BACKGROUND: There are no data comparing the 6–9
month oral three-drug Nix regimen (bedaquiline, pretomanid
and linezolid [BPaL]) to conventional regimens
containing bedaquiline (B, BDQ) and linezolid (L, LZD).
METHODS : Six-month post end-of-treatment outcomes
were compared between Nix-TB (n ¼ 109) and 102
prospectively recruited extensively drug-resistant TB
patients who received an ~18-month BDQ-based
regimen (median of 8 drugs). A subset of patients
received BDQ and LZD (n ¼ 86), and a subgroup of
these (n¼75) served as individually matched controls in
a pairwise comparison to determine differences in
RESULT S : Favourable outcomes (%) were significantly
better with BPaL than with the B–L-based combination
regimen (98/109, 89.9% vs. 56/86, 65.1%; adjusted relative risk ratio [aRRR] 1.35; P , 0.001) and in the
matched pairwise analysis (67/75, 89.3% vs. 48/75,
64.0%; aRRR 1.39; P ¼ 0.001), despite significantly
higher baseline bacterial load and prior second-line drug
exposure in the BPaL cohort. Time to culture conversion
(P , 0.001), time to unfavourable outcome (P , 0.01)
and time to death (P , 0.03) were significantly better or
lower with BPaL than the B-L-based combinations.
CONCLUS ION: The BPaL regimen (and hence substitution
of multiple other drugs by pretomanid and/or
higher starting-dose LZD) may improve outcomes in
drug-resistant TB patients with poor prognostic features.
However, prospective controlled studies are
required to definitively answer this question.