EVALUATION OF THE EFFECTIVENESS OF IMPLEMENTING BEDAQUILINE-BASED ORAL REGIMENS FOR THE TREATMENT OF RIFAMPICIN-RESISTANT TUBERCULOSIS IN THE STATE OF SÃO PAULO

Tuberculosis remains the infectious disease with the highest morbidity and mortality worldwide, despite the numerous advances achieved throughout its history with humankind. Drug-resistant variants pose a particular challenge for disease control and effective treatment, given the limited arsenal of available drugs. The recent implementation of bedaquiline-based regimens represents an advance in combating this condition, although few studies have evaluated the public health impact of their implementation. The present study aimed to evaluate the impacts of implementing oral regimens based on bedaquiline for the treatment of rifampicin-resistant tuberculosis variants in the state of São Paulo since the release of this drug. Data entered into the Sistema de Informações de Tratamentos Especiais de Tuberculose (SITE-TB) from 2014 to 2024 were used, and patients were evaluated according to treatment outcomes based on the regimens employed. This is a retrospective study including 1,398 patients evaluated between 2014 and 2024, of whom 1,016 were users of aminoglycoside/fluoroquinolone-based regimens and 382 were users of bedaquiline-based regimens. In agreement with the literature, bedaquiline-based regimens, when compared to traditional regimens, presented higher sputum culture conversion rates, lower toxicity rates (4% vs. 9%, respectively), and lower failure rates (1% vs. 6%, respectively), with statistical significance. Despite this, a marked increase in treatment abandonment rates was observed among bedaquiline users compared to those on traditional regimens (35% vs. 16%, respectively), which in turn promoted a marked reduction in cure rates among patients using bedaquiline (39% vs. 61%, respectively). Our data not only point to an unprecedented finding in the literature ‒ given the scarcity of studies evaluating the effectiveness of bedaquiline implementation for the treatment of drug-resistant tuberculosis in the public health setting ‒ but also demonstrate outcome trends contrary to those expected based on pivotal clinical trials supporting the use of this drug. These findings further corroborate the interpretation that tuberculosis treatment abandonment is not limited to characteristics inherent to the drugs used, with long treatment durations and social determinants being essential factors in determining treatment success or failure.