Abstract
SUMMARYBACKGROUND: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 = 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 = 86), and a subgroup of these (n = 75) served as individually matched controls in a pairwise comparison to determine differences in regimen efficacy.RESULTS: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 = 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.CONCLUSION: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.
Highlights
There are no data comparing the 6–9 month oral three-drug Nix regimen to conventional regimens containing bedaquiline (B, BDQ) and linezolid (L, LZD)
The comparator cohort was enrolled between August 2013 and August 2018 in a prospectively recruited observational trial from Brooklyn Chest Hospital, which is the designated XDR-TB treatment centre in the Western Cape Province of South Africa
The overall relative risk ratio (RRR) for death in the NixTB vs. the XDR-TB comparator cohort is shown in Supplementary Table S4B and the RRR for death stratified by CD4 count is shown in Supplementary Table S4C
Summary
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 1⁄4 109) 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 1⁄4 86), and a subgroup of these (n 1⁄4 75) served as individually matched controls in a pairwise comparison to determine differences in regimen efficacy. R E S U LT 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 1⁄4 0.001), despite significantly higher baseline bacterial load and prior second-line drug exposure in the BPaL cohort.
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