TABLE 4.
Safety Outcomes for Patients Comparing AEs in Individuals With METAVIR F0-F2 Versus F3-F4
| METAVIR | METAVIR | Total | ||
|---|---|---|---|---|
| AEs | F0-F2 (n 5 38) | F3-F4 (n 5 23) | P Value* | (n 5 61) |
| Any AE | 22 (58) | 12 (52) | 0.79 | 34 (56) |
| Grade 3 or 4 AE | 2 (5.3) | 4 (17.4) | 0.18 | 6 (9.8) |
| Death† | 0 | 0 | — | — |
| Hepatic decompensation | 0 | 2 (8.7) | 0.13 | 2 (3.3) |
| Interruption of therapy | 0 | 1 (4.3)‡ | 0.37 | 1 (1.6) |
| Emergency department visit or hospital admission | 2 (5.3) | 4 (17.4) | 0.12 | 6 (9.8) |
| Rash | 5 (13) | 2 (8.7) | 0.70 | 7 (11.5) |
| Photosensitivity | 5 (13) | 3 (13) | — | 8 (13) |
| Fatigue | 13 (34.2) | 4 (17.4) | 0.23 | 17 (27.9) |
| Headache | 8 (21) | 3 (13) | 0.51 | 11 (18) |
| Nausea | 3 (7.9) | 3 (13) | 0.66 | 6 (9.8) |
| Increase in bilirubin (>1 mg/dL) | 1 (2.6) | 1 (4.3) | — | 2 (3.3) |
| Increase in creatinine (>0.5 mg/dL) | 3 (7.9) | 2 (8.7) | — | 5 (8.2) |
| Anemia (decrease in hemoglobin <10 g/dL) | 1 (2.6) | 1 (4.3) | — | 2 (3.3) |
| Infection | 1 (2.6) | 1 (4.3) | — | 2 (3.3) |
*
Fisher’s exact test.
†
Two patients died after SVR12 (not related to therapy).
‡
Interruption of therapy not related to AEs from antiviral agents.