Table 4.

Lersivirine pharmacokinetics when coadministered with rifampin (study 1) or rifabutin (study 2)

Parameter (units)	Study 1 (effect of rifampin on PKs of lersivirine)						Study 2 (effect of rifabutin on PKs of lersivirine)
	Treatment 1 (n = 13)a		Treatment 2 (n = 14)b		Ratio of adjusted geometric means (A/B)	90% CI	Treatment 1 (n = 17)c		Treatment 2 (n = 17)d		Ratio of adjusted geometric means (A/B)	90% CI
	Geometric mean (% CV)	Adjusted geometric mean (A)e	Geometric mean (% CV)	Adjusted geometric mean (B)			Geometric mean (% CV)	Adjusted geometric mean (A)	Geometric mean (% CV)	Adjusted geometric mean (B)
AUC24 (ng · h/ml)	2,023 (24)	2,016	13,868 (22)	13,691	0.15	0.13, 0.17	11,670 (18)	11,700	17,870 (21)	17,760	0.66	0.61, 0.71
Cmax (ng/ml)	375 (34)	373	2,185 (25)	2,145	0.17	0.15, 0.21	2,139 (24)	2,127	2,880 (31)	2,837	0.75	0.67, 0.84
C24 (ng/ml)	6 (65)	6.2	78 (49)	78.1	0.08	0.06, 0.11	48.5 (34)	49	117.3 (42)	117.6	0.42	0.36, 0.48
t1/2 (h)	4.7 (35)		5.8 (23)				4.9 (16)		6.1 (30)
Tmax (h)f	2 (1–3)		2.5 (0.5–4.0)				3 (1–6)		3 (1–6)

^aTreatment was with lersivirine at 1,000 mg q.d. plus rifampin at 600 mg q.d. Four subjects did not have samples for PK analysis collected due to discontinuations.

^bTreatment was with lersivirine at 1,000 mg q.d. plus placebo q.d. Three subjects did not have PK samples collected due to discontinuations. n = 13 for adjusted geometric means.

^cTreatment was with lersivirine at 1,000 mg q.d. plus rifabutin at 300 mg q.d. One subject discontinued due to an AE of pyrexia.

^dTreatment was with lersivirine at 1,000 mg q.d. One subject discontinued due to an AE of pyrexia.

^eThe adjusted geometric mean was obtained by exponentiation of the mean estimate from the statistical analysis. Natural log-transformed data were analyzed using a mixed-effect model with sequence, period, and treatment as fixed effects and subject within sequence as a random effect.

^fData represent median (range).