Table 5.
Effect of predicted UGT1A1 activity on exposure to parenteral cabotegravir LA (400 mg every 4 weeks or 600 mg every 8 weeks) at Week 48 of the cabotegravir LA + rilpivirine LA maintenance phase of LATTE-2 (NCT02120352)
Endpoint | Total n | Association of genetically predicted UGT1A1 activity with endpoint |
Mean [n] (range) by predicted UGT1A1 activity stratum |
Fold-change in exposure (low vs normal) | |||
---|---|---|---|---|---|---|---|
P value | parameter estimate (SE) | normal | reduced | low | |||
C tau (μg/mL) | 159 | 0.0037 | 0.26 (0.10) |
|
|
|
1.24 |
AUCtau (h·μg/mL) | 212 | 0.0162 | 250.10 (116.08) |
|
|
|
1.16 |
C max (μg/mL) | 212 | 0.0047 | 0.41 (0.16) |
|
|
|
1.18 |
C avgi (μg/mL) | 204 | 0.0094 | 0.19 (0.08) |
|
|
|
1.16 |
SE, standard error.