Roig-Sanchis Joan, Bosch-Nicolau Pau, Silgado Aroa, Salvador Fernando, Sánchez-Montalvá Adrián, Aznar Marisa, Oliveira Inés, Espinosa-Pereiro Juan, Serre-Delcor Núria, Pou Diana, Martínez-Campreciós Joan, Sulleiro Elena, Molina Israel
International Health Unit Vall d'Hebron-Drassanes, Infectious Diseases Department, Vall d'Hebron University Hospital, PROSICS Barcelona, Barcelona, Spain.
International Health Unit Vall d'Hebron-Drassanes, Infectious Diseases Department, Vall d'Hebron University Hospital, PROSICS Barcelona, Barcelona, Spain; Centro de Investigación Biomédica en Red de Enfermedades Infecciosas, Instituto de Salud Carlos III, Madrid, Spain.
Clin Microbiol Infect. 2025 Sep;31(9):1539-1545. doi: 10.1016/j.cmi.2025.03.018. Epub 2025 Mar 27.
The CHAGASAZOL trial compared posaconazole and benznidazole for treating chronic Chagas disease. Posaconazole showed poor short-term efficacy by means of real-time polymearse chain reaction (qPCR) compared with benznidazole, but few studies have reported long-term follow-up using this tool. The aim of this study was to provide a more comprehensive analysis of the CHAGASAZOL cohort through 11 years of follow-up.
This is a prospective observational cohort of individuals who were included in the CHAGASAZOL trial. Data were censored as of 31 December 2023. Subjects initially treated with posaconazole with a positive qPCR were offered re-treatment with benznidazole. All patients underwent clinical and electrocardiographic evaluations as well as a qPCR at a 6-month or 1-year interval. The primary objective was parasitological failure, defined as any positive qPCR in peripheral blood at any time during follow-up.
Seventy-two participants were enrolled (median follow-up: 71 months, range 1-147 months). At baseline, 59 (82%) were classified as indeterminate forms, 9 (12%) as cardiac, 2 (3%) as digestive, and 2 (3%) as mixed forms. Forty-eight participants received posaconazole, 45 completing at least 1 follow-up visit. Up to 43 of 45 (95%) presented a positive qPCR, and of them, 35 accepted to be retreated with benznidazole. Considering those treated with benznidazole (either initially or as a re-treatment), only 3 of 51 (6%) showed a positive qPCR. Four (5.5%) participants showed cardiac progression after 3-10 years of follow-up, with an incident rate of 0.94 events per 100 person-years. Two of them had received the complete benznidazole treatment, 1 was partially treated (17 days) and 1 was only treated with posaconazole before clinical progression.
Even if benznidazole showed parasitological efficacy, lifelong follow-up should be offered to individuals living with Chagas disease, as both parasitological failure and clinical progression can occur many years after diagnosis and treatment.
CHAGASAZOL试验比较了泊沙康唑和苯硝唑治疗慢性恰加斯病的效果。与苯硝唑相比，通过实时聚合酶链反应（qPCR）检测，泊沙康唑显示出较差的短期疗效，但很少有研究报告使用该工具进行长期随访的情况。本研究的目的是通过11年的随访，对CHAGASAZOL队列进行更全面的分析。
这是一个纳入CHAGASAZOL试验的前瞻性观察队列。数据截至2023年12月31日进行审查。最初接受泊沙康唑治疗且qPCR呈阳性的受试者接受苯硝唑重新治疗。所有患者每6个月或1年进行一次临床和心电图评估以及qPCR检测。主要目标是寄生虫学失败，定义为随访期间外周血qPCR在任何时间呈阳性。
共纳入72名参与者（中位随访时间：71个月，范围1 - 147个月）。基线时，59人（82%）被分类为不确定型，9人（12%）为心脏型，2人（3%）为消化型，2人（3%）为混合型。48名参与者接受了泊沙康唑治疗，45人完成了至少1次随访。45人中多达43人（95%）qPCR呈阳性，其中35人接受了苯硝唑重新治疗。考虑那些接受苯硝唑治疗的患者（无论是初始治疗还是重新治疗），51人中只有3人（6%）qPCR呈阳性。4名（5.5%）参与者在随访3 - 10年后出现心脏进展，发生率为每100人年0.94次事件。其中2人接受了完整的苯硝唑治疗，1人接受了部分治疗（17天），1人在临床进展前仅接受了泊沙康唑治疗。
即使苯硝唑显示出寄生虫学疗效，但对于恰加斯病患者应提供终身随访，因为寄生虫学失败和临床进展都可能在诊断和治疗多年后发生。
