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Consensus framework for developing a target product profile of real-time PCR in Chagas disease therapeutic monitoring
Alejandro G Schijman1, Colin Forsyth2, Alba Abras3
1Laboratorio de Biologia Molecular de la Enfermedad de Chagas, Instituto de Investigaciones en Ingeniería Genética y Biología Molecular "Dr Héctor Torres" (INGEBI-CONICET), Buenos Aires, Argentina.
Insights
Chagas disease diagnosis and treatment face challenges. Experts convened to standardize quantitative PCR (qPCR) methods for better drug development and clinical trial evaluation.
Area of Science:
- Neglected tropical diseases
- Parasitology
- Clinical pharmacology
Background:
- Chagas disease is a neglected global health issue with significant diagnostic and therapeutic hurdles.
- Chronic Chagas disease can lead to severe cardiac and digestive complications in 20-40% of cases.
- Lack of reliable prognostic markers necessitates early diagnosis and effective treatment strategies.
Purpose of the Study:
- To address limitations in evaluating Chagas disease treatments due to inconsistent diagnostic biomarkers.
- To establish consensus on quantitative PCR (qPCR) protocols for clinical trials.
- To define a target product profile for qPCR assays to support drug development and regulatory approval.
Main Methods:
- Convening a panel of experts by the Drugs for Neglected Diseases initiative.
- Reviewing existing quantitative PCR (qPCR) methodologies for Chagas disease.
- Developing recommendations for standardized qPCR application in clinical trials.
Main Results:
- Identified heterogeneity in current qPCR protocols as a major barrier.
- Highlighted the need for standardized biomarkers to assess treatment response.
- Proposed a consensus on qPCR application to improve Chagas disease drug evaluation.
Conclusions:
- Standardized qPCR methods are crucial for reliable assessment of Chagas disease treatment efficacy.
- Developing a target product profile for qPCR will facilitate drug development and regulatory processes.
- Improved diagnostic tools are essential for managing Chagas disease and its complications.
Abstract:
Chagas disease remains a neglected global health problem with major diagnostic and therapeutic challenges. Progression from acute to chronic infection may lead to cardiac or digestive complications in approximately 20-40% of patients, depending on geographic region and duration of follow-up. However, reliable prognostic markers are still lacking, underscoring the importance of early diagnosis and timely treatment. For over 40 years, therapy has relied on benznidazole and nifurtimox, effective in acute but inconsistent in chronic disease, with frequent adverse effects undermining adherence. Current research is testing shorter regimens, lower doses, and novel compounds. Their evaluation is constrained by the lack of standardized biomarkers of treatment response. Serology requires decades to confirm treatment effect, whereas quantitative PCR (qPCR) enables earlier detection of therapeutic failure. However, heterogeneity of qPCR protocols hampers cross-trial comparisons and meta-analyses. To resolve these limitations, the Drugs for Neglected Diseases initiative convened experts to build consensus on qPCR application in clinical trials aiming to define a target product profile supporting drug development and regulatory approval.
