Background: Short, all oral 6-month regimens of bedaquiline-pretomanid-linezolid (BPaL) were highly effective for the treatment of drug-resistant tuberculosis in clinical trials. Scarce data about the programmatic use of BPaL schemes.

Aim: To assess the efficacy and safety of BPaL regimens in program settings.

Methods: Per WHO recommendations, the Georgian National TB Program implemented BPaL regimens (with 1200 mg linezolid) for the treatment of pulmonary Pre-XDR-TB (resistance to rifampin and fluoroquinolones) in January 2021. Eligible participants without prior exposure to bedaquiline, linezolid or delamanid were selected based on rapid molecular tests and subsequent drug susceptibility test (DST).

Results: From January 2021 to June 2022, 23 HIV (-) negative patients were enrolled in BPaL regimens. The median (IQR) age was 38 (28-46) years, and 21 (91.3%) were male. Seven (30.4%) participants were excluded after receiving DST due to detected resistance to component drugs (to bedaquiline-in 5 (21.7%) cases, to delamanid-in 2 (8.7%) cases, to linezolid-in 1 (4.3%) case). The median (IQR) time from BPaL initiation to receiving DST was 36 (21.5-59.5) days. In the remaining 16 patients, 2 (12,5%) experienced linezolid-related adverse events, which were resolved by linezolid dose reduction to 600 mg. All 16 (100%) patients achieved sputum culture conversion (SCC). The median (IQR) time to SCC was 33 (30.8-60.0) days. Favorable treatment outcomes received 14 (87.5%) patients and 2 (12,5%) persons were lost to follow-up.

Conclusion: BPaL regimens showed excellent efficacy and good safety in program settings in Georgia. Urgent need to develop rapid tests for new drugs to avoid delaying adequate treatment.