Table 3A.
Visits | |||||||
---|---|---|---|---|---|---|---|
Adjusted means | Adjusted difference in means | ||||||
Markers |
T0 95% CI |
T6 95% CI |
T12 95% CI |
T0 95% CI p-Value |
T6 95% CI p-Value |
T12 95% CI p-Value |
p-Value* |
CD4 TM, cells/mm3 | |||||||
RCT arm | 0.019 | ||||||
DTG/3TC | 45.4 (37.1, 53.8) | 60.2 (51.8, 68.5) | 56.7 (48.5, 65.0) | 0 | 0 | 0 | |
B/F/TAF | 54.4 (45.6, 63.3) | 55.6 (46.8, 64.5) | 62.2 (53.2, 71.2) | 9.0 (−3.5, 21.5) | −4.6 (−17.1, 8.0) | 5.4 (−7.1, 18.0) | |
0.161 | 0.477 | 0.399 | |||||
CD4 EMRA, cells/mm3 | |||||||
RCT arm | 0.019 | ||||||
DTG/3TC | 19.3 (10.8, 27.8) | 22.3 (13.8, 30.8) | 22.0 (13.6, 30.5) | 0 | 0 | 0 | |
B/F/TAF | 23.8 (14.8, 32.9) | 20.2 (11.2, 29.3) | 24.8 (15.7, 33.9) | 4.6 (−8.3, 17.5) | −2.0 (−14.9, 10.9) | 2.7 (−10.2, 15.6) | |
0.486 | 0.758 | 0.680 | |||||
CD4 CD57 PD1, cells/mm3 | |||||||
RCT arm | 0.159 | ||||||
DTG/3TC | 11.3 (7.0, 15.5) | 15.7 (11.5, 20.0) | 15.8 (11.6, 20.0) | 0 | 0 | 0 | |
B/F/TAF | 15.1 (10.6, 19.6) | 15.6 (11.1, 20.1) | 19.0 (14.5, 23.6) | 3.8 (−2.6, 10.1) | −0.1 (−6.5, 6.2) | 3.2 (−3.2, 9.6) | |
0.248 | 0.970 | 0.323 | |||||
CD4 subsets (change) by study arm—adjusted analysis. | |||||||
Visits | |||||||
Adjusted mean changes from T0 | Adjusted difference in mean changes from T0 | ||||||
Markers | |||||||
T0
95% CI |
T6
95% CI |
T12
95% CI |
T0
95% CI p-Value |
T6
95% CI p-Value |
T12
95% CI p-Value |
p-Value* | |
CD4 TM, cells/mm3 | |||||||
RCT arm | 0.066 | ||||||
DTG/3TC | 0.1 (−5.4, 5.7) | 11.9 (6.4, 17.5) | 13.0 (7.5, 18.4) | 0 | 0 | 0 | |
B/F/TAF | −0.2 (−6.1, 5.6) | 2.3 (−3.6, 8.2) | 9.0 (3.1, 15.0) | −9.6 (−17.9, −1.3) | −3.9 (−12.3, 4.4) | ||
0.025 | 0.358 | ||||||
CD4 EMRA, cells/mm3 | |||||||
RCT arm | 0.285 | ||||||
DTG/3TC | 0.1 (−2.5, 2.8) | 0.4 (−2.3, 3.0) | 3.2 (0.5, 5.8) | 0 | 0 | 0 | |
B/F/TAF | −0.1 (−2.9, 2.7) | −3.5 (−6.3, −0.7) | 0.4 (−2.4, 3.3) | −3.8 (−7.8, 0.1) | −2.7 (−6.7, 1.2) | ||
0.058 | 0.179 | ||||||
CD4 CD57 PD1, cells/mm3 | |||||||
RCT arm | 0.366 | ||||||
DTG/3TC | −0.1 (−2.5, 2.4) | 3.5 (1.0, 5.9) | 4.8 (2.3, 7.2) | 0 | 0 | 0 | |
B/F/TAF | 0.1 (−2.5, 2.7) | 0.7 (−1.9, 3.3) | 3.6 (1.0, 6.3) | −2.8 (−6.4, 0.9) | −1.2 (−4.8, 2.5) | ||
0.144 | 0.543 |
RCT, randomized clinical trial; VL, viral load.
* F-test type 3 interaction p-value.
& Adjusted for age, nationality, AIDS, duration of HIV, duration of VL suppression, and CD4 count nadir.