article · International Journal of Mycobacteriology
Treating drug-resistant tuberculosis is challenging due to the toxicity associated with traditional injectable drugs. This study examined medical records from 114 adults treated for rifampicin-resistant or multidrug-resistant tuberculosis at a specialised hospital in Tanzania. Patients received either a 9 to 11 month injectable-containing regimen between 2018 and 2019, or a modified all-oral bedaquiline-based regimen between June 2020 and May 2021. Although the injectable group showed faster culture conversion at two months, reaching 100 percent compared to 90 percent in the oral group, the overall results favoured the all-oral approach. Patients on the all-oral regimen achieved a higher treatment success rate of 94.4 percent compared to 76.7 percent for those on injectables. Furthermore, mortality up to 12 months post-treatment was significantly lower in the all-oral group at 5.6 percent, compared to 14.0 percent among patients receiving injectables.
Drug-resistant tuberculosis remains a severe global health threat, often requiring lengthy treatments with toxic injectable medications. Demonstrating that an all-oral bedaquiline-based regimen delivers superior cure rates and reduces patient deaths provides critical clinical evidence to support phasing out painful injectable therapies in routine healthcare settings.
The findings provide clinical evidence relevant to healthcare providers, public health programmes, and pharmaceutical suppliers involved in tuberculosis treatment. The regimens studied are based on existing approved medicines, indicating that the insights are ready for immediate real-world clinical and policy adoption to transition tuberculosis treatment protocols to oral therapies.
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BACKGROUND: Drug-resistant tuberculosis (TB), especially rifampicin-resistant/multidrug-resistant TB (RR/MDR-TB), remains difficult to treat due to toxic aminoglycosides. The World Health Organization recommended all-oral bedaquiline-based regimens, but evidence comparing their effectiveness to injectable-containing regimens is limited. This study evaluated treatment success between both approaches. METHODS: This was a retrospective study, which included 114 adults aged 18 years and above with RR/MDR-TB treated at Kibong'oto Infectious Diseases Hospital with either a 9-11-month injectable-containing regimen from 2018 to 2019 or a modified all-oral bedaquiline regimen from June 2020 to May 2021. Patients were followed monthly for smear/culture conversion and clinical outcomes up to 12 months posttreatment. Analysis was performed using SPSS version 25. RESULTS: Of 114 patients, 71 (62.3%) received an all-oral bedaquiline-containing regimen. Overall, 80 (70.2%) patients were male, with a median age of 37 years (interquartile range: 29-48); 27 (23.9%) patients were human immunodeficiency virus infected, and 37 (22.5%) had prior TB treatment. Culture conversion at month 2 occurred in all 43 patients on injectable regimens, compared to 63 (90%) patients on all-oral regimens (P = 0.03). Treatment success was higher in the all-oral group at 63 (94.4%), compared to 33 (76.7%) in the injectable group (P = 0.001). Mortality was 7 (14.0%) in the injectable group and 4 (5.6%) in the all-oral group (P = 0.004). CONCLUSION: All-oral bedaquiline regimens demonstrated higher treatment success and lower 12-month posttreatment mortality, while injectable regimens had faster culture conversion at month 2, but poorer overall outcomes, supporting the use of all-oral treatment.
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DOI: 10.4103/ijmy.ijmy_98_25
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