Long-term comparative pharmacovigilance of orally transmitted Chagas disease: first report

Noya, Belkisyolé Alarcón de; Ruiz-Guevara, Raiza; Noya, Óscar; Castro, Julio; Ossenkopp, John; Díaz-Bello, Zoraida; Colmenares, Cecilia; Suárez, José Antonio; Noya-Alarcón, Óscar; Naranjo, Laura; Gutiérrez, Humberto; Quinci, Giuseppa; Torres, Jaime R.

doi:10.1080/14787210.2017.1286979

Cited by 18 publications

(22 citation statements)

References 29 publications

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“…We included three RCTs [ 20 , 21 , 22 ] and 10 observational studies [ 23 , 24 , 25 , 26 , 27 , 28 , 29 , 30 , 31 , 32 ]. The studies were conducted in Latin American countries or in non-endemic countries with Latin American immigrants ( Table 1 ).…”

Section: Resultsmentioning

confidence: 99%

“…Variation in BNZ treatment lengths (≤60 days and >60 days) did not show a statistically significant difference in efficacy [25]. Of the four trypanocidals used (BNZ, NFX, POS and E1224), BNZ was the most efficacious in terms of PCR conversion (clearance of parasite) and sero-reversion (quantitative decrease in anti-T. cruzi antibodies) in all studies that measured parasite efficacy [20][21][22][23][24].…”

Section: Infection-related Outcomesmentioning

confidence: 91%

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A Rapid Review on the Efficacy and Safety of Pharmacological Treatments for Chagas Disease

et al. 2021

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Chagas disease remains a neglected tropical disease, causing significant burden in the Americas and countries that receive immigrants from endemic nations. Current pharmaceutical treatments are suboptimal, not only varying drastically in efficacy, depending on the stage of disease, but also presenting significant risk of adverse events. The objective of this review is to provide a timely update on the efficacy and safety of current trypanocidals. Eligible studies published from January 2015 to December 2020 were retrieved by one reviewer from six electronic databases. Ana-lysis was done with review management software and risk of bias was assessed using tools appropriate for the type of study (i.e., experimental or observational). Thirteen studies (10 observational and three RCTs) were included in the analysis. All 13 studies tested Benznidazole (BNZ) or Nifurtimox (NFX), and two studies also tested Posaconazole (POS) or E1224 (Ravucanazole). BNZ was found to be the most efficacious trypanocidal drug compared to Nifurtimox, POS, and E1224; it also resulted in the highest percentage of adverse effects (AEs) and treatment discontinuation due to its toxicity. Adults experienced higher frequency of neurological AEs while taking BNZ or NFX compared to children. Children had a higher frequency of general AEs compared to adults while taking BNZ. Overall, BNZ is still the most efficacious, but development of new, less toxic drugs is paramount for the quality of life of patients. Studies testing combination therapies and shorter regimens are needed, as is the devising of better clinical parameters and laboratory biomarkers to evaluate treatment efficacy. Considering the variability in methodology and reporting of the studies included in the present analysis, we offer some recommendations for the improvement and replicability of clinical studies investigating pharmacological treatment of Chagas disease. These include full disclosure of methodology, standardization of outcome measures, and always collecting and reporting data on both the efficacy of trypanocidals and on safety outcomes.

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Section: Resultsmentioning

confidence: 99%

Section: Infection-related Outcomesmentioning

confidence: 91%

A Rapid Review on the Efficacy and Safety of Pharmacological Treatments for Chagas Disease

et al. 2021

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“…Current clinical guidelines recommend treating T. cruzi-infected people if they are asymptomatic or present early symptoms of the disease (Table 1) [4,5]. Benznidazole (BNZ) and nifurtimox (NFX) are the first-line antiparasitic treatments currently available, both with long administration regimens (60 days) that can produce adverse side effects [6][7][8]. Despite the fact they are not 100% effective in patients with chronic disease [9][10][11][12], they are the only drugs currently registered, and the benefits of their administration have been confirmed in several clinical studies [9][10][11][12][13][14].…”

Section: Introductionmentioning

confidence: 99%

Target product profile for a test for the early assessment of treatment efficacy in Chagas disease patients: An expert consensus

et al. 2020

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“…Approved drugs for treatment of T. cruzi infection (benznidazole and nifurtimox) are complex, and adverse events reactions (ADRs) are frequent. Onset of ADRs is one of the main causes of patients abandoning treatment, resulting in therapeutic failure or ineffective treatment [4][5][6][7][8][9].…”

Section: Introductionmentioning

confidence: 99%

Strengthening the Bolivian pharmacovigilance system: New surveillance strategies to improve care for Chagas disease and tuberculosis

Cortes-Serra

Saravia

Grágeda³

et al. 2020

PLoS Negl Trop Dis

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Chagas disease (CD) and tuberculosis (TB) are important health problems in Bolivia. Current treatments for both infections require a long period of time, and adverse drug reactions (ADRs) are frequent. This study aims to strengthen the Bolivian pharmacovigilance system, focusing on CD and TB. A situation analysis of pharmacovigilance in the Department of Cochabamba was performed. The use of a new local case report form (CRF) was implemented, together with the CRF established by the Unidad de Medicamentos y Tecnología en Salud (UNIMED), in several healthcare centers. Training and follow-up on drug safety monitoring and ADR reporting was provided to all health professionals involved in CD and TB treatment. A comparative analysis of the reported ADRs using the CRF provided by UNI-MED, the new CRF proposal, and medical records, was also performed. Our results showed that out of all patients starting treatment for CD, 37.9% suffered ADRs according to the medical records, and 25.3% of them were classified as moderate/severe (MS). Only 47.4% of MS ADRs were reported to UNIMED. Regarding TB treatment, 9.9% of all patients suffered ADRs, 44% of them were classified as MS, and 75% of MS ADRs were reported to UNI-MED. These findings show that the reinforcement of the Bolivian pharmacovigilance system is an ambitious project that should involve a long-term perspective and the engagement of national health workers and other stakeholders at all levels. Continuity and perseverance are essential to achieve a solid ADR reporting system, improving patient safety, drug efficacy and adherence to treatment.

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Long-term comparative pharmacovigilance of orally transmitted Chagas disease: first report

Abstract: Frequency and severity of side effects during treatment of acute oral infection by T. cruzi demand direct supervision and close follow-up, even in those asymptomatic, to prevent life-threatening situations.

Cited by 18 publications

References 29 publications

A Rapid Review on the Efficacy and Safety of Pharmacological Treatments for Chagas Disease

A Rapid Review on the Efficacy and Safety of Pharmacological Treatments for Chagas Disease

Target product profile for a test for the early assessment of treatment efficacy in Chagas disease patients: An expert consensus

Strengthening the Bolivian pharmacovigilance system: New surveillance strategies to improve care for Chagas disease and tuberculosis

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