Table:
Patient characteristics according to phenotypic bedaquiline resistance profile at follow-up
| Overall (n=40) | Bedaquiline phenotype at follow-up | p value | ||
|---|---|---|---|---|
| Susceptible (n=18) | Resistant (n=22) | |||
| Demographics | ||||
| Age at diagnosis of current episode (years) | 36 (27–45) | 34 (27–43) | 36 (27–45) | 0·75 |
| Sex | ||||
| Female | 11 (28%) | 5 (28%) | 6 (27%) | 0·97 |
| Male | 29 (73%) | 13 (72%) | 16 (73%) | 0·96 |
| Clinical characteristics | ||||
| HIV positive | 21 (53%) | 7 (39%) | 14 (64%) | 0·12 |
| CD4 count (× 109 cells per L)* | 168 (61–394) | 235 (28–631) | 157 (66–314) | 0·70 |
| Antiretroviral therapy | 18/21 (86%) | 5/7 (71%) | 13/14 (93%) | 0·49 |
| Treatment history | ||||
| Previous tuberculosis | 32 (80%) | 13 (72%) | 19 (86%) | 0·27 |
| Previous drug-resistant tuberculosis | 20/32 (63%) | 8/13 (62%) | 12/19 (63%) | 0·93 |
| Days between baseline and follow-up isolate | 429 (291–564) | 369 (252–592) | 439 (365–578) | 0·44 |
| Any clofazimine exposure (prior or concurrent) | 29 (73%) | 10 (56%) | 19 (86%) | 0·03 |
| Prior clofazimine† | 7/26 (27%) | 2/8 (25%) | 5/18 (28%) | 0·88 |
| Concurrent with bedaquiline† | 20/26 (77%) | 6/8 (75%) | 14/18 (78%) | 0·88 |
| Treatment and drug resistance | ||||
| Bedaquiline treatment duration (days) | 185 (168–265) | 181 (168–267) | 193 (168–266) | 0·80 |
| Baseline fluoroquinolone resistance‡ | 18/39 (46%) | 4 (22%) | 14/21 (67%) | 0·01 |
| Overall drug resistance patient categorisation | ||||
| Pre-multidrug-resistant or rifampicin mono-resistant tuberculosis | 2/36 (6%) | 2/16 (13%) | 0 | 0·10 |
| Multidrug resistant | 8/36 (22%) | 6/16 (38%) | 2/20 (10%) | 0·05 |
| Multidrug resistant plus resistance to a fluoroquinolone | 20/36 (56%) | 7/16 (44%) | 13/20 (65%) | 0·20 |
| Multidrug resistant plus resistance to a fluoroquinolone and second-line injectable | 6/36 (17%) | 1/16 (6%) | 5/20 (25%) | 0·43 |
| Treatment regimen | ||||
| Total number of drugs (excluding bedaquiline)§ | 7 (6–9) | 7 (6–12) | 8 (6–9) | 0·85 |
| Likely effective¶ | 4 (3–5) | 5 (4–6) | 3 (3–4) | <0·0001 |
| Treatment outcomes | ||||
| Favourable outcome | 8 (20%) | 7 (39%) | 1 (5%) | <0^0001 |
| Cured | 4 (10%) | 3 (17%) | 1 (5%) | 0·20 |
| Treatment completed | 4 (10%) | 4 (22%) | 0 | 0·02 |
| Unfavourable outcome | 25 (63%) | 6 (33%) | 19 (86%) | <0·0001 |
| Treatment failed | 5 (13%) | 0 | 5 (23%) | 0·03 |
| Died | 20 (50%) | 6 (33%) | 14 (64%) | 0·06 |
| Lost to follow-up | 4 (10%) | 3 (17%) | 1 (5%) | 0·20 |
| Not evaluable | 3 (8%) | 2 (11%) | 1 (5%) | 0·43 |
Data are n (%), n/N (%), or median (IQR), unless otherwise specified. Those with resistance were more likely to have baseline fluoroquinolone resistance, clofazimine exposure, fewer likely effective drugs, and an adverse treatment outcome versus susceptible patients at follow-up.
One (3%) of 40 patients had unknown CD4 count.
Three (8%) of 40 patients had a record of clofazimine treatment (two bedaquiline-susceptible patients and one bedaquiline-resistant patient) but no date.
Detected by whole-genome sequencing or programmatic line probe assay. One result unavailable.
Two (5%) of 40 patients were excluded due to unknown background tuberculosis drug regimens.
Two whole-genome sequencing results unavailable.