Table 2 Efficacy outcomes, treatment success rates and sensitivity analyses by day 42 among the enrolled participants
Variable | Artemether lumefantrine + efavirenz-based ART N = 152 |
|---|---|
Early treatment failure-no. (%) | 0 |
Late clinical failure-no. (%) | 0 |
Late parasitological failure-no. (%) | 25 (16.4) |
Recrudescence | 0 |
Reinfection | 17 (11.2) |
PCR indeterminate or sample unavailable | 8 (5.2) |
Treatment success rate by day 42 | |
PCR-unadjusted treatment success rate | |
Intention-to-treat analysis | |
Number of patients | 152 |
Rate-% (95% CI) | 83.6 (76.7–88.7) |
Per-protocol analysis | |
Number of patients | 142 |
Rate-% (95% CI) | 82.4 (75.1–87.9) |
PCR-adjusted success rate excluding indeterminate or unavailable PCR samples | |
Intention-to-treat analysis | |
Number of patients | 144 |
Rate-% (95% CI) | 100 |
Per-protocol analysis | |
Number of patients | 134 |
Rate-% (95% CI) | 100 |
Sensitivity analyses of treatment success rate by day 42 | |
PCR-adjusted success rate (scenario 1a) | |
Intention-to-treat analysis | |
Number of patients | 152 |
Rate-% (95% CI) | 100 |
Per-protocol analysis | |
Number of patients | 142 |
Rate-% (95% CI) | 100 |
PCR-adjusted success rate (scenario 2b) | |
Intention-to-treat analysis | |
Number of patients | 152 |
Rate-% (95% CI) | 94.7 (89.8–97.4) |
Per-protocol analysis | |
Number of patients | 142 |
Rate-% (95% CI) | 94.4 (89.1–97.2) |
Treatment success rate by day 42 according to use of cotrimoxazolec | |
On cotrimoxazole prophylaxis in the intention-to treat analysis | |
Number of patients | 53 |
PCR-adjusted rate-% (95% CI) | 100 |
Not on cotrimoxazole prophylaxis in the intention-to-treat analysis | |
Number of patients | 88 |
PCR-adjusted rate-% (95% CI) | 100 |