Table 3

Summary of outcome measures

VariableViusid (N=50)Placebo (N=50)HR* (95% CI)p Value
No of patients (%)
Primary outcomes, no (%)
 Overall survival45 (90)37 (74)0.27 (0.08 to 0.92)0.036
Secondary outcomes, no (%)
 Time to disease progression14 (28)24 (48)0.47 (0.22 to 0.89)0.044
 Time to diagnosis of hepatocellular carcinoma1 (2)6 (12)0.15 (0.019 to 0.90)0.046
 Worsening of Child–Pugh score in at least two points7 (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 points6 (12)15 (30)0.39 (0.15 to 0.92)0.042
 Ascites7 (14)16 (32)0.32 (0.11 to 0.90)0.031
 Hepatic encephalopathy1 (2)5 (10)0.20 (0.10 to 1.7)0.10
 Spontaneous bacterial peritonitis1 (2)5 (10)0.20 (0.13 to 1.7)0.09
 Upper-gastrointestinal bleeding8 (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.