Peginterferon plus ribavirin and sustained virological response in HCV-related cirrhosis: Outcomes and factors predicting response

Objectives: Patients with hepatitis C virus (HCV) cirrhosis are difficult to treat and have a high risk of liver decompensation or hepatocellular carcinoma. We sought to identify factors that could predict treatment response. Methods: Collaborating centers (n26) provided data for patients (n568) with HCV cirrhosis undergoing treatment with peginterferon-α plus ribavirin (RBV). Univariate and multivariate analyses were used to evaluate factors predicting treatment outcomes. Results: Sustained viral response (SVR) in naive patients was 30.7%, with no significant differences between centers. Median follow-up was 35 months (range: 1-81). Factors predicting SVR were: non-genotype 1 (odds ratio (OR)4.183; 95% confidence interval (CI): 2.353-7.438) overall dose and 80% of the scheduled time of treatment (OR3.177; 95% CI: 1.752-5.760); serum γ-glutamyl transpeptidase (GGT) 76 IU per ml (OR4.092; 95% CI: 2.418-6.927); baseline viral load 6 × 10 5 (OR2.597; 95% CI: 1.583-4.262); absence of ultrasound signs of portal hypertension (OR2.067; 95% CI: 1.26-3.39). No patient with a HCV-RNA decline 1 log 10 at week 4 achieved SVR. Event-free survival at 5 years was 91% in patients with SVR vs. 59% in non-responders (P=0.001). Overall survival in patients with SVR was 98% vs. 86% in non-responders (P=0.005). Independent factors predicting events were absence of SVR (hazard ratio (HR)2.66; 95% CI: 1.32-5.54), baseline serum albumin 3.9 g per 100 ml (HR3.06; 95% CI: 1.81-5.15), presence of esophageal varices on endoscopy (HR2.489; 95% CI: 1.546-4). Improved outcome was more evident in responders with less advanced disease at baseline. Conclusions: SVR can be achieved in approximately one-third of patients with HCV-related cirrhosis. SVR independently reduces the likelihood of clinical decompensation and improves survival.