International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases · 2026
Treatment outcomes and drug-related adverse events across four short-course RR-TB regimens in South Africa: A retrospective analysis.
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Ndjeka Norbert, Perumal Rubeshan, Romanowski Kamila, Mathema Hlengani, Amusa Lateef Babatunde, Campbell Jonathon R, Conradie Francesca, Schaaf Hendrik Simon, Meintjes Graeme, Romero Rodolfo, Menzies Dick, Oelofse Suzette, Dheda Keertan, Naidoo Kogieleum
Аннотация
BACKGROUND: Shorter all-oral regimens for the treatment of multidrug-resistant tuberculosis or rifampicin-resistant tuberculosis (MDR/RR-TB) have improved efficacy, but their performance under programmatic conditions remains insufficiently characterized.
METHODS: We retrospectively evaluated treatment outcomes and drug-related adverse events (AEs) among 396 randomly selected patients from four facilities in three provinces across South Africa. Patients received four different short-course regimens sequentially introduced into national programme: i) injectable 9-11-month (injectable-regimen), ii) bedaquiline-ethionamide-containing (ethionamide-regimen), iii) bedaquiline-linezolid-containing (linezolid-regimen), and iv) bedaquiline-pretomanid-linezolid-levofloxacin regimen (BPaL-L).
RESULTS: Compared with the injectable regimen, the ethionamide-regimen (adjusted odds ratio [aOR] 1.98, 95% CI: 1.07-3.65) and BPaL-L (aOR 2.31; 95% CI: 1.23-4.33) had higher odds of treatment success; the linezolid-regimen did not (aOR 1.68; 95% CI: 0.92-3.06). The linezolid and BPaL-L regimens had similar odds of grade 3 or higher AEs, and comparable AE-related drug discontinuation. Toxicity patterns differed, from hearing loss with injectables to anaemia and neurotoxicity with BPaL-L.
CONCLUSION: Under programmatic conditions, the BPaL-L regimen achieved the highest treatment success while maintaining manageable safety profiles. These findings provide valuable evidence to guide patient management and support implementation of novel MDR/RR-TB regimens in high-burden settings.
METHODS: We retrospectively evaluated treatment outcomes and drug-related adverse events (AEs) among 396 randomly selected patients from four facilities in three provinces across South Africa. Patients received four different short-course regimens sequentially introduced into national programme: i) injectable 9-11-month (injectable-regimen), ii) bedaquiline-ethionamide-containing (ethionamide-regimen), iii) bedaquiline-linezolid-containing (linezolid-regimen), and iv) bedaquiline-pretomanid-linezolid-levofloxacin regimen (BPaL-L).
RESULTS: Compared with the injectable regimen, the ethionamide-regimen (adjusted odds ratio [aOR] 1.98, 95% CI: 1.07-3.65) and BPaL-L (aOR 2.31; 95% CI: 1.23-4.33) had higher odds of treatment success; the linezolid-regimen did not (aOR 1.68; 95% CI: 0.92-3.06). The linezolid and BPaL-L regimens had similar odds of grade 3 or higher AEs, and comparable AE-related drug discontinuation. Toxicity patterns differed, from hearing loss with injectables to anaemia and neurotoxicity with BPaL-L.
CONCLUSION: Under programmatic conditions, the BPaL-L regimen achieved the highest treatment success while maintaining manageable safety profiles. These findings provide valuable evidence to guide patient management and support implementation of novel MDR/RR-TB regimens in high-burden settings.