Efficacy and safety of switching to dolutegravir/lamivudine in virologically suppressed people with HIV-1 aged ≥ 50 years: week 48 pooled results from the TANGO and SALSA studies

Table 2 Adverse Events Through Week 48 Overall and by Age: TANGO and SALSA Pooled Safety Population^a

Parameter, n (%)	Overall		< 50 y		50 to < 65 y		≥ 65 y
Parameter, n (%)	DTG/3TC (N = 615)	CAR (N = 618)	DTG/3TC (N = 438)	CAR (N = 432)	DTG/3TC (N = 163)	CAR (N = 157)	DTG/3TC (N = 14)	CAR (N = 29)
Any AE	475 (77)	464 (75)	333 (76)	330 (76)	133 (82)	113 (72)	9 (64)	21 (72)
AEs leading to withdrawal	18 (3)	5 (< 1)	11 (3)	2 (< 1)	7 (4)	2 (1)	0	1 (3)
Grade 2–5 AEs	281 (46)	303 (49)	189 (43)	206 (48)	85 (52)	82 (52)	7 (50)	15 (52)
Drug-related AEs	93 (15)^b	21 (3)^c	65 (15)	18 (4)	25 (15)	3 (2)	3 (21)^d	0
Serious AEs^e	28 (5)^f	32 (5)	18 (4)^f	16 (4)	8 (5)	12 (8)	2 (14)	4 (14)

AE adverse event, CAR current antiretroviral regimen, DTG dolutegravir, 3TC lamivudine, TDF tenofovir disoproxil fumarate
^aIn TANGO, 1 participant was found to be taking a TDF-based regimen and was excluded from the safety population. ^bThe most common (≥ 0.5%) grade 2–5 drug-related AEs reported were grade 2 insomnia (7/615 [1.1%]) and weight increase (4/615 [0.7%]); there were no grade ≥ 3 drug-related AEs. ^cThe most common grade 2–5 drug-related AE was grade 2 gastroesophageal reflux disease (2/618 [0.3%]); 2 grade 3 drug-related AEs were reported (hypertriglyceridemia (1/618 [0.2%]) and hypercholesterolemia (1/618 [0.2%]). ^d4 drug-related AEs were reported (flatulence, vertigo, abnormal dreams, and renal impairment). ^eThere were no drug-related serious AEs. ^f2 non–drug-related fatal serious AEs were reported (gunshot wound [homicide] and unknown cause)

ISSN: 1742-6405