Table 3.
Summary of Adverse Events in the Safety Populations
| Day 1 to Week 48 | Week 24 to Week 48 | |||
|---|---|---|---|---|
| DTG/3TC (n = 246) | CAR (n = 247) | DTG/3TC (n = 236) | CAR (n = 242) | |
| Any AE | 180 (73) | 172 (70) | 110 (47) | 100 (41) |
| AEs occurring in ≥5% of participants in either group | ||||
| Weight increased | 20 (8) | 5 (2) | 8 (3) | 2 (<1) |
| Headache | 16 (7) | 17 (7) | 7 (3) | 6 (2) |
| COVID-19 | 15 (6) | 11 (4) | 7 (3) | 7 (3) |
| Back pain | 14 (6) | 7 (3) | 4 (2) | 4 (2) |
| Insomnia | 14 (6) | 4 (2) | 4 (2) | 0 |
| Dizziness | 13 (5) | 6 (2) | 2 (<1) | 1 (<1) |
| Upper respiratory tract infection | 11 (4) | 15 (6) | 6 (3) | 5 (2) |
| Drug-related AEs | 48 (20) | 16 (6) | 11 (5) | 4 (2) |
| Drug-related grade 2–5 AEs | 12 (5) | 6 (2) | 2 (<1)a | 2 (<1)b |
| Drug-related grade 2–5 AEs occurring in ≥2 participants in either group | ||||
| Weight increased | 3 (1) | 0 | 0 | 0 |
| Insomnia | 3 (1) | 1 (<1) | 0 | 0 |
| Glomerular filtration rate decreased | 2 (<1) | 0 | 0 | 0 |
| AEs leading to withdrawalc | 5 (2) | 3 (1) | 1 (<1) | 2 (<1) |
| Drug-related AEs leading to withdrawal | 4 (2) | 1 (<1) | 0 | 1 (<1) |
| Any SAEs | 7 (3) | 16 (6) | 3 (1) | 7 (3) |
| Drug-related SAEs | 0 | 0 | 0 | 0 |
Data are presented as n (%).
Abbreviations: AE, adverse event; CAR, current antiretroviral regimen; COVID-19, coronavirus disease 2019; DTG/3TC, dolutegravir/lamivudine; SAE, serious adverse event.
aTwo drug-related grade 2–5 AEs occurred in the DTG/3TC group: grade 2 hypertriglyceridemia (n = 1) and grade 2 renal impairment (n = 1).
bTwo drug-related grade 2–5 AEs occurred in the CAR group: grade 2 creatinine renal clearance increased (n = 1) and grade 3 hypercholesterolemia (n = 1).
cThe following AEs leading to withdrawal from the study were observed in ≥1 participant in either treatment group (DTG/3TC, n [%]; CAR, n [%]): insomnia (2 [<1%]; 0), alcohol abuse (1 [<1%]; 0), anxiety (1 [<1%]; 0), suicidal ideation (0; 1 [<1%]), ulcerative colitis (0; 1 [<1%]), death (1 [<1%]; 0), postprocedural complication (0; 1 [<1%]), and weight increased (1 [<1%]; 0); ulcerative colitis, death, and postprocedural complication were considered unrelated to study treatment.