Table 1.

Characteristics of Participants at Baseline

CharacteristicsOverall
n(%)
Total29 340(100)
GenderMale21 818(74.4)
Female7478(25.5)
Transgender44(0.1)
EthnicityaWhite20 419(82.8)
Black2983(12.1)
Other1267(5.1)
Body Mass Index (kg/m2)a<18.5873(4.6)
18.5–<2511 321(59.9)
25–<301547(8.2)
30+5159(27.3)
Geographical RegionbWestern Europe12 810(43.7)
Southern Europe6626(22.6)
Northern Europe7069(24.1)
Eastern Europe2832(9.7)
HIV RiskaMSM13 229(47.0)
IDU3993(14.2)
Heterosexual10 253(36.4)
Other654(2.3)
ART HistoryART naive7172(24.4)
ART experienced, VL <200 cps/mL19 951(68.0)
ART experienced, VL ≥200 cps/mL2217(7.6)
Smoking StatusaNever8207(44.0)
Current8196(43.9)
Previous2261(12.1)
Hepatitis Ca,c5940(23.6)
Hepatitis Ba,d1340(5.5)
Prior hypertensiona,e5683(23.5)
Prior diabetesa,f1170(5.0)
Prior AIDSa5785(20.9)
Prior cancera1742(6.1)
Prior end-stage liver diseasea184(0.9)
Prior end-stage renal diseasea102(0.4)
Prior cardiovascular diseasea,g666(2.5)
Prior chronic kidney diseasea,h541(2.0)
Prior dyslipidemiaa,i17 984(82.5)
Baseline date, month/year, median (IQR)01/12(01/12–02/13)
Age, years, median (IQR)44.3(36.2–51.3)
CD4 cell nadir, cells/mm3,j, median (IQR)241.0(120.0–384.0)
CD4 at baseline, cells/mm3,j, median (IQR)524.0(357.0–715.0)
Viral load at baseline, cps/mL, median (IQR)39.0(19.0–2228.5)
Total duration of previous ART, years, median (IQR)7.7(3.0–13.9)
CharacteristicsOverall
n(%)
Total29 340(100)
GenderMale21 818(74.4)
Female7478(25.5)
Transgender44(0.1)
EthnicityaWhite20 419(82.8)
Black2983(12.1)
Other1267(5.1)
Body Mass Index (kg/m2)a<18.5873(4.6)
18.5–<2511 321(59.9)
25–<301547(8.2)
30+5159(27.3)
Geographical RegionbWestern Europe12 810(43.7)
Southern Europe6626(22.6)
Northern Europe7069(24.1)
Eastern Europe2832(9.7)
HIV RiskaMSM13 229(47.0)
IDU3993(14.2)
Heterosexual10 253(36.4)
Other654(2.3)
ART HistoryART naive7172(24.4)
ART experienced, VL <200 cps/mL19 951(68.0)
ART experienced, VL ≥200 cps/mL2217(7.6)
Smoking StatusaNever8207(44.0)
Current8196(43.9)
Previous2261(12.1)
Hepatitis Ca,c5940(23.6)
Hepatitis Ba,d1340(5.5)
Prior hypertensiona,e5683(23.5)
Prior diabetesa,f1170(5.0)
Prior AIDSa5785(20.9)
Prior cancera1742(6.1)
Prior end-stage liver diseasea184(0.9)
Prior end-stage renal diseasea102(0.4)
Prior cardiovascular diseasea,g666(2.5)
Prior chronic kidney diseasea,h541(2.0)
Prior dyslipidemiaa,i17 984(82.5)
Baseline date, month/year, median (IQR)01/12(01/12–02/13)
Age, years, median (IQR)44.3(36.2–51.3)
CD4 cell nadir, cells/mm3,j, median (IQR)241.0(120.0–384.0)
CD4 at baseline, cells/mm3,j, median (IQR)524.0(357.0–715.0)
Viral load at baseline, cps/mL, median (IQR)39.0(19.0–2228.5)
Total duration of previous ART, years, median (IQR)7.7(3.0–13.9)

Abbreviations: AIDS, acquired immune deficiency syndrome; ART, antiretroviral therapy; cps, copies; HIV, human immunodeficiency virus; IDU, intravenous drug user; INSTI, integrase inhibitor; IQR, interquartile range; MSM, men who have sex with men; VL, viral load.

Due to small numbers, Australia was combined with Northern Europe, and Eastern Central Europe combined with Eastern Europe.

Hepatitis C (HCV) was defined by use of anti-HCV medication, a positive HCV antibody test, a positive HCV RNA qualitative test, HCV RNA-VL >615 IU/mL, and/or a positive genotype test [25].

Hepatitis B (HBV) was defined by a positive HBV surface antigen and/or HBV RNA-VL >357 IU/mL.

Hypertension 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 mmHg, respectively.

Diabetes was defined by a reported diagnosis, use of antidiabetic medication, glucose ≥11.1 mmol/L, and/or HbA1c ≥6.5% or ≥48 mmol/mol.

Cardiovascular disease (CVD) was defined using a composite diagnosis of myocardial infarction, stroke, or invasive cardiovascular procedure.

Chronic kidney disease (CKD) 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-EPI creatinine equation [26].

Dyslipidemia was defined as total cholesterol >239.4 mg/dL or HDL cholesterol <34.7 mg/dL or triglyceride >203.55 mg/dL or use of lipid-lowering treatments [27].

CD4 and CD8 cell counts were taken as the most recent measurements in the 12 months before baseline. If no measurements were taken before baseline, the first measurement within 12 weeks after baseline was used, and CD4 cell nadir was recorded as the same as CD4 cell count at baseline.

Denominator for percentages is all participants with nonmissing data.

NOTES: Total unknown no. (%): ethnicity 4671 (15.9), body mass index 10 440 (35.6), smoking status 10 676 (36.4), HIV risk 1211 (4.1), HCV 4145 (14.1), HBV 4853 (16.5), hypertension 5126 (17.5), diabetes 6116 (20.8), prior AIDS 1594 (5.4), prior cancer 610 (2.1), prior end-stage liver disease 9143 (31.2), prior end-stage renal disease 2480 (8.5), prior CVD 2865 (9.8), prior CKD 2865 (9.8), dyslipidemia 7543 (25.7).

Table 1.

Characteristics of Participants at Baseline

CharacteristicsOverall
n(%)
Total29 340(100)
GenderMale21 818(74.4)
Female7478(25.5)
Transgender44(0.1)
EthnicityaWhite20 419(82.8)
Black2983(12.1)
Other1267(5.1)
Body Mass Index (kg/m2)a<18.5873(4.6)
18.5–<2511 321(59.9)
25–<301547(8.2)
30+5159(27.3)
Geographical RegionbWestern Europe12 810(43.7)
Southern Europe6626(22.6)
Northern Europe7069(24.1)
Eastern Europe2832(9.7)
HIV RiskaMSM13 229(47.0)
IDU3993(14.2)
Heterosexual10 253(36.4)
Other654(2.3)
ART HistoryART naive7172(24.4)
ART experienced, VL <200 cps/mL19 951(68.0)
ART experienced, VL ≥200 cps/mL2217(7.6)
Smoking StatusaNever8207(44.0)
Current8196(43.9)
Previous2261(12.1)
Hepatitis Ca,c5940(23.6)
Hepatitis Ba,d1340(5.5)
Prior hypertensiona,e5683(23.5)
Prior diabetesa,f1170(5.0)
Prior AIDSa5785(20.9)
Prior cancera1742(6.1)
Prior end-stage liver diseasea184(0.9)
Prior end-stage renal diseasea102(0.4)
Prior cardiovascular diseasea,g666(2.5)
Prior chronic kidney diseasea,h541(2.0)
Prior dyslipidemiaa,i17 984(82.5)
Baseline date, month/year, median (IQR)01/12(01/12–02/13)
Age, years, median (IQR)44.3(36.2–51.3)
CD4 cell nadir, cells/mm3,j, median (IQR)241.0(120.0–384.0)
CD4 at baseline, cells/mm3,j, median (IQR)524.0(357.0–715.0)
Viral load at baseline, cps/mL, median (IQR)39.0(19.0–2228.5)
Total duration of previous ART, years, median (IQR)7.7(3.0–13.9)
CharacteristicsOverall
n(%)
Total29 340(100)
GenderMale21 818(74.4)
Female7478(25.5)
Transgender44(0.1)
EthnicityaWhite20 419(82.8)
Black2983(12.1)
Other1267(5.1)
Body Mass Index (kg/m2)a<18.5873(4.6)
18.5–<2511 321(59.9)
25–<301547(8.2)
30+5159(27.3)
Geographical RegionbWestern Europe12 810(43.7)
Southern Europe6626(22.6)
Northern Europe7069(24.1)
Eastern Europe2832(9.7)
HIV RiskaMSM13 229(47.0)
IDU3993(14.2)
Heterosexual10 253(36.4)
Other654(2.3)
ART HistoryART naive7172(24.4)
ART experienced, VL <200 cps/mL19 951(68.0)
ART experienced, VL ≥200 cps/mL2217(7.6)
Smoking StatusaNever8207(44.0)
Current8196(43.9)
Previous2261(12.1)
Hepatitis Ca,c5940(23.6)
Hepatitis Ba,d1340(5.5)
Prior hypertensiona,e5683(23.5)
Prior diabetesa,f1170(5.0)
Prior AIDSa5785(20.9)
Prior cancera1742(6.1)
Prior end-stage liver diseasea184(0.9)
Prior end-stage renal diseasea102(0.4)
Prior cardiovascular diseasea,g666(2.5)
Prior chronic kidney diseasea,h541(2.0)
Prior dyslipidemiaa,i17 984(82.5)
Baseline date, month/year, median (IQR)01/12(01/12–02/13)
Age, years, median (IQR)44.3(36.2–51.3)
CD4 cell nadir, cells/mm3,j, median (IQR)241.0(120.0–384.0)
CD4 at baseline, cells/mm3,j, median (IQR)524.0(357.0–715.0)
Viral load at baseline, cps/mL, median (IQR)39.0(19.0–2228.5)
Total duration of previous ART, years, median (IQR)7.7(3.0–13.9)

Abbreviations: AIDS, acquired immune deficiency syndrome; ART, antiretroviral therapy; cps, copies; HIV, human immunodeficiency virus; IDU, intravenous drug user; INSTI, integrase inhibitor; IQR, interquartile range; MSM, men who have sex with men; VL, viral load.

Due to small numbers, Australia was combined with Northern Europe, and Eastern Central Europe combined with Eastern Europe.

Hepatitis C (HCV) was defined by use of anti-HCV medication, a positive HCV antibody test, a positive HCV RNA qualitative test, HCV RNA-VL >615 IU/mL, and/or a positive genotype test [25].

Hepatitis B (HBV) was defined by a positive HBV surface antigen and/or HBV RNA-VL >357 IU/mL.

Hypertension 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 mmHg, respectively.

Diabetes was defined by a reported diagnosis, use of antidiabetic medication, glucose ≥11.1 mmol/L, and/or HbA1c ≥6.5% or ≥48 mmol/mol.

Cardiovascular disease (CVD) was defined using a composite diagnosis of myocardial infarction, stroke, or invasive cardiovascular procedure.

Chronic kidney disease (CKD) 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-EPI creatinine equation [26].

Dyslipidemia was defined as total cholesterol >239.4 mg/dL or HDL cholesterol <34.7 mg/dL or triglyceride >203.55 mg/dL or use of lipid-lowering treatments [27].

CD4 and CD8 cell counts were taken as the most recent measurements in the 12 months before baseline. If no measurements were taken before baseline, the first measurement within 12 weeks after baseline was used, and CD4 cell nadir was recorded as the same as CD4 cell count at baseline.

Denominator for percentages is all participants with nonmissing data.

NOTES: Total unknown no. (%): ethnicity 4671 (15.9), body mass index 10 440 (35.6), smoking status 10 676 (36.4), HIV risk 1211 (4.1), HCV 4145 (14.1), HBV 4853 (16.5), hypertension 5126 (17.5), diabetes 6116 (20.8), prior AIDS 1594 (5.4), prior cancer 610 (2.1), prior end-stage liver disease 9143 (31.2), prior end-stage renal disease 2480 (8.5), prior CVD 2865 (9.8), prior CKD 2865 (9.8), dyslipidemia 7543 (25.7).

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