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Abstract
The most neglected aspects of Chagas disease (CD) have been patient care and treatment. Despite recent progress in the development of potentially improved drugs, there is no consensus among different research groups on the lack of therapeutic response markers to evaluate efficacy of newly proposed drugs early after treatment. A systematic review of current evidence regarding molecules which are potential biomarkers for therapeutic response has been conducted using quality assessment and target responses as primary criteria. The review provides a panorama of the cumulative evidence and specific needs for development of a battery of complementary biomarkers which together fulfill ideal or acceptable criteria to evaluate early responses to treatment for chronic CD. There are several marker candidates which together may fulfill acceptable criteria to indicate the efficacy of a trypanocidal treatment. Data from ongoing studies are considered essential to improve assessment of existing markers and to identify those for early follow-up of treated patients.
Acknowledgements
We are grateful to A Fernández–Villegas from IPBLN for her collaboration in the searching of manuscripts on immunology biomarkers, and A Debrabant for his contribution regarding aptamers data.
Financial & competing interests disclosure
The NHEPACHA network is supported by DNDi (Drugs for Neglected Tropical Diseases initiative). Members of the NHEPACHA network. Apart from the authors of this article, the working group of NHEPACHA comprises BA de Noya (Instituto Medicina Tropical - Universidad Central de Venezuela (IMT-UCV); T Araujo-Jorge Fundaçao Oswaldo Cruz – Instituto Oswaldo Cruz(FIOCRUZ), Brasil; M Grijalva, Centro de Investigación de Enfermedades Infecciosas de la Pontificia Universidad Católica del Ecuador (CIEI-PUCE); F Guhl Universidad de los Andes (UA-CIMPAT), Colombia; Faustino Torrico, Universidad Mayor de San Simón (UMSS), Bolivia; Marcelo Abril, Fundación Mundo Sano, Argentina.
The CRESIB and IPBLN research members were partially supported by the Tropical Disease Cooperative Research Network (RICET - grants RD12/0018/0010 and RD12/0018/0021). MCT and MCL were also supported by Plan Nacional de I+D+I (MINECO-Spain) grants BFU2010-1670 and SAF2012-35777 and FEDER. MJP and JG received research funds from the Agencia de Gestio d’Ajuts Universitaris i de Recerca (AGAUR; grant 2009SGR385) and from Fundación Mundo Sano. J.B. and S.S.E. are members of the Research Career of CONICET, Argentina.
The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.
No writing assistance was utilized in the production of this manuscript.
Key issues
There is a lack of biomarkers for early therapeutic response to antitrypanocidal drugs.
Accurate and early biomarkers that assess the effectiveness of new drugs or which are useful for management of patients with Chagas CD are needed.
Certain biomarkers have shown their effectiveness to assess treatment response in different CD stages including DNA amplification techniques.
There is heterogeneity of treatment response and therapeutic failure biomarkers available.
Data suggest that no current biomarker may be sensitive enough to be used as a single tool to monitor the efficacy of a trypanocidal treatment.
Early surrogate markers of therapeutic response in chronic CD should be defined following quality criteria. Using the target product profile model, acceptable and ideal characteristics for a biomarker are proposed to evaluate response to treatment in patients with chronic CD.