TABLE 6

Summary of efavirenz DDI predictions

	Dose (Duration)	Predicted DDI (AUCR)				Observed DDI (AUCR)
	Dose (Duration)	R3	RIS	Net Effect	SimCYP	AUCR Change
	mg
Compound
Carbamazepine	200-400	0.15	0.69	0.64	0.48	0.64
Ezetimibe	10	0.87	0.99	1.00	1.00	0.91
	10	0.87	0.99	1.00	1.00	1.1
Indinavir	200	0.53	0.82	0.93	1.12	0.81
Itraconazole	1250	1.00	1.00	1.00	1.04	1.0
Nelfinavir	750	0.21	0.80	0.87	1.02	0.83
	750	0.21	0.80	0.92	1.02	1.0
	750	0.21	0.80	0.92	1.01	1.1
Nevirapine	400	0.20	0.69	0.65	0.86	0.71
Rifampin	450	0.13	0.66	0.48	0.81	0.61
	600	0.12	0.65	0.44	0.79	0.44
	600	0.12	NA	NA	0.87	0.63
	10.5 mg/kg	0.12	NA	NA	0.94	0.78
	600	0.12	NA	NA	0.92	0.82
Ritonavir	100	0.20	0.94	0.97	0.85	1.0
Saquinavir	1600	0.32	0.93	0.96	1.0	0.89

Prediction error (GMFE)^a		3.25	1.12	1.09	1.22
True positives		100	100	100	33
True negatives		19	100	100	63
False positives		70	0	0	0
False negatives		0	0	0	67

NA, not applicable (data were not included in the prediction, since efavirenz was administered as multiple doses prior to dosing with precipitant drugs).
↵^a Percent of clinical trials that were predicted as false negative, false positive, true negative, or true positive with respect to induction based on the 0.8-fold cutoff criterion.