Table 1 Baseline characteristics of study participants by PrEP user status

From: Adults on pre-exposure prophylaxis (tenofovir-emtricitabine) have faster clearance of anti-HIV monoclonal antibody VRC01

Characteristics

Categories

Non-PrEP Users (N = 24a)

PrEP Users (N = 24a)

  

N (%)

VRC01 Dose (mg/kg) Received

10 mg/kg

12 (50%)

12 (50%)

 

30 mg/kg

12 (50%)

12 (50%)

Demographics

 Sex assigned at birth

Male

23 (95.8%)

24 (100%)

 

Female

1 (4.2%)

0 (0%)

 Race

Black

6 (25.0%)

7 (29.2%)

 

Other

18 (75%)

17 (70.8%)

  

Median (Range)

Body mass index (kg/m2)

 

25.8 (19.7, 37.6)

25.4 (18.6, 34.5)

Weight (kg)

 

75.2 (59.9, 130.2)

80.8 (55.7, 106.1)

Age (y)

 

31 (19, 50)

27 (20, 43)

Vital Signs

 Diastolic blood pressure (mmHg)

 

74 (59, 89)

76 (58, 94)

 Systolic blood pressure (mmHg)

 

122 (109, 136)

124 (95, 146)

 Pulse rate (beats/min)

 

77 (51, 101)

78 (50, 105)

 Respiratory rate (breaths/min)

 

16 (12, 24)

17 (12, 24)

 Temperature (°C)

 

36.6 (36.0, 37.1)

36.8 (35.8, 37.3)

Safety hematology and chemistry labs

 Alanine aminotransferase (units/L)

 

20 (8, 87)

20 (7, 70)

 Basophils (cells/mm3)

 

31 (0, 140)

23 (0, 100)

 Creatinine clearance (CrCL) (mL/min)

 

126.2 (80.8, 212.3)

128.9 (81.2, 180.9)

 Eosinophils (cells/mm3)

 

101 (38, 380)

120 (10, 600)

 Hematocrit (%)

 

43.6 (39.9, 48.0)

44.1 (40.2, 48.5)

 Hemoglobin (g/dl)

 

14.6 (12.8, 15.6)

14.5 (12.9, 16.3)

 Lymphocytes (cells/mm3)

 

1932 (1043, 3058)

1800 (920, 3759)

 Erythrocyte mean corpuscular volume (fL)

 

90.4 (80.0, 100.3)

91 (84.6, 96.7)

 Monocytes (cells/mm3)

 

455 (211, 740)

485 (260, 3160)

 Neutrophils (cells/mm3)

 

3192 (1712, 5988)

3370 (1138, 5483)

 Platelets (103/mm3)

 

229.5 (148.0, 335.0)

227.5 (169.0, 432.0)

 Leukocytes (103/mm3)

 

5.9 (4.2, 9.8)

6 (3.1, 9.9)

Inflammatory markersa (pg/mL)

 IFN-γ

 

3.1 (0.7, 11.6)

5.5 (0.9, 454.9)

 IL-6

 

0.4 (0.1, 1.3)

0.4 (0.1, 2.9)

 IL-8

 

13.6 (4.8, 91.3)

10.4 (8.0, 53.2)

 IL-10

 

0.3 (0.1, 0.5)

0.4 (0.1, 2.8)

 TNF-α

 

1.2 (0.6, 13.2)

1.3 (0.8, 14.8)

Intestinal permeabilitya

 Intestinal Fatty Acid Binding protein (I-FABP) (pg/mL)

 

710.1 (295.6, 3453.0)

980.2 (230.3, 3169.3)

 Lipopolysaccharide Binding Protein (LBP) (mcg/mL)

 

17.9 (4.8, 25.8)

17.6 (9.2, 28.1)

HIV-1 exposure

 Behavioral risk score

 

−0.9 (−2.2, 1.0)

−0.6 (−1.8, 0.8)

  1. A participant was defined as a PrEP user if they met the following criteria during the study in HVTN 704/HPTN 085: (1) accessed the PrEP referral program on at least one occasion per self-report, (2) self-reported intermittent or continuous PrEP use, and (3) confirmation of ≥3 positive Tenofovir Disoproxil Fumarate (TDF)-detection tests out of dry blood spot (DBS) samples collected at approximately all 10 infusion visits. A participant was defined as a non-PrEP user if they did not self-report any PrEP use and had no DBS samples tested positive for TDF.
  2. aOne non-PrEP user participant and one PrEP user participant who started PrEP after enrollment had missing baseline specimen and hence missing cytokine and permeability marker measurements.
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