Abstract
Currently, new chemotherapy regimens for drug-resistant tuberculosis are being actively introduced into phthisiatric practice around the world, using new and promising chemotherapy drugs.
Objective: to evaluate the efficacy, safety, and economic feasibility of clofazimine in the treatment of drug-resistant tuberculosis based on data from randomized clinical trials, cohort studies, and observational studies.
Methods. In preparation for the publication, a search was conducted in the PubMed, Web of Science, and EMBASE databases for studies published before January 1, 2025. An analysis was conducted of published randomized controlled trials, cohort studies, and observational studies comparing treatment regimens for multidrug-resistant TB with and without clofazimine, as well as regimens with other drugs (bedaquiline, linezolid, and delamanid). The study evaluated the efficacy (sputum culture conversion, treatment success), safety (frequency and types of adverse events), and economic feasibility (drug costs, treatment duration, and indirect costs).
Results. Clofazimine shows significant efficacy in TB treatment regimens with various types of drug resistance, not limited to MDR TB, but also demonstrating potential for XDR TB. The drug significantly accelerates the conversion of sputum culture and increases the success rates of treatment. Clofazimine is generally well-tolerated in the treatment of drug resistance ТB, but its use is associated with specific, manageable adverse events (AE). The most common AE are skin discoloration (up to 94.3% of patients) and ichthyosis (47.2%). Clofazimine-based regimens have significant cost-effectiveness due to reduced treatment duration and improved resource utilization in low-income settings. Studies show that clofazimine-containing regimens can reduce the treatment duration for MDR TB from 18–24 months to 9 months, which reduces healthcare costs and patient burden.
Conclusion. Clofazimine demonstrates significant efficacy, safety, and cost-effectiveness in the treatment of drug-resistant TB, especially in resource-constrained settings. It has a predictable safety profile, but requires ECG monitoring when co-prescribed with other QT-prolonging drugs. Its use is cost-effective as part of a strategy to implement shorter treatment regimens.