BackgroundEtiological treatment of Chagas disease in chronic asymptomatic patients is still in debate and the adverse effects of traditional drugs are one of the main concerns in clinical practice. This study evaluated retrospectively the safety profile of benznidazole (BZN) and identified predictive factors for definite treatment interruption and development of severe reactions in adult patients treated with BZN in Colombia.MethodsRetrospective follow-up study conducted by review of medical records of adults with chronic Chagas disease treated with BZN in Colombia. A parametric survival analysis based on a generalized gamma distribution was used for assessing risk factors for treatment interruption. A multinomial logistic regression model was used to estimate the probability of severe adverse drug reactions (ADRs). Statistical associations were expressed as time ratios (TR) and adjusted odds ratios (aOR) respectively.ResultsIn total 224 adults patients treated with BZN were included; 172 (76.8%) completed the standard therapy (60 days of treatment), 205 (91.5%) presented ADRs and 52 cases (23.2%) required treatment interruption. The predominant symptoms were: rash (37.9%), itching (33.7%), epigastric pain (26.4%), abdominal bloating (24.2%) and nausea (22.1%). ADRs were mild (57.4%), moderate (35.5%) and severe (7.3%). Time to treatment interruption was significantly shorter when using doses of BZN ≥ 6 mg/kg/day (TR 0.55; 95% CI 0.39–0.76), presenting severe ADRs (TR 0.12; 95% CI: 0.07–0.19) and eosinophilia (TR 0.68; 95% CI: 0.49–0.94). Female sex (aOR 3.98; 95% CI 1.56–10.16), dose of BZN ≥ 6 mg/kg/day (aOR 1.41; 95% CI 1.17–1.70) and presence of > 3 ADRs (aOR 6.47; 95% CI 1.24–34.34) were considered as risk factors for developing severe ADRs.ConclusionsDose, severity of ADRs, eosinophilia and female sex were the main predictors for treatment interruption or severe ADRs. The potential implications of these findings are discussed.

Cómo citar este artículo: Cucunubá ZM, et al. Primer consenso colombiano sobre Chagas congénito y orientación clínica a mujeres en edad fértil con diagnóstico de Chagas. Infectio. 2014. http://dx.

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Chagas disease affects over six million people, but less than 1% are diagnosed and treated. Complicated diagnostic processes are a major barrier. Colombia's previous diagnostic algorithm, using inhouse tests, was difficult to scale up, creating significant access barriers for patients. A new algorithm using commercially manufactured immunoassays would potentially improve access, but these tests' performance in Colombian patients with Chagas disease is not well known. Methods: We assessed seven commercially available assays. Samples (n = 501), 93.8% originating from Colombia, were characterized as positive or negative based on standard procedure at the National Reference Laboratory. Performance characteristics were calculated for individual assays and hypothetical test pairings, then compared to the existing algorithm. Results: Five of seven assays exhibited sensitivity >98% while six showed specificity >97%. A total antigen ELISA paired with a recombinant assay provided similar performance to the current diagnostic process. Six of six assays tested proved capable of detecting different Trypanosoma cruzi genetic lineages. Conclusions: The study indicated that several commercial assays accurately detect T. cruzi infection in Colombian patients. A simplified testing process with two commercial assays could perform comparably to the previous process, reducing cost and accessibility barriers and facilitating national scale-up.

The vast majority of people with Chagas disease (CD) are undiagnosed and untreated. Improving access to diagnosis and treatment for CD involves confronting a wide range of barriers. This report discusses a collaborative approach to eliminate barriers and increase the availability of CD testing and treatment. Potential areas for intervention are selected based on burden of disease, support of local champions, and commitment from national and local authorities. A 4D approach (diagnose, design, deliver, and demonstrate impact) is then implemented. The diagnose step involves gathering key stakeholders at a seminar to collaboratively identify important barriers and propose solutions. The design step creates a specific plan to act upon the seminar’s conclusions with consensus on core indicators. The deliver step entails implementing the plan at pilot locations, while simultaneously strengthening health system capacity for CD testing and treatment. Lastly, the demonstrate impact step compares baseline data with annual post-implementation data to measure progress. In Colombia, this approach has helped simplify testing procedures and increase CD testing and treatment access in pilot communities, though challenges remain. The 4D approach represents one of several pathways toward ensuring that the best therapeutic and diagnostic products reach people affected by neglected tropical diseases.