Factors associated with the rapid implementation process of the fixed-dose combination RHZE tuberculosis regimen in brazil: an ecological study

BACKGROUND: 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. We evaluated factors associated with the speed of the new regimen implementation process in this continent-sized country. METHODS: We 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. RESULTS: Rapid 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. CONCLUSIONS: We 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.