Table 1.
Baseline characteristics.
| Total Cohort | NA | IFNα | P Value | |
| Total, n (%) | 53 | 23 (43) | 23 (43) | |
| Sex, n (%) | Female = 21 (40) Male = 32 (60) | Female = 8 (35) Male = 15 (65) | Female = 9 (40) Male = 14 (60) | .76 |
| Age, y, mean (range) | 48 (24–69) | 48 (28–67) | 45 (24–69) | .37 |
| BMI, kg/m2, mean (range) | 26 ± 4 (17–41) | 25 ± 4 (17–32) | 25 ± 3 (21–32) | .97 |
| Previous therapy, n (%) | 18 (34) | 9 (39) | 9 (39) | |
| AST, U/I, median ± SD (range) | 80 ± 989 (16–5968) | 83 ± 1225 (20–5968) | 80 ± 886 (25–3536) | .45 |
| ALT, U/I, median ± SD (range) | 73 ± 1210 (10–6666) | 94 ± 1370 (32–6666) | 79 ± 1241 (15–5038) | .99 |
| AST/ALT ratio, mean ± SD (range) | 1.0 ± 0.4 (0.3–2.3) | 1.1 ± 0.4 (0.4–2.0) | 1.0 ± 0.4 (0.3–1.9) | .23 |
| gGT, U/I, median ± SD (range) | 54 ± 138 (16–938) | 63 ± 194 (16–938) | 59 ± 68 (19–254) | .57 |
| AP, U/I, mean ± SD (range) | 103 ± 57 (42–309) | 111 ± 43 (45–203) | 119 ± 66 (42–309) | .91 |
| Bilirubin, mg/dL, median ± SD (range) | 1.0 ± 4.2 (0.3–19.8) | 1.1 ± 2.7 (0.4–13.4) | 0.6 ± 5.7 (0.3–19.8) | .04 |
| Albumin, g/dL, median ± SD (range) | 3.8 ± 0.7 (2.2–4.6) | 3.4 ± 0.7 (2.2–4.2) | 4.1 ± 0.4 (3.4–4.6) | .004 |
| Platelets, 1000/mL, median ± SD (range) | 115 ± 80.1 (21–359) | 102 ± 63.1 (26–248) | 180 ± 81.4 (21–319) | .03 |
| INR, mean ± SD (range) | 1.24 ± 0.25 (0.97–2.34) | 1.28 ± 0.22 (0.98–2.00) | 1.22 ± 0.30 (0.99–2.34) | .08 |
| MELD, mean ± SD (range) | 11 ± 5 (6–27) | 12 ± 4 (7–22) | 10 ± 6 (6–27) | .04 |
| Child Pugh classes, n patients (%) | A = 26/41 (63) B = 13 (32) C = 2 (5) | A = 7/18 (39) B = 10 (56) C = 1 (6) | A = 14/17 (82) B = 2 (12) C = 1 (6) | .02 |
| APRI score, median ± SD (range) | 1.5 ± 14.5 (0.1–88.4) | 3.3 ± 17.9 (0.2–88.4) | 1.2 ± 12.8 (0.3–50.5) | .14 |
| HBsAg levels, IU/mL, median ± SD (range) | 10068 ± 8295 (38–28060) | 9858 ± 6976 (1924–26136) | 12121 ± 9795 (554–28060) | .83 |
| HBeAg, n patients (%) | 7/41 (17) | 5/20 (25) | 2/14 (14) | .45 |
| Anti-HBs, n patients (%) | 0/42 (0) | 0 (0) | 0 (0) | |
| Anti-HBc, n patients (%) | 44/44 (100) | 20/20 (100) | 17/17 (100) | |
| Anti-HBe, n patients (%) | 29/41 (71) | 12/20 (60) | 12/15 (80) | .21 |
| HBV DNA viremia, n patients (%) | 26/49 (53) | 7/22 (32) | 13/20 (65) | .03 |
| HBV DNA levels, IU/mL, median ± SD (range) | 16 ± 2578473 (0–17860000) | 0 ± 217813 (0–217813) | 84 ± 4095899 (0–17860000) | .09 |
| HDV RNA levels, IU/mL, median ± SD (range) | 60800 ± 411327 (60–1983000) | 63800 ± 275451 (60–786000) | 218000 ± 554163 (60–1983000) | .85 |
| Liver cirrhosis at baseline, n patients (%) | 28 (53) | 15 (65) | 11 (48) | .23 |
| Clinical endpoints at baseline, n patients (%) | 13/52 (25) | 8 (35) | 5 (22) | .33 |
Statistical comparison between NA and IFNα-based therapy group based on ANOVA (continuous values), Chi-Squared analysis (discrete values) and Mann–Whitney U test (non-normal distributed). ALT = alanine-aminotransferase, Anti-HBc = antibody against hepatitis B core antigen, Anti-HBe = antibody against hepatitis B envelope antigen, Anti-HBs = antibody against hepatitis B surface antigen, AP = alkaline phosphatase, APRI = AST to platelet ratio index, AST = aspartate-aminotransferase, gGT = gamma-glutamyltransferase, HBeAg = hepatitis B envelope antigen, HBsAg = hepatitis B surface antigen, HBV = hepatitis B virus, HDV = hepatitis delta virus, IFNα = interferon alpha, INR = international normalized ratio, MELD = Model of End-Stage Liver Disease, n = number, NA = nucleos(t)ide analogues, SD = standard deviation, U/l = Units per litre.