Evaluating Treatment and Safety Outcomes of a Shorter Regimen for Drug-Resistant TB in Nigeria: An Implementation Research Study

The introduction of significantly shorter, all-oral regimens has significantly shifted the management of drug-resistant tuberculosis (DR-TB) towards a more tolerable and patient-centred therapeutic approach that aims to enhance treatment adherence, clinical outcomes, and quality of life among patients. Nigeria has gradually adopted this all-oral, shorter regimen, but the impact of this regimen in programmatic settings has not yet been studied. In 2022, a longitudinal, two-armed cohort study was conducted to explore the effectiveness, safety, and feasibility of the all-oral shorter regimen in the programmatic management of RR/MDR-TB in Nigeria. Consenting and eligible RR/MDR-TB patients receiving the all-oral regimen (intervention group) in four states were consecutively enrolled and compared to those receiving the standard of care (SOC). Treatment effectiveness, proportion, and 95% confidence intervals of favourable and unfavourable outcomes were measured at the end of treatment and during follow-up (six and 12 months post-treatment). In total 383 Participants were followed monthly throughout the 9-12-month treatment phase and then reassessed at 6 and 12 months after treatment completion, giving a total possible observation period of up to 24 months (185 received the intervention and 198 the standard of care). At the end of follow-up, there was a higher but non-significant proportion of favourable outcomes among the intervention vs. SOC group (80% vs. 69.7%); a higher proportion of favourable outcomes was also noted at the end of treatment among intervention participants (81.1 vs. 76.8%). Around one third of patients reported at least one serious adverse event (SAE), with no significant differences between arms, and none were deemed related to the use of medication. Intervention participants reported greater improvements in health-related quality of life between baseline and four months compared to those receiving the SOC. These findings support the programmatic use of all-oral shorter treatment for RR/MDR-TB as a regimen that is effective, tolerable, safe, and associated with enhanced health-related quality of life for patients in Nigeria.