Effectiveness of RHZE-FDC (fixed-dose combination)compared to RH-FDC + Z for tuberculosistreatment in Brazil: a cohort study

Braga, José Ueleres
Trajman, Anete
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BMC Infectious Diseases
Background:In 2009, Brazil was the sole high-burden country to use three drugs [rifampin (R), isoniazid (H) andpyrazinamide (Z)] as the standard treatment for sensitive tuberculosis, with RH in fixed-dose combination (FDC).In December 2009, the country has adopted the FDC four-drug regimen including ethambutol (E). The rationalewas the expectation to reduce default and resistance rates, by increasing adherence to treatment and avoidingmonotherapy. However, there is no consensus on the superior effectiveness of the RHZE-FDC regimen overRH-FDC + Z. In particular, few studies evaluated its influence on default and smear negativation rates.Methods:We conducted a historic cohort study to assess the effectiveness of RHZE-FDC for the treatment oftuberculosis in Brazil, measured by the rates of treatment default and smear negativation in the second month oftreatment, using secondary data from the national information system known as SINAN-TB.Results:The RHZE-FDC had a protective effect against treatment default compared to RH-FDC + Z, reducing itby 14%. However, it was not possible to show an effect of the RHZE-FDC on the rate of second month smearnegativation. In addition to the regimen, other well-studied individual characteristics, such as older age (over 38 years)and higher education occupation were also protective against default. Conversely, alcoholism increased the probabilityof defaulting. These programmatic findings suggests the benefits of RHZE-FDC over RH-FDC + Z.Conclusion:Our analysis of a cohort database in a high burden country shows that compared to RH-FDC + Z,RHZE-FDC reduces the default rates, independently of other influencing individual or health service factors.Keywords:Effectiveness, Fixed-dose combination, Treatment, Tuberculosis
Braga JU, Trajman A.Effectiveness of RHZE-FDC (fixed-dose combination) compared to RH-FDC + Z for tuberculosis treatment in Brazil: a cohort study. BMC Infect Dis. 2015; 15:81.