Table 2.

Snapshot Outcomes at Week 48 in the ITT-E Population

	DTG/3TC (n = 246)	CAR (n = 247)
HIV-1 RNA <50 copies/mL	232 (94)	229 (93)
HIV-1 RNA ≥50 copies/mL	1 (<1)	3 (1)
Data in window and HIV-1 RNA ≥50 copies/mL	1 (<1)a	1 (<1)b
Discontinued for lack of efficacy	0	2 (<1)c
Discontinued for other reason and HIV-1 RNA ≥50 copies/mL	0	0
Change in ART	0	0
No virologic data	13 (5)	15 (6)
Discontinued because of AE or deathd	5 (2)	2 (<1)
Discontinued for other reasonse	7 (3)	10 (4)
On study but missing data in windowf	1 (<1)	3 (1)

Data are presented as n (%).

Abbreviations: AE, adverse event; ART, antiretroviral therapy; CAR, current antiretroviral regimen; DTG/3TC, dolutegravir/lamivudine; HIV-1, human immunodeficiency virus 1; ITT-E, intention-to-treat–exposed.

^aParticipant had HIV-1 RNA 53 copies/mL at week 48, followed by 2 retests with HIV-1 RNA ≥50 copies/mL, and was withdrawn with HIV-1 RNA <40 copies/mL after week 52.

^bParticipant had HIV-1 RNA 90 copies/mL at week 36 and was withdrawn during the week 48 window with HIV-1 RNA 68 copies/mL.

^cParticipants were withdrawn after consecutive HIV-1 RNA ≥50 to <200 copies/mL.

^dReasons for discontinuation due to AEs in DTG/3TC group: insomnia (n = 2), alcohol abuse/anxiety (n = 1), weight increased (n = 1), and unknown cause of death (n = 1); in CAR group: ulcerative colitis and postoperative complications (n = 1 each); last on-treatment HIV-1 RNA were all <50 copies/mL.

^eOther reasons for discontinuation included protocol deviation (n = 6), participant withdrawal (n = 6), pregnancy (n = 2), physician decision (n = 2), and lost to follow-up (n = 1).

^fMissing data in window due to coronavirus disease 2019 (COVID-19) pandemic (n = 2 in the CAR group only).