Table 3.
Summary of analyses of time to culture conversion in MGIT and on LJ culture to 8 weeks (post hoc), and on LJ culture excluding patients without positive LJ at baseline (post hoc)
| Control | RIF35HZE | RIFQHZ | RIF20QHZ | RIF20MHZ | |
|---|---|---|---|---|---|
| MGIT culture censored at 8 weeks (post hoc) | |||||
| Cumulative probability of culture conversion by 8 weeks | 32% | 49% | 34·5% | 27·8% | 46·2% |
| Adjusted hazard ratio (95% CI)* | .. | 2·06 (1·26–3·38) p=0·004 | 1·04 (0·59–1·81) p=0·90 | 0·91 (0·49–1·67) p=0·76 | 1·67 (1·01–2·67) p=0·05 |
| Unadjusted hazard ratio (95% CI) | .. | 1·73 (1·07–2·82) p=0·03 | 1·07 (0·62–1·86) p=0·81 | 0·87 (0·48–1·58) p=0·64 | 1·47 (0·90–2·40) p=0·13 |
| Solid LJ culture censored at 8 weeks (post hoc) | |||||
| Cumulative probability of culture conversion by 8 weeks | 80·9% | 88·0% | 83·9% | 82·6% | 82·7% |
| Adjusted hazard ratio (95% CI)* | .. | 1·17 (0·83–1·64) | 1·00 (0·70–1·42) | 1·06 (0·74–1·52) | 0·76 (0·54–1·07) |
| Adjusted log-rank test* | .. | p=0·38 | p=1·00 | p=0·75 | p=0·12 |
| Unadjusted hazard ratio (95% CI) | .. | 1·24 (0·88–1·73) | 1·09 (0·77–1·55) | 1·12 (0·79–1·60) | 0·88 (0·63–1·24) |
| Unadjusted log-rank test | .. | p=0·22 | p=0·62 | p=0·53 | p=0·48 |
| Solid LJ culture censored at 12 weeks excluding without a positive culture on LJ solid media before or within the 2 weeks of randomisation (post hoc) | |||||
| Number in analysis (total=297) | 101 | 46 | 45 | 47 | 58 |
| Cumulative probability of culture conversion by 8 weeks | 96·7% | 100·0% | 92·8% | 93·3% | 97·8% |
| Adjusted hazard ratio (95% CI)* | .. | 1·37 (0·95–1·99) | 0·84 (0·58–1·23) | 1·00 (0·69–1·45) | 0·88 (0·62–1·24) |
| Adjusted log-rank test* | .. | p=0·19 | p=0·78 | p=0·62 | p=0·37 |
| Unadjusted hazard ratio (95% CI) | .. | 1·37 (0·95–1·98) | 0·92 (0·64–1·34) | 1·05 (0·73–1·51) | 0·95 (0·67–1·33) |
| Log-rank test, unadjusted | .. | p=0·07 | p=0·65 | p=0·76 | p=0·73 |
LJ=Löwenstein-Jensen. MGIT=mycobacteria growth indicator tube. RIF35HZE=rifampicin 35 mg/kg, isoniazid, pyrazinamide, ethambutol. RIFQHZ=rifampicin 10 mg/kg, isoniazid, pyrazinamide, SQ109 300 mg. RIF20QHZ=rifampicin 20 mg/kg, isoniazid, pyrazinamide, SQ109 300 mg. RIF20MHZ=rifampicin 20 mg/kg, isoniazid, pyrazinamide, moxifloxacin 400 mg. Doses of concomitant drugs are detailed in Procedures.
*
Analysis adjusted for HIV status, GeneXpert cycle threshold (<16, ≥16), and site. MGIT analyses also adjusted for baseline time to positivity.