsWe conducted a retrospective cross-sectional study of newly diagnosed TB cases in Brazil’s notifiable disease registry, which includes information on diagnostic tests performed, from January 2015 through December 2018. We quantified reported use of TB diagnostics across incarcerated and non-incarcerated populations and tested for municipality-level factors associated with diagnostic usage among the incarcerated population with generalized linear regression.ResultsBetween 2015 and 2018, 258,014 individuals were newly diagnosed with TB, including 27,400 (10.6%) incarcerated individuals. Among these, 27.5% had an Xpert MTB/RIF test reported; 71.5% had sputum smear; 34.1% had culture; 70.9% had chest radiography. Xpert MTB/RIF use was greater among incarcerated than non-incarcerated individuals (36.2% vs 26.5%, p5000) with rates of Xpert MTB/RIF usage below the national average in incarcerated individuals.ConclusionPrioritizing expansion of rapid molecular diagnostics in prisons, particularly in regions with limited current usage of molecular diagnostics, will be an essential component of TB control.

BackgroundTuberculosis notifications in Latin American prisons have more than doubled over the past two decades; however, treatment outcomes and their determinants among incarcerated individuals in this region are not well understood.MethodsNewly diagnosed drug-susceptible tuberculosis cases reported to Brazil’s Sistema de Informação de Agravos de Notificação (SINAN) between January 2015 and December 2017 were included. Multivariate logistic regression was used to assess socioeconomic and clinical factors associated with treatment success among incarcerated individuals.ResultsIncarcerated individuals (n=17,776) had greater treatment success than non-incarcerated individuals (n=160,728; 82.2% vs 75.1%, pConclusionTuberculosis treatment success among incarcerated individuals in Brazil is higher than non-incarcerated individuals, but both fall below WHO targets. Expanding the use of DOT and services for socially and medically vulnerable individuals may improve outcomes in carceral settings.

Background Treatment outcomes were evaluated of a cohort of new pulmonary tuberculosis (TB) cases that were rifampicin resistant, multidrug-resistant, or extensively resistant during 2013 and 2014 in Brazil. The objective of this study is to identify factors associated with unfavorable treatment outcomes for drug-resistant TB cases. Methods The Brazilian Special Tuberculosis Treatment Information System (SITE-TB) was the main data source. The independent variables were classified into four blocks (block I: individual characteristics; block II: clinical characteristics and proposed treatment; block III: treatment follow-up characteristics; and block IV: TB history). The category of successful therapeutic outcome was compared with lost to follow-up, failure, and death. Considering the multiple outcomes as the dependent variable, the odds ratios (OR) and its respective 95% confidence interval (95% CI) were estimated by multinomial logistic regression. Results After applying the exclusion criteria, 980 (98.8%) individuals were included in the study. Of these, 621 (63.4%) had successful treatment, 163 (16.6%) lost to follow-up, 76 (7.8%) failed, and 120 (12.2%) died. Important factors associated with lost to follow-up in the final model included use of illicit drugs (OR = 2.5 95% CI: 1.57–3.82). Outcome failure was associated with having disease in both lungs (OR = 2.0; 95% CI: 1.09–3.62) and using more than one or not using injectable medication (OR = 2.8; 95% CI: 1.05–7.69). Major factors for the death outcome were at least 60 years old (OR = 3.4; 95% CI: 1.90–6.03) and HIV positive (OR = 2.7; 95% CI: 1.45–4.83). Conclusions The factors associated with unfavorable treatment outcomes were different. Some of these factors are specific to each outcome, which reflects the complexity of providing care to these individuals.

Resumo: O objetivo do trabalho foi avaliar a cobertura e a confiabilidade do encerramento dos casos de tuberculose drogarresistente (TB DR), do Sistema de Informação de Tratamentos Especiais de Tuberculose (SITE-TB), que ocorreram no Brasil no período de 2013 a 2016, a partir de relacionamentos probabilísticos com o Sistema de Informação de Agravos de Notificação (SINAN), Gerenciador de Ambiente Laboratorial (GAL) e Sistema de Informações sobre Mortalidade (SIM). Os casos de TB DR com início de tratamento entre 2013 e 2016 no Brasil constituíram a população do estudo. O relacionamento com o SINAN avaliou a cobertura e estimou a subnotificação dos casos de TB DR. Aplicou-se o método de captura-recaptura, com uso do estimador de Chapman. O relacionamento com o GAL identificou casos diagnosticados pelo laboratório que não estavam notificados no SITE-TB. O relacionamento com o SIM avaliou a confiabilidade do encerramento óbito no SITE-TB, utilizando o coeficiente kappa. Estimou-se uma população de 2.945 (IC95%: 2.365-3.602) casos novos de TB DR com o estimador de Chapman. No GAL, foram encontrados 1.626 indivíduos não notificados no SITE-TB, mesmo com exame laboratorial confirmatório de resistência aos medicamentos antiTB. Classificou-se como excelente, PABAK (prevalance and bias adjusted kappa) de 0,86 (IC95%: 0,85-0,87), a concordância entre o desfecho óbito do SITE-TB e o SIM. Os resultados mostraram que ainda temos lacunas relacionadas ao diagnóstico e ao tratamento da TB DR no Brasil. A subnotificação no SITE-TB de casos de TB DR representa um desafio para o controle da doença. A localização desses indivíduos e o início precoce do tratamento devem constituir uma ação priorizada nos serviços de saúde. Abstract: The study aimed to assess the coverage and reliability of drug-resistant tuberculosis (DR-TB) case closure in the Information System on Special Treatments for Tuberculosis (SITE-TB in Portuguese) in Brazil from 2013 to 2016, based on probabilistic linkage with the Information System on Diseases of Notification (SINAN), Laboratory Environment Manager (GAL), and Mortality Information System (SIM). The study population consisted of DR-TB cases that initiated treatment from 2013 to 2016 in Brazil. Linkage with SINAN assessed the coverage and estimated underreporting of DR-TB cases. The capture-recapture method was applied, using the Chapman estimator. Linkage with GAL identified cases diagnosed by the laboratory that had not been reported to SITE-TB. Linkage with SIM assessed the reliability of case closure by death in SITE-TB, using the kappa coefficient. We estimated a population of 2,945 (95%CI: 2,365-3,602) new cases of DR-TB with the Chapman estimator. We located 1,626 individuals in the GAL database that had not been reported to SITE-TB, even with laboratory confirmation of drug resistance. PABAK (prevalance and bias adjusted kappa) of 0.86 (95%CI: 0.85-0.87) was classified as excellent for the agreement in death as the outcome between the SITE-TB and SIM databases. The results pointed to persistent gaps related to diagnosis and treatment of DR-TB in Brazil. Underreporting of DR-TB cases in the SITE-TB database poses a challenge for TB control. Identification of these individuals and early start of treatment should be prioritized in health services. Resumen: El objetivo de este trabajo fue evaluar la cobertura y fiabilidad del cierre de casos de tuberculosis resistente a multiple medicamentos (TB DR; por sus siglas en portugués) en el Sistema de Información de Tratamientos Especiales de Tuberculosis (SITE-TB), que se produjeron en Brasil durante el período de 2013 a 2016, a partir de relaciones probabilísticas con el Sistema de Información de Enfermedades de Notificación (SINAN por sus siglas en portugués), Gestor de Ambiente de Laboratorio (GAL) y Sistema de Información sobre Mortalidad (SIM). La población del estudio fueron los casos de TB DR con inicio de tratamiento entre 2013 y 2016 en Brasil. La relación con el SINAN evaluó la cobertura y estimó la subnotificación de los casos de TB DR. Se aplicó el método de captura-recaptura, utilizando el estimador de Chapman. La relación con el GAL identificó casos diagnosticados por el laboratorio que no estaban notificados en el SITE-TB. La relación con el SIM evaluó la fiabilidad del cierre óbito en el SITE-TB, utilizando el coeficiente kappa. Se estimó que para una población de 2.945 (IC95%: 2.365-3.602) casos nuevos de TB DR con el estimador de Chapman. Se encontraron en el GAL a 1.626 individuos no notificados en el SITE-TB, incluso con examen de laboratorio confirmatorio de resistencia a los medicamentos antiTB. Se clasificó como excelente, PABAK (prevalance and bias adjusted kappa) de 0,86 (IC95%: 0,85-0,87), la concordancia entre el resultado óbito del SITE-TB y el SIM. Los resultados mostraron que todavía existen lagunas relacionadas con el diagnóstico y el tratamiento de la TB DR en Brasil. La subnotificación en el SITE-TB de casos de TB DR representa un desafío para el control de la enfermedad. La localización de esos individuos y el inicio precoz del tratamiento debe ser una acción priorizada en los servicios de salud.

The study aimed to assess the coverage and reliability of drug-resistant tuberculosis (DR-TB) case closure in the Information System on Special Treatments for Tuberculosis (SITE-TB in Portuguese) in Brazil from 2013 to 2016, based on probabilistic linkage with the Information System on Diseases of Notification (SINAN), Laboratory Environment Manager (GAL), and Mortality Information System (SIM). The study population consisted of DR-TB cases that initiated treatment from 2013 to 2016 in Brazil. Linkage with SINAN assessed the coverage and estimated underreporting of DR-TB cases. The capture-recapture method was applied, using the Chapman estimator. Linkage with GAL identified cases diagnosed by the laboratory that had not been reported to SITE-TB. Linkage with SIM assessed the reliability of case closure by death in SITE-TB, using the kappa coefficient. We estimated a population of 2,945 (95%CI: 2,365-3,602) new cases of DR-TB with the Chapman estimator. We located 1,626 individuals in the GAL database that had not been reported to SITE-TB, even with laboratory confirmation of drug resistance. PABAK (prevalance and bias adjusted kappa) of 0.86 (95%CI: 0.85-0.87) was classified as excellent for the agreement in death as the outcome between the SITE-TB and SIM databases. The results pointed to persistent gaps related to diagnosis and treatment of DR-TB in Brazil. Underreporting of DR-TB cases in the SITE-TB database poses a challenge for TB control. Identification of these individuals and early start of treatment should be prioritized in health services.

The Special Tuberculosis Treatment Information System (SITE-TB) arose mainly from the need to routinely monitor all persons with drug-resistant tuberculosis (DR-TB) in Brazil, as well as to qualify tuberculosis' drug control. Developed by the Professor Hélio Fraga Reference Center and the Management Sciences for Health/Brazil Project, this online system was implemented in 2013 in all Brazilian states. In addition to DR-TB, the system registers people with drug-sensitive tuberculosis with special regimen indications, and those with nontuberculous mycobacterial infections identified by differential diagnosis of tuberculosis. All confirmed tuberculosis cases should be notified on the Notifiable Diseases Information System (SINAN). In situations where treatment with special regimens is necessary, the case is closed on SINAN and notified on SITE-TB. Professionals from tuberculosis reference centers report and monitor these cases on the system, as well as manage tuberculosis' drugs.O Sistema de Informação de Tratamentos Especiais de Tuberculose (SITE-TB) surgiu da necessidade principal de monitorar, rotineiramente, todas as pessoas com tuberculose drogarresistente (TBDR) no Brasil, e qualificar o controle dos fármacos antituberculose. Desenvolvido pelo Centro de Referência Professor Hélio Fraga e pelo projeto Management Sciences for Health/Brasil, esse sistema online foi implantado em 2013, em todas as Unidades da Federação. Além da TBDR, no SITE-TB são registradas pessoas com tuberculose sensível com indicação de esquema especial, e aquelas com micobacterioses não tuberculosas identificadas por diagnóstico diferencial de tuberculose. Toda pessoa com tuberculose confirmada deve ser notificada no Sistema de Informação de Agravos de Notificação (Sinan). Em situações nas quais se faz necessário tratamento com esquema especial, o caso é encerrado no Sinan e notificado no SITE-TB. Profissionais das unidades de referência para tuberculose fazem a notificação e acompanhamento desses casos no sistema, assim como a gestão dos medicamentos.El Sistema de Información de Tratamientos Especiales de Tuberculosis (SITE-TB) surgió principalmente de la necesidad de monitorear rutinariamente todas las personas con tuberculosis drogorresistente (TB-DR) en Brasil y cualificar el control de drogas antituberculosis. Desarrollado por el Centro de Referencia Profesor Hélio Fraga y el proyecto Management Sciences for Health/Brasil, este sistema online fue implantado en 2013 en todos los estados del país. Además de TB-DR, el SITE-TB registra personas con tuberculosis sensible con indicación de régimen especial, y aquellas con micobacteriosis no tuberculosas identificadas por diagnóstico diferencial de tuberculosis. Toda persona con tuberculosis confirmada debe ser notificada en el Sistema de Información de Agravamientos de Notificación (SINAN). Para situaciones en las que se hace necesario tratamiento con régimen especial, el caso se cierra en el SINAN y se notifica en el SITE-TB. Los profesionales de las unidades de referencia para TB son los que hacen la notificación y seguimiento de estos casos en el sistema, así como la gestión de las drogas antituberculosis.

Objectives To identify scenarios based on socioeconomic, epidemiological and operational healthcare factors associated with tuberculosis incidence in Brazil. Design Ecological study. Settings The study was based on new patients with tuberculosis and epidemiological/operational variables of the disease from the Brazilian National Information System for Notifiable Diseases and the Mortality Information System. We also analysed socioeconomic and demographic variables. Participants The units of analysis were the Brazilian municipalities, which in 2015 numbered 5570 but 5 were excluded due to the absence of socioeconomic information. Primary outcome Tuberculosis incidence rate in 2015. Data analysis We evaluated as independent variables the socioeconomic (2010), epidemiological and operational healthcare indicators of tuberculosis (2014 or 2015) using negative binomial regression. Municipalities were clustered by the k-means method considering the variables identified in multiple regression models. Results We identified two clusters according to socioeconomic variables associated with the tuberculosis incidence rate (unemployment rate and household crowding): a higher socioeconomic scenario (n=3482 municipalities) with a mean tuberculosis incidence rate of 16.3/100 000 population and a lower socioeconomic scenario (2083 municipalities) with a mean tuberculosis incidence rate of 22.1/100 000 population. In a second stage of clusterisation, we defined four subgroups in each of the socioeconomic scenarios using epidemiological and operational variables such as tuberculosis mortality rate, AIDS case detection rate and proportion of vulnerable population among patients with tuberculosis. Some of the subscenarios identified were characterised by fragility in their information systems, while others were characterised by the concentration of tuberculosis cases in key populations. Conclusion Clustering municipalities in scenarios allowed us to classify them according to the socioeconomic, epidemiological and operational variables associated with tuberculosis risk. This classification can support targeted evidence-based decisions such as monitoring data quality for improving the information system or establishing integrative social protective policies for key populations.

Dissertação (mestrado)—Universidade de Brasília, Faculdade de Medicina, Núcleo de Medicina Tropical, 2015. Ainda que com o advento da terapia antorretroviral a tuberculose continua como a principal causa de óbito por doença infecciosa definida entre as pessoas que vivem com HIV/aids. O objetivo desse trabalho foi verificar os fatores associados ao óbito na coinfecção TB-HIV no Brasil no ano de 2011. Foi realizado um estudo do tipo caso controle, com análise por regressão logística multivariada. A fonte de dados para os casos de tuberculose foi o Sinan TB. Com o objetivo de qualificar os dados, o Sinan TB foi relacionado com o Sinan Aids, Siscel e Siclom. Para verificação dos óbitos foi realizado o relacionamento com o SIM. Nos resultados, demonstrou-se que os fatores de risco para o óbito foram: idade >50 anos (OR=2,48; IC95% 1,01 a 6,08), uso de álcool (OR=1,84; IC95% 1,45 a 2,34) e forma clínica da TB (pulmonar e extrapulmonar) (OR=1,85; IC95% 1,36 a 2,52). Os fatores observados como proteção foram: a realização do LT-CD4+ (OR=0,68; IC95% 0,54 a 0,86), estar em TARV (OR=0,50; IC95%0,39 a 063) e estar em TDO (OR=0,69; IC95% 0,39 a 0,63). Os resultados demonstram uma situação de alerta em relação a coinfecção TB-HIV no Brasil, apesar dos avanços na estruturação da assistência à saúde no país, o acesso a um seguimento da coinfecção TB-HIV integral ainda é limitado, o que favorece a alta mortalidade nessa população. Há necessidade de revisão das estratégias nacionais, com priorização da coinfecção TB-HIV pelos programas de tuberculose e de HIV/Aids, matriciamento da assistência de tal modo que profissionais capacitados façam o diagnóstico oportuno da tuberculose e do HIV, além do início em tempo adequado do tratamento antirretroviral. Even with the advent of antiretroviral therapy, tuberculosis still remains the main cause of death from infectious disease among people living with HIV / AIDS. The purpose of this study was to verify the associated factors with TB and HIV co-infection deaths in Brazil in 2011. A case-control study was conducted through multivariate logistic regression analysis. The Information System for Notifiable Diseases (Sinan) was the data source for TB cases, and for data qualification other databases from the Ministry of Health were used, such as: laboratory (Siscel), antiretroviral (Siclom) and Sinan AIDS databases, and from the Mortality Information System (SIM). The results were considered risk factors for mortality: age> 50 years (OR=2.48; IC95% 1.01 to 6.08), alcohol use (OR=1.84; IC95% 1.45 to 2.34) and clinical form of pulmonary and extrapulmonary TB (OR=1.85; IC95% 1.36 to 2.52). Factors considered protection were the LT-CD4+ conducted (OR=0.68; IC95% 0.54 to 0.86), being on ART (OR=0.50; IC95%0.39 a 0.63) and be in DOT (OR=0.69; IC95% 0.39 a 0.63). The results describe an alarm situation related to TB/HIV co-infection in Brazil. Despite the progresses related to the structure reform in the health care services in the country, access to TB/HIV integral follow up is still limited, which favors high mortality rates among this population. There is an evident need for national strategies updates regarding recognizing the importance of TB/HIV co-infection to both diseases programmes (TB and HIV/AIDS). The organization of assistance so that trained providers are able to early diagnose TB and HIV, in addition to timely starting antiretroviral treatment.

O tratamento da tuberculose (TB) causa frequentes reações adversas por necessitar da associação de quatro fármacos e por ser frequentemente usado em associação com outros medicamentos, como antirretrovirais e hipoglicemiantes, que apresentam importantes interações com os tuberculostáticos. Com o propósito de reforçar a farmacovigilância em TB no Brasil, o Programa Nacional de Controle da Tuberculose e a Agência Nacional de Vigilância Sanitária desenvolveram um projeto piloto para estimular a notificação das reações adversas aos tuberculostáticos. Foram realizadas capacitações e visitas de monitoramentos em três unidades de saúde de referência para o tratamento da TB. Dentre as dificuldades identificadas, encontramos limitações ao acesso ao sistema NOTIVISA, a precariedade da rede de internet, a ausência de registro das reações adversas nos prontuários dos pacientes, a reduzida integração multiprofissional, o pouco envolvimento dos gestores e a fragilidade dos fluxos de informação. Como desdobramentos, materiais instrucionais foram elaborados, a ficha de notificação do NOTIVISA foi aprimorada, indicadores para o monitoramento das notificações foram propostos e os fluxos redefinidos. Concluímos que a parceria foi bem sucedida, e sugerimos estratégia semelhante para outros programas. A integração das equipes de saúde e a elaboração de ferramentas simplificadas de notificação são desafios a serem vencidos para conferir sustentabilidade às ações de farmacovigilância no país.

The difficulties in managing multidrug-resistant tuberculosis (MDR-TB) and extensively drug-resistant (XDR) TB are well known. The regimens are very expensive, often toxic, and require up to 24 months to achieve an acceptable probability of success [1–3]. The first nationwide report on the drug resistance profile of the drugs composing the WHO “shorter” regimen in Brazil

Although clofazimine is used to treat multidrug-resistant tuberculosis (MDR-TB), there is scant information on its effectiveness and safety. The aim of this retrospective, observational study was to evaluate these factors as well as the tolerability of clofazimine in populations in Brazil, where it was administered at a daily dose of 100 mg·day−1 (body weight ≥45 kg) as part of a standardised MDR-TB treatment regimen until 2006 (thereafter pyrazinamide was used).All MDR-TB patients included in the Sistema de Informação de Tratamentos Especiais da Tuberculose (SITETB) individual electronic register were analysed. The effectiveness of clofazimine was assessed by comparing the treatment outcomes of patients undergoing clofazimine-containing regimens against those undergoing clofazimine-free regimens and its safety by describing clofazimine-attributed adverse events. A total of 1446 patients were treated with clofazimine-containing regimens and 1096 with pyrazinamide-containing regimens.Although success rates were similar in patients treated with clofazimine versus those treated with pyrazinamide (880 out of 1446, 60.9%, versus 708 out of 1096, 64.6%; p=0.054), clofazimine-treated cases exhibited higher death rates due to tuberculosis than pyrazinamide-treated ones (314 out of 1446, 21.7%, versus 120 out of 1096, 10.9%) but fewer failures (78 out of 1446, 5.4%, versus 95 out of 1096, 8.7%) and less loss to follow-up (144 out of 1446, 10.0%, versus 151 out of 1096, 13.8%). No relevant differences were detected when comparing adverse events in patients treated with clofazimine-containing regimens to those treated with clofazimine-free regimens. However, the incidence of side-effects was less than previously reported (gastro-intestinal complaints: 10.5%; hyper-pigmentation: 50.2%; neurological disturbances: 9–13%).