High-dose gatifloxacin-based shorter treatment regimens for MDR/RR-TB. (February 2022)

• Record Type: Journal Article
• Authors: Nie, Qi; Tao, Lixuan; Li, Yingying; Chen, Nanshan; Chen, Hua; Zhou, Yong; Wang, Yanqiu; Chen, Huidong; Tang, Qiuping; Wang, Xianguang; Huang, Chaolin; Yang, Chengfeng
• Is Part Of: International journal of infectious diseases. Volume 115(2022)
• Page Start: 142
• Page End: 148
• Publication Date: 2022-02
• Subjects: Multidrug-Resistant tuberculosis -- MDR-TB -- Shorter treatment regimen -- STR -- Gatifloxacin -- ADR; Communicable diseases -- Periodicals; Communicable Diseases -- Periodicals; Communicable diseases; Periodicals; Electronic journals; 616.9
• DOI: 10.1016/j.ijid.2021.11.037
• Languages: English
• ISSNs: 1201-9712

Abstract

Highlights: High-dose gatifloxacin-based shorter treatment regimen is successful Hepatotoxicity and QT interval prolongation in the shorter treatment regimen Principles for constructing a tuberculosis treatment regimen Abstract: Setting: The shorter treatment regimen (STR) for multidrug- or rifampicin-resistant tuberculosis (MDR/RR-TB) has achieved successful outcomes in many countries. However, there are few studies on high-dose gatifloxacin-based STR with adverse drug reactions (ADRs) and management. Design: A prospective observational study was conducted with MDR/RR-TB patients who were treated with a standardized 9 or 12 - month regimen: including gatifloxacin (Gfx), clofazimine (Cfz), ethambutol (EMB), and pyrazinamide (PZA), and supplemented by amikacin (Am), isoniazid (INH), and prothionamide (Pto) during an intensive phase of 4 or 6 - month. Monitored ADRs monthly until treatment completion and then followed up every three months for one year. Results: Among the 42 eligible patients, 35 (83.3%) completed treatment successfully, 1 (2.4%) lost to follow-up (LTFU), and 6 (14.3%) failed due to ADRs, with no death. The most important ADR was drug-induced liver damage, which occurred in 24 out of 42 (57.1%) patients and resulted in 4 (9.5%) failed treatments and 4 (9.5%) adjusted treatments. QT interval prolongation occurred in 17 out of 42 (40.5%) patients, 9 (21.4%) of them with the corrected QT interval according to Fridericia (QTcF) > 500 ms resulting in 7 (16.7%) adjusted treatments. Conclusions: This study confirmed the effectiveness of the high-dose gatifloxacin-based STR but severe ADRs, especially hepatotoxicity and QT interval prolongation should never be ignored.