Effectiveness and safety of b e daquiline-base d, modifie d all-oral 9-11-month treatment regimen for rifampicin-resistant tuberculosis in Vietnam

Objectives: World Health Organization recommends a 7-drug 9-11-month rifampicin-resistant tuberculo-sis (RR-TB) short treatment regimen (STR). To reduce the pill burden, we assessed the safety and effec-tiveness of a 5-drug 9-11-month modified STR (mSTR).Methods: Prospective cohort study of an all-oral mSTR (comprising bedaquiline, levofloxacin, linezolid [LZD], clofazimine, and/or pyrazinamide) for patients with RR-TB without confirmed fluoroquinolone re-sistance, enrolled in Vietnam between 2020-2021.Results: A total of 108 patients were enrolled in this study. Overall, 63 of 74 (85%) achieved culture con-version at 2 months. Of 106 evaluated, 95 (90%) were successfully treated, six (6%) were lost-to -follow-up, one (1%) died, and four (4%) had treatment failure, including three with permanent regimen change owing to adverse events (AE) and one with culture reversion. Of 108, 32 (30%) patients encountered at least one AE. Of 45 AEs recorded, 13 (29%) were serious (hospitalization, life threatening, or death). The median time to AE was 3 months (IQR: 2-5). A total of 26 AEs led to regimen adaptation: either dose reduction (N = 1), drug temporary interruption (N = 19), or drug permanent discontinuation (N = 6, 4 attributed to LZD).Conclusion: The high treatment success of 5-drug mSTR might replace the 7-drug regimen in routine care. AEs were frequent, but manageable in most patients. Active AEs monitoring is essential, particularly when using LZD throughout.(c) 2022 Published by Elsevier Ltd on behalf of International Society for Infectious Diseases. This is an open access article under the CC BY-NC-ND IGO license ( http://creativecommons.org/licenses/by-nc-nd/3.0/igo/ )

Automated summary

This study evaluated the safety and effectiveness of a modified short treatment regimen (mSTR) consisting of 5 drugs. The results showed a high treatment success rate and suggested that the mSTR could replace the standard 7-drug regimen. Although adverse events occurred in some patients, they were mostly manageable.