Table 2.
Summary of darunavir/ritonavir pharmacokinetic parameters in children within CHAPAS-4 and reference study
| Total | TAF/FTC | ABC/3TC | ZDV/3TC | Adultsa | |
|---|---|---|---|---|---|
| Darunavir | |||||
| AUC0–24h (h mg/L) | 94.3 (50) | 90.0 (49) | 79.5 (52) | 122.4 (45) | Median (range); 69.4 (33.0–88.4) |
| Ctrough (mg/L) | 1.5 (111) | 1.4 (94) | 1.1 (191) | 2.5 (70) | Mean (SD); 1.4 (0.5) |
| Cmax (mg/L) | 9.1 (35) | 9.0 (35) | 7.8 (26) | 10.4 (37) | Mean (SD); 5.5 (1.3) |
| Tmax, h | 4 (3.9–4.0) | 4 (3.9–4.03) | 4 (2.0–4.0) | 4.0 (4.0–5.02) | Median (range); 3.0 (1.0–4.1) |
| T1/2, h | 9.1 (54) | 8.5 (50.0) | 8.4 (68) | 11.8 (48) | Mean (SD); 16.8 (7.2) |
| Cl/F (L/h) | 7.4 (54) | 7.7 (52) | 9.6 (50) | 5.4 (45) | — |
| Vd/F | 97.0 (67) | 90.5 (70) | 131.2 (69) | 88.8 (54) | — |
| Ritonavir | |||||
| AUC0–24h (h mg/L) | 9.1 (47) | 9.1 (40) | 7.0 (38) | 11.8 (58) | — |
| Cmax (mg/L) | 1.1 (67) | 1.2 (46) | 0.8 (33) | 1.3 (129) | — |
Data are presented as GM (coefficient of variation), except for Tmax, which is presented as median (interquartile range).
AUC0–24h/Ctrough: n = 57, Cmax/Tmax: n = 58, T1/2: n = 45.
TAF/FTC, tenofovir alafenamide/emtricitabine; ABC/3TC, abacavir/lamivudine; ZDV/3TC, zidovudine/lamivudine.
aWeek 4 data from ARTEMIS trial, adults on 800/100 mg darunavir/ritonavir QD.14