Table 3.

Drug Concentrations and HIV incidence in iPrEx OLE by subgroup.

Drug Level by Dried Blood Spot	Gender	Person Years	Percent of FU	Number HIV+	Rate HIV/100 PY	Rate Ratio Off-PrEP Ref	P Value	Rate Ratio BLQ Ref	P Value
Off PrEP	MSM	447		12	2.68 (1.56–5.03)	Reference
	TGW	53		1	1.90 (0.11–8.35)	Reference
BLQ	MSM	326	24	17	5.21 (3.28–8.77)	1.94 (0.94–4.17)	0.08	Reference
	TGW	58	29	1	1.72 (0.10–7.56)	0.91 (0.04–22.86)	0.94	Reference
<2 Pills/Week	MSM	324	24	8	2.47 (1.26–5.55)	0.92 (0.36–2.23)	0.86	0.49 (0.20–1.04)	0.06
	TGW	76	38	1	1.31 (0.07–5.79)	0.69 (0.03–17.50)	0.80	0.39 (0.02–19.08)	0.84
2–3 Pills/Week	MSM	156	12	1	0.64 (0.04–2.83)	0.24 (0.01–1.22)	0.09	0.12 (0.01–0.56)	0.0037
	TGW	24	12	0	0.00 (0.00–7.80)	0.00 (0.00–13.03)	0.39	0.00 (0.00–14.16)	0.41
4–6 Pills/Week	MSM	288	22	0	0.00 (0.00–0.67)	0.00 (0.00–0.27)	<0.001	0.00 (0.00–0.13)	<0.0001
	TGW	28	14	0	0.00 (0.00–6.84)	0.00 (0.00–10.93)	0.36	0.00 (0.00–12.08)	0.38
Daily	MSM	176	13	0	0.00 (0.00–1.09)	0.00 (0.00–0.44)	0.00	0.00 (0.00–0.22)	<0.0001
	TGW	5	3	0	0.00 (0.00–35.18)	0.00 (0.00–56.25)	0.66	0.00 (0.00–62.16)	0.67
Missing	MSM	62	5	0	0.00 (0.00–3.08)	0.00 (0.00–1.25)	0.08	0.00 (0.00–0.63)	0.01
	TGW	9	4	0	0.00 (0.00–21.47)	0.00 (0.00–34.33)	0.58	0.00 (0.00–37.93)	0.59
If 4–6 and Daily were combined
≥4 Pills/Week	MSM	463	35	0	0.00 (0.00–0.41)	0.00 (0.00–0.17)	<0.001	0.00 (0.00–0.08)	<0.0001
	TGW	34	17	0	0.00 (0.00–5.73)	0.00 (0.00–9.16)	0.32	0.00 (0.00–10.12)	0.34

Abbreviations: FU is Followup. BLQ is below limit of quantitation. MSM is men who have sex with men. TGW is trans/women identified participants, or MSM who report use of feminizing hormones.