Table 1.
Main characteristics of HIV patients treated with DTG plus 3TC by sex, presence of comorbidities, and AIDS.
| Overall (n = 1032) |
Female (n = 221) |
Male (n = 811) |
p-Value | without Comorbidities (n = 617) |
with Any Comorbidity (n = 415) |
p-Value | No-AIDS Patient (n = 634) |
AIDS Patient (n = 118) |
p-Value | |
|---|---|---|---|---|---|---|---|---|---|---|
| DEMOGRAPHICS | ||||||||||
| Age, median [IQR] | 50.0 [40.0, 57.0] |
53.0 [45.0, 58.0] |
48.0 [38.0, 57.0] |
<0.001 | 45.0 [36.0, 54.0] |
54.0 [47.0, 59.5] |
<0.001 | 47.0 [37.2, 55.0] |
56.0 [53.0, 62.0] |
<0.001 |
| Age of HIV diagnosis, median [IQR] | 37.0 [27.0, 47.0] |
38.0 [29.0, 49.0] |
36.0 [26.0, 46.0] |
0.126 | 33.0 [24.0, 42.0] |
42.0 [30.0, 52.0] |
<0.001 | 34.0 [24.0, 45.0] |
45.5 [32.0, 53.8] |
<0.001 |
| Male, n (%) | 811 (78.6) | - | - | <0.001 | 491 (79.6) | 320 (77.1) | 0.384 | 512 (80.8) | 89 (75.4) | 0.229 |
|
Spanish nationality,
n (%) |
764 (76.9) | 156 (73.2) | 608 (77.8) | 0.186 | 460 (77.7) | 304 (75.6) | 0.492 | 405 (66.9) | 97 (82.2) | 0.001 |
| COMORBIDITIES, n (%) | ||||||||||
| Arterial hypertension | 119 (11.5) | 26 (11.8) | 93 (11.5) | 0.997 | - | - | - | 83 (13.1) | 34 (28.8) | <0.001 |
| Diabetes | 50 (4.8) | 9 (4.1) | 41 (5.1) | 0.67 | - | - | - | 35 (5.5) | 15 (12.7) | 0.007 |
| Dyslipidaemia | 211 (20.4) | 48 (21.7) | 163 (20.1) | 0.663 | - | - | - | 168 (26.5) | 41 (34.7) | 0.085 |
| Heart Disease | 29 (2.8) | 4 (1.8) | 25 (3.1) | 0.432 | - | - | - | 19 (3.0) | 9 (7.6) | 0.030 |
| Cerebrovascular disease | 9 (0.9) | 2 (0.9) | 7 (0.9) | 1.000 | - | - | - | 4 (0.6) | 5 (4.2) | 0.004 |
| Peripheral vascular disease | 11 (1.1) | 2 (0.9) | 9 (1.1) | 1.000 | - | - | - | 8 (1.3) | 3 (2.5) | 0.518 |
| Kidney failure | 40 (3.9) | 6 (2.7) | 34 (4.2) | 0.417 | - | - | - | 28 (4.4) | 12 (10.2) | 0.020 |
| Osteoporosis/Osteopenia | 31 (3.0) | 13 (5.9) | 18 (2.2) | 0.009 | - | - | - | 24 (3.8) | 7 (5.9) | 0.409 |
| Chronic pulmonary disease | 48 (4.7) | 14 (6.3) | 34 (4.2) | 0.246 | - | - | - | 36 (5.7) | 11 (9.3) | 0.196 |
| Psychiatric disorders | 78 (7.6) | 23 (10.4) | 55 (6.8) | 0.096 | - | - | - | 60 (9.5) | 17 (14.4) | 0.144 |
| Cancer | 14 (1.4) | 5 (2.3) | 9 (1.1) | 0.325 | - | - | - | 10 (1.6) | 4 (3.4) | 0.334 |
| Chronic liver disease | 106 (10.3) | 30 (13.6) | 76 (9.4) | 0.089 | - | - | - | 71 (11.2) | 35 (29.7) | <0.001 |
| Number of comorbidities, n (%) | ||||||||||
| One | 617 (59.8) | 126 (57.0) | 491 (60.5) | 0.439 | - | - | - | 315 (49.7) | 26 (22.0) | <0.001 |
| Two | 220 (21.3) | 45 (20.4) | 175 (21.6) | - | - | 181 (28.5) | 37 (31.4) | |||
| Three | 105 (10.2) | 24 (10.9) | 81 (10.0) | - | - | 79 (12.5) | 25 (21.2) | |||
| Four | 54 (5.2) | 17 (7.7) | 37 (4.6) | - | - | 35 (5.5) | 18 (15.3) | |||
| Five | 29 (2.8) | 8 (3.6) | 21 (2.6) | - | - | 19 (3.0) | 10 (8.5) | |||
| Six | 4 (0.4) | 0 (0.0) | 4 (0.5) | - | - | 4 (0.6) | 0 (0.0) | |||
| HIV INFECTION | ||||||||||
| Transmission pathways, n (%) | ||||||||||
| Sexual intercourse | 684 (67.8) | 118 (53.6) | 566 (71.7) | <0.001 | 455 (75.5) | 229 (56.4) | <0.001 | 426 (69.4) | 64 (54.7) | <0.001 |
| Intravenous drug injectors | 191 (18.9) | 61 (27.7) | 130 (16.5) | 81 (13.4) | 110 (27.1) | 84 (13.7) | 35 (29.9) | |||
| Immune status, median [IQR] | ||||||||||
| Baseline CD4+ (cells/mm3) | 753.0 [549.0, 977.0] |
763.0 [590.5, 985.0] |
744.0 [543.0, 975.8] |
0.358 | 752.5 [551.5, 980.0] |
759.0 [531.0, 975.0] |
0.944 | 786.5 [596.5, 1005.8] |
604.0 [404.5, 933.0] |
<0.001 |
| 24 weeks CD4+ (cells/mm3) | 770.5 [592.8, 980.0] |
785.0 [601.0, 986.5] |
766.0 [592.0, 970.8] |
0.482 | 766.0 [596.5, 976.5] |
773.0 [590.0, 982.0] |
0.933 | 808.0 [630.5, 1000.5] |
644.0 [449.0, 875.5] |
<0.001 |
| 48 weeks CD4+ (cells/mm3) | 782.0 [574.0, 1004.0] |
779.0 [606.0, 978.0] |
784.5 [567.0, 1012.5] |
0.996 | 789.0 [589.0, 1034.0] |
776.0 [559.5, 948.8] |
0.179 | 801.0 [591.5, 1029.5] |
628.0 [424.2, 866.0] |
<0.001 |
| 96 weeks CD4+ (cells/mm3) | 823.0 [613.2, 1048.0] |
802.0 [652.0, 1037.0] |
839.0 [604.5, 1051.0] |
0.854 | 831.0 [633.5, 1058.5] |
803.0 [560.2, 1036.5] |
0.306 | 851.0 [678.0, 1125.0] |
649.0 [440.5, 856.2] |
<0.001 |
| Baseline CD8+ (cells/mm3) | 867.5 [630.0, 1179.5] |
805.0 [589.5, 1084.5] |
878.0 [653.0, 1196.5] |
0.048 | 880.0 [632.0, 1156.0] |
861.0 [627.0, 1198.0] |
0.752 | 875.0 [637.5, 1199.5] |
827.0 [609.0, 1100.0] |
0.141 |
| 24 weeks CD8+ (cells/mm3) | 897.0 [656.0, 1220.0] |
792.0 [603.0, 1188.5] |
913.0 [674.0, 1247.0] |
0.020 | 895.0 [677.5, 1244.5] |
898.0 [636.0, 1211.2] |
0.793 | 899.5 [656.8, 1241.0] |
871.0 [635.0, 1134.0] |
0.517 |
| 48 weeks CD8+ (cells/mm3) | 908.0 [638.5, 1229.8] |
817.0 [533.0, 1119.0] |
922.0 [661.5, 1248.5] |
0.020 | 910.0 [639.5, 1257.5] |
907.0 [640.0, 1208.0] |
0.897 | 900.0 [635.5, 1220.5] |
959.5 [603.2, 1224.8] |
0.651 |
| 96 weeks CD8+ (cells/mm3) | 906.0 [628.5, 1241.5] |
922.0 [625.0, 1222.5] |
906.0 [634.5, 1268.5] |
0.903 | 980.0 [673.2, 1280.0] |
893.0 [617.0, 1227.0] |
0.491 | 956.0 [672.0, 1246.0] |
862.0 [484.5, 1152.5] |
0.094 |
| Baseline CD4+/CD8+ (cells/mm3) | 0.9 [0.6, 1.2] |
0.9 [0.7, 1.4] |
0.9 [0.6, 1.2] |
0.033 | 0.9 [0.6, 1.2] |
0.9 [0.6, 1.3] |
0.601 | 0.9 [0.7, 1.3] |
0.8 [0.5, 1.1] |
0.003 |
| 24 weeks CD4+/CD8+ (cells/mm3) | 0.9 [0.6, 1.2] |
1.0 [0.7, 1.3] |
0.8 [0.6, 1.2] |
0.011 | 0.9 [0.7, 1.2] |
0.9 [0.6, 1.2] |
0.855 | 0.9 [0.7, 1.2] |
0.7 [0.5, 1.1] |
0.001 |
| 48 weeks CD4+/CD8+ (cells/mm3) | 0.9 [0.6, 1.2] |
1.0 [0.7, 1.4] |
0.9 [0.6, 1.2] |
0.034 | 0.9 [0.6, 1.3] |
0.9 [0.6, 1.2] |
0.635 | 0.9 [0.7, 1.3] |
0.7 [0.5, 1.0] |
<0.001 |
| 96 weeks CD4+/CD8+ (cells/mm3) | 0.9 [0.7, 1.3] |
0.9 [0.7, 1.3] |
0.9 [0.7, 1.3] |
0.770 | 0.9 [0.7, 1.3] |
0.9 [0.7, 1.3] |
0.981 | 0.9 [0.7, 1.4] |
0.8 [0.7, 1.2] |
0.198 |
| HIV DIAGNOSIS n (%) | ||||||||||
| Previous treatments, n (%) | ||||||||||
| ABC/3TC | 384 (37.2) | 77 (34.8) | 307 (37.9) | 0.458 | 156 (25.3) | 228 (54.9) | <0.001 | 319 (50.3) | 64 (54.2) | 0.495 |
| FTC/TDF | 459 (44.5) | 96 (43.4) | 363 (44.8) | 0.784 | 193 (31.3) | 266 (64.1) | <0.001 | 367 (57.9) | 90 (76.3) | <0.001 |
| FTC/TAF | 149 (14.4) | 22 (10.0) | 127 (15.7) | 0.042 | 70 (11.3) | 79 (19.0) | <0.001 | 131 (20.7) | 18 (15.3) | 0.220 |
| PI ^ | 271 (26.3) | 79 (35.7) | 192 (23.7) | <0.001 | 77 (12.5) | 194 (46.7) | <0.001 | 202 (31.9) | 66 (55.9) | <0.001 |
| INSTI | 475 (46.0) | 82 (37.1) | 393 (48.5) | 0.003 | 229 (37.1) | 246 (59.3) | <0.001 | 407 (64.2) | 67 (56.8) | 0.153 |
| NNRTI | 340 (32.9) | 82 (37.1) | 258 (31.8) | 0.161 | 113 (18.3) | 227 (54.7) | <0.001 | 270 (42.6) | 67 (56.8) | 0.006 |
| Reasons for switching, n (%) | ||||||||||
| Toxicity | 168 (16.3) | 45 (20.4) | 123 (15.2) | 0.080 | 40 (6.5) | 128 (30.8) | <0.001 | 119 (18.8) | 48 (40.7) | <0.001 |
| Drug interaction | 61 (5.9) | 22 (10.0) | 39 (4.8) | 0.007 | 15 (2.4) | 46 (11.1) | <0.001 | 48 (7.6) | 13 (11.0) | 0.282 |
| Simplification | 587 (56.9) | 105 (47.5) | 482 (59.4) | 0.002 | 269 (43.6) | 318 (76.6) | <0.001 | 493 (77.8) | 93 (78.8) | 0.895 |
| Transition therapy to injectable drugs | 9 (0.9) | 1 (0.5) | 8 (1.0) | 0.727 | 5 (0.8) | 4 (1.0) | 1.000 | 9 (1.4) | 0 (0.0) | 0.400 |
| Simplicity | 33 (3.2) | 5 (2.3) | 28 (3.5) | 0.499 | 16 (2.6) | 17 (4.1) | 0.244 | 24 (3.8) | 8 (6.8) | 0.218 |
| Cost | 26 (2.5) | 5 (2.3) | 21 (2.6) | 0.974 | 6 (1.0) | 20 (4.8) | <0.001 | 13 (2.1) | 13 (11.0) | <0.001 |
| COINFECTIONS, n (%) | ||||||||||
| HBV diagnosis | 192 (27.9) | 36 (27.1) | 156 (28.1) | 0.904 | 56 (18.6) | 136 (35.1) | <0.001 | 139 (24.3) | 51 (44.0) | <0.001 |
| HBsAg positive | 10 (5.3) | 1 (2.8) | 9 (5.9) | 0.738 | 3 (5.7) | 7 (5.1) | 1 | 4 (2.9) | 6 (11.8) | 0.043 |
| HCV positive ELISA | 160 (23.0) | 41 (30.4) | 119 (21.2) | 0.032 | 19 (6.3) | 141 (35.7) | <0.001 | 111 (19.2) | 49 (42.2) | <0.001 |
| HCV positive PCR | 52 (34.7) | 16 (42.1) | 36 (32.1) | 0.359 | 4 (23.5) | 48 (36.1) | 0.451 | 26 (25.5) | 26 (54.2) | 0.001 |
| VIRAL LOAD < 50 copies/mL, n (%) | ||||||||||
| Baseline | 943 (96.0) | 206 (95.4) | 737 (96.2) | 0.716 | 565 (95.4) | 378 (96.9) | 0.318 | 576 (95.8) | 107 (96.4) | 0.991 |
| 24 weeks | 889 (96.6) | 196 (97.5) | 693 (96.4) | 0.574 | 539 (96.6) | 350 (96.7) | 1.000 | 532 (96.7) | 100 (95.2) | 0.638 |
| 48 weeks | 743 (97.5) | 162 (96.4) | 581 (97.8) | 0.463 | 467 (98.1) | 276 (96.5) | 0.256 | 393 (97.3) | 81 (94.2) | 0.258 |
| 96 weeks | 417 (98.3) | 98 (97.0) | 319 (98.8) | 0.456 | 304 (99.0) | 113 (96.6) | 0.181 | 126 (97.7) | 38 (95.0) | 0.735 |
^ In some patients previous treatments included PI in combination con INSTI.