Fardhdiani Vini, Trush Olena, Lytvynenko Nataliia, Pylypchuk Svitlana, Terleeva Yana, Malakyan Khachatur, Rupasinghe Praharshinie, Wally Yves, Duka Marve, Didyk Vitaly Stephanovich, Siomak Olga Valentinovna, Blyzniuk Oleksandr, Furin Jennifer, Donchuk Dmytro, Laxmeshwar Chinmay, Isaakidis Petros
Médecins Sans Frontières, Zhytomyr, Ukraine.
Médecins Sans Frontières, Brussels, Belgium.
PLOS Glob Public Health. 2025 May 23;5(5):e0003983. doi: 10.1371/journal.pgph.0003983. eCollection 2025.
The World Health Organization has called for operational research on all-oral shorter regimens for rifampin-resistant and multidrug-resistant forms of tuberculosis (RR/MDR-TB). We followed a cohort of patients in Zhytomyr, Ukraine for effectiveness, safety, tolerability and feasibility of bedaquiline & delamanid-based treatment regimens under programmatic conditions. This was a single-arm implementation study. All consenting persons with RR/MDR-TB were enrolled between 1 April 2019 and 31 May 2021 and followed up 12-months after treatment completion. We assessed quality of life and depression symptoms between start and end-of-treatment. We enrolled 300 patients. Overall, 212 (71%) patients were cured, 22 (7%) patients completed treatment, median time to culture conversion was 58 days (IQR:30-75), and 21% and 27% of patients had at least one serious or Grade 3/4 adverse event, respectively. The overall BREF-WHO/Quality of Life score improved between baseline and end-of-treatment, from average 52.64(std. dev:21.63) to 57.15(std. dev:21.43) while Patient Health Questionnaire-9(PHQ-9) score decreased from 6.67(std. dev:4.75) at baseline to 5.34(std. dev: 5.18) at end-of-treatment. Twelve months post-treatment 174/234(74%) were alive and recurrence-free, 17(7%) patients died, one (<1%) had recurrent TB, while 42 (18%) were lost from the post-treatment follow-up. All-oral short-term regimens showed high success under programmatic conditions in Ukraine, despite extreme implementation challenges during the COVID-pandemic and the Russia-Ukraine war. Moreover, this was a cohort of patients with high levels of co-morbidities and substance use. A multidisciplinary, psychosocial support model might have contributed to satisfactory treatment outcomes, improved quality of life and decreased symptoms of depression among people living with RR/MDR-TB.
世界卫生组织呼吁对利福平耐药和耐多药结核病（RR/MDR-TB）的全口服短疗程进行运筹学研究。我们在乌克兰日托米尔对一组患者进行了观察，以了解在项目条件下基于贝达喹啉和地拉马尼的治疗方案的有效性、安全性、耐受性和可行性。这是一项单臂实施研究。所有同意参与的RR/MDR-TB患者于2019年4月1日至2021年5月31日入组，并在治疗完成后随访12个月。我们评估了治疗开始和结束时的生活质量和抑郁症状。我们招募了300名患者。总体而言，212名（71%）患者治愈，22名（7%）患者完成治疗，培养转阴的中位时间为58天（四分位间距：30-75），分别有21%和27%的患者发生至少一次严重或3/4级不良事件。治疗开始至结束时，BREF-WHO/生活质量总分有所改善，从平均52.64（标准差：21.63）提高到57.15（标准差：21.43），而患者健康问卷-9（PHQ-9）评分从基线时的6.67（标准差：4.75）降至治疗结束时的5.34（标准差：5.18）。治疗后12个月，234名患者中有174名（74%）存活且无复发，17名（7%）患者死亡，1名（<1%）患者结核病复发，42名（18%）患者在治疗后随访中失访。尽管在新冠疫情和俄乌战争期间面临极端的实施挑战，但全口服短期方案在乌克兰的项目条件下显示出高成功率。此外，这是一组合并症和药物使用水平较高的患者。多学科的社会心理支持模式可能有助于RR/MDR-TB患者获得满意的治疗结果、改善生活质量并减轻抑郁症状。
