Table 3.
Adequate clinical and parasitological response (ACPR) in the intent-to-treat population
|
Outcome |
Pyronaridine-artesunate |
Artemether-lumefantrine |
Difference (95% CI); |
|---|---|---|---|
| P valuea | |||
| Day-28 PCR-corrected ACPR,b n/N |
333/355 |
167/180 |
|
| % (95% CI) |
93.8 (90.8–96.1) |
92.8 (88.0–96.1) |
1.0 (–3.2 to 6.2); P = .65 |
| P value (exact binomial test)c |
0.0077 |
NC |
|
| Total failures |
22 (6.2) |
13 (7.2) |
|
| Early treatment failure |
2 (0.6) |
0 |
|
| Late clinical failure |
2 (0.6) |
0 |
|
| Late parasitological failure |
6 (1.7) |
2 (1.1) |
|
| Missing = failure |
10 (2.8) |
6 (3.3) |
|
| Re-infection before day 28 |
2 (0.6) |
5 (2.8) |
|
| Day-28 crude ACPR, n/N |
308/355 |
151/180 |
|
| % (95% CI) |
86.8 (82.8–90.1) |
83.9 (77.7–88.9) |
2.9 (–3.2 to 9.7); P = .37 |
| Total failures |
47 (13.2) |
29 (16.1) |
|
| Early treatment failure |
2 (0.6) |
0 |
|
| Late clinical failure |
6 (1.7) |
4 (2.2) |
|
| Late parasitological failure |
29 (8.2) |
19 (10.6) |
|
| Missing = failure |
10 (2.8) |
6 (3.3) |
|
| Day-42 PCR-corrected ACPR,b n/N |
271/355 |
140/180 |
|
| % (95% CI) |
76.3 (71.6–80.7) |
77.8 (71.0–83.6) |
–1.4 (–8.6 to 6.4); P = .71 |
| Total failures |
84 (23.7) |
40 (22.2) |
|
| Early treatment failure |
2 (0.6) |
0 |
|
| Late clinical failure |
2 (0.6) |
0 |
|
| Late parasitological failure |
15 (4.2) |
6 (3.3) |
|
| Missing = failure |
12 (3.4) |
6 (3.3) |
|
| Re-infection before day 42 |
53 (14.9) |
28 (15.6) |
|
| Day-42 crude ACPR, n/N |
264/355 |
136/180 |
|
| % (95% CI) |
74.4 (69.5–78.8) |
75.6 (68.6–81.6) |
–1.2 (–8.6 to 6.8); P = .77 |
| Total failures |
91 (25.6) |
44 (24.4) |
|
| Early treatment failure |
2 (0.6) |
0 |
|
| Late clinical failure |
14 (3.9) |
5 (2.8) |
|
| Late parasitological failure |
63 (17.7) |
33 (18.3) |
|
| Missing = failure | 12 (3.4) | 6 (3.3) |
NC, not calculated. Values are n (%) unless otherwise indicated.
a Non-inferiority of pyronaridine-artesunate to artemether-lumefantrine is concluded if the lower limit of the 95% CI for the difference is > –10%. Two-sided Chi-square test for superiority was performed only when non-inferiority was demonstrated.
b Corrected for re-infection using polymerase chain reaction (PCR) genotyping.
c For the hypothesis that the ACPR in the pyronaridine-artesunate group is ≤90%.
Note: There were no instances of indeterminate PCR results in the intent-to-treat population.