Consensus framework for developing a target product profile of real-time PCR in Chagas disease therapeutic monitoring

Schijman AG, Forsyth C, Abras A, Almeida IC, Alonso-Padilla J, Alonso-Vega C, Ballart-Ferrer C, Bisio M, Britto C, Dumonteil E, Flores-Chavez M, Gallego M, Herrera-Bernal CP, Lopez-Albizu C, Moreira OC, Muñoz-Calderon A, Pinto L, Ramirez JC, Scandale I, Shikanai-Yasuda MA, Sosa-Estani S, Pinazo MJ PLOS Neglected Tropical Diseases 2026;20(7): e0014452. doi:10.1371/journal.pntd.0014452

Summary: For over 40 years, the only treatments for Chagas disease have been benznidazole and nifurtimox, drugs which are effective in the acute stage but inconsistent in chronic disease, which cause frequent adverse effects that undermine adherence. Current research into shorter regimens, lower doses, and novel compounds is constrained by the lack of standardized biomarkers of treatment response. While serology requires decades to confirm treatment effect, quantitative PCR enables earlier detection of therapeutic failure. However, heterogeneity of quantitative PCR protocols hampers cross-trial comparisons and meta-analyses. To resolve these limitations, DNDi convened experts to build consensus on quantitative PCR application in clinical trials, aiming to define a target product profile to support drug development and regulatory approval.

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