Table 4.
Elvitegravir and Cobicistat Exposure at Delivery and in Infants, Median (IQR)
| At Delivery (n=15) | ||
|---|---|---|
| Elvitegravir | Cobicistat | |
| Cord Blood (ng/mL) | 540.6 (197.1 – 792.4) | <10 (<10 – 29.2) |
| Maternal Plasma (ng/mL) | 543.0 (66.95 – 976.35) | 172.4 (<10 – 319.5) |
| Cord Blood/Maternal Plasma Ratio | 0.91 (0.65 –1.03)1 | 0.09 (0.05 – 0.12)2 |
| Elvitegravir Infant Washout Samples after Delivery (n=27)3,4 | ||
| Maximum observed concentration (ng/mL) | 161.0 (31.0, 373.5) | |
| Concentration (2 – 10 hours, ng/mL) | 131.9 (24.4, 396.0) | |
| Concentration (18 – 28 hours, ng/mL) | 31.9 (11.5, 87.9) | |
| Concentration (36 – 72 hours, ng/mL) | <10 (<10 – 10.5) | |
| Concentration (5 – 9 days, ng/mL) | <10 (<10 – <10) | |
| T1/2 (hr) | 7.6 (6.3, 10.2) | |
Calculated in 12 patients for whom both cord blood and maternal plasma samples were obtained at time of delivery with quantifiable elvitegravir concentrations (> 10 ng/mL).
Calculated in 7 patients for whom both cord blood and maternal plasma samples were obtained at time of delivery with quantifiable cobicistat concentrations (> 10 ng/mL).
Washout samples were obtained from a total of 27 infants. The numbers of infants used to describe the maximum observed concentration and concentrations at 2 – 10 hours, 18 – 28 hours, 36 – 72 hours, and 5 – 9 days were 25, 25, 24, and 23. The elimination haf-life was calculated from concentration data from 17 infants.
Cobicistat was below the limit of quantitation (10 ng/mL) in all infant washout samples after delivery.