title: Peginterferon plus ribavirin and sustained virological response in HCV-related cirrhosis: outcomes and factors predicting response.
abstract: OBJECTIVE
  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 (n=26) provided data for patients (n=568) 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 (OR=3.177; 95% CI: 1.752-5.760); serum γ-glutamyl transpeptidase (GGT) <76 IU per ml (OR=4.092; 95% CI: 2.418-6.927); baseline viral load <6 × 10(5) (OR=2.597; 95% CI: 1.583-4.262); absence of ultrasound signs of portal hypertension (OR=2.067; 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 (HR=3.06; 95% CI: 1.81-5.15), presence of esophageal varices on endoscopy (HR=2.489; 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.
authors.affiliation: Hospital Universitario Fundación Alcorcón, Madrid, Spain. cfernandez@fhalcorcon.es
authors.forename: Conrado M
authors.initials: CM
authors.lastname: Fernández-Rodríguez
authors.forename: Sonia
authors.initials: S
authors.lastname: Alonso
authors.forename: Stella M
authors.initials: SM
authors.lastname: Martinez
authors.forename: Xavier
authors.initials: X
authors.lastname: Forns
authors.forename: Jose M
authors.initials: JM
authors.lastname: Sanchez-Tapias
authors.forename: Diego
authors.initials: D
authors.lastname: Rincón
authors.forename: Gil
authors.initials: G
authors.lastname: Rodriguez-Caravaca
authors.forename: Rafael
authors.initials: R
authors.lastname: Bárcena
authors.forename: Miguel A
authors.initials: MA
authors.lastname: Serra
authors.forename: Manuel
authors.initials: M
authors.lastname: Romero-Gómez
authors.forename: Inmaculada
authors.initials: I
authors.lastname: Fernandez
authors.forename: Javier
authors.initials: J
authors.lastname: Garcia-Samaniego
authors.forename: Javier
authors.initials: J
authors.lastname: Fuente
authors.forename: Ricard
authors.initials: R
authors.lastname: Solá
authors.forename: Ricardo
authors.initials: R
authors.lastname: Moreno-Otero
authors.forename: Ramón
authors.initials: R
authors.lastname: Planas
mesh_terms: D000998:Antiviral Agents / Q000627:therapeutic use; D015331:Cohort Studies; D005260:Female; D005838:Genotype; D016174:Hepacivirus / Q000235:genetics; D006526:Hepatitis C / Q000150:complications / Q000188:drug therapy* / Q000235:genetics; D006801:Humans; D057194:Intention to Treat Analysis; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000627:therapeutic use*; D008103:Liver Cirrhosis / Q000150:complications / Q000188:drug therapy* / Q000235:genetics; D008297:Male; D008875:Middle Aged; D016017:Odds Ratio; D011092:Polyethylene Glycols / Q000627:therapeutic use*; D011994:Recombinant Proteins; D012189:Retrospective Studies; D012254:Ribavirin / Q000627:therapeutic use*; D016896:Treatment Outcome; D019562:Viral Load
chemical_list: D000998:Antiviral Agents; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; D012254:Ribavirin; C100416:peginterferon alfa-2a