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. 2018 Mar 8;57(11):1421–1433. doi: 10.1007/s40262-018-0642-9

Table 1.

Patient and study characteristics summarized by study [reference]

Study 1 [50] Study 2 [18] Study 3 [17] Study 4 [19] Study 5 [13] Study 6 [16] Study 7 [14]
Number of patients 14 1091 25 172 25 27 97
Number of patients included 11 129 7 14 25 26 46
Number of samples
 Pregnant 110 NA NA NA 224 317 123
 Not pregnant 109 541 77 23 199 199 46
Median gestational age at sampling times, years (range) 34 (32–36) NA NA NA 34 (29–38) 29 (21–37) 37 (33–39)
Sampling design (hours postdose) Rich crossover: 0 (predose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 Sparse: mid-dose Rich: 0 (predose), 1, 2, 3, 4, 6, 8, 10, 12, 16, 24 Sparse: mid-dose Rich crossover: 0 (predose), 1, 2, 4, 6, 8, 12, 24 Rich crossover: 0 (predose), 1, 2, 4, 6, 8, 12, 24 Sparse crossover: mid-dose
Lower limit of quantification (mg/L) 0.05 0.05 0.05 0.01 0.03 0.03 0.02
Median weight (range)
 Second trimester NA NA NA NA 78 (69–89) [n = 3] 83 (54–129) [n = 14] NA
 Third trimester 69 (45–124) [n = 11] NA NA NA 69 (40–130) [n = 25] 80 (55–128) [n = 25] 72 (52–112) [n = 33]
 Not pregnant 76 (50–132) [n = 11] 60 (40–100) 53 (46–64) 60 (49–71) 63 (37–125) [n = 25] 74 (47–126) [n = 26] 67 (42–105) [n = 39]
CYP2B6 phenotype Not determined Not determined Not determined Not determined Not determined Not determined 1 not determined
 Poor metabolizer 10
 Intermediate metabolizer 25
 Extensive metabolizer 26
Efavirenz dose, mg 600 600 600 600 (300 mg, n = 1; 400 mg, n = 1) 600 (800 mg, n = 3) 600 600
Population 100% Black Mixed international (Thailand, South Africa, South America, Western Countries) 100% Black 100% Caucasian 84% Thai, 16% Caucasian 56% Hispanic, 4% unknown, 40% non-Hispanic 100% Black

NA not available, CYP cytochrome P450