Table 1.
Characteristics of patients included in the analysis; all values are median (IQR) or total number (%). DHA-PPQ: dihydroartemisinin-piperaquine; AS-MQ: artesunate-mefloquine; AL: artemether-lumefantrine; AST: Aspartate transaminase; ALT: alanine transaminase; ULN: Upper limit of normal. *Two patients suffered from a grade 3 (severe) ALT and/or AST increase which scored as a grade 3 level at day 7 (2).
| Day 0 | Day 3 | Day 7 | Day 28 | Peak concentration during study | |
|---|---|---|---|---|---|
| Number of subjects | 250 | 250 | 243 | 229 | 250 |
| Age | 27·0 (19·0-35·0) | ||||
| Gender (Male/total) (%) | 215/250 (86·0) | 215/250 (86·0) | 208/243 (85·6) | 197/229 (86·0) | |
| Temperature | 37·5 (36·9–38·1) | 36·4 (36·0–36·7) | 36·4 (36·0–36·7) | 36·3 (36·0–36·7) | |
| Treatment | |||||
| DHA-PPQ (n, % of total) | 61 (24·4) | 61 (24·4) | 59 (24·3) | 50 (21·8) | |
| AS-MQ (n, % of total) | 73 (29·2) | 73 (29·2) | 71 (29·2) | 69 (30·1) | |
| AL (n, % of total) | 116 (46·4) | 116 (46·4) | 113 (46·5) | 110 (48·0) | |
| Parasitaemia at baseline (parasites/microliter) | 26,376 (8,672-70,462) | ||||
| AST (U/L) | 34 (28–42) | 30 (24–40) | 35 (29–47) | 31 (26–39) | 44 (34–59) |
| ALT (U/L) | 24 (18–34) | 26 (19–36) | 34 (24–48) | 22 (17–31) | 38 (26–55) |
| Alkaline phosphatase (U/L) | 255 (215–361) | 253 (204–340) | 257 (214–336) | 249 (206–334) | 289 (236–404) |
| Bilirubine (total) umol/L | 1·0 (0·7–1·5) | 0·5 (0·3–0·6) | 0·5 (0·4–0·6) | 0·5 (0·4–0·7) | 1 (0·7–1·5) |
| Liver enzyme abnormalities | |||||
| None (< 1·0xULN) | 96 (38·4) | 117 (46·8) | 82 (33·7) | 113 (49·3) | |
| Mild (> 1·0 ≤ 2·5 × ULN) | 137 (54·8) | 120 (48·0) | 139 (57·2) | 109 (47·6) | |
| Moderate (> 2·5 ≤ 5·0xULN) | 16 (6·4) | 10 (4·0) | 18 (7·4) | 6 (2·6) | |
| Severe (> 5·0xULN) | 1 (0·4) | 3 (1·2)* | 4 (1·7)* | 1 (0·4) | |