Table 1.
Characteristics of Participants at Regimen Start
| Overall | 3-Drug Regimens | 2-Drug Regimens | |||||
|---|---|---|---|---|---|---|---|
| Characteristic | N | (%) | n | (%) | n | (%) | |
| Total | 9791 | (100) | 8703 | (88.9) | 1088 | (11.1) | |
| Geographical region of Europea | Western | 4955 | (50.6) | 4537 | (52.1) | 418 | (38.4) |
| Southern | 2261 | (23.1) | 1763 | (20.3) | 498 | (45.8) | |
| Northern/Australia | 1679 | (17.1) | 1573 | (18.1) | 106 | (9.7) | |
| Eastern | 896 | (9.2) | 830 | (9.5) | 66 | (6.1) | |
| Gender | Male | 7048 | (72.0) | 6253 | (71.9) | 795 | (73.1) |
| Female | 2738 | (28.0) | 2445 | (28.1) | 293 | (26.9) | |
| Transgender | 3 | (0.0) | 3 | (0.0) | 0 | (0.0) | |
| Ethnicity | White | 6976 | (81.9) | 6147 | (81.5) | 829 | (84.9) |
| Black | 1125 | (13.2) | 1017 | (13.5) | 108 | (11.1) | |
| Other | 416 | (4.9) | 376 | (5.0) | 40 | (4.1) | |
| BMI/kg/m2 | <18.5 | 363 | (4.9) | 310 | (4.6) | 53 | (7.2) |
| 18.5 to <25 | 4182 | (56.0) | 3752 | (55.8) | 430 | (58.1) | |
| ≥25 | 2923 | (39.1) | 2666 | (39.6) | 257 | (34.7) | |
| Smoking status | Never | 2764 | (40.9) | 2505 | (40.8) | 259 | (41.5) |
| Current | 2836 | (41.9) | 2599 | (42.3) | 237 | (38.0) | |
| Previous | 1162 | (17.2) | 1034 | (16.8) | 128 | (20.5) | |
| HIV viral load, copies/mL | <200 | 8588 | (87.7) | 7648 | (87.9) | 940 | (86.4) |
| ≥200 | 1203 | (12.3) | 1055 | (12.1) | 148 | (13.6) | |
| HIV risk | Men who have sex with men | 4037 | (43.0) | 3631 | (43.5) | 406 | (39.6) |
| Intravenous drug user | 1536 | (16.4) | 1343 | (16.1) | 193 | (18.8) | |
| Heterosexual | 3469 | (37.0) | 3076 | (36.8) | 393 | (38.3) | |
| Other | 337 | (3.6) | 303 | (3.6) | 34 | (3.3) | |
| Prior AIDS, noncancer | 2021 | (22.1) | 1731 | (21.2) | 290 | (29.1) | |
| Prior ADC | 440 | (4.8) | 379 | (4.6) | 61 | (5.8) | |
| HCVb | 2568 | (28.0) | 2268 | (27.9) | 300 | (29.0) | |
| HBVd | 488 | (5.5) | 445 | (5.6) | 43 | (4.2) | |
| Hypertensione | 2620 | (33.1) | 2302 | (32.0) | 318 | (44.5) | |
| Diabetesf | 711 | (8.6) | 604 | (8.3) | 107 | (11.7) | |
| Prior non-ADC | 429 | (4.7) | 376 | (4.6) | 53 | (5.1) | |
| Prior ESLD | 87 | (1.2) | 72 | (1.1) | 15 | (1.8) | |
| Prior ESRD | 52 | (0.5) | 35 | (0.4) | 17 | (1.6) | |
| Prior CVDg | 362 | (4.1) | 285 | (3.6) | 77 | (8.0) | |
| Prior fracture | 508 | (6.6) | 468 | (6.7) | 40 | (6.2) | |
| Prior CKDh | 436 | (4.9) | 333 | (4.2) | 103 | (10.6) | |
| Prior CLEEi | 3628 | (38.7) | 3247 | (39.0) | 381 | (36.0) | |
| Dyslipidemiaj | 6587 | (75.7) | 5787 | (74.7) | 800 | (83.9) | |
| Any prior comorbidity | 7257 | (88.8) | 6373 | (87.9) | 884 | (95.6) | |
| Continuous variables, median (interquartile range) | |||||||
| Regimen start, month/year (mm/yy) | 07/15 | (04/14–08/16) | 07/15 | (03/14–07/16) | 12/15 | (11/14–01/17) | |
| Age, years | 48.3 | (40.3–54.9) | 47.7 | (39.7–54.3) | 52.6 | (46.7–59.0) | |
| CD4 cell count nadir, cells/mm3,k | 202.0 | (91.0–309.0) | 206.0 | (96.0–312.0) | 170.0 | (68.0–280.0) | |
| CD4 cell count at regimen start, cells/mm3,k | 608.0 | (423.0–810.0) | 605.0 | (424.0–809.0) | 622.0 | (408.6–814.1) | |
| CD8 cell count at regimen start, cells/mm3,k | 790.0 | (572.0–1087.0) | 786.0 | (571.0–1081.0) | 827.0 | (579.5–1119.5) | |
| Number of antiretrovirals previously exposed to | 6 | (4–9) | 6 | (4–8) | 8 | (5–11) | |
| Total previous treatment duration, months | 9.9 | (4.7–16.6) | 9.5 | (4.5–16.1) | 14.3 | (6.4–19.0) |
Baseline is defined as the date of starting a regimen of interest. P values for comparisons of 2-drug regimens and 3-drug regimens were all <0.05, except for gender (P = .59), prior ESLD (0.09), CD4 cell count at regimen start (0.55), and CD8 cell count at regimen start (0.08). Denominator for percentages is all participants with nonmissing data. Total unknown n (%): ethnicity, 1274 (13.0); BMI, 2323 (23.7); smoking status, 3029 (30.9); HIV risk, 412 (4.2); prior AIDS-non cancer, 636 (6.5); prior AIDS cancer, 570 (5.8); HCV, 623 (6.4); HBV, 896 (9.2); hypertension, 1880 (19.2); diabetes, 1565 (16.0); prior non-AIDS-defining cancer, 570 (5.8); prior ESLD, 2288 (23.4); prior ESRD, 721 (7.4); prior CVD, 866 (8.8); prior fracture, 2135 (21.8); prior CKD, 857 (8.8); prior CLEE, 405 (4.1); dyslipidemia, 1086 (11.1); prior comorbidity, 1616 (16.5).
Abbreviations: ADC, AIDS-defining cancer; BMI, body mass index; CKD, chronic kidney disease; CLEE, chronic liver enzyme elevation; CVD, cardiovascular disease; ESLD, end stage liver disease; ESRD, end stage renal disease; HBV, hepatitis B surface antigenemia; HCV, hepatitis C AB positive; HIV, human immunodeficiency virus.
aDue to small numbers, Australia was combined with Northern Europe, and Eastern Central Europe was combined with Eastern Europe.
bHCV was defined by use of anti-HCV medication, a positive HCV antibody test, a positive HCV RNA qualitative test, HCV RNA viral load (VL) >615 IU/mL, and/or a positive genotype test [26].
dHBV was defined by a positive HBV surface antigen and/or HBV-RNA VL >357 IU/mL.
eHypertension was confirmed by use of antihypertensives at any time before regimen start or if the most recent systolic or diastolic blood pressure measurement before regimen start was higher than 140 or 90 mm Hg, respectively.
fDiabetes was defined by a reported diagnosis, use of antidiabetic medication, glucose ≥11.1 mmol/L, and/or HbA1c ≥6.5% or ≥48 mmol/mol.
gCVD was defined using a composite diagnosis of myocardial infarction, stroke, or invasive cardiovascular procedure.
hCKD was confirmed if there were 2 consecutive measurements of estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m2 measured at least 3 months apart. eGFR was calculated using the CKD-epidemiology (EPI) creatinine equation [27].
iChronic liver enzyme elevation was confirmed if there were 2 consecutive measurements of ALT >50 IU/L for males or >35 IU/L for females, measured between 6 months and 2 years apart. One normal alanine aminotranferase (ALT) measurement was allowed between elevated measurements.
jDyslipidemia was defined as total cholesterol >239.4 mg/dL or high-density lipoprotein cholesterol <34.7 mg/dL or triglyceride >203.55 mg/dL or use of lipid-lowering treatments [28].
kCD4 and CD8 cell counts were taken as the most recent measurements in the 12 months prior to regimen start. If no measurements were taken prior to starting the regimen, the first measurement within 12 weeks after regimen start was used, and CD4 cell nadir was recorded the same as CD4 cell count at regimen start.