Table 1.
Characteristics | At initiation of an LPV-based regimen | At the time of TASER-P study enrollment | Children with virologic failure at any time after study entrya | Children with LPV concentration <1.0 mg/L (either trough or random) |
---|---|---|---|---|
Number of patients | 223 | 223 | 37 | 15 |
Age in years, median (IQR) | 7.4 (5.2–10.14) | 10.4 (7.9–13.4) | 11.3 (7.9–14.5) | 10.3 (4.2–13.9) |
Male sex, n (%) | 136 (61) | 23 (62) | 11 (73) | |
Country, n (%) | ||||
Thailand | 90 (40) | 14 (38) | 9 (60) | |
Vietnam | 112 (50) | 20 (54) | 5 (33) | |
Indonesia | 21 (9) | 3 (8) | 1 (7) | |
WHO clinical staging, n (%)b | ||||
1–2 | 100 (45) | 20 (54) | 7 (47) | |
3–4 | 99 (44) | 15 (41) | 7 (47) | |
CD4 lymphocyte count, cells/mm3 n (%) | 190 (85) | 194 (87) | 34 (92) | 14 (93) |
Median (IQR) | 293 (146–596) | 759 (569–1066) | 583 (415–763) | 482 (410–625) |
CD4 lymphocyte percentage, n (%) | 175 (79) | 172 (77) | 31 (84) | 14 (93) |
Median (IQR) | 13 (7– 20) | 25 (19–31) | 20 (12–24) | 16 (12–20) |
Log10 HIV RNA level, copies/mL, n (%) | 169 (76) | 223 (100) | 37 (100) | 15 (100) |
Median (IQR) | 5.0 (4.3–5.6) | 2.4 (1.6–2.5) | 4.4 (3.7–4.9) | 4.9 (4.7–5.3) |
Duration on LPV, years | ||||
Median (IQR) | 2.5 (1.3–4.1) | 2.9 (1.5–4.4) | 1.6 (0.8–2.6) | |
6–<24 months | 48 (22) | 6 (16) | 6 (40) | |
≥24 months | 175 (78) | 31 (84) | 9 (60) | |
LPV dose (mg/kg) | ||||
Median (IQR) | 19.4 (16.2–22.6) | 21.1 (16.3–24.2) | 17.1 (14.9–24.6) | |
BW <20 kg | 22.1 (18.9–24.6) | 24.2 (21.3–26.7) | 24.6 (21.3–26.7) | |
BW 20–30 kg | 19.5 (17.2–22.9) | 22.2 (18.9–23.3) | 18.9 (15.3–38.1) | |
BW >30 kg | 17.3 (13.8–20.8) | 16.2 (14.2–20.7) | 16.1 (14.7–17.1) | |
LPV concentration (mg/L) | ||||
Median (IQR) | 6.9 (4.0–9.7) | 6.5 (0.1–12.5) | 0.1 (0.1–0.1) | |
Body surface area (m2), n (%) | 222 (99.6) | 37 (100) | 15 (100) | |
Median (IQR) | 1 (0.8–1.22) | 1 (0.8–1.2) | 0.9 (0.6–1.3) | |
Adherence assessment, n (%) | ||||
Pill count ≥95% | 192 (86) | 29 (83) | 11 (79) | |
VAS report ≥95% | 200 (90) | 30 (86) | 10 (77) |
For this study virologic failure (VF) was defined as having HIV RNA >1,000 copies/mL
Some unknown or missing data.
WHO World Health Organization; IQR Interquartile range; BW body weight; mg milligrams; kg kilograms; VL viral load; lopinavir; VAS Visual analogue scale.