Table 1.

Characteristics of 713 Participants in the SCOLTA Dolutegravir Cohort, According to Antiretroviral Regimen

Total3TC+DTGRPV+DTGPI+DTG3TC/ABC/DTGTDF/FTC+DTGTAF/FTC+DTG
n = 713n = 75n = 45 n = 60 n = 326n = 148 n = 59P
Sex M, No. (%)533 (74.7)59 (78.7)26 (57.8)45 (75.0)244 (74.8)111 (75.0)48 (81.4).12
Age, mean ± SD, y47.2 ± 11.650.6 ± 11.151.8 ± 10.850.4 ± 11.346.9 ± 11.545.0 ± 11.243.8 ± 12.4<.0001
Caucasian, No. (%)648 (90.9)69 (92.0)43 (95.6)55 (91.7)294 (90.2)139 (93.9)48 (81.4).09
Weight, mean ± SD, kg70.5 ± 13.473.3 ± 13.970.2 ± 13.370.4 ± 11.569.8 ± 13.170.6 ± 14.671.4 ± 13.0.46
BMI (n = 608), mean ± SD, kg/m224.2 ± 4.024.5 ± 3.5 25.0 ± 3.824.2 ± 3.524.0 ± 4.024.0 ± 4.224.7 ± 4.3.61
Risk factor for HIV acquisition, No. (%)
Sexual513 (72.0)59 (78.7)33 (73.3)39 (65.0)245 (75.2)85 (57.4)52 (88.1)
IVDU112 (15.7)8 (10.7)11 (24.2)14 (23.3)42 (12.8)32 (21.6)5 (8.5)<.0001
Other88 (12.3)8 (10.7)1 (2.2)7 (11.7)39 (12.0)31 (21.0)2 (3.4)
CD4, mean ± SD, cells/mL570 ± 367725 ± 422699 ± 318614 ± 317617 ± 359419 ± 330364 ± 312<.0001
CD4/CD8 (n = 616), median (IQR) 0.64 (0.34–0.99)0.90 (0.57–1.23)0.92 (0.62–1.14)0.67 (0.50–0.97)0.68 (0.41–1.03)0.44 (0.17–0.74)0.38 (0.11–0.67)<.0001
Naïve, No. (%)195 (27.4)5 (6.7)1 (2.2)1 (1.7)75 (23.0)68 (45.9)45 (76.3)<.0001
CDC stage C, No. (%)159 (22.3)10 (13.3)9 (20.0)20 (33.3)69 (21.2)38 (25.7)13 (22.0).07
HIV-RNA >50 copies/mL (experienced participants), No. (%)95 (18.3)6 (8.6)1 (2.3)22 (37.3)39 (15.5)24 (30.0)3 (21.4)<.0001
Years of ART (experienced participants), median (IQR)9.8 (4.3–17.4)10.8 (7.5–17.6)12.1 (6.7–18.3)13.5 (6.8–19.2)7.9 (4.0–15.5)9.2 (3.2–17.3)9.1 (4.5–19.0).004
HCV active infection (baseline), No. (%)66 (9.3)2 (2.7)2 (4.4)7 (11.7)27 (8.3)25 (16.9)3 (5.1).004
HCV eradication during follow-up (n = 66), No. (%)30 (45.4)0 (0)1 (50.0)3 (42.9)15 (55.6)10 (40.0)1 (33.3).66
Statin use at baseline, No. (%)65 (9.1)11 (14.7)7 (15.6)9 (15.0)26 (8.0)9 (6.1)3 (5.1).05
Statin started during the first year of observation (n = 648), No. (%)17 (2.6)2 (3.1)3 (7.9)2 (3.9)6 (2.0)3 (2.2)1 (1.8).38
Total3TC+DTGRPV+DTGPI+DTG3TC/ABC/DTGTDF/FTC+DTGTAF/FTC+DTG
n = 713n = 75n = 45 n = 60 n = 326n = 148 n = 59P
Sex M, No. (%)533 (74.7)59 (78.7)26 (57.8)45 (75.0)244 (74.8)111 (75.0)48 (81.4).12
Age, mean ± SD, y47.2 ± 11.650.6 ± 11.151.8 ± 10.850.4 ± 11.346.9 ± 11.545.0 ± 11.243.8 ± 12.4<.0001
Caucasian, No. (%)648 (90.9)69 (92.0)43 (95.6)55 (91.7)294 (90.2)139 (93.9)48 (81.4).09
Weight, mean ± SD, kg70.5 ± 13.473.3 ± 13.970.2 ± 13.370.4 ± 11.569.8 ± 13.170.6 ± 14.671.4 ± 13.0.46
BMI (n = 608), mean ± SD, kg/m224.2 ± 4.024.5 ± 3.5 25.0 ± 3.824.2 ± 3.524.0 ± 4.024.0 ± 4.224.7 ± 4.3.61
Risk factor for HIV acquisition, No. (%)
Sexual513 (72.0)59 (78.7)33 (73.3)39 (65.0)245 (75.2)85 (57.4)52 (88.1)
IVDU112 (15.7)8 (10.7)11 (24.2)14 (23.3)42 (12.8)32 (21.6)5 (8.5)<.0001
Other88 (12.3)8 (10.7)1 (2.2)7 (11.7)39 (12.0)31 (21.0)2 (3.4)
CD4, mean ± SD, cells/mL570 ± 367725 ± 422699 ± 318614 ± 317617 ± 359419 ± 330364 ± 312<.0001
CD4/CD8 (n = 616), median (IQR) 0.64 (0.34–0.99)0.90 (0.57–1.23)0.92 (0.62–1.14)0.67 (0.50–0.97)0.68 (0.41–1.03)0.44 (0.17–0.74)0.38 (0.11–0.67)<.0001
Naïve, No. (%)195 (27.4)5 (6.7)1 (2.2)1 (1.7)75 (23.0)68 (45.9)45 (76.3)<.0001
CDC stage C, No. (%)159 (22.3)10 (13.3)9 (20.0)20 (33.3)69 (21.2)38 (25.7)13 (22.0).07
HIV-RNA >50 copies/mL (experienced participants), No. (%)95 (18.3)6 (8.6)1 (2.3)22 (37.3)39 (15.5)24 (30.0)3 (21.4)<.0001
Years of ART (experienced participants), median (IQR)9.8 (4.3–17.4)10.8 (7.5–17.6)12.1 (6.7–18.3)13.5 (6.8–19.2)7.9 (4.0–15.5)9.2 (3.2–17.3)9.1 (4.5–19.0).004
HCV active infection (baseline), No. (%)66 (9.3)2 (2.7)2 (4.4)7 (11.7)27 (8.3)25 (16.9)3 (5.1).004
HCV eradication during follow-up (n = 66), No. (%)30 (45.4)0 (0)1 (50.0)3 (42.9)15 (55.6)10 (40.0)1 (33.3).66
Statin use at baseline, No. (%)65 (9.1)11 (14.7)7 (15.6)9 (15.0)26 (8.0)9 (6.1)3 (5.1).05
Statin started during the first year of observation (n = 648), No. (%)17 (2.6)2 (3.1)3 (7.9)2 (3.9)6 (2.0)3 (2.2)1 (1.8).38

Abbreviations: 3TC, lamivudine; ABC, abacavir; ART, antiretroviral therapy; BMI, body mass index; CDC, Centers for Disease Control and Prevention; DTG, dolutegravir; FTC, emtricitabine; HCV, hepatitis C virus; IQR, interquartile range; IVDU, intravenous drug use; RPV, rilpivirine; PI, protease inhibitor (atazanavir, darunavir); SCOLTA, Surveillance Cohort Long-Term Toxicity Antiretrovirals; TAF, tenofovir alafenamide; TDF, tenofovir disoproxil fumarate.

Table 1.

Characteristics of 713 Participants in the SCOLTA Dolutegravir Cohort, According to Antiretroviral Regimen

Total3TC+DTGRPV+DTGPI+DTG3TC/ABC/DTGTDF/FTC+DTGTAF/FTC+DTG
n = 713n = 75n = 45 n = 60 n = 326n = 148 n = 59P
Sex M, No. (%)533 (74.7)59 (78.7)26 (57.8)45 (75.0)244 (74.8)111 (75.0)48 (81.4).12
Age, mean ± SD, y47.2 ± 11.650.6 ± 11.151.8 ± 10.850.4 ± 11.346.9 ± 11.545.0 ± 11.243.8 ± 12.4<.0001
Caucasian, No. (%)648 (90.9)69 (92.0)43 (95.6)55 (91.7)294 (90.2)139 (93.9)48 (81.4).09
Weight, mean ± SD, kg70.5 ± 13.473.3 ± 13.970.2 ± 13.370.4 ± 11.569.8 ± 13.170.6 ± 14.671.4 ± 13.0.46
BMI (n = 608), mean ± SD, kg/m224.2 ± 4.024.5 ± 3.5 25.0 ± 3.824.2 ± 3.524.0 ± 4.024.0 ± 4.224.7 ± 4.3.61
Risk factor for HIV acquisition, No. (%)
Sexual513 (72.0)59 (78.7)33 (73.3)39 (65.0)245 (75.2)85 (57.4)52 (88.1)
IVDU112 (15.7)8 (10.7)11 (24.2)14 (23.3)42 (12.8)32 (21.6)5 (8.5)<.0001
Other88 (12.3)8 (10.7)1 (2.2)7 (11.7)39 (12.0)31 (21.0)2 (3.4)
CD4, mean ± SD, cells/mL570 ± 367725 ± 422699 ± 318614 ± 317617 ± 359419 ± 330364 ± 312<.0001
CD4/CD8 (n = 616), median (IQR) 0.64 (0.34–0.99)0.90 (0.57–1.23)0.92 (0.62–1.14)0.67 (0.50–0.97)0.68 (0.41–1.03)0.44 (0.17–0.74)0.38 (0.11–0.67)<.0001
Naïve, No. (%)195 (27.4)5 (6.7)1 (2.2)1 (1.7)75 (23.0)68 (45.9)45 (76.3)<.0001
CDC stage C, No. (%)159 (22.3)10 (13.3)9 (20.0)20 (33.3)69 (21.2)38 (25.7)13 (22.0).07
HIV-RNA >50 copies/mL (experienced participants), No. (%)95 (18.3)6 (8.6)1 (2.3)22 (37.3)39 (15.5)24 (30.0)3 (21.4)<.0001
Years of ART (experienced participants), median (IQR)9.8 (4.3–17.4)10.8 (7.5–17.6)12.1 (6.7–18.3)13.5 (6.8–19.2)7.9 (4.0–15.5)9.2 (3.2–17.3)9.1 (4.5–19.0).004
HCV active infection (baseline), No. (%)66 (9.3)2 (2.7)2 (4.4)7 (11.7)27 (8.3)25 (16.9)3 (5.1).004
HCV eradication during follow-up (n = 66), No. (%)30 (45.4)0 (0)1 (50.0)3 (42.9)15 (55.6)10 (40.0)1 (33.3).66
Statin use at baseline, No. (%)65 (9.1)11 (14.7)7 (15.6)9 (15.0)26 (8.0)9 (6.1)3 (5.1).05
Statin started during the first year of observation (n = 648), No. (%)17 (2.6)2 (3.1)3 (7.9)2 (3.9)6 (2.0)3 (2.2)1 (1.8).38
Total3TC+DTGRPV+DTGPI+DTG3TC/ABC/DTGTDF/FTC+DTGTAF/FTC+DTG
n = 713n = 75n = 45 n = 60 n = 326n = 148 n = 59P
Sex M, No. (%)533 (74.7)59 (78.7)26 (57.8)45 (75.0)244 (74.8)111 (75.0)48 (81.4).12
Age, mean ± SD, y47.2 ± 11.650.6 ± 11.151.8 ± 10.850.4 ± 11.346.9 ± 11.545.0 ± 11.243.8 ± 12.4<.0001
Caucasian, No. (%)648 (90.9)69 (92.0)43 (95.6)55 (91.7)294 (90.2)139 (93.9)48 (81.4).09
Weight, mean ± SD, kg70.5 ± 13.473.3 ± 13.970.2 ± 13.370.4 ± 11.569.8 ± 13.170.6 ± 14.671.4 ± 13.0.46
BMI (n = 608), mean ± SD, kg/m224.2 ± 4.024.5 ± 3.5 25.0 ± 3.824.2 ± 3.524.0 ± 4.024.0 ± 4.224.7 ± 4.3.61
Risk factor for HIV acquisition, No. (%)
Sexual513 (72.0)59 (78.7)33 (73.3)39 (65.0)245 (75.2)85 (57.4)52 (88.1)
IVDU112 (15.7)8 (10.7)11 (24.2)14 (23.3)42 (12.8)32 (21.6)5 (8.5)<.0001
Other88 (12.3)8 (10.7)1 (2.2)7 (11.7)39 (12.0)31 (21.0)2 (3.4)
CD4, mean ± SD, cells/mL570 ± 367725 ± 422699 ± 318614 ± 317617 ± 359419 ± 330364 ± 312<.0001
CD4/CD8 (n = 616), median (IQR) 0.64 (0.34–0.99)0.90 (0.57–1.23)0.92 (0.62–1.14)0.67 (0.50–0.97)0.68 (0.41–1.03)0.44 (0.17–0.74)0.38 (0.11–0.67)<.0001
Naïve, No. (%)195 (27.4)5 (6.7)1 (2.2)1 (1.7)75 (23.0)68 (45.9)45 (76.3)<.0001
CDC stage C, No. (%)159 (22.3)10 (13.3)9 (20.0)20 (33.3)69 (21.2)38 (25.7)13 (22.0).07
HIV-RNA >50 copies/mL (experienced participants), No. (%)95 (18.3)6 (8.6)1 (2.3)22 (37.3)39 (15.5)24 (30.0)3 (21.4)<.0001
Years of ART (experienced participants), median (IQR)9.8 (4.3–17.4)10.8 (7.5–17.6)12.1 (6.7–18.3)13.5 (6.8–19.2)7.9 (4.0–15.5)9.2 (3.2–17.3)9.1 (4.5–19.0).004
HCV active infection (baseline), No. (%)66 (9.3)2 (2.7)2 (4.4)7 (11.7)27 (8.3)25 (16.9)3 (5.1).004
HCV eradication during follow-up (n = 66), No. (%)30 (45.4)0 (0)1 (50.0)3 (42.9)15 (55.6)10 (40.0)1 (33.3).66
Statin use at baseline, No. (%)65 (9.1)11 (14.7)7 (15.6)9 (15.0)26 (8.0)9 (6.1)3 (5.1).05
Statin started during the first year of observation (n = 648), No. (%)17 (2.6)2 (3.1)3 (7.9)2 (3.9)6 (2.0)3 (2.2)1 (1.8).38

Abbreviations: 3TC, lamivudine; ABC, abacavir; ART, antiretroviral therapy; BMI, body mass index; CDC, Centers for Disease Control and Prevention; DTG, dolutegravir; FTC, emtricitabine; HCV, hepatitis C virus; IQR, interquartile range; IVDU, intravenous drug use; RPV, rilpivirine; PI, protease inhibitor (atazanavir, darunavir); SCOLTA, Surveillance Cohort Long-Term Toxicity Antiretrovirals; TAF, tenofovir alafenamide; TDF, tenofovir disoproxil fumarate.

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