Table 1 Demographics and patient characteristics (intent-to-treat population)
Parameter | Naïve (N = 27) | Restart (N = 30) | Switch (N = 10) | Total (N = 67) |
|---|---|---|---|---|
Sex; n (%) male | 17 (63%) | 22 (73%) | 6 (60%) | 45 (67%) |
Age (years); median [range] | 34 [23-49] | 38.5 [26-54] | 40.5 [31-49] | 37 [23-54] |
BMI (kg/m2); median [range] | 21.77 [15.6-30.9] | 21.90 [13.1-32.2] | 24.44 [17.0-34.1] | 22.13 [13.1-34.1] |
Time since onset infection (years); median [range] | 4.79 [0.1-23.8] | 9.18 [2.4-19.3] | 12.41 [3.6-16.3] | 8.70 [0.1-23.8] |
HIV-1 RNA ≥ 400 copies/mL; n (%) | 24 (89%)1 | 28 (93%)1 | 0 (0%) | 52 (81%)1 |
HIV-1 RNA (log10 copies/mL); median [IQR] | 5.00 [4.7-5.6] | 4.70 [4.1-5.3] | 1.69 [1.69-1.69] | 4.70 [3.50-5.21] |
CD4+ cell count (cells/mm3); median [IQR] | 193 [54-256] | 169 [91-285] | 436 [289-694] | 207 [100-297] |
CD8+ cell count (cells/mm3); median [IQR] | 592 [445-1059] | 879 [437-1329] | 870 [490-1129] | 764 [442-1190] |
Antiretroviral medications started at baseline as part of combination regimen | ||||
NRTI; n/N (%) | 67/67 (100) | |||
Tenofovir disoproxil fumarate (TDF); n (%) | 27/27 (100) | 30/30 (100) | 10/10 (100) | 67/67 (100) |
Emtricitabine or Lamivudine (FTC/3TC) | 27/27 (100) | 27/30 (90) | 10/10 (100) | 64/67 (96) |
Didanosine (DDI) | 0 | 3/30 (10) | 1/10 (10) | 4/67 (6) |
Tenofovir disoproxil fumarate | - | - | - | 67/67 (100) |
Emtricitabine | - | - | - | 47/67 (70) |
Lamivudine | - | - | - | 15/67 (22) |
PI; n/N (%) | - | - | - | 55/67 (82) |
Atazanavir/Ritonavir (ATV/r) | 19/27 (70) | 22/30 (73) | 8/10 (80) | 49/67 (73) |
Atazanavir | 1/27 (4) | 4/30 (13) | 1/10 (10) | 6/67 (9) |
NNRTI; n/N (%) | - | - | - | 11/67 (16) |
Efavirenz (EFV) | 5/27 (19) | 2/30 (7) | 0 | 7/67 (10) |
Nevirapine (NVP) | 2/27 (7) | 2/30 (7) | 0 | 4/67 (6) |
Regimen: n/N (%) | ||||
PI + NRTI | 20/27 (74) | 26/30 (87) | 9/10 (90) | 55/67 (82) |
TDF + FTC or 3TC + ATV/r | 19/27 (70) | 19/30 (63) | 8/10 (80) | 46/67 (69) |
TDF + FTC or 3TC + ATV | 1/27 (4) | 4/30 (13) | 1/10 (10) | 6/67 (9) |
TDF + DDI + ATV/r | 0 | 3/30 (10%) | 0 | 3/67 (4) |
NNRTI + NRTI; n (%) | 7/27 (26) | 4/30 (13) | 0 | 11/67 (16) |
TDF + FTC or 3TC + EFV | 5/27 (19) | 2/30 (7) | 0 | 7/67 (10) |
TDF + FTC or 3TC + NVP | 2/27 (7) | 2/30 (7) | 0 | 4/67 (6) |
All NRTI; n (%) | 0 | 0 | 1/10 (10) | 1/67 (1) |
TDF + FTC or 3TC + DDI | 1/10 (10) | 1/67 (1) | ||
Opiate treatment at screening | ||||
Time since onset opiate treatment (years); median [range] | 3.01 [0.1-11.7] | 6.03 [0.00-24.7] | 8.24 [0.2-18.1] | 5.26 [0.0-24.7] |
Time since start stable dose (years); median [range] | - | - | - | 1.6 [0-11.7] |
Opiate treatment dose (mg); mean (SD) | ||||
Methadone (n = 57; 85%) | 84.1 (33.31) | 98.2 (49.47) | 70.0 (62.29) | 88.8 (44.5 mg) |
Levomethadone (n = 9; (13%) | 70.02 | 12.0 (20.41) | 73.8 (39.45) | 93.9 (36.8 mg) |
Buprenorphine (n = 1; 1%) | - | 12.0 | - | 12.02 |