TABLE 2.
Baseline demographics and characteristics of HIV-negative, hepatitis B core antibody-positive (anti-HBc+) cohort stratified by hepatitis B surface antibody (anti-HBs) status
| During treatment | Total (N = 17 266) | Anti-HBs-/unknown (N = 7174) | Anti-HBs+ (N = 10 092) |
|---|---|---|---|
| ALT ≥2× ULN, N (%) | 2336 (14) | 922 (13) | 1414 (14) |
| ALT ≥4× ULN, N (%) | 577 (3) | 236 (3) | 341 (3) |
| ALT >300 IU/mL during treatment, N (%) | 31 (0) | 11 (0) | 20 (0) |
| ALT >1000 IU/mL during treatment, N (%) | 3 (0) | 1 (0) | 2 (0) |
| HBV DNA increase 1-log during therapy, N (%) | 1 (0) | 1 (0) | 1 (0) |
| Significant hepatic events during therapy, N (%)a | 4 (0.0) | 1 (0.0) | 3 (0.0) |
| HBV DNA flare | 1 | 0 | 1 |
| Undetermined cause | 3 | 1 | 3 |
| Post-treatment | Total (N = 13 390) | Anti-HBs-negative or unknown (N = 5536) | Anti-HBs+ (N = 7854) |
| ALT ≥2× ULN after treatment, N (%) | 1264 (9) | 509 (9) | 755 (10) |
| ALT ≥4× ULN after treatment, N (%) | 387 (3) | 167 (3) | 220 (3) |
| ALT >300 IU/mL after treatment, N (%) | 58 (0.4) | 23 (0.4) | 35 (0.4) |
| ALT >300 IU/mL during or after treatment, N (%) | 85 (0.6) | 33 (0.6) | 52 (0.7) |
| ALT >1000 IU/mL during treatment, N (%) | 10 (0.1) | 4 (0.1) | 6 (0.1) |
| HBV DNA tested at baseline, N (%) | 840 (5) | 495 (7) | 345 (3) |
| HBV DNA increase 1-log after therapy, N (%) | 3 (0.0) | 2 (0.0) | 1 (0.0) |
| Significant hepatic events after therapy, N (%)a | 35 (0.3) | 11 (0.2) | 24 (0.3) |
| Post-treatmentb | Total (N = 10 595) | Anti-HBs-negative or unknown (N = 3930) | Anti-HBs+ (N = 6265) |
| ALT ≥2× ULN after treatment, N (%) | 1102 (10) | 445 (10) | 657 (10) |
| ALT ≥4× ULN after treatment, N (%) | 340 (3) | 150 (3) | 190 (3) |
| ALT >300 IU/mL after treatment, N (%) | 50 (0.5) | 19 (0.5) | 30 (0.5) |
| ALT >300 IU/mL during or after treatment, N (%) | 70 (0.7) | 26 (0.7) | 43 (0.7) |
| ALT >1000 IU/mL during treatment, N (%) | 7 (0.1) | 2 (0.1) | 5 (0.1) |
| HBV DNA increase 1-log after therapy, N (%) | 3 (0.0) | 2 (0.0) | 1 (0.0) |
| Significant hepatic events after therapy, N (%)a | 31 (0.3) | 10 (0.3) | 21 (0.3) |
| HBV DNA flare, N (%) | 1 | 0 (0) | 1 (4.8) |
| Confirmed, N (%) no HBV DNA flare | 10 | 2 (20.0) | 8 (38.1) |
| Undetermined cause, N (%) | 20 | 8 (80.0) | 12 (57.1) |
ALT, alanine aminotransferase.
a
Significant hepatic events were defined as an increase in ALT >100 IU/L and increase in total bilirubin >2.5 μg/dL.
b
Post-treatment values reported for patients with complete ALT data in the absence of hepatitis C relapse