Abstract
BackgroundThe Brazilian National Tuberculosis Control Program (NTCP) recommended the fixed-dose four-drug combination (FDC-RHZE) regimen to treat new tuberculosis cases in December 2009, expecting to increase adherence and avoid resistance. We evaluated factors associated with the speed of the new regimen implementation process in this continent-sized country.MethodsWe conducted an ecological study based on the Brazilian Case Notification Database (SINAN) having the Brazilian municipalities as the analytical unit. Municipalities with at least one case reported from December 2009 to March 2011 were considered eligible. The association of rapid (≤ 3 months) implementation of the new regimen with demographic, epidemiological and operational health service characteristics, such as compliance with NTCP recommendations (supervised treatment, bacteriological confirmation of the diagnosis and monthly bacteriological monitoring), was analyzed. We used the adjusted odds ratios (OR) and their 95% confidence interval (CI) to assess the association of independent variables with the outcome in a multiple logistic regression model.ResultsRapid implementation of the new regimen in municipalities was associated with small populations (OR=25.5, 95% CI= 19.1-34.1), low population density (OR=2.3, 95% CI= 1.9–2.9), low tuberculosis incidence rates (OR=8.8, 95% CI= 6.7–11.4) and good compliance with other NTCP recommendations.ConclusionsWe showed that SINAN secondary data analysis is feasible and useful to learn lessons from. Municipalities with high tuberculosis burden and large populations need special attention for implementing new recommendations. This is particularly important considering the Global Alliance pipeline for new tuberculosis treatment regimens.
Highlights
The Brazilian National Tuberculosis Control Program (NTCP) recommended the fixed-dose four-drug combination (FDC-RHZE) regimen to treat new tuberculosis cases in December 2009, expecting to increase adherence and avoid resistance
The objective of the present study is to investigate sociodemographic, epidemiological and operational factors associated with the implementation process of the fixed-dose combination (FDC)-RHZE regimen for tuberculosis treatment in Brazilian municipalities
New adolescent and adult (>10 years) cases notified between December 2009 and March 2011 using the four drugs (R, H, Z and E) after the starting month of implementation of the FDCRHZE, as informed by the State Health Secretaries, were considered as users of the new FDC-RHZE regimen
Summary
The Brazilian National Tuberculosis Control Program (NTCP) recommended the fixed-dose four-drug combination (FDC-RHZE) regimen to treat new tuberculosis cases in December 2009, expecting to increase adherence and avoid resistance. In 1996, the Brazilian National Tuberculosis Control Program (NTCP) incorporated the directly observed treatment strategy (DOTS) for reaching World Health Organization (WHO) cure targets and reducing default rates, preventing emergence of resistant bacillus [1]. By the end of 2009, Brazil was the only high-burden country to use a treatment regimen with only three drugs [fixed-dose combination (FDC)-Rifampin and Isoniazid (RH) and Pyrazinamide (Z)]. Despite a free-of-charge treatment, the default rates were around 9.3%, attaining 14% in some states [4] At this point, the NTCP advisory board revised the Brazilian Tuberculosis Guidelines and recommended the WHO-suggested four-drug FDC regimen for tuberculosis treatment for adolescents and adults (over 10 years old). The NTCP expected that the inclusion of a fourth drug would fight the emergence of resistance, which was, at that point, widely spread in Eastern Europe, Asia and Africa [6]
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