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. 2020 May 3;75(8):2240–2248. doi: 10.1093/jac/dkaa147

Table 3.

Effect of predicted UGT1A1 activity on steady-state exposure to oral cabotegravir 30 mg/day in pooled analyses of six Phase I and II studies and maximum on-treatment changes in Tbili and ALT in the LATTE study (all patients)

Endpoint Total N Association of genetically predicted UGT1A1 activity with endpoint
 Mean [n] (range) by predicted UGT1A1 activity stratum
 Fold-change in exposure (low versus normal)
P value parameter estimate (SE) normal reduced low
C tau (μg/mL) 346 4.89 × 10–11 0.19 (0.03)

  • 4.03 [128]

  • (1.02–8.51)

  • 4.72 [162]

  • (1.06–19.30)

  • 6.06 [56]

  • (1.49–12.60)

 1.50
AUCtau (h·μg/mL) 59 0.0013 20.03 (5.89)

  • 131.43 [24]

  • (81.88–192.82)

  • 156.44 [26]

  • (89.31–217.46)

  • 185.10 [9]

  • (84.12–233.49)

 1.41
C max (μg/mL) 59 0.0213 0.78 (0.33)

  • 7.64 [24]

  • (4.21–11.30)

  • 8.62 [26]

  • (4.73–11.40)

  • 9.75 [9]

  • (5.40–13.00)

 1.28
Maximum change from baseline (×ULN)
Tbili 163a 7.97 × 10–6 0.13 (0.03)

  • 0.20 [56]

  • (−0.09 to 0.55)

  • 0.28 [82]

  • (−0.55 to 0.91)

  • 0.49 [25]

  • (−0.27 to 1.27)

 2.45
ALT 163a 0.6674 −0.03 (0.06)

  • 0.60 [56]

  • (−0.19 to 10.56)

  • 0.57 [82]

  • (−0.48 to 8.67)

  • 0.41 [25]

  • (−0.02 to 1.35)

 0.68

BL, baseline; SE, standard error.

a

The analyses of changes in Tbili and ALT include patients who received 10, 30 and 60 mg oral cabotegravir.