TABLE 6.
Comparison of ATV, LPV, and DRV plasma PK following coadministration of 50 mg EBR once daily and 300 mg ATV/100 mg RTV once daily, 400 mg LPV/100 mg RTV twice daily, or 600 mg DRV/100 mg RTV twice daily for 7 days versus administration of the boosted HIV protease inhibitor for 14 days to healthy adult participants (trial 3)
| PK parameter | GM (95% CI) | GM (95% CI) | GMR (90% CI) | Pseudo-within-subject CV (%)a |
|---|---|---|---|---|
| ATV PK parameters with EBR/ATV/RTVb | ATV/RTV, (n = 8)c | EBR + ATV/RTV (n = 8)c | EBR + ATV/RTV vs ATV/RTV | |
| AUC0–24 (ng × h/ml)d | 57,800 (46,000–72,500) | 61,700 (47,500–80,000) | 1.07 (0.98–1.17) | 9.4 |
| Cmax (ng/ml)d | 5,740 (4,720–6,970) | 5,840 (4,790–7,100) | 1.02 (0.96–1.08) | 6.3 |
| C24 (ng/ml)d | 1,230 (803–1,880) | 1,410 (899–2,220) | 1.15 (1.02–1.19) | 12.4 |
| Tmax (h)e | 3.00 (2.00–5.00) | 3.5 (2.00–5.00) | ||
| LPV PK parameters with EBR/LPV/RTVf | LPV/RTV (n = 9)g | EBR + LPV/RTV (n = 9)g | EBR + LPV/RTV vs LPV/RTV | |
| AUC0–12 (ng × h/ml)d | 101,000 (83,300–121,000) | 103,000 (84,000–126,000) | 1.02 (0.93–1.13) | 11.4 |
| Cmax (ng/ml)d | 11,600 (9,880–13,600) | 11,800 (10,200–13,800) | 1.02 (0.92–1.13) | 11.4 |
| C12 (ng/ml)d | 5,780 (4,210–7,930) | 6,170 (4,490–8,480) | 1.07 (0.97–1.18) | 10.9 |
| Tmax (h)e | 4.00 (3.00–6.00) | 4.01 (3.00–8.00) | ||
| DRV PK parameter with EBR/DRV/RTVh | DRV/RTV (n = 8)i | EBR + DRV/RTV (n = 8)i | EBR + DRV/RTV vs DRV/RTV | |
| AUC0–12 (ng × h/ml)d | 54,000 (48,700–60,000) | 51,400 (42,800–61,900) | 0.95 (0.86–1.06) | 10.9 |
| Cmax (ng/ml)d | 7,190 (6,650–7,900) | 6,800 (5,720–8,090) | 0.95 (0.85–1.05) | 10.8 |
| C12 (ng/ml)d | 2,870 (2,230–3,700) | 2,700 (2,030–3,600) | 0.94 (0.85–1.05) | 11.4 |
| Tmax (h)e | 3.00 (2.00–5.00) | 3.5 (2.00–5.00) |
Pseudo-within-subject percent CV = 100 × sqrt([σ2A + σ2B – 2σAB]/2), where σ2A and σ2B are the estimated variances on the log scale for the two treatments and σAB is the corresponding estimated covariance, each obtained from the linear mixed-effects model.
ATV plasma PK following ATV/RTV administration alone and coadministration with EBR.
One participant was discontinued by the investigator on day 13 of period 2, and one participant was discontinued by the investigator on day 7 of period 2.
Back-transformed least-squares mean and CI from a linear mixed-effects model with natural-log-transformed values.
Median and range are reported for Tmax.
LPV plasma PK following LPV/RTV administration alone and coadministration with EBR.
One participant withdrew from the study on day 4 of period 2 (during the administration of LPV).
DRV plasma PK following DRV/RTV administration alone and coadministration with EBR.
One participant was discontinued from the study on day 11 of period 2, and one participant was discontinued from the study on day 13 of period 2.