Introduction
Methods
Inclusion criteria
Outcomes
Statistical approach
Results
Characteristics of study population
Full population (N = 8173) | DTG (n = 3914) | EVG (n = 1331) | RAL (n = 2928) | |
---|---|---|---|---|
Mean age (sd) | 49.7 (13.9) | 50.6 (14.4) | 48.4 (17.2) | 49.0 (11.4) |
Age category | ||||
< 50 years | 4189 (51.3%) | 1773 (45.3%) | 789 (59.3%) | 1627 (55.6%) |
≥ 50 years | 3984 (48.7%) | 2141 (54.7%) | 542 (40.7%) | 1301 (44.4%) |
Sex | ||||
Female | 2198 (27.4%) | 1007 (26.3%) | 330 (25.7%) | 861 (29.6%) |
Male | 5819 (72.6%) | 2823 (73.7%) | 952 (74.3%) | 2044 (70.4%) |
Nationality | ||||
Italian | 6443 (88.6%) | 3051 (88.1%) | 914 (84.9%) | 2478 (90.8%) |
Non-Italian | 827 (11.4%) | 412 (11.9%) | 163 (15.1%) | 252 (9.2%) |
Risk group | ||||
Heterosexual | 2929 (35.8%) | 1406 (35.9%) | 498 (37.4%) | 1025 (35.0%) |
PWID | 2054 (25.1%) | 890 (22.7%) | 214 (16.1%) | 950 (32.4%) |
MSM | 1637 (20.0%) | 873 (22.3%) | 344 (25.8%) | 420 (14.3%) |
Other | 1553 (19.0%) | 745 (19.0%) | 275 (20.7%) | 533 (18.2%) |
Median diagnosis year (IQR) | 2005 (1998–2013) | 2006 (1998–2013) | 2010 (2002–2015) | 2002 (1998–2010) |
Median viral loadLog10 (IQR) Viral load at baseline | 1.70 (1.70–2.39) | 1.70 (1.70–1.94) | 1.70 (1.70–3.13) | 1.70 (1.70–2.78) |
< 50 | 5712 (69.9%) | 2877 (73.5%) | 908 (68.2%) | 1927 (65.8%) |
50–9999 | 1211 (14.8%) | 526 (13.4%) | 172 (12.9%) | 513 (17.5%) |
> 10,000 | 1250 (15.3%) | 511 (13.1%) | 251 (18.9%) | 488 (16.7%) |
Median CD4 count (IQR) CD4 count at baseline | 530 (320–770) | 582 (364–821) | 560 (354–761) | 455 (267–684) |
< 500 cells | 3519 (46.0%) | 1468 (39.9%) | 527 (43.0%) | 1524 (55.6%) |
500 + cells | 4123 (54.0%) | 2208 (60.1%) | 699 (57.0%) | 1216 (44.4%) |
Regimen | ||||
2 drugs | 2023 (24.8%) | 977 (25.0%) | 0 (0.0%) | 1046 (35.7%) |
3 drugs | 6150 (75.2%) | 2937 (75.0%) | 1333 (100.0%) | 1882 (64.3%) |
cART status | ||||
Naïve | 1388 (17.0%) | 650 (16.6%) | 331 (24.9%) | 407 (13.9%) |
Experienced | 6785 (83.0%) | 3264 (83.4%) | 1000 (75.1%) | 2521 (86.1%) |
Cohort | ||||
2009–11 | 1134 (13.9%) | 15 (0.4%) | 0 (0.0%) | 1119 (38.2%) |
2012–14 | 1103 (13.5%) | 24 (0.6%) | 101 (7.6%) | 978 (33.4%) |
2015–17 | 5936 (72.6%) | 3875 (99.0%) | 1230 (92.4%) | 831 (28.4%) |
Hepatitis at baseline | ||||
No | 5435 (66.5%) | 2726 (69.6%) | 1017 (76.4%) | 1692 (57.8%) |
Yes | 2738 (33.5%) | 1188 (30.4%) | 314 (23.6%) | 1236 (42.2%) |
Interruption for: efficacy | 846 (10.4%) | 316 (8.1%) | 125 (9.4%) | 405 (13.8%) |
Convenience | 822 (10.1%) | 261 (6.7%) | 96 (7.2%) | 465 (15.9%) |
Safety | 1832 (22.4%) | 458 (11.7%) | 153 (11.5%) | 1221 (41.7%) |
Durability | 2784 (34.1%) | 746 (19.1%) | 266 (20.0%) | 1772 (60.5%) |
Associations with interruption for the metrics of durability
Hazards of interruption (95% confidence interval) due to: | ||||
---|---|---|---|---|
Efficacy | Convenience | Safety | Durability | |
Age | ||||
< 50 years | Reference category | Reference category | Reference category | Reference category |
≥ 50 years | 0.88 (0.75;1.03) | 0.65 (0.55;0.77) | 1.51 (1.36;1.67) | 1.14 (1.05;1.24) |
Sex | ||||
Female | Reference category | Reference category | Reference category | Reference category |
Male | 0.97 (0.82;1.16) | 0.69 (0.58;0.83) | 0.92 (0.82;1.04) | 0.85 (0.78;0.94) |
Nationality | ||||
Italian | Reference category | Reference category | Reference category | Reference category |
Non-Italian | 1.22 (0.96;1.54) | 1.27 (1.00;1.62) | 0.91 (0.76;1.1) | 1.07 (0.93;1.23) |
Risk group | ||||
Heterosexual | Reference category | Reference category | Reference category | Reference category |
PWID | 1.21 (0.95;1.54) | 1.49 (1.16;1.91) | 1.01 (0.87;1.18) | 1.10 (0.97;1.25) |
MSM | 0.84 (0.65;1.08) | 1.21 (0.95;1.54) | 0.93 (0.79;1.08) | 0.98 (0.86;1.11) |
Other | 1.02 (0.80;1.29) | 0.90 (0.69;1.17) | 0.93 (0.79;1.1) | 0.92 (0.81;1.06) |
Diagnosis year | 1.25 (1.16;1.36) | 0.91 (0.84;0.99) | 0.91 (0.87;0.96) | 0.92 (0.88;0.96) |
Virally suppressed at baseline | ||||
Yes | Reference category | |||
No | 0.97 (0.79;1.21) | 1.10 (0.91;1.32) | 1.17 (1.05;1.32) | 1.25 (1.14;1.37) |
CD4 count at baseline | ||||
< 500 cells | Reference category | Reference category | Reference category | Reference category |
500 + cells | 0.71 (0.60;0.84) | 1.16 (0.98;1.37) | 0.86 (0.78;0.96) | 0.93 (0.86;1.02) |
cART status | ||||
Naïve | Reference category | Reference category | Reference category | Reference category |
Experienced | 2.05 (1.55;2.71) | 0.77 (0.58;1.03) | 1.16 (0.94;1.42) | 1.09 (0.93;1.28) |
Regimen | ||||
2 drugs | Reference category | Reference category | Reference category | Reference category |
3 drugs | 0.98 (0.83;1.16) | 1.17 (0.98;1.40) | 1.23 (1.11;1.38) | 1.21 (1.10;1.32) |
Cohort | ||||
2009–11 | Reference category | Reference category | Reference category | Reference category |
2012–14 | 1.09 (0.76;1.56) | 1.66 (1.17;2.37) | 1.83 (1.47;2.26) | 1.78 (1.49;2.13) |
2015–17 | 1.03 (0.61;1.73) | 1.97 (1.16;3.34) | 1.31 (0.94;1.84) | 1.43 (1.08;1.89) |
Time between diagnosis and therapy (days) | 1.26 (1.16;1.37) | 0.90 (0.83;0.98) | 0.90 (0.86;0.95) | 0.91 (0.87;0.95) |
Hepatitis at baseline | ||||
Not | Reference category | Reference category | Reference category | Reference category |
Yes | 0.97 (0.79;1.21) | 1.04 (0.84;1.30) | 1.19 (1.04;1.36) | 1.15 (1.03;1.28) |
Associations with interruption for the metrics of efficacy
Associations with interruption for the metrics of convenience
Associations with interruption for the metrics of safety
Associations with interruption by strata of therapy type
Hazards of interruption (95% confidence interval) due to: | ||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Efficacy | Convenience | Safety | Durability | |||||||||
DTG | RAL | EVG | DTG | RAL | EVG | DTG | RAL | EVG | DTG | RAL | EVG | |
Age | ||||||||||||
< 50 years | Ref. cat | Ref. cat | Ref. cat | Ref. cat | Ref. cat | Ref. cat | Ref. cat | Ref. cat | Ref. cat | Ref. cat | Referent | Referent |
≥ 50 years | 1.00 (0.76;1.31) | 1.06 (0.85;1.32) | 1.04 (0.66;1.64) | 0.59 (0.44;0.79) | 0.67 (0.54;0.83) | 0.71 (0.40;1.25) | 1.92 (1.52;2.43) | 1.40 (1.24;1.58) | 1.44 (0.97;2.13) | 1.19 (1.00;1.41) | 1.13 (1.02;1.25) | 1.08 (0.79;1.47) |
Sex | ||||||||||||
Female | Ref. cat | Ref. cat | Ref. cat | Ref. cat | Ref. cat | Ref. cat | Ref. cat | Ref. cat | Ref. cat | Ref. cat | Referent | Referent |
Male | 1.09 (0.80;1.48) | 0.92 (0.72;1.17) | 0.74 (0.46;1.19) | 0.56 (0.40;0.76) | 0.79 (0.63;1.00) | 0.73 (0.39;1.35) | 0.88 (0.69;1.11) | 1.01 (0.87;1.16) | 0.64 (0.42;0.99) | 0.76 (0.63;0.91) | 0.94 (0.84;1.06) | 0.67 (0.47;0.94) |
Nationality | ||||||||||||
Italian | Ref. cat | Ref. cat | Ref. cat | Ref. cat | Ref. cat | Ref. cat | Ref. cat | Ref. cat | Ref. cat | Ref. cat | Ref. cat | Ref. cat |
Non-Italian | 0.88 (0.57;1.35) | 1.79 (1.29;2.49) | 1.77 (1.03;3.06) | 1.39 (0.93;2.07) | 1.24 (0.89;1.73) | 1.14 (0.56;2.30) | 0.62 (0.41;0.94) | 1.04 (0.83;1.31) | 0.81 (0.45;1.46) | 0.88 (0.67;1.17) | 1.15 (0.96;1.37) | 1.06 (0.70;1.61) |
Risk group | ||||||||||||
Heterosexual | Ref. cat | Ref. cat | Ref. cat | Ref. cat | Ref. cat | Ref. cat | Ref. cat | Ref. cat | Ref. cat | Ref. cat | Ref. cat | Ref. cat |
PWID | 1.32 (0.86;2.03) | 1.21 (0.88;1.66) | 1.76 (0.91;3.40) | 1.62 (1.01;2.62) | 1.49 (1.09;2.04) | 1.33 (0.59;3.00) | 1.22 (0.87;1.7) | 0.93 (0.78;1.11) | 1.05 (0.59;1.89) | 1.31 (1.00;1.71) | 1.03 (0.88;1.20) | 1.08 (0.68;1.72) |
MSM | 0.75 (0.50;1.14) | 0.95 (0.67;1.36) | 0.82 (0.42;1.61) | 1.21 (0.79;1.85) | 1.19 (0.86;1.65) | 1.52 (0.77;3.03) | 0.92 (0.68;1.24) | 0.89 (0.73;1.08) | 1.38 (0.82;2.34) | 0.97 (0.76;1.23) | 0.93 (0.79;1.09) | 1.41 (0.95;2.11) |
Other | 1.28 (0.89;1.84) | 0.77 (0.53;1.11) | 1.03 (0.58;1.85) | 0.90 (0.57;1.43) | 0.96 (0.67;1.35) | 0.57 (0.23;1.43) | 0.76 (0.54;1.06) | 0.95 (0.78;1.16) | 1.21 (0.71;2.04) | 0.87 (0.67;1.13) | 0.93 (0.79;1.10) | 0.90 (0.58;1.39) |
Diagnosis year | 1.01 (0.99;1.04) | 1.02 (1.00;1.05) | 0.97 (0.93;1.01) | 1.01 (0.99;1.04) | 1.03 (1.01;1.05) | 1.01 (0.96;1.06) | 1.02 (1.00;1.04) | 1.02 (1.00;1.03) | 1.01 (0.98;1.05) | 1.01 (1.00;1.03) | 1.02 (1.01;1.03) | 1.01 (0.98;1.04) |
Not virally suppressed at baseline | 3.97 (3.01;5.24) | 4.29 (3.39;5.44) | 3.44 (2.18;5.41) | 1.01 (0.70;1.47) | 0.99 (0.79;1.25) | 1.94 (1.06;3.57) | 1.17 (0.90;1.52) | 1.11 (0.97;1.26) | 1.60 (1.04;2.47) | 1.19 (0.97;1.47) | 1.17 (1.04;1.30) | 1.90 (1.36;2.66) |
CD4 count at baseline | ||||||||||||
< 500 cells | Ref. cat | Ref. cat | Ref. cat | Ref. cat | Ref. cat | Ref. cat | Ref. cat | Ref. cat | Ref. cat | Ref. cat | Ref. cat | Ref. cat |
500 + cells | 0.55 (0.42;0.73) | 1.05 (0.83;1.32) | 0.72 (0.46;1.13) | 1.15 (0.85;1.56) | 1.32 (1.07;1.63) | 0.90 (0.53;1.54) | 0.88 (0.71;1.09) | 0.92 (0.81;1.05) | 0.75 (0.51;1.10) | 0.93 (0.79;1.10) | 1.03 (0.92;1.14) | 0.77 (0.57;1.04) |
cART status | ||||||||||||
Naïve | Ref. cat | Ref. cat | Ref. cat | Ref. cat | Ref. cat | Ref. cat | Ref. cat | Ref. cat | Ref. cat | Ref. cat | Ref. cat | Ref. cat |
Experienced | 1.89 (1.23;2.92) | 1.89 (1.26;2.84) | 2.57 (1.21;5.45) | 0.84 (0.48;1.47) | 0.80 (0.55;1.17) | 0.92 (0.42;2.00) | 1.11 (0.70;1.75) | 1.10 (0.86;1.40) | 1.65 (0.84;3.21) | 1.10 (0.78;1.55) | 1.06 (0.87;1.29) | 1.34 (0.83;2.15) |
Positive hepatitis diagnosis at baseline | 0.91 (0.62;1.32) | 1.13 (0.85;1.50) | 0.82 (0.45;1.50) | 1.19 (0.78;1.81) | 0.89 (0.67;1.17) | 1.60 (0.80;3.21) | 0.93 (0.70;1.26) | 1.23 (1.05;1.44) | 1.44 (0.88;2.33) | 1.01 (0.80;1.28) | 1.13 (0.99;1.29) | 1.47 (1.00;2.17) |