Assessed for eligibility N=78
Enrollment Dates of inclusion
1
stpatient: 27-Nov-15 Last patient: 27-Oct-16
Excluded:
Not meeting elegibility criteria: 3 Randomized
n=75
Allocated to Control: 25 Allocated to RAL/3TC: 50
Excluded: 1 (consent
witdrawal prior to initiation of medication) Discontinued study medication: 5 (20%)
Lost to follow-up: 2 Virological failure: 1 Change ART: 2
Discontinued study medication: 2 (4%) Medical decision: 1
Pregnancy: 1
Supplementary Figure 1. Patients’ disposition.
Change in Control (n=25)
Change in RAL/3TC (n=49)
Change in RAL/3TC vs. Change in
Control
P- value
PSQI score 1.088 (0.714; 1.658) 0.957 (0.716; 1.280) 0.880 (0.528; 1.468) 0.6243 Adherence, Morisky 3.309 (0.903; 12.130) 1.074 (0.471; 2.449) 0.325 (0.070; 1.512) 0.1517 CD4 cells/mm2 0.990 (0.762; 1.287) 0.972 (0.816; 1.157) 0.981 (0.716; 1.344) 0.9054 CD8 cells/mm2 0.867 (0.664; 1.133) 0.905 (0.757; 1.081) 1.043 (0.757; 1.438) 0.7965 Creatinine, mg/dL 1.042 (0.912; 1.190) 0.977 (0.894; 1.068) 0.938 (0.799; 1.101) 0.4318 eGFR <90 mL/min, CKD EPI 1.268 (0.529; 3.041) 0.917 (0.273; 3.081) 0.723 (0.162; 3.226) 0.6705 Triglycerides, mg/dL 0.901 (0.681; 1.191) 0.992 (0.822; 1.196) 1.101 (0.787; 1.541) 0.5744 Total cholesterol, mg/dL -1.280 (-27.798; 25238) 0.803 (-16.986; 18.593) 2.083 (-29.849; 34.016) 0.8983 LDL cholesterol, mg/dL 2.222 (-20.663; 25.108) -0.611 (-16.103; 14.881) -2.834 (-30.469; 24.802) 0.8407 HDL cholesterol, mg/dL -0.099 (-8.578; 8.380) 1.158 (-4.530; 6.845) 1.257 (-8.953; 11.466) 0.8094 Glucose, mg/dL 0.970 (0.878; 1.072) 0.922 (0.862; 0.986) 0.950 (0.843; 1.071) 0.4046 Insulin, U/L 0.866 (0.571; 1.313) 0.896 (0.666; 1.206) 1.035 (0.621; 1.727) 0.8938 25OH Vitamin D, ng/mL 1.762 (1.246; 2.490) 1.526 (1.201; 1.938) 0.866 (0.569; 1.319) 0.5034 Urine beta-2 microglobulin, mg/g 1.325 (0.278; 6.318) 0.410 (0.149; 1.123) 0.309 (0.048; 1.986) 0.2162
PSQI: Pittsburg Sleep Quality Index
Supplementary Table 1. Change in laboratory parametres,
Change in Control (n=25)
Change in RAL/3TC (n=49)
Change in RAL/3TC vs. Change in
Control
P-value
BMI, kg/m
2-0.107 (-0.261; 0.072) 0.046(--0.093; 0.144) 0.152(0.071; 0.168) 0.0532 Fat (DXA)
Total body fat, grams -270 (-602; 61) 51 (-189; 284) 321 (-84; 726) 0.1200
Trunk fat, grams 88 (-240; 416) 20 (-206; 245) -69 (-467; 330) 0.7358
Bone (DXA) Lumbar spine T-score (mean, SD)
Total hip BMD g/cm
20.15 (-0.37; 0.68) -0.067 (-0.43; 0.29) -0.22 (-0.85; 0.42) 0.4981 Femur T-score
(mean, SD)
0.01 (0; 0.02) 0 (-0.01; 0.02) -0.01 (-0.02; 0.02) 0.3366 L1-L4 BMD g/cm
20.16 (-0.55; 0.78) 0.09 (-0.37; 0.55) -0.03 (-0.84; 0.78) 0.9455 Lumbar spine T-score
(mean, SD)
0 ( -0.01; 0.02) -0.01 (-0.02; 0.02) 0 (-0.02; 0.02) 0.8455
Supplementary Table 2. Change in body composition parametres.
HR: 1.00 (95% CI 0.54; 1.83)
Incidence Rate Ratio (IRR)
95% CI P-Value
Control 1
0.5550
RAL/3TC 0.87 (0.55; 1.38)