Cohort evaluation of an all-oral shorter regimen for drug-resistant tuberculosis in Ecuador.

BACKGROUND: Tuberculosis (TB) remains the leading cause of death from infectious agents globally and disproportionately affects people living with HIV. In 2023, 10.6 million TB cases were reported worldwide, including 8,200 in Ecuador. Between 2020 and 2023, TB incidence in Ecuador increased from 31.2 to 48.1 per 100,000 population, alongside rising rifampicin- and fluoroquinolone-resistant TB cases. Treatment success declined from 76.2% in 2019 to 69.2% in 2021, highlighting the need for more effective and patient-centered treatment strategies. This study evaluated the effectiveness, safety, and adherence of a nine-month all-oral shorter regimen compared with a standard injectable-based regimen and descriptively assessed outcomes of the BPaL regimen under routine programmatic conditions.

METHODS: We conducted a cohort study across 61 health units in three cantons in Ecuador’s Zone 8: Guayaquil, Durán, and Samborondón. Between February 2020 and December 2022, 155 patients with multidrug-resistant or rifampicin-resistant TB (MDR/RR-TB) and nine with additional fluroquinolone-resistance were enrolled. Patients received either a nine-month all-oral shorter regimen comprising bedaquiline, linezolid, fluoroquinolones, and clofazimine ( = 98) or a standard nine-month injectable-based regimen ( = 57). Nine patients with fluroquinolone-resistant TB received the BpaL regimen. Treatment effectiveness, safety, and adherence were assessed using clinical and laboratory data.

RESULTS: The all-oral shorter regimen demonstrated higher effectiveness than the standard regimen (74% vs. 42%), along with lower mortality (4% vs. 7%), reduced loss to follow-up (20% vs. 47%), and higher adherence (93% vs. 79%). The BPaL regimen showed 89% effectiveness with 100% adherence. QTcF prolongation (Fridericia-corrected QT interval was the most frequent adverse event in the all-oral regimen but was generally mild.

CONCLUSIONS: In this programmatic cohort, the nine-month all-oral shorter and BPaL regimens were associated with favorable treatment outcomes, acceptable safety profiles, improved adherence, and reduced loss to follow-up compared with injectable-based therapy. These findings supported Ecuador’s adoption of the short all-oral regimen as the national standard for RR/MDR-TB treatment in 2024. Continued programmatic monitoring is essential to confirm sustained effectiveness and safety in routine practice.