Table 3.
AEs Through Week 48 by Availability of Historical Resistance Results at Screening and Overall: TANGO and SALSA Pooled Safety Population
| No Historical Resistance Results at Screening | Historical Resistance Results at Screening | Overall | ||||
|---|---|---|---|---|---|---|
| Parameter | DTG/3TC (n = 294) | CAR (n = 276) | DTG/3TC (n = 321) | CAR (n = 342) | DTG/3TC (n = 615) | CAR (n = 618) |
| Any AE | 223 (76) | 196 (71) | 252 (79) | 268 (78) | 475 (77) | 464 (75) |
| AEs leading to withdrawal | 11 (4) | 3 (1) | 7 (2) | 2 (<1) | 18 (3) | 5 (<1) |
| Drug-related AEs | 49 (17) | 15 (5) | 44 (14) | 6 (2) | 93 (15) | 21 (3) |
| Grade 2–5 AEs | 126 (43) | 115 (42) | 155 (48) | 188 (55) | 281 (46) | 303 (49) |
| Any serious AE | 13 (4) | 15 (5) | 15 (5) | 17 (5) | 28 (5) | 32 (5) |
Data are presented as No. (%). In TANGO, 1 participant was taking a TDF-based regimen and was thus excluded from the safety population.
Abbreviations: AE, adverse event; CAR, current antiretroviral regimen; DTG/3TC, dolutegravir/lamivudine; TDF, tenofovir disoproxil fumarate.