Table 3. Open in new tab Immune...

	ITT-E (n = 130)	B/F/TAF, 3DR (n = 43)	DTG/3TC, 2DR (n = 87)
CD4 T
CD4 T	0.94	.82	1.07	0.93	.82	1.04	0.99	.91	1.07
HLA-DR	1.10	.98	1.22	1.14	1.02	1.26	1.04	.97	1.11
CD38^a	1.17	−.99	3.33	2.07	.04	4.11	0.90	−.51	2.31
TIGIT	0.97	.92	1.02	1.02	.97	1.07	1.05	1.01	1.09
LAG-3	0.86	.67	1.09	0.99	.79	1.24	1.16	.99	1.36
PD-1	0.99	.90	1.08	1.02	.93	1.11	1.03	.97	1.10
T_EM	1.05	.95	1.16	0.99	.9	1.09	0.94	.88	1.01
T_EM HLA-DR	1.22	*1.06*	*1.41*	1.25	1.10	1.43	1.03	.94	1.12
T_EM HLA-DR⁺PD-1⁺CD38⁻	1.16	*1.01*	*1.34*	1.11	.97	1.28	0.96	.87	1.06
T_EMRA	1.19	.92	1.54	1.09	.84	1.41	0.92	.77	1.09
T_EMRA PD-1	0.79	*.64*	*.96*	0.86	.70	1.06	1.10	.97	1.24
CD8 T
CD8 T	0.95	.84	1.08	0.93	.83	1.04	0.97	.91	1.05
HLA-DR	1.09	.91	1.30	1.23	1.04	1.47	1.14	1.01	1.28
CD38	1.08	.97	1.21	1.13	1.01	1.26	1.04	.97	1.12
TIGIT	0.98	.93	1.04	1.02	.97	1.08	1.04	1.00	1.08
LAG-3	0.86	.69	1.06	1.10	.89	1.36	1.28	1.11	1.49
PD-1	0.94	.88	1.00	1.02	.95	1.09	1.09	1.04	1.14
PD-1⁺HLA-DR⁻CD38⁻	0.91	*.84*	*.97*	0.96	.90	1.03	1.06	1.01	1.12
CD27⁺ T_EMRA	1.02	.92	1.12	1.01	.91	1.11	0.99	.93	1.05
PD-1	0.93	*.87*	*.99*	0.98	.92	1.05	1.06	1.01	1.11
PD-1⁺ HLA-DR⁻CD38⁻	0.87	*.77*	*.99*	0.98	.86	1.11	1.12	1.03	1.22
TIGIT	0.93	*.89*	*.99*	0.99	.94	1.04	1.05	1.02	1.09
CD27⁻ T_EMRA	1.05	.91	1.20	0.96	.84	1.10	0.92	.85	1.00
PD-1⁺HLA-DR⁻CD38⁻	0.84	.73	.98	0.92	.80	1.07	1.09	1.00	1.20
CD25⁺CD45RA⁺	1.13	.94	1.36	1.17	.97	1.42	1.04	.91	1.18
PD-1	0.88	.80	.98	0.95	.85	1.05	1.07	1.00	1.15
CD8 NKT
CD8 NKT	0.98	.88	1.09	0.95	.85	1.06	0.96	.89	1.04
HLA-DR	1.61	*1.13*	*2.29*	1.58	1.13	2.23	0.99	.78	1.24
γδ T
γδ T	0.90	.81	.99	0.91	.83	1.00	1.02	.95	1.09
CD8⁺	1.10	1.02	1.17	1.06	.99	1.14	0.97	.93	1.02
CD4⁻CD8⁻	0.90	.84	.97	0.94	.87	1.01	1.04	.99	1.09
HLA-DR	1.13	.93	1.37	1.26	1.05	1.51	1.11	.98	1.27
CD38	1.26	*1.06*	*1.51*	1.23	1.04	1.46	0.98	.87	1.09
PD-1	1.36	*1.22*	*1.51*	1.21	1.09	1.33	0.89	.83	.95
LAG-3, MFI^a	−3.42	−13.64	6.80	−0.27	−9.62	9.09	3.15	−3.13	9.43
TIGIT, MFI	1.85	*1.36*	*2.51*	1.56	1.15	2.11	0.84	.69	1.03

ITT-E (n = 130)

B/F/TAF, 3DR (n = 43)

DTG/3TC, 2DR (n = 87)

Treatment Ratio 3DR/2DR

Week 48 Visit to Baseline Ratio

Marker

Estimate

95% LCL

95% UCL

Estimate

95% LCL

95% UCL

Estimate

95% LCL

95% UCL

CD4 T

0.94

.82

1.07

0.93

.82

1.04

0.99

.91

1.07

HLA-DR

1.10

.98

1.22

1.14

1.02

1.26

1.04

.97

1.11

CD38^a

1.17

−.99

3.33

2.07

.04

4.11

0.90

−.51

2.31

TIGIT

0.97

.92

1.02

.97

1.07

1.05

1.01

1.09

LAG-3

0.86

.67

1.09

0.99

.79

1.24

1.16

.99

1.36

PD-1

0.99

.90

1.08

1.02

.93

1.11

1.03

.97

1.10

T_EM

1.05

.95

1.16

0.99

1.09

0.94

.88

1.01

T_EM HLA-DR

1.22

1.06

1.41

1.25

1.10

1.43

1.03

.94

1.12

T_EM HLA-DR⁺PD-1⁺CD38⁻

1.16

1.01

1.34

1.11

.97

1.28

0.96

.87

1.06

T_EMRA

1.19

.92

1.54

1.09

.84

1.41

0.92

.77

1.09

T_EMRA PD-1

0.79

.64

.96

0.86

.70

1.06

1.10

.97

1.24

CD8 T

0.95

.84

1.08

0.93

.83

1.04

0.97

.91

1.05

HLA-DR

1.09

.91

1.30

1.23

1.04

1.47

1.14

1.01

1.28

CD38

1.08

.97

1.21

1.13

1.01

1.26

1.04

.97

1.12

TIGIT

0.98

.93

1.04

1.02

.97

1.08

1.04

1.00

1.08

LAG-3

0.86

.69

1.06

1.10

.89

1.36

1.28

1.11

1.49

PD-1

0.94

.88

1.00

1.02

.95

1.09

1.04

1.14

PD-1⁺HLA-DR⁻CD38⁻

0.91

.84

.97

0.96

.90

1.03

1.06

1.01

1.12

CD27⁺ T_EMRA

1.02

.92

1.12

1.01

.91

1.11

0.99

.93

1.05

PD-1

0.93

.87

.99

0.98

.92

1.05

1.06

1.01

1.11

PD-1⁺ HLA-DR⁻CD38⁻

0.87

.77

.99

0.98

.86

1.11

1.12

1.03

1.22

TIGIT

0.93

.89

.99

0.99

.94

1.04

1.05

1.02

1.09

CD27⁻ T_EMRA

1.05

.91

1.20

0.96

.84

1.10

0.92

.85

1.00

PD-1⁺HLA-DR⁻CD38⁻

0.84

.73

.98

0.92

.80

1.07

1.09

1.00

1.20

CD25⁺CD45RA⁺

1.13

.94

1.36

1.17

.97

1.42

1.04

.91

1.18

PD-1

0.88

.80

.98

0.95

.85

1.05

1.07

1.00

1.15

CD8 NKT

0.98

.88

1.09

0.95

.85

1.06

0.96

.89

1.04

HLA-DR

1.61

1.13

2.29

1.58

1.13

2.23

0.99

.78

1.24

γδ T

0.90

.81

.99

0.91

.83

1.00

1.02

.95

1.09

CD8⁺

1.10

1.02

1.17

1.06

.99

1.14

0.97

.93

1.02

CD4⁻CD8⁻

0.90

.84

.97

0.94

.87

1.01

1.04

.99

1.09

HLA-DR

1.13

.93

1.37

1.26

1.05

1.51

1.11

.98

1.27

CD38

1.26

1.06

1.51

1.23

1.04

1.46

0.98

.87

1.09

PD-1

1.36

1.22

1.51

1.21

1.09

1.33

0.89

.83

.95

LAG-3, MFI^a

−3.42

−13.64

6.80

−0.27

−9.62

9.09

3.15

−3.13

9.43

TIGIT, MFI

1.85

1.36

2.51

1.56

1.15

2.11

0.84

.69

1.03

	ITT-E (n = 130)	B/F/TAF, 3DR (n = 43)	DTG/3TC, 2DR (n = 87)
CD4 T
CD4 T	0.94	.82	1.07	0.93	.82	1.04	0.99	.91	1.07
HLA-DR	1.10	.98	1.22	1.14	1.02	1.26	1.04	.97	1.11
CD38^a	1.17	−.99	3.33	2.07	.04	4.11	0.90	−.51	2.31
TIGIT	0.97	.92	1.02	1.02	.97	1.07	1.05	1.01	1.09
LAG-3	0.86	.67	1.09	0.99	.79	1.24	1.16	.99	1.36
PD-1	0.99	.90	1.08	1.02	.93	1.11	1.03	.97	1.10
T_EM	1.05	.95	1.16	0.99	.9	1.09	0.94	.88	1.01
T_EM HLA-DR	1.22	*1.06*	*1.41*	1.25	1.10	1.43	1.03	.94	1.12
T_EM HLA-DR⁺PD-1⁺CD38⁻	1.16	*1.01*	*1.34*	1.11	.97	1.28	0.96	.87	1.06
T_EMRA	1.19	.92	1.54	1.09	.84	1.41	0.92	.77	1.09
T_EMRA PD-1	0.79	*.64*	*.96*	0.86	.70	1.06	1.10	.97	1.24
CD8 T
CD8 T	0.95	.84	1.08	0.93	.83	1.04	0.97	.91	1.05
HLA-DR	1.09	.91	1.30	1.23	1.04	1.47	1.14	1.01	1.28
CD38	1.08	.97	1.21	1.13	1.01	1.26	1.04	.97	1.12
TIGIT	0.98	.93	1.04	1.02	.97	1.08	1.04	1.00	1.08
LAG-3	0.86	.69	1.06	1.10	.89	1.36	1.28	1.11	1.49
PD-1	0.94	.88	1.00	1.02	.95	1.09	1.09	1.04	1.14
PD-1⁺HLA-DR⁻CD38⁻	0.91	*.84*	*.97*	0.96	.90	1.03	1.06	1.01	1.12
CD27⁺ T_EMRA	1.02	.92	1.12	1.01	.91	1.11	0.99	.93	1.05
PD-1	0.93	*.87*	*.99*	0.98	.92	1.05	1.06	1.01	1.11
PD-1⁺ HLA-DR⁻CD38⁻	0.87	*.77*	*.99*	0.98	.86	1.11	1.12	1.03	1.22
TIGIT	0.93	*.89*	*.99*	0.99	.94	1.04	1.05	1.02	1.09
CD27⁻ T_EMRA	1.05	.91	1.20	0.96	.84	1.10	0.92	.85	1.00
PD-1⁺HLA-DR⁻CD38⁻	0.84	.73	.98	0.92	.80	1.07	1.09	1.00	1.20
CD25⁺CD45RA⁺	1.13	.94	1.36	1.17	.97	1.42	1.04	.91	1.18
PD-1	0.88	.80	.98	0.95	.85	1.05	1.07	1.00	1.15
CD8 NKT
CD8 NKT	0.98	.88	1.09	0.95	.85	1.06	0.96	.89	1.04
HLA-DR	1.61	*1.13*	*2.29*	1.58	1.13	2.23	0.99	.78	1.24
γδ T
γδ T	0.90	.81	.99	0.91	.83	1.00	1.02	.95	1.09
CD8⁺	1.10	1.02	1.17	1.06	.99	1.14	0.97	.93	1.02
CD4⁻CD8⁻	0.90	.84	.97	0.94	.87	1.01	1.04	.99	1.09
HLA-DR	1.13	.93	1.37	1.26	1.05	1.51	1.11	.98	1.27
CD38	1.26	*1.06*	*1.51*	1.23	1.04	1.46	0.98	.87	1.09
PD-1	1.36	*1.22*	*1.51*	1.21	1.09	1.33	0.89	.83	.95
LAG-3, MFI^a	−3.42	−13.64	6.80	−0.27	−9.62	9.09	3.15	−3.13	9.43
TIGIT, MFI	1.85	*1.36*	*2.51*	1.56	1.15	2.11	0.84	.69	1.03

Table 3.

Open in new tab

Immune Activation and Exhaustion Markers

	ITT-E (n = 130)			B/F/TAF, 3DR (n = 43)			DTG/3TC, 2DR (n = 87)
	Treatment Ratio 3DR/2DR			Week 48 Visit to Baseline Ratio			Week 48 Visit to Baseline Ratio
Marker	Estimate	95% LCL	95% UCL	Estimate	95% LCL	95% UCL	Estimate	95% LCL	95% UCL
CD4 T
CD4 T	0.94	.82	1.07	0.93	.82	1.04	0.99	.91	1.07
HLA-DR	1.10	.98	1.22	1.14	1.02	1.26	1.04	.97	1.11
CD38^a	1.17	−.99	3.33	2.07	.04	4.11	0.90	−.51	2.31
TIGIT	0.97	.92	1.02	1.02	.97	1.07	1.05	1.01	1.09
LAG-3	0.86	.67	1.09	0.99	.79	1.24	1.16	.99	1.36
PD-1	0.99	.90	1.08	1.02	.93	1.11	1.03	.97	1.10
T_EM	1.05	.95	1.16	0.99	.9	1.09	0.94	.88	1.01
T_EM HLA-DR	1.22	*1.06*	*1.41*	1.25	1.10	1.43	1.03	.94	1.12
T_EM HLA-DR⁺PD-1⁺CD38⁻	1.16	*1.01*	*1.34*	1.11	.97	1.28	0.96	.87	1.06
T_EMRA	1.19	.92	1.54	1.09	.84	1.41	0.92	.77	1.09
T_EMRA PD-1	0.79	*.64*	*.96*	0.86	.70	1.06	1.10	.97	1.24
CD8 T
CD8 T	0.95	.84	1.08	0.93	.83	1.04	0.97	.91	1.05
HLA-DR	1.09	.91	1.30	1.23	1.04	1.47	1.14	1.01	1.28
CD38	1.08	.97	1.21	1.13	1.01	1.26	1.04	.97	1.12
TIGIT	0.98	.93	1.04	1.02	.97	1.08	1.04	1.00	1.08
LAG-3	0.86	.69	1.06	1.10	.89	1.36	1.28	1.11	1.49
PD-1	0.94	.88	1.00	1.02	.95	1.09	1.09	1.04	1.14
PD-1⁺HLA-DR⁻CD38⁻	0.91	*.84*	*.97*	0.96	.90	1.03	1.06	1.01	1.12
CD27⁺ T_EMRA	1.02	.92	1.12	1.01	.91	1.11	0.99	.93	1.05
PD-1	0.93	*.87*	*.99*	0.98	.92	1.05	1.06	1.01	1.11
PD-1⁺ HLA-DR⁻CD38⁻	0.87	*.77*	*.99*	0.98	.86	1.11	1.12	1.03	1.22
TIGIT	0.93	*.89*	*.99*	0.99	.94	1.04	1.05	1.02	1.09
CD27⁻ T_EMRA	1.05	.91	1.20	0.96	.84	1.10	0.92	.85	1.00
PD-1⁺HLA-DR⁻CD38⁻	0.84	.73	.98	0.92	.80	1.07	1.09	1.00	1.20
CD25⁺CD45RA⁺	1.13	.94	1.36	1.17	.97	1.42	1.04	.91	1.18
PD-1	0.88	.80	.98	0.95	.85	1.05	1.07	1.00	1.15
CD8 NKT
CD8 NKT	0.98	.88	1.09	0.95	.85	1.06	0.96	.89	1.04
HLA-DR	1.61	*1.13*	*2.29*	1.58	1.13	2.23	0.99	.78	1.24
γδ T
γδ T	0.90	.81	.99	0.91	.83	1.00	1.02	.95	1.09
CD8⁺	1.10	1.02	1.17	1.06	.99	1.14	0.97	.93	1.02
CD4⁻CD8⁻	0.90	.84	.97	0.94	.87	1.01	1.04	.99	1.09
HLA-DR	1.13	.93	1.37	1.26	1.05	1.51	1.11	.98	1.27
CD38	1.26	*1.06*	*1.51*	1.23	1.04	1.46	0.98	.87	1.09
PD-1	1.36	*1.22*	*1.51*	1.21	1.09	1.33	0.89	.83	.95
LAG-3, MFI^a	−3.42	−13.64	6.80	−0.27	−9.62	9.09	3.15	−3.13	9.43
TIGIT, MFI	1.85	*1.36*	*2.51*	1.56	1.15	2.11	0.84	.69	1.03

	ITT-E (n = 130)			B/F/TAF, 3DR (n = 43)			DTG/3TC, 2DR (n = 87)
	Treatment Ratio 3DR/2DR			Week 48 Visit to Baseline Ratio			Week 48 Visit to Baseline Ratio
Marker	Estimate	95% LCL	95% UCL	Estimate	95% LCL	95% UCL	Estimate	95% LCL	95% UCL
CD4 T
CD4 T	0.94	.82	1.07	0.93	.82	1.04	0.99	.91	1.07
HLA-DR	1.10	.98	1.22	1.14	1.02	1.26	1.04	.97	1.11
CD38^a	1.17	−.99	3.33	2.07	.04	4.11	0.90	−.51	2.31
TIGIT	0.97	.92	1.02	1.02	.97	1.07	1.05	1.01	1.09
LAG-3	0.86	.67	1.09	0.99	.79	1.24	1.16	.99	1.36
PD-1	0.99	.90	1.08	1.02	.93	1.11	1.03	.97	1.10
T_EM	1.05	.95	1.16	0.99	.9	1.09	0.94	.88	1.01
T_EM HLA-DR	1.22	*1.06*	*1.41*	1.25	1.10	1.43	1.03	.94	1.12
T_EM HLA-DR⁺PD-1⁺CD38⁻	1.16	*1.01*	*1.34*	1.11	.97	1.28	0.96	.87	1.06
T_EMRA	1.19	.92	1.54	1.09	.84	1.41	0.92	.77	1.09
T_EMRA PD-1	0.79	*.64*	*.96*	0.86	.70	1.06	1.10	.97	1.24
CD8 T
CD8 T	0.95	.84	1.08	0.93	.83	1.04	0.97	.91	1.05
HLA-DR	1.09	.91	1.30	1.23	1.04	1.47	1.14	1.01	1.28
CD38	1.08	.97	1.21	1.13	1.01	1.26	1.04	.97	1.12
TIGIT	0.98	.93	1.04	1.02	.97	1.08	1.04	1.00	1.08
LAG-3	0.86	.69	1.06	1.10	.89	1.36	1.28	1.11	1.49
PD-1	0.94	.88	1.00	1.02	.95	1.09	1.09	1.04	1.14
PD-1⁺HLA-DR⁻CD38⁻	0.91	*.84*	*.97*	0.96	.90	1.03	1.06	1.01	1.12
CD27⁺ T_EMRA	1.02	.92	1.12	1.01	.91	1.11	0.99	.93	1.05
PD-1	0.93	*.87*	*.99*	0.98	.92	1.05	1.06	1.01	1.11
PD-1⁺ HLA-DR⁻CD38⁻	0.87	*.77*	*.99*	0.98	.86	1.11	1.12	1.03	1.22
TIGIT	0.93	*.89*	*.99*	0.99	.94	1.04	1.05	1.02	1.09
CD27⁻ T_EMRA	1.05	.91	1.20	0.96	.84	1.10	0.92	.85	1.00
PD-1⁺HLA-DR⁻CD38⁻	0.84	.73	.98	0.92	.80	1.07	1.09	1.00	1.20
CD25⁺CD45RA⁺	1.13	.94	1.36	1.17	.97	1.42	1.04	.91	1.18
PD-1	0.88	.80	.98	0.95	.85	1.05	1.07	1.00	1.15
CD8 NKT
CD8 NKT	0.98	.88	1.09	0.95	.85	1.06	0.96	.89	1.04
HLA-DR	1.61	*1.13*	*2.29*	1.58	1.13	2.23	0.99	.78	1.24
γδ T
γδ T	0.90	.81	.99	0.91	.83	1.00	1.02	.95	1.09
CD8⁺	1.10	1.02	1.17	1.06	.99	1.14	0.97	.93	1.02
CD4⁻CD8⁻	0.90	.84	.97	0.94	.87	1.01	1.04	.99	1.09
HLA-DR	1.13	.93	1.37	1.26	1.05	1.51	1.11	.98	1.27
CD38	1.26	*1.06*	*1.51*	1.23	1.04	1.46	0.98	.87	1.09
PD-1	1.36	*1.22*	*1.51*	1.21	1.09	1.33	0.89	.83	.95
LAG-3, MFI^a	−3.42	−13.64	6.80	−0.27	−9.62	9.09	3.15	−3.13	9.43
TIGIT, MFI	1.85	*1.36*	*2.51*	1.56	1.15	2.11	0.84	.69	1.03

Immunological changes after 48 weeks, corrected for age category (≤50 y, > 50 y), CD4/CD8 ratio, smoking status, and baseline response value in the ITT-E population. Estimated ratios are reported with upper and lower confidence interval limit estimates, calculated using an ordinary linear regression model applied to change from baseline in natural log-transformed imputed data. The confidence intervals highlighted in bold and italic do not contain the null value for the treatment ratios. Confidence intervals for the week 48 visit to baseline ratios that do not contain the null value are in bold.

Abbreviations: 2DR, 2-drug regimen; 3DR, 3-drug regimen; 3TC, lamivudine; B, bictegravir; DTG, dolutegravir; F, emtricitabine; ITT-E, intention to treat exposed; LCL, lower confidence interval limit; MFI, median fluorescence intensity; TAF, TAF, tenofovir alafenamide; UCL, upper confidence interval limit.

^aFor untransformed end points, the estimated arithmetic mean difference in (absolute) change from baseline between groups is reported with 95% confidence interval. The gating strategy can be found in Supplementary Figure 2.

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