Clinical Protocol and Therapeutic Guidelines on Chagas Disease: Achievement will bring advances in disease control

PCDT is a strategic tool for the Unified Health System (SUS) while providing mechanisms for clinical monitoring on the effectiveness of the treatment and the occurrence of adverse effects, besides being a support tool to deliver drugs and procedures

Launched on February, 2016, the construction and approval process of the Clinical Protocol and Therapeutic Guidelines (PCDT) in Chagas disease was closed this year after the publication of decree nº 57 (SCTIE/MS 57/2018), that confirmed the decision to approve the PCDT within the Unified Health System (SUS) in the official Diary (DOU) of October 31, 2018 (Report 397 – Clinical Protocol and Therapeutic Guidelines for Chagas Disease).

Throughout this process, the Brazilian Society of Tropical Medicine (BSTM) has had an important participation by the direct insertion of its members both in these Elaborator Group and in the PCDTp Management Committee, says Dr. Alberto Novaes Ramos Jr. from the Federal University of Ceará (UFC) Medical School, one of the members of the group of experts in creating this Protocol. In addition, in the 2017 editions (coordinated by Dr. Alberto Novaes) and the 2018 Meeting of Applied Research on Chagas Disease, the SBMT provided the insertion of activities for discussion and development of this process with the presence of the Ministry of health and national and international researchers.

PCDT is a strategic tool for the Unified Health System (SUS) while providing mechanisms for clinical monitoring of the effectiveness of the treatment and the occurrence of adverse effects, besides being a support tool to deliver drugs and procedures According to Dr. Alberto Novaes, the document brings very relevant advances to expand the recognition of people affected by the disease in the SUS basic attention network, expanding the access not only for diagnosis, but also to treat the disease (both in parasitological as clinical complications) in the pursuit of a comprehensive care. PCDT updates are supposed to happen every two years, as an opportunity to review in the light of the countrys technical, scientific and political advances on the theme.

The document brings important advances regarding the right to health for people with Chagas disease and their families. According to the Chief of the Laboratory of Clinical Research on Chagas Disease (LAPCLIN-CHAGAS/INI/Fiocruz) at the Evandro Chagas National Institute of Infectious Diseases (INI) at the Oswaldo Cruz Foundation (Fiocruz) , Prof. Dr. Andrea Silvestre de Sousa, former coordinator of the 2018 ChagasLeish meeting and representative of INI/Fiocruz in designing the PCDT, this is a historical document of significant progress to deepen the integration of Chagas disease in the Unified Health Systems public policies. Fiocruzs position consolidated its mission of institutional cooperation and ratifies its role as a reference and historical significance in a national level.

Dr. Alberto Novaes stresses that despite the achievement, there is still much to be done to implement the PCDT in the real context of the health care network, thus preserving the guarantees to its full extent. Data countersigned by the 2nd Brazilian Consensus on Chagas Disease  reveal the true size of the challenge:  estimates point that from 1.9 to 4.6 million people are infected by the Trypanosoma cruzi in Brazil. This way, the BSTM reiterates the importance of the recommendations contained in this document to implement serological diagnostic for infection by T. cruzi in the Country by appropriate tracking strategies within epidemiological contexts of higher risk and without age limitation, including prenatal scope. Besides this, the PCDT reinforced the need to integrate parasitological treatment for indicated cases to the SUS care network, especially to basic care network, says Dr. Alberto Novaes. The BSTM also calls attention to issues related to comprehensive care, that should incorporate the appropriate management of chronic forms of the disease within the SUS network.

According to Dr. Andrea Silvestre, the LapClin Chagas / INI, a laboratory that promotes research and comprehensive care to one of the largest national cohorts of people with Chagas disease, also reiterates the recommendation of the document, and that serological tests should be offered in a broad and integrated manner throughout the SUS network, particularly in the basic care network, allowing the parasitological and / or symptomatic treatment, when appropriately indicated, are able to reduce the high morbimortality burden associated with the chronic cardiac and digestive forms of the disease.

Finally, Dr. Alberto Novaes emphasizes the strong recommendation in the PCDT to have Chagas Disease in its chronic phase listed as an obligatory notifiable event in Brazil, considering its relevance to public health in face of the magnitude expressed in the mortality and morbidity rates, as well as its spread potential, its transcendence, the vulnerability and the international commitments undertaken, especially those in the 2030 Sustainable Development Goals (SDG) agenda in its objective 3, goal 3.3. This recommendation is consented among all experts, but still awaits its implementation by the Ministry of Health. With the publication of the PCDT, we expect that this decision will be taken as soon as possible, says Dr. Andrea Silvestre.

From elaboration to final approval

 Once the theme was listed and defined in the project’s, scope definition, on April 14, 2016, the Chagas Disease combat Day, a public inquiry about the first phase of the PCDT elaboration proposal was launched aiming at the attention and aid of the people with the disease in Brazil. The poll intended to enable the participation of the society from the very beginning of the preparation of the PCDT.

After this poll, the first meeting of the Chagas Disease PCDT Steering Committee  was held in May 20, 2016, and was joined by some departments of the Ministry of Health and medical experts, among other partners in the area, including many BSTM members (Dr. Alberto Novaes Ramos Jr., Dr. Alejandro Luquetti, Dr. Andrea Silvestre de Sousa, Dr. João Carlos Pinto Dias, Dr. Maria Aparecida Shikanai Yasuda and Dr. Wilson de Oliveira Jr. The main objectives of the meeting were the initial discussion of the proposal in regarding the PCDT scope, as well as the analysis and systematization of contributions received through public poll on the subject, held from April 14, to May 3, 2016.

Elaborating and evaluating the contempt happened between 2016 and 2017, when the document was submitted to intense technical and scientific debates within the Elaborating Group and the Steering Committee. After the first final version was consolidated, it was submitted to the Plenary of the National Technology Incorporation Commission in SUS (CONITEC) and was rejected in the first evaluation of 2018. After reviewed and applying the recommendations, it was submitted again, and this time, approved. Afterwards, it was submitted to public consultation  for broad participation of the civil society. The proposal had over 150 stakes.

On October, 30, 2018 the final document of the Chagas Disease PCDT was approved, after more than two years in development. A great achievement that should have strong impact in Brazil, but also in endemic and non-endemic areas in pursuit of controlling the disease. For such, we will await its full implementation in SUS reality, based on initiatives that consider actions to support the strengthening of: epidemiological intelligence; health management and planning; integral care; health information, education and communication; and other strategic researches, adds Dr. Alberto Novaes while ensuring the BSTM will be closely following and actively participating in all initiatives of this new movement.…