Darunavir/cobicistat/emtricitabine/tenofovir alafenamide in treatment-experienced, virologically suppressed patients with HIV-1: subgroup analyses of the phase 3 EMERALD study

Table 1 Summary of AEs through week 48 by demographic characteristics

Parameter, n (%)	Age subgroups^a				Gender subgroups				Race subgroups
	≤ 50 years		> 50 years		Men		Women		Non-black/African American		Black/African American
	D/C/F/TAF	Control	D/C/F/TAF	Control	D/C/F/TAF	Control	D/C/F/TAF	Control	D/C/F/TAF	Control	D/C/F/TAF	Control
n	507	252	256	126	623	313	140	65	597	293	155	82
Any AE	418 (82)	207 (82)	207 (81)	104 (83)	510 (82)	260 (83)	115 (82)	51 (79)	496 (83)	241 (82)	120 (77)	67 (82)
Related	103 (20)	15 (6)	35 (14)	13 (10)	110 (18)	26 (8)	28 (20)	2 (3)	112 (19)	21 (7)	23 (15)	7 (9)
Serious AEs	20 (4)	9 (4)	15 (6)	9 (7)	31 (5)	14 (5)	4 (3)	4 (6)	31 (5)	13 (4)	4 (3)	5 (6)
Related	0	0	1 (< 1)^b	0	1 (< 1)	0	0	0	1 (< 1)	0	0	0
Grade 3–4 AEs	32 (6)	20 (8)	20 (8)	11 (9)	42 (7)	26 (8)	10 (7)	5 (8)	45 (8)	26 (9)	6 (4)	5 (6)
Related	7 (1)	1 (< 1)	3 (1)	3 (2)	8 (1)	4 (1)	2 (1)	0	8 (1)	4 (1)	2 (1)	0
AEs leading to discontinuation	6 (1)	1 (< 1)	5 (2)	4 (3)	10 (2)	5 (2)	1 (1)	0	8 (1)	5 (2)	3 (2)	0
Related	5 (1)	0	3 (1)^c	3 (2)	7 (1)	3 (1)	1 (1)	0	7 (1)	3 (1)	1 (1)	0

AE adverse event, D/C/F/TAF darunavir/cobicistat/emtricitabine/tenofovir alafenamide
^aRates of related AEs in the D/C/F/TAF and control arms, respectively, for patients ≤ 50 years without polypharmacy were: 0% (0/436) and 0% (0/206) with serious related AEs; 1% (6/436) and 1% (1/206) with grade 3–4 related AEs; 1% (5/436) and 0% (0/206) discontinued due to related AEs. Rates of related AEs in the D/C/F/TAF and control arms, respectively, for patients > 50 years with polypharmacy were: 0% (0/108) and 0% (0/50) with serious related AEs; 0% (0/108) and 2% (1/50) with grade 3–4 related AEs; 0% (0/108) and 2% (1/50) discontinued due to related AEs
^bThis patient had grade 3 pancreatitis; this AE led to discontinuation
^cEach patient had 1 study drug-related AE leading to discontinuation (pancreatitis, increase alanine aminotransferase, and urticaria)

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