A tertiary care facility in Ukraine, a high multiand extensively drug-resistant tuberculosis (MDR/ XDR-TB) burden country. Objectives: To assess the management and treatment outcomes of MDR, pre-XDR-TB and XDR-TB. Design: Cohort study using programme data, 2006-2011. Results: Of 484 individuals with drug-resistant TB, 217 (45%) had MDR-, 153 (32%) pre-XDR-and 114 (24%) XDR-TB. Of all resistant types completing the intensive phase of treatment, 322 (67%) were alive and had culture converted. This included 157 (72%) with MDR-and 61 (54%) with XDR-TB. At the end of the continuation phase of treatment, 106 (22%) had treatment success and 378 (78%) had unfavourable outcomes, including 110 (23%) failures, 21 (4%) deaths, 71 (15%) losses to follow-up and 176 (36%) with an unknown outcome. This was associated with more than one lung cavity being affected, a history of treatment with second-line anti-tuberculosis drugs, poor adherence and XDR-TB. A total of 226 (47%) patients reported at least one adverse drug reaction, the most common being gastrointestinal and vestibular toxicity. Conclusion: Outcomes of MDR-and XDR-TB were satisfactory in the intensive phase; however, this was not sustained during the ambulatory period. If we are to do better, urgent measures are needed to improve ambulatory management, including making safer, shorter and more effective drug regimens available. * Percentage calculated using all patients starting treatment as denominator. SD = standard deviation.
New 6-months regimen based on bedaquiline, pretomanid and linesolid (BPaL), evaluated in TB-PRACTECAL clinical trial, is one of modern treatments for extensively drug resistant tuberculosis. Patients on BPaL should be carefully observed for side effects, especially liver toxicity, myelosuppression, peripheral and optic neuropathy, QT-interval prolongation and pancreatitis. A clinical case of extensively drug resistant tuberculosis with the outcomes of BPaL regimen treatment on the backgrounds of side effects is presented in current report. This case demonstrates that timely and thorough monitoring of side effects allows to preserve the BPaL regimen modality, regardless the occurrence of several adverse effects in one person and to complete the prescribed course of treatment, which resulted in cure. Key words: extensively drug resistant tuberculosis, BPaL regimen of treatment, saide effects.
Objective — to study the effectiveness of treatment of MDR-TB (multidrug-resistant tuberculosis) and preXDR-TB/XDR-TB (pre-extensively and extensively drug resistant tuberculosis), depending on the composition of ITRs (individualized treatment regimens).
Materials and methods. Тhe prospective observational study included 566 patients with MDR/preXDR-TB and XDR-TB during 2016—2020 on the scientific clinical bases of the SI «National Institute of Phthisiology and Pulmonology named after F.G. Yanovsky NAMS of Ukraine» and ME «Kryvyi Rih Anti-tuberculosis Dispensary» Dnipropetrovsk Regional Council Department. Patients were prescribed individualized treatment regimens in cases where short (standard or modified) regimens could not be prescribed. Patients were divided into comparison groups: 469 of them were treated with antimycobacterial therapy including bedaquiline and other effective antimycobacterial drugs groups A—C (without delamanid) — group 1. And 97 patients who were treated with the inclusion of both new antimycobacterial drugs (bedaquiline and delamanid) — group 2.
Results and discussion. Regardless of whether the delamanid, in addition to bedaquiline and other drugs selected for the scheme according to WHO recommendations, «effective treatment» was found in 91.3 against 88.6 % of patients. In the remote period (6-month — 4-year follow-up period) there was no recurrence of the disease, regardless of the composition of the regime. The loss of treatment effectiveness was due to deaths from non-tuberculosis reasons and those lost for follow-up.
Conclusions. For highly effective treatment, individualized regimens should include bedaquidine and linezolid from group A, and for previously ineffectively treated patients, clofazimine and carbapenems must be included (possibility to include 4 or more effective AMDs in ITR). For patients with fluoroquinolone resistance, treatment should include delamanid.
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