Table 2.
HBV status during immune checkpoint inhibitors therapy
| N (%) | HBV DNA ≤100 IU/mL on NUCs (n=35) | HBV DNA >100 IU/mL on NUCs (n=19) | Patients with HBV without NUCs (n=6) |
| Baseline HBV DNA | |||
| Undetectable | 31 (88.6) | 0 | 1 (16.7) |
| Median (range) for detectable cases, IU/mL | 41 (12–82) | 187 000 (109 –27 500 000) | 777 (252–35 900) |
| HBV reactivation | 0 | 0 | 1 |
| HBV DNA during ICI treatment | |||
| ≥1 log10 elevation | 0 | 0 | 1 (16.7) |
| ≥2 log10 elevation | 0 | 0 | 0 |
| Undetectable to detectable | 3 (8.6) | 0 | 0 |
| Undetectable to >1000 IU/mL | 0 | 0 | 0 |
| Peak HBV DNA during ICI, IU/mL. median (range) | <10 (<10–1130) | 381 (<10–2700) | 70 (<10–1 68 000) |
| Hepatitis flare | |||
| ALT >100 U/L | 10 (28.6) | 11 (57.9) | 2 (33.3) |
| ALT >5X ULN | 5 (14.3) | 4 (21.1) | 1 (16.7) |
| ALT >10X ULN | 2 (5.7) | 2 (10.5) | 0 (0) |
| Icteric flare* | 5 (14.3) | 6 (31.6) | 2 (33.3) |
| HBV DNA elevation and ALT >100 U/L | 0 | 0 | 1 (16.7) |
| iRAE hepatitis | 1 (2.9) | 1 (5.3) | 0 (0) |
*Icteric flare is defined as serum ALT raised >3X ULN together with serum total bilirubin >2X ULN.
ALT, alanine aminotransferase; HBV, hepatitis B virus; ICI, immune checkpoint inhibitor; iRAE, immunotherapy related adverse event; NUCs, nucleos(t)ide analogs; ULN, upper limit of normal.