Abstract P090 – Table 1. Week 48 efficacy (ITT‐E population, Snapshot) and safety (safety populationa) results from the pooled analysis of the TANGO and SALSA trials. | ||||||||
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White | Black | Asian | Other racesb | |||||
DTG/3TC | CAR | DTG/3TC | CAR | DTG/3TC | CAR | DTG/3TC | CAR | |
Efficacy parameter | (N = 445) | (N = 433) | (N = 96) | (N = 106) | (N = 44) | (N = 52) | (N = 30) | (N = 28) |
HIV‐1 RNA ≥50 copies/mL, n (%) | 0 | 2 (<1) | 1 (1) | 2 (2) | 0 | 1 (2) | 1 (3) | 0 |
HIV‐1 RNA <50 copies/mL, n (%) | 418 (94) | 405 (94) | 88 (92) | 96 (91) | 42 (95) | 49 (94) | 28 (93) | 25 (89) |
CD4+ count, cells/mm3 | ||||||||
Baseline, mean (SD) | 718.3 | 729.9 | 747.6 | 751.5 | 576.2 | 577.9 | 667.1 | 653.6 |
(301.2) | (277.7) | (322.2) | (285.7) | (196.4) | (236.7) | (329.1) | (284.1) | |
Adjusted mean change (SE)c | 25.0 | ‐1.5 | 42.6 | ‐12.3 | ‐30.5 | 18.2 | 6.8 | ‐13.5 |
(8.4) | (8.2) | (18.3) | (17.0) | (26.9) | (24.2) | (32.0) | (32.7) | |
CD4+/CD8+ ratio | ||||||||
Baseline, mean (SD) | 1.1 (0.6) | 1.1 (0.5) | 1.1 (0.6) | 1.2 (0.6) | 0.9 (0.4) | 0.9 (0.4) | 1.0 (0.3) | 1.0 (0.4) |
Adjusted mean change (SE)d | 0.039 | 0.056 | 0.041 | 0.045 | 0.021 | 0.033 | 0.027 | 0.064 |
(0.0097) | (0.0104) | (0.0211) | (0.0215) | (0.0308) | (0.0304) | (0.0365) | (0.0412) | |
White | Black | Asian | Other racesb | |||||
DTG/3TC | CAR | DTG/3TC | CAR | DTG/3TC | CAR | DTG/3TC | CAR | |
Safety parameter, n (%) | (N = 445) | (N = 432) | (N = 96) | (N = 106) | (N = 44) | (N = 52) | (N = 30) | (N = 28) |
Any AE | 344 (77) | 331 (77) | 72 (75) | 77 (73) | 33 (75) | 38 (73) | 26 (87) | 18 (64) |
AEs leading to withdrawal | 14 (3) | 3 (<1) | 2 (2) | 2 (2) | 2 (5) | 0 | 0 | 0 |
Grade 2 to 5 AEs | 205 (46) | 215 (50) | 42 (44) | 51 (48) | 17 (39) | 24 (46) | 17 (57) | 13 (46) |
Drug‐related AEs | 60 (13) | 9 (2) | 16 (17) | 3 (3) | 8 (18) | 8 (15) | 9 (30) | 1 (4) |
Any SAE | 18 (4) | 18 (4) | 6 (6) | 9 (8) | 3 (7) | 4 (8) | 1 (3) | 1 (4) |
3TC, lamivudine; CAR, current antiretroviral regimen; DTG, dolutegravir; MMRM, mixed‐models repeated‐measures.
aIn TANGO, one participant was found to be taking a TDF‐based regimen and was excluded from the safety population;
bincludes American Indian or Alaska Native, Native Hawaiian or Other Pacific Islander, mixed White race, and multiple races;
cMMRM analysis adjusting for treatment; visit; age; sex; baseline CD4+ cell count; baseline third agent; baseline BMI; race; study (combined analysis only); and treatment‐by‐visit, baseline CD4+ cell count‐by‐visit, visit‐by‐race, treatment‐by‐race, and treatment‐by‐visit‐by‐race interactions, with visit as repeated factor;
dMMRM analysis adjusting for treatment; visit; age; sex; baseline CD4+ cell count; baseline third agent; baseline CD4+/CD8+ ratio; baseline BMI; race; study (combined analysis only); and treatment‐by‐visit, baseline CD4+/CD8+ ratio‐by‐visit, visit‐by‐race, treatment‐by‐race, and treatment‐by‐visit‐by‐race interactions, with visit as repeated factor.