Operational Study of Efficacy and Safety of 9-Month Multi- and Pre-Extesively Drug Resistant Tuberculosis Therapy in the Russian Federation ; Операционное исследование эффективности и безопасности 9-месячной терапии туберкулеза с множественной и пре-широкой лекарственной устойчивостью микобактерии в Российской Федерации
| Title: | Operational Study of Efficacy and Safety of 9-Month Multi- and Pre-Extesively Drug Resistant Tuberculosis Therapy in the Russian Federation ; Операционное исследование эффективности и безопасности 9-месячной терапии туберкулеза с множественной и пре-широкой лекарственной устойчивостью микобактерии в Российской Федерации |
|---|---|
| Authors: | Khimova E.S.; Volchenkov G.V.; Perkhin D.V.; Dyzhik E.S.; Sveshnikova O.M.; Kuznetsova T.A.; Makhmaeva S.V.; Verkhovaya V.N.; Chernykh M.A.; Guryeva T.I.; Bagai A.V.; Nikishova E.I.; Eliseev P.I.; Postoev V.A.; Maryandyshev A.O. |
| Source: | Annals of the Russian academy of medical sciences; Vol 80, No 2 (2025); 97-108 ; Вестник Российской академии медицинских наук; Vol 80, No 2 (2025); 97-108 ; 2414-3545 ; 0869-6047 ; 10.15690/vramn.802 |
| Publisher Information: | "Paediatrician" Publishers LLC |
| Publication Year: | 2025 |
| Collection: | Annals of the Russian academy of medical sciences / Вестник Российской академии медицинских наук |
| Subject Terms: | tuberculosis; multi-drug resistant; drug-related side effects and adverse reactions; levofloxacin; bedaquiline; clofazimine; linezolid; delamanid; oral drug administration; туберкулез; множественная лекарственная устойчивость; побочные эффекты; связанные с приемом лекарств; левофлоксацин; бедаквилин; клофазимин; линезолид; деламанид; пероральный прием лекарственных средств |
| Description: | Background. The World Health Organization (WHO) recommends conducting regional operational studies of fully oral modified shorter treatment regimens for multidrug/rifampicin-resistant tuberculosis in different countries to achieve an indicator of tuberculosis treatment effectiveness. Aims — to evaluate the efficacy and safety of 9-month, fully oral four-component treatment regimen for patients with MDR and pre-XDR-TB in two administrative regions of the Russian Federation. Methods. In frame of operational research conducted in the Arkhangelsk and Vladimir regions, 167 MDR-TB patients started 9-month treatment. Based on results of drug susceptibility testing of mycobacteria to fluoroquinolones, 134 participans received therapy with combination of levofloxacin (Lfx), bedaquiline (Bdq), linezolid (Lzd), clofazimine (Cfz), one patient — with levofloxacin (Lfx), bedaquiline (Bdq), delamanid (Dlm), clofazimine (Cfz), and 32 patients with — bedaquiline (Bdq), linezolid (Lzd), delamanid (Dlm) and clofazimine (Cfz). The molecular genetic verification of MDR-TB was 98.2%. HIV and hepatitis C co-infection was confirmed for 13.2% and 16.8% of participants, respectively. Adults, two teenagers and a pregnant woman participated in the study. Results. Favorable treatment outcomes were registered for 137 (82%) patients. Two of them had recurrence of the active TB disease. 15 (9%) patients were lost-to-follow-up, 7 (4.2%) patients had failure outcomes, and 8 (4.8%) patients died during treatment. On average, the culture conversion occurred after the first month of treatment. Active safety monitoring revealed 483 adverse events in 167 patients, the most frequent were: hepatotoxic reaction (in 89 patients, 53.3%), anemia (in 62 patients, 37.1%), QT prolongation (in 41 patients, 24.6%), polyneuropathy (in 45 patients, 26.9%). The frequency of serious adverse events was 9.5% of total number of adverse events. Conclusions. The results of an operational study of fully oral 9-month four-component treatment regimens demonstrate the ... |
| Document Type: | article in journal/newspaper |
| File Description: | application/pdf |
| Language: | Russian |
| Relation: | https://vestnikramn.spr-journal.ru/jour/article/view/18020/2128; https://vestnikramn.spr-journal.ru/jour/article/downloadSuppFile/18020/145798; https://vestnikramn.spr-journal.ru/jour/article/downloadSuppFile/18020/145850; https://vestnikramn.spr-journal.ru/jour/article/downloadSuppFile/18020/145851; https://vestnikramn.spr-journal.ru/jour/article/downloadSuppFile/18020/145852; https://vestnikramn.spr-journal.ru/jour/article/downloadSuppFile/18020/146031; https://vestnikramn.spr-journal.ru/jour/article/downloadSuppFile/18020/146032; https://vestnikramn.spr-journal.ru/jour/article/downloadSuppFile/18020/146033 |
| DOI: | 10.15690/vramn18020 |
| Availability: | https://vestnikramn.spr-journal.ru/jour/article/view/18020; https://doi.org/10.15690/vramn18020 |
| Rights: | Copyright (c) 2025 "Paediatrician" Publishers LLC |
| Accession Number: | edsbas.8C14E3A3 |
| Database: | BASE |