Brazilian Thoracic Association recommendations for the management of post-tuberculosis lung disease.

Historically, all efforts against tuberculosis were focused on rapid diagnosis and effective treatment to break the chain of transmission of Mycobacterium tuberculosis. However, in the last few years, more and more evidence has been found on the dramatic consequences of the condition defined as post-tuberculosis lung disease (PTLD). Approximately one third of patients surviving pulmonary tuberculosis face considerable ongoing morbidities, including respiratory impairment, psychosocial challenges, and reduced health-related quality of life after treatment completion. Given the important global and local burden of tuberculosis, as well as the estimated burden of PTLD, the development of a consensus document by a Brazilian scientific society-Sociedade Brasileira de Pneumologia e Tisiologia (SBPT)-was considered urgent for the prevention and management of this condition in order to allocate resources to and within tuberculosis services appropriately and serve as a guide for health care professionals. A team of eleven pulmonologists and one methodologist was created by the SBPT to review the current evidence on PTLD and develop recommendations adapted to the Brazilian context. The expert panel selected the topics on the basis of current evidence and international guidelines. During the first phase, three panel members drafted the recommendations, which were divided into three sections: definition and prevalence of PTLD, assessment of PTLD, and management of PTLD. In the second phase, all panel members reviewed, discussed, and revised the recommendations until a consensus was reached. The document was formally approved by the SBPT in a special session organized during the 2023 SBPT Annual Conference.

Cost analysis of GenoType® MTBDRplus and GenoType® MTBDRsl at the State Laboratory of São Paulo, Brazil.

BACKGROUND: We aimed to evaluate the costs of GenoType® MTBDRplus and MTBDRsl incurred during the diagnosis of first- and second-line drug-resistant tuberculosis (TB) in São Paulo, Brazil. METHODS: Mean and activity-based costs of GenoType® were calculated in a referral laboratory for TB in Brazil. RESULTS: The mean cost value and activity-based cost of GenoType® MTBDRplus were USD 19.78 and USD 35.80 and those of MTBDRsl were USD 54.25 and USD 41.85, respectively. CONCLUSIONS: The cost of GenoType® MTBDRplus was reduced owing to the high number of examinations performed and work optimization.

Nontuberculous mycobacteria in patients of a specialty hospital.

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.

Brazilian Thoracic Association recommendations for the management of post-tuberculosis lung disease / Recomendações da Sociedade Brasileira de Pneumologia e Tisiologia para o manejo da doença pulmonar pós-tuberculose

ABSTRACT Historically, all efforts against tuberculosis were focused on rapid diagnosis and effective treatment to break the chain of transmission of Mycobacterium tuberculosis. However, in the last few years, more and more evidence has been found on the dramatic consequences of the condition defined as post-tuberculosis lung disease (PTLD). Approximately one third of patients surviving pulmonary tuberculosis face considerable ongoing morbidities, including respiratory impairment, psychosocial challenges, and reduced health-related quality of life after treatment completion. Given the important global and local burden of tuberculosis, as well as the estimated burden of PTLD, the development of a consensus document by a Brazilian scientific society-Sociedade Brasileira de Pneumologia e Tisiologia (SBPT)-was considered urgent for the prevention and management of this condition in order to allocate resources to and within tuberculosis services appropriately and serve as a guide for health care professionals. A team of eleven pulmonologists and one methodologist was created by the SBPT to review the current evidence on PTLD and develop recommendations adapted to the Brazilian context. The expert panel selected the topics on the basis of current evidence and international guidelines. During the first phase, three panel members drafted the recommendations, which were divided into three sections: definition and prevalence of PTLD, assessment of PTLD, and management of PTLD. In the second phase, all panel members reviewed, discussed, and revised the recommendations until a consensus was reached. The document was formally approved by the SBPT in a special session organized during the 2023 SBPT Annual Conference.

RESUMO Historicamente, todos os esforços contra a tuberculose concentraram-se no diagnóstico rápido e no tratamento efetivo para quebrar a cadeia de transmissão do Mycobacterium tuberculosis. No entanto, nos últimos anos, têm sido encontradas mais e mais evidências sobre as dramáticas consequências da condição definida como doença pulmonar pós-tuberculose (DPPT). Aproximadamente um terço dos pacientes que sobrevivem à tuberculose pulmonar enfrenta morbidades consideráveis e persistentes, incluindo comprometimento respiratório, desafios psicossociais e redução da qualidade de vida relacionada à saúde após o término do tratamento. Diante da importante carga global e local da tuberculose, bem como da carga estimada da DPPT, considerou-se urgente o desenvolvimento de um documento de consenso por uma sociedade científica brasileira - a Sociedade Brasileira de Pneumologia e Tisiologia (SBPT) - para a prevenção e manejo dessa condição, a fim de alocar recursos de forma adequada para e nos serviços de tuberculose e servir de guia para os profissionais de saúde. Uma equipe de onze pneumologistas e um metodologista foi criada pela SBPT para revisar as evidências atuais sobre a DPPT e desenvolver recomendações adaptadas ao contexto brasileiro. O painel de especialistas selecionou os temas com base nas evidências atuais e diretrizes internacionais. Durante a primeira fase, três membros do painel redigiram as recomendações, que foram divididas em três seções: definição e prevalência de DPPT, avaliação da DPPT e manejo da DPPT. Na segunda fase, todos os membros do painel analisaram, discutiram e revisaram as recomendações até chegar a um consenso. O documento foi aprovado formalmente pela SBPT em sessão especial organizada durante o Congresso Anual da SBPT de 2023.

Nontuberculous mycobacteria in patients of a specialty hospital

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.

Cost analysis of GenoType® MTBDRplus and GenoType® MTBDRsl at the State Laboratory of São Paulo, Brazil

ABSTRACT Background: We aimed to evaluate the costs of GenoType® MTBDRplus and MTBDRsl incurred during the diagnosis of first- and second-line drug-resistant tuberculosis (TB) in São Paulo, Brazil. Methods: Mean and activity-based costs of GenoType® were calculated in a referral laboratory for TB in Brazil. Results: The mean cost value and activity-based cost of GenoType® MTBDRplus were USD 19.78 and USD 35.80 and those of MTBDRsl were USD 54.25 and USD 41.85, respectively. Conclusions: The cost of GenoType® MTBDRplus was reduced owing to the high number of examinations performed and work optimization.

Molecular characterization of nontuberculous Mycobacteria in a tuberculosis and HIV reference unit in the State of Amazonas, Brazil.

BACKGROUND: In recent years, the prevalence of nontuberculous mycobacterial (NTM) infections has increased in different regions of the world. The American Thoracic Society (ATS) recommends standardized identification criteria, reinforcing the need for faster and less complicated clinical and laboratory techniques. METHODS: In this retrospective study, NTM species isolated from pulmonary, extrapulmonary, and disseminated samples from patients treated at a TB/HIV reference unit in the State of Amazonas from 2011 to 2014 were identified through a combination of molecular techniques. RESULTS: To identify the molecular technique, 50 cryopreserved NTM cultures were recovered and subcultivated in culture medium. The potentially pathogenic NTM species identified were M. avium, M. intracellulare, M. kansasii, M. chelonae, M. abscessus, M. fortuitum, and M. peregrinum. Results of GenoType® showed moderate agreement with those of genomic sequencing (kappa = 0.60), whereas the results obtained by the PRA-hsp65 technique disagreed with the results obtained by sequencing (kappa = 0.49). CONCLUSIONS: Our findings highlight that GenoType CM is a good method for the identification of NTM, as well as the need for the application of standardized criteria, such as those set forth by the ATS.

Molecular characterization of nontuberculous Mycobacteria in a tuberculosis and HIV reference unit in the State of Amazonas, Brazil

ABSTRACT Background: In recent years, the prevalence of nontuberculous mycobacterial (NTM) infections has increased in different regions of the world. The American Thoracic Society (ATS) recommends standardized identification criteria, reinforcing the need for faster and less complicated clinical and laboratory techniques. Methods: In this retrospective study, NTM species isolated from pulmonary, extrapulmonary, and disseminated samples from patients treated at a TB/HIV reference unit in the State of Amazonas from 2011 to 2014 were identified through a combination of molecular techniques. Results: To identify the molecular technique, 50 cryopreserved NTM cultures were recovered and subcultivated in culture medium. The potentially pathogenic NTM species identified were M. avium, M. intracellulare, M. kansasii, M. chelonae, M. abscessus, M. fortuitum, and M. peregrinum. Results of GenoType® showed moderate agreement with those of genomic sequencing (kappa = 0.60), whereas the results obtained by the PRA-hsp65 technique disagreed with the results obtained by sequencing (kappa = 0.49). Conclusions: Our findings highlight that GenoType CM is a good method for the identification of NTM, as well as the need for the application of standardized criteria, such as those set forth by the ATS.

The impact of the stratification by degree of clinical severity and abandonment risk of tuberculosis treatment.

OBJECTIVE: Evaluate the impact of the instrument of the "Stratification by Degree of Clinical Severity and Abandonment Risk of Tuberculosis Treatment" (SRTB) on the tuberculosis outcome. METHODS: This study was a pragmatic clinical trial involving patients with a confirmed diagnosis of tuberculosis treated at one of the 152 primary health care units in the city of Belo Horizonte, Brazil, between May of 2016 and April of 2017. Cluster areas for tuberculosis were identified, and the units and their respective patients were divided into intervention (use of SRTB) and nonintervention groups. RESULTS: The total sample comprised 432 participants, 223 and 209 of whom being allocated to the nonintervention and intervention groups, respectively. The risk of treatment abandonment in the nonintervention group was significantly higher than was that in the intervention group (OR = 15.010; p < 0.001), regardless of the number of risk factors identified. Kaplan-Meier curves showed a hazard ratio of 0.0753 (p < 0.001). CONCLUSIONS: The SRTB instrument was effective in reducing abandonment of tuberculosis treatment, regardless of the number of risk factors for that. This instrument is rapid and easy to use, and can be adapted to different realities. Its application showed characteristics predisposing to a non-adherence to the treatment and established bases to mitigate its impact.

Pulmonary functional assessment: longitudinal study after treatment of pulmonary tuberculosis.

Even when treated adequately, pulmonary tuberculosis can lead to pulmonary sequelae. Patients treated for PTB between 2012 and 2016 answered a standardized questionnaire and underwent chest radiography and spirometry, measurement of absolute pulmonary volume, Diffusing Capacity for Carbon Monoxide (DLCO) and the 6-min walk test (6MWT) on two occasions: within the first year after the end of treatment (follow-up 1), and one and two years after follow-up 1 (follow-up 2). A total of 55 patients they underwent spirometry, 23 (41.82%) had obstructive ventilatory disorder (OVD) and eight (14.5%) had moderate OVD. In total, 29 patients underwent pulmonary function tests (PFTs) and 24 patients underwent the 6MWT on two occasions. The functional changes after PTB treatment appear not to have varied between one and two years of follow-up. There was a correlation between low FEV1 and low DLCO (p<0.001); low DLCO and low 6MWT (p<0.001) and radiographic abnormalities and low FEV1 (p=0.033). The most frequently observed change in spirometry was found in patients with OVD.

Assessment of factors associated with potential drug-drug interactions in patients with tuberculosis and HIV/AIDS.

INTRODUCTION: The concomitant use of antituberculosis and antiretroviral drugs, as well as drugs to treat other diseases, can cause drug-drug interactions. This study aimed to describe potential drug-drug interactions (pDDI) in patients with TB and HIV/AIDS co-infection, as well as to analyze possible associated factors. METHODS: This study was performed in a reference hospital for infectious and contagious diseases in the southeastern region of Brazil and evaluated adult patients co-infected with tuberculosis and HIV/AIDS. A cross-sectional study was conducted in which sociodemographic, clinical, and pharmacotherapeutic characteristics were assessed. The pDDI were identified using the Drug-Reax software. Association analysis was performed using either a chi-squared test or a Fisher's exact test. Correlation analysis was performed using the Spearman's coefficient. RESULTS: The study included 81 patients, of whom 77 (95.1%) were exposed to pDDI. The most frequent interactions were between antituberculosis and antiretroviral drugs, which can cause therapeutic ineffectiveness and major adverse reactions. A positive correlation was established between the number of associated diseases, the number of drugs used, and the number of pDDI. An association was identified between contraindicated and moderate pDDI with excessive polypharmacy and hospitalization. CONCLUSIONS: We found a high frequency of pDDI, especially among those hospitalized and those with excessive polypharmacy. These findings highlight the importance of pharmacists in the pharmacotherapeutic monitoring in these patients.

Diagnosis of tuberculosis: a consensus statement from the Brazilian Thoracic Association.

Early, accurate diagnosis of tuberculosis is one of the major pillars of the control of the disease. The purpose of this consensus statement is to provide health professionals with the most current, useful evidence for the diagnosis of tuberculosis in Brazil. To that end, the Tuberculosis Committee of the Brazilian Thoracic Association brought together 14 members of the Association with recognized expertise in tuberculosis in Brazil to compose the statement. A nonsystematic review of the following topics was carried out: clinical diagnosis, bacteriological diagnosis, radiological diagnosis, histopathological diagnosis, diagnosis of tuberculosis in children, and diagnosis of latent tuberculosis infection.

[Performance assessment of primary healthcare services in tuberculosis control in a city in Southeast Brazil]. / Avaliação do desempenho dos serviços de atenção primária à saúde no controle da tuberculose em metrópole do Sudeste do Brasil.

The World Health Organization highlights the importance of health services organization and performance in tuberculosis (TB) control activities. This study aimed to assess the performance of primary healthcare services in Belo Horizonte, Minas Gerais State, Brazil, in TB control activities in the dimensions Structure and Process, before and after the use of a validated instrument called Stratification by Degree of Clinical Risk and Tuberculosis Treatment Dropout (ERTB). This was a descriptive and prospective study with two interviews (455 professionals), the second of which after the ERTB. Performance classification was: ≤ 49.9%, critical; 50-79.9%, unsatisfactory, and ≥ 80%, satisfactory. The comparative assessment used the McNemar statistical test with p < 0.05. After risk stratification, most of the variables in each dimension improved significantly. The authors conclude that it was possible to identify satisfactory performance in most of the variables assessed in the Structure and Process dimensions in primary healthcare services in Belo Horizonte in relation to TB control activities, using a standardized questionnaire.

A Organização Mundial da Saúde destaca a importância da organização e do desempenho dos serviços de saúde nas ações de controle da tuberculose. O objetivo deste estudo foi avaliar o desempenho dos serviços de atenção primaria à saúde em Belo Horizonte, Minas Gerais, Brasil, em relação às ações de controle da tuberculose nos eixos Estrutura e Processo, antes e após a utilização do instrumento validado denominado Estratificação por Grau de Risco Clínico e de Abandono do Tratamento da Tuberculose (ERTB). Estudo descritivo e prospectivo, no qual foram realizadas duas entrevistas (455 profissionais), tendo a segunda ocorrido após a ERTB. A classificação do desempenho seguiu os valores: ≤ 49,9%, críticos; entre 50% e 79,9%, insatisfatórios; e, ≥ 80%, satisfatórios. Na avaliação comparativa, foi utilizado o teste estatístico de McNemar, com p < 0,05. Após a estratificação de risco, a maior parte das variáveis de cada eixo melhorou significativamente. Nós concluímos que, por meio de um questionário padronizado, foi possível identificar o desempenho satisfatório dos serviços de atenção primária à saúde em Belo Horizonte em relação às ações de controle da tuberculose, na maioria das variáveis avaliadas nos eixos Estrutura e Processo.

La Organización Mundial de la Salud destaca la importancia de la organización y del desempeño de los servicios de salud en acciones de control de la tuberculosis. El objetivo de este estudio fue evaluar el desempeño de los servicios de atención primaria en salud en Belo Horizonte, Minas Gerais, Brasil, en relación con las acciones de control de la tuberculosis respecto a los ejes Estructura y Proceso, antes y después de la utilización del instrumento validado, denominado Estratificación por Grado de Riesgo Clínico y de Abandono del Tratamiento de la Tuberculosis (ERTB). Se trata de un estudio descriptivo y prospectivo, donde se realizaron dos entrevistas (455 profesionales), siendo que la segunda se produjo tras la ERTB. La clasificación del desempeño siguió los valores: ≤ 49,9%, críticos; entre 50 y 79,9%, insatisfactorios; y, ≥ 80%, satisfactorios. En la evaluación comparativa, se utilizó el test estadístico de McNemar, con p < 0,05. Tras la estratificación de riesgo, la mayor parte de las variables de cada eje mejoró significativamente. Concluimos que fue posible identificar el desempeño satisfactorio en la mayoría de las variables evaluadas en los ejes Estructura y Proceso de los servicios de atención primaria en salud en Belo Horizonte, en relación con las acciones de control de la tuberculosis mediante un cuestionario estandarizado.

Cost-effectiveness of Xpert®MTB/RIF in the diagnosis of tuberculosis: pragmatic study.

INTRODUCTION: The intensification of research and innovation with the creation of networks of rapid and effective molecular tests as strategies for the end of tuberculosis are essential to avoid late diagnosis and for the eradication of the disease. We aimed to evaluate the cost-effectiveness of Xpert®MTB/RIF (Xpert) in the diagnosis of drug-resistant tuberculosis in reference units, in scenarios with and without subsidies, and the respective cost adjustment for today. METHODS: The analyses were performed considering as criterion of effectiveness, negative culture or clinical improvement in the sixth month of follow-up. The comparison was performed using two diagnostic strategies for the drug susceptibility test (DST), BactecTMMGITTM960 System, versus Xpert. The cost effectiveness and incremental cost-effectiveness ratio (ICER) were calculated and dollar-corrected for American inflation (US$ 1.00 = R$ 5,29). RESULTS: Subsidized Xpert had the lowest cost of US$ 33.48 (R$67,52) and the highest incremental average efficiency (13.57), thus being a dominated analysis. After the inflation was calculated, the mean cost was DST-MGIT=US$ 74.85 (R$ 396,73) and Xpert = US$ 37.33 (R$197,86) with subsidies. CONCLUSIONS: The Xpert in the diagnosis of TB-DR in these reference units was cost-effective with subsidies. In the absence of a subsidy, Xpert in TB-DR is not characterized as cost effective. This factor reveals the vulnerability of countries dependent on international organizations' subsidy policies.

Diagnosis of tuberculosis: a consensus statement from the Brazilian Thoracic Association / Consenso sobre o diagnóstico da tuberculose da Sociedade Brasileira de Pneumologia e Tisiologia

ABSTRACT Early, accurate diagnosis of tuberculosis is one of the major pillars of the control of the disease. The purpose of this consensus statement is to provide health professionals with the most current, useful evidence for the diagnosis of tuberculosis in Brazil. To that end, the Tuberculosis Committee of the Brazilian Thoracic Association brought together 14 members of the Association with recognized expertise in tuberculosis in Brazil to compose the statement. A nonsystematic review of the following topics was carried out: clinical diagnosis, bacteriological diagnosis, radiological diagnosis, histopathological diagnosis, diagnosis of tuberculosis in children, and diagnosis of latent tuberculosis infection.

RESUMO O diagnóstico precoce e adequado da tuberculose é um dos pilares mais importantes no controle da doença. A proposta deste consenso brasileiro é apresentar aos profissionais da área de saúde um documento com as evidências mais atuais e úteis para o diagnóstico da tuberculose. Para tanto, a Comissão de Tuberculose da Sociedade Brasileira de Pneumologia e Tisiologia reuniu 14 membros da Sociedade com reconhecida experiência em tuberculose no Brasil. Foi realizada uma revisão não sistemática dos seguintes tópicos: diagnóstico clínico, diagnóstico bacteriológico, diagnóstico radiológico, diagnóstico histopatológico, diagnóstico da tuberculose na criança e diagnóstico da tuberculose latente.

Avaliação do desempenho dos serviços de atenção primária à saúde no controle da tuberculose em metrópole do Sudeste do Brasil / Performance assessment of primary healthcare services in tuberculosis control in a city in Southeast Brazil / Evaluación del desempeño de los servicios de atención primaria en salud para el control de la tuberculosis en metrópolis del sudeste de Brasil

Resumo: A Organização Mundial da Saúde destaca a importância da organização e do desempenho dos serviços de saúde nas ações de controle da tuberculose. O objetivo deste estudo foi avaliar o desempenho dos serviços de atenção primaria à saúde em Belo Horizonte, Minas Gerais, Brasil, em relação às ações de controle da tuberculose nos eixos Estrutura e Processo, antes e após a utilização do instrumento validado denominado Estratificação por Grau de Risco Clínico e de Abandono do Tratamento da Tuberculose (ERTB). Estudo descritivo e prospectivo, no qual foram realizadas duas entrevistas (455 profissionais), tendo a segunda ocorrido após a ERTB. A classificação do desempenho seguiu os valores: ≤ 49,9%, críticos; entre 50% e 79,9%, insatisfatórios; e, ≥ 80%, satisfatórios. Na avaliação comparativa, foi utilizado o teste estatístico de McNemar, com p < 0,05. Após a estratificação de risco, a maior parte das variáveis de cada eixo melhorou significativamente. Nós concluímos que, por meio de um questionário padronizado, foi possível identificar o desempenho satisfatório dos serviços de atenção primária à saúde em Belo Horizonte em relação às ações de controle da tuberculose, na maioria das variáveis avaliadas nos eixos Estrutura e Processo.

Abstract: The World Health Organization highlights the importance of health services organization and performance in tuberculosis (TB) control activities. This study aimed to assess the performance of primary healthcare services in Belo Horizonte, Minas Gerais State, Brazil, in TB control activities in the dimensions Structure and Process, before and after the use of a validated instrument called Stratification by Degree of Clinical Risk and Tuberculosis Treatment Dropout (ERTB). This was a descriptive and prospective study with two interviews (455 professionals), the second of which after the ERTB. Performance classification was: ≤ 49.9%, critical; 50-79.9%, unsatisfactory, and ≥ 80%, satisfactory. The comparative assessment used the McNemar statistical test with p < 0.05. After risk stratification, most of the variables in each dimension improved significantly. The authors conclude that it was possible to identify satisfactory performance in most of the variables assessed in the Structure and Process dimensions in primary healthcare services in Belo Horizonte in relation to TB control activities, using a standardized questionnaire.

Resumen: La Organización Mundial de la Salud destaca la importancia de la organización y del desempeño de los servicios de salud en acciones de control de la tuberculosis. El objetivo de este estudio fue evaluar el desempeño de los servicios de atención primaria en salud en Belo Horizonte, Minas Gerais, Brasil, en relación con las acciones de control de la tuberculosis respecto a los ejes Estructura y Proceso, antes y después de la utilización del instrumento validado, denominado Estratificación por Grado de Riesgo Clínico y de Abandono del Tratamiento de la Tuberculosis (ERTB). Se trata de un estudio descriptivo y prospectivo, donde se realizaron dos entrevistas (455 profesionales), siendo que la segunda se produjo tras la ERTB. La clasificación del desempeño siguió los valores: ≤ 49,9%, críticos; entre 50 y 79,9%, insatisfactorios; y, ≥ 80%, satisfactorios. En la evaluación comparativa, se utilizó el test estadístico de McNemar, con p < 0,05. Tras la estratificación de riesgo, la mayor parte de las variables de cada eje mejoró significativamente. Concluimos que fue posible identificar el desempeño satisfactorio en la mayoría de las variables evaluadas en los ejes Estructura y Proceso de los servicios de atención primaria en salud en Belo Horizonte, en relación con las acciones de control de la tuberculosis mediante un cuestionario estandarizado.

Assessment of factors associated with potential drug-drug interactions in patients with tuberculosis and HIV/AIDS

Abstract INTRODUCTION: The concomitant use of antituberculosis and antiretroviral drugs, as well as drugs to treat other diseases, can cause drug-drug interactions. This study aimed to describe potential drug-drug interactions (pDDI) in patients with TB and HIV/AIDS co-infection, as well as to analyze possible associated factors. METHODS: This study was performed in a reference hospital for infectious and contagious diseases in the southeastern region of Brazil and evaluated adult patients co-infected with tuberculosis and HIV/AIDS. A cross-sectional study was conducted in which sociodemographic, clinical, and pharmacotherapeutic characteristics were assessed. The pDDI were identified using the Drug-Reax software. Association analysis was performed using either a chi-squared test or a Fisher's exact test. Correlation analysis was performed using the Spearman's coefficient. RESULTS: The study included 81 patients, of whom 77 (95.1%) were exposed to pDDI. The most frequent interactions were between antituberculosis and antiretroviral drugs, which can cause therapeutic ineffectiveness and major adverse reactions. A positive correlation was established between the number of associated diseases, the number of drugs used, and the number of pDDI. An association was identified between contraindicated and moderate pDDI with excessive polypharmacy and hospitalization. CONCLUSIONS: We found a high frequency of pDDI, especially among those hospitalized and those with excessive polypharmacy. These findings highlight the importance of pharmacists in the pharmacotherapeutic monitoring in these patients.

Cost-effectiveness of Xpert®MTB/RIF in the diagnosis of tuberculosis: pragmatic study

Abstract INTRODUCTION: The intensification of research and innovation with the creation of networks of rapid and effective molecular tests as strategies for the end of tuberculosis are essential to avoid late diagnosis and for the eradication of the disease. We aimed to evaluate the cost-effectiveness of Xpert®MTB/RIF (Xpert) in the diagnosis of drug-resistant tuberculosis in reference units, in scenarios with and without subsidies, and the respective cost adjustment for today. METHODS: The analyses were performed considering as criterion of effectiveness, negative culture or clinical improvement in the sixth month of follow-up. The comparison was performed using two diagnostic strategies for the drug susceptibility test (DST), BactecTMMGITTM960 System, versus Xpert. The cost effectiveness and incremental cost-effectiveness ratio (ICER) were calculated and dollar-corrected for American inflation (US$ 1.00 = R$ 5,29). RESULTS: Subsidized Xpert had the lowest cost of US$ 33.48 (R$67,52) and the highest incremental average efficiency (13.57), thus being a dominated analysis. After the inflation was calculated, the mean cost was DST-MGIT=US$ 74.85 (R$ 396,73) and Xpert = US$ 37.33 (R$197,86) with subsidies. CONCLUSIONS: The Xpert in the diagnosis of TB-DR in these reference units was cost-effective with subsidies. In the absence of a subsidy, Xpert in TB-DR is not characterized as cost effective. This factor reveals the vulnerability of countries dependent on international organizations' subsidy policies.

The impact of the stratification by degree of clinical severity and abandonment risk of tuberculosis treatment / O impacto da estratificação por grau de risco clínico e de abandono do tratamento da tuberculose

ABSTRACT Objective: Evaluate the impact of the instrument of the "Stratification by Degree of Clinical Severity and Abandonment Risk of Tuberculosis Treatment" (SRTB) on the tuberculosis outcome. Methods: This study was a pragmatic clinical trial involving patients with a confirmed diagnosis of tuberculosis treated at one of the 152 primary health care units in the city of Belo Horizonte, Brazil, between May of 2016 and April of 2017. Cluster areas for tuberculosis were identified, and the units and their respective patients were divided into intervention (use of SRTB) and nonintervention groups. Results: The total sample comprised 432 participants, 223 and 209 of whom being allocated to the nonintervention and intervention groups, respectively. The risk of treatment abandonment in the nonintervention group was significantly higher than was that in the intervention group (OR = 15.010; p < 0.001), regardless of the number of risk factors identified. Kaplan-Meier curves showed a hazard ratio of 0.0753 (p < 0.001). Conclusions: The SRTB instrument was effective in reducing abandonment of tuberculosis treatment, regardless of the number of risk factors for that. This instrument is rapid and easy to use, and can be adapted to different realities. Its application showed characteristics predisposing to a non-adherence to the treatment and established bases to mitigate its impact.

RESUMO Objetivo: Avaliar o impacto do instrumento denominado "Estratificação por Grau de Risco Clínico e de Abandono do Tratamento da Tuberculose" (ERTB) nos desfechos da tuberculose. Métodos: Ensaio clínico pragmático envolvendo pacientes com diagnóstico confirmado de tuberculose atendidos em uma das 152 unidades de atenção primária à saúde na cidade de Belo Horizonte (MG) entre maio de 2016 e abril de 2017. Foram identificadas áreas de cluster para tuberculose, e as unidades e os respectivos pacientes foram divididos em grupos intervenção (uso do instrumento ERTB) e não intervenção. Resultados: A amostra total foi composta por 432 participantes, dos quais 223 e 209 foram alocados nos grupos não intervenção e intervenção, respectivamente. O risco de abandono do tratamento no grupo não intervenção foi significativamente maior do que no grupo intervenção (OR = 15,010; p < 0,001), independentemente do número de fatores de risco identificados. As curvas de Kaplan-Meier mostraram uma razão de risco de 0,0753 (p < 0,001). Conclusões: O instrumento ERTB foi eficaz em reduzir o abandono do tratamento da tuberculose, independentemente do número de fatores de risco identificados. Esse instrumento é rápido e fácil de utilizar e pode ser adaptado a diferentes realidades.

Cost analysis of smear microscopy and the Xpert assay for tuberculosis diagnosis: average turnaround time.

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.