Cox modeling of factors associated with risk of treatment failure by day 28 in the intent-to-treat population (N = 268, 17 treatment failure)
| Variable | Events/Patients (%) | Hazard Ratio 95% CI | P Value |
|---|---|---|---|
| Day 7 concentration | 14/203 (6.9%) | 0.02 (0.01–0.11) | <0.001 |
| Day 7 LF cutoff | 0.010 | ||
| <600 ng/ml | 11/85 (12.9%) | 5.32 (1.48–19.07) | |
| >600 ng/ml | 3/118 (2.5%) | 1 (Reference) | |
| Pregnancy | 0.45 | ||
| Pregnant | 14/199 (7.0%) | 1.61 (0.46–5.61) | |
| Nonpregnant | 3/69 (4.3%) | 1 (Reference) | |
| Age | 17/268 (6.3%) | 0.97 (0.91–1.04) | 0.37 |
| Hb | 17/268 (6.3%) | 0.91 (0.65–1.26) | 0.59 |
| Trimester | |||
| Second | 15/170 (8.8%) | 0.04 (0.00–16.54) | 0.29 |
| Third | 0/30 (0%) | — | |
| Gravida | 0.46 | ||
| Primigravida | 7/82 (8.5%) | 1.49 (0.52–4.24) | |
| Multigravida | 7/117 (6.0%) | 1 (Reference) | |
| Baseline parasitaemia | |||
| <1000 | 3/48 (6.2%) | 0.75 (0.08–7.17) | 0.79 |
| 1000–10,000 | 13/208 (6.2%) | 0.77 (0.10–5.87) | 0.79 |
| >10,000 | 1/11 (8.3%) | 1 (Reference) | |
| CYP3A4*1B | |||
| CYP3A4*1/*1 | 4/24 (16.7%) | 3.25 (0.95–11.09) | 0.06 |
| CYP3A4*1/*1B | 6/106 (5.7%) | 1.08 (0.36–3.20) | 0.89 |
| CYP3A4*1B/*1B | 7/135 (5.2%) | 1 (Reference) | |
| Number of CYP3A5*1 | |||
| Zero | 2/62 (3.2%) | 0.50 (0.09–2.59) | 0.41 |
| One | 10/122 (8.2%) | 1.28 (0.44–3.74) | 0.65 |
| Two | 5/80 (6.2%) | 1 (Reference) | |
| ABCB1 rs3842 | |||
| A/A | 8/147 (5.4%) | 0.61 (0.24–1.58) | 0.31 |
| A/G | 9/100 (9.0%) | 1 (Reference) | |
| G/G | 0/19 (0%) | — | |
| ABCB c. 3435 | |||
| C/C | 13/188 (6.9) | 1.12 (0.37–3.43) | 0.84 |
| C/T | 4/63 (6.3) | 1 (Reference) | |
| T/T | 0/4 (0%) | — |