Variable | Viusid (N=50) | Placebo (N=50) | HR* (95% CI) | p Value |
No of patients (%) | ||||
Primary outcomes, no (%) | ||||
Overall survival | 45 (90) | 37 (74) | 0.27 (0.08 to 0.92) | 0.036 |
Secondary outcomes, no (%) | ||||
Time to disease progression | 14 (28) | 24 (48) | 0.47 (0.22 to 0.89) | 0.044 |
Time to diagnosis of hepatocellular carcinoma† | 1 (2) | 6 (12) | 0.15 (0.019 to 0.90) | 0.046 |
Worsening of Child–Pugh score in at least two points | 7 (14) | 19 (38) | 0.34 (0.14 to 0.81) | 0.015 |
Worsening of Model for End-Stage Liver Disease score in at least four points | 6 (12) | 15 (30) | 0.39 (0.15 to 0.92) | 0.042 |
Ascites | 7 (14) | 16 (32) | 0.32 (0.11 to 0.90) | 0.031 |
Hepatic encephalopathy | 1 (2) | 5 (10) | 0.20 (0.10 to 1.7) | 0.10 |
Spontaneous bacterial peritonitis | 1 (2) | 5 (10) | 0.20 (0.13 to 1.7) | 0.09 |
Upper-gastrointestinal bleeding | 8 (16) | 10 (20) | 0.78 (0.31 to 1.99) | 0.67 |
↵* HRs were computed using the Cox proportional hazard model adjusted for sex and age, baseline Child–Pugh and Model for End-Stage Liver Disease scores, previous history of clinical decompensation, and current use of diuretics and propranolol. CI denotes the CI for the HR.
↵† All cases of hepatocellular carcinoma were diagnosed during the second year of treatment.