TABLE 3.
NA treatment should be immediately re‐installed if one of the following criteria is met: |
1. Confirmed (i.e., two consecutive central laboratory results) increase in direct bilirubin from baseline and ALT ULN at the confirmatory test |
2. Confirmed sustained increase in prothrombin time ≥ 2.0 seconds from baseline with appropriate vitamin K levels and elevated ALT |
3. Confirmed elevated ALT 10× ULN with or without associated symptoms |
4. ALT 2× ULN and ≤ 5× ULN persisting for ≥ 84 days (12 weeks) as well as an HBV‐DNA relapse ≥ 20,000 copies/mL |
5. ALT 5× ULN and ≤ 10× ULN persisting for ≥ 28 days (4 weeks) |