Table 7.
Safety and Tolerability of Treatment Regimens in Patients with G3-HCV Cirrhosis
| Parameter | Group I (n=70) | Group II (n=87) | Group III (n=76) | p-value |
|---|---|---|---|---|
| Any AE | 13 (14.2) | 43 (49.4) | 66 (86.8) | - |
| Death | 0 | 1 (1.1) | 0 | - |
| SAEs | 1 (1.6) | 2 (2.2) | 0 | 0.4 |
| Recurrence ascites | 1 (1.6) | 0 | 0 | |
| Pneumonia | 0 | 1 (1.1) | 0 | |
| Atrial fibrillation | 0 | 1 (1.1) | 0 | |
| AE that led to discontinuation | 0 | 0 | 0 | - |
| AEs | ||||
| Fatigue | 10 (14.3) | 19 (21.8) | 28 (36.8) | 0.005 |
| Anemia (grade 2/3) | 3 (4.8) | 17 (19.5) | 30 (39.5) | 0.000 |
| Headache | 0 | 5 (5.7) | 6 (7.9) | 0.08 |
| Diarrhea | 0 | 2 (2.3) | 2 (2.6) | 0.4 |
| Drop out | 0 | 1 (1.1) | 0 | - |
| RBV dose reduction | NA | 2 (2.3) | 10 (14) | 0.007 |
| HCC de novo | 1 (1.4)* | 0 | 0 | - |
| HCC recurrence | 0 | 1 (1.1)† | 0 | - |
Data are presented as number (%). Group I, daclatasvir (DCV) + sofosbuvir (SOF) without ribavirin (RBV); group II, DCV/SOF with RBV flat dose of 800 mg/dL; group III, DCV/SOF with RBV weight-based dose.
G3-HCV, genotype 3 hepatitis C virus; AE, adverse event; SAE, severe adverse event; NA, not applicable; HCC, hepatocellular carcinoma.
*
At 8 months after the end of treatment; †Dropped out due to HCC recurrence.