Table 4.
Association Between ALT Flares >10× ULN and Clinical Outcomes for HBeAg-Negative Participants
| Clinical outcome | Participants free of ALT flares | Participants with ALT flares | P value | ||||
|---|---|---|---|---|---|---|---|
| Treatment initiation | N = 1172 | N = 37 | <.0001 | ||||
| N | PYR | Rate | N | PYR | Rate | ||
| 110 | 1190.7 | 9 | 17 | 24.7 | 69 | ||
| Specific treatments | |||||||
| ETV or TDF | 87 | 11 | |||||
| Other NA | 8 | 5 | |||||
| PEG-IFN | 10 | 0 | |||||
| Combination | 5 | 1 | |||||
| HBV DNA decline (>1 log) | N = 1115 | N = 33 | |||||
| N | PYR | Rate | N | PYR | Rate | .003 | |
| Untreateda | 203 | 889.7 | 23 | 10 | 16.9 | 59 | |
| Treateda | 64 | 48.5 | 132 | 14 | 10.8 | 129 | .94 |
| HBsAg loss | N = 904 | N = 31 | |||||
| N | PYR | Rate | N | PYR | Rate | ||
| Untreateda | 15 | 761.8 | 2 | 1 | 11.0 | 9 | .14 |
| Treateda | 0 | 41.4 | 0.0 | 0 | 9.3 | 0.0 | 1.0 |
| Disease progressionb | 2 | 0 | 1.0 | ||||
ALT, alanine aminotransferase; Combination, being in >1 of the previous therapy groups in the course of the 48-week window; HBeAg, hepatitis B e antigen; HBsAg, hepatitis B surface antigen; HBV, hepatitis B virus; IFN, interferon (including pegylated [PEG] form); NA, nucleoside analogue (entecavir and tenofovir); Other NA, telbivudine, adefovir, emtricitabine, truvada, lamivudine; PYR, person-years; ULN, upper limit of normal.
Event rates per 100 PYR. Event must occur within 48 weeks (± 12-week window) of ALT flare. Participants may contribute PYR as both treated and untreated.
Disease progression is defined as composite outcome of hepatic decompensation (variceal bleeding, ascites, hepatic encephalopathy), death, or transplant.