Article Figures & Data
Figures
- FIG. 1.
Correlation between serum HBcrAg concentration and ALT, serum HBV DNA, intrahepatic total HBV DNA, and cccDNA levels. Open squares, circles, and triangles indicate samples which are HBeAg-positive, whereas closed squares, circles, and triangles indicate samples lacking HBeAg.
Tables
- TABLE 1.
Correlation of HBcrAg concentration with clinical parameters
Patient (n = 54) characteristic Valuea kU/ml HBcrAg [median (range)] P value Males/females 44:10 1,070 (<1.0-899,000) vs 7,660 (12.8-356,000) 0.130 Age (yrs) 42 ± 10 HBeAg/anti-HBe 17:37 35,700 (1,320-899,000) vs 153 (<1.0-49,600) <0.001 ALT level (IU/liter) 86 (21-576) ≤2 × ULN (n = 29) vs >2 × ULN (n = 25) 1,180 (<1.0-899,000) vs 1,860 (1.0-366,000) 0.621 Serum HBV DNA (copies/ml) 1.7 × 107 (<300-3.6 × 109) Intrahepatic total HBV DNA (copies/cell) 33.3 (<0.002-670) Intrahepatic cccDNA (copies/cell) 1.3 (<0.002-23.3) HBcrAg concn (kU/ml) 1,180 (<1.0-9.0 × 105) ↵ a Mean ratio, mean ± standard deviation, or median (range).
- TABLE 2.
Correlation of HBcrAg concentration with histology and hepatocyte HBcAg immunostaining data
Histology data (n = 54) No. (%) of patients kU/ml HBcrAg [median (range)] P value Knodell necroinflammation score 0-5 27 (50) 23.8 (<1.0-899,000)} 0.056 6-9 23 (42)} 2,850 (55.6-51,900) >9 4 (8) Knodell fibrosis score 0 18 (33)} 193 (<1.0-899,000)} 0.079 1 12 (22) 3 21 (39)} 2,990 (55.6-92,600) 4 3 (6) % Staining (n = 38) Cytoplasmic HBcAg 0 14 (37) 124 (2.4-8,700) <0.001 ≤5 13 (34) 2,670 (23.8-92,600) 6-25 5 (13) 49,600 (17,200-126,000) 26-50 4 (11) 129,000 (1,860-899,000) 51-75 2 (5) 204,000 (41,700-366,000)} Nuclear HBcAg 0 15 (39) 1,150 (2.4-51,900) 0.004 ≤5 14 (37) 2,210 (23.8-92,600) 6-25 6 (16) 10,500 (1,860-244,000) 26-50 3 (8) 366,000 (41,700-899,000)} - TABLE 3.
Correlation between histological improvement and reduction in levels of intrahepatic and serum HBV DNA and serum HBcrAg during treatment
Marker Median log reduction at wk 48 with improvement in Knodell histological index of: P value >2 ≤2 Intrahepatic total HBV DNA (copies/cell) 2.07 1.83 0.071 cccDNA (copies/cell) 1.09 0.75 0.022 HBcrAg (kU/ml) 1.72 0.83 0.031 Serum HBV DNA (copies/ml) 4.84 4.42 0.094 - TABLE 4.
Correlation between the degree of cytoplasmic and nuclear HBcAg staining and the logarithmic reduction in level of HBcrAg at week 48 of therapy
Location % of cells that stained pos at wk 48 for HBcAg No. of patients Median reduction in HBcrAg (log10 kU/ml) P value Cytoplasm 0 26 1.87 0.017 ≤5 8 1.36 6-25 3 0.5 26-50 1 0.3 Nucleus 0 27 1.75 ≤5 7 1.34 0.007 6-25 4 0.4 - TABLE 5.
Baseline and week-24 parameters which are predictive of undetectable serum HBV DNA at week 48 of therapy
Parameter Value Proportion (%) of patients with undetectable serum HBV DNA P value Baseline HBcrAg <40,000 vs ≥40,000 kU/ml 29/31 (94) vs 2/8 (25) <0.001 Baseline intrahepatic total HBV DNA <100 vs ≥100 copies/cell 27/29 (93) vs 2/8 (25) < 0.001 Baseline cccDNA <5 vs ≥5 copies/cell 27/29 (93) vs 2/8 (25) < 0.001 Baseline cytoplasmic HBcAg staining ≤25% vs >25% 28/32 (88) vs 2/6 (33) 0.012 Baseline nuclear HBcAg staining ≤25% vs >25% 30/35 (86) vs 0/3 (0) 0.007 Wk-24 HBcrAg <200 vs ≥200 kU/ml 22/23 (96) vs 9/16 (56) 0.004
