Table 2.
Comparison of observed concentrations of cabotegravir and rilpivirine with reported thresholds.
| Observed concentrations | Number (%) |
||
|---|---|---|---|
| Overall (569 samples, 186 PWH) | Males (486 samples, 153 PWH) | Females (83 samples, 33 PWH) | |
| Cabotegravir q8w | |||
| Plasma concentrations | |||
| <1120 ng/mL (Q1Ctrough)a | 210 (37%) | 195 (40%) | 15 (18%) |
| <664 ng/mL (4xPAIC90)b | 83 (15%) | 75 (15%) | 8 (10%) |
| ≤166 ng/mL (PAIC90) | 8 (1%) | 8 (2%) | – |
| PWH with ≥1 measurement | |||
| <1120 ng/mL (Q1Ctrough)a | 106 (57%) | 94 (61%) | 12 (36%) |
| <664 ng/mL (4xPAIC90)b | 56 (30%) | 48 (31%) | 8 (24%) |
| ≤166 ng/mL (PAIC90) | 8 (4%) | 8 (5%) | – |
| PWH with ≥2 measurements | |||
| <1120 ng/mL (Q1Ctrough)a | 57 (31%) | 55 (36%) | 2 (6%) |
| <664 ng/mL (4xPAIC90)b | 18 (10%) | 18 (12%) | – |
| ≤166 ng/mL (PAIC90) | – | – | – |
| Rilpivirine q8w | |||
| Plasma concentrations | |||
| <50 ng/mL (4xPAIC90)c | 273 (48%) | 231 (48%) | 42 (51%) |
| <32 ng/mL (Q1Ctrough)a | 104 (18%) | 81 (17%) | 23 (28%) |
| ≤12 ng/mL (PAIC90) | 3 (<1%) | – | 3 (4%) |
| PWH with ≥1 measurement | |||
| <50 ng/mL (4xPAIC90)c | 119 (64%) | 99 (65%) | 20 (61%) |
| <32 ng/mL (Q1Ctrough)a | 60 (32%) | 47 (31%) | 13 (39%) |
| ≤12 ng/mL (PAIC90) | 2 (1%) | – | 2 (6%) |
| PWH with ≥2 measurements | |||
| <50 ng/mL (4xPAIC90)c | 76 (41%) | 66 (43%) | 10 (30%) |
| <32 ng/mL (Q1Ctrough)a | 25 (13%) | 22 (14%) | 3 (9%) |
| ≤12 ng/mL (PAIC90) | 1 (<1%) | – | 1 (3%) |
PWH: people with HIV; BMI: body-mass index; q8w: every 8 weeks.
a
Correspond to the limit of the first quartile (25th percentile) when considering all rilpivirine and cabotegravir concentrations observed in phase III FLAIR4 and ATLAS.13