Peginterferon Plus Ribavirin and Sustained Virological Response in HCV-Related Cirrhosis: Outcomes and Factors Predicting Response

Am J Gastroenterol advance online publication 10 August 2010; doi: 10.1038/ajg.2010.294

Conrado M Fernández-Rodríguez MD 1, Sonia Alonso MD 1, Stella M Martinez MD 2, Xavier Forns MD 2, Jose M Sanchez-Tapias MD 2, Diego Rincón MD 3, Gil Rodriguez-Caravaca MD 1, Rafael Bárcena MD 4, Miguel A Serra MD 5, Manuel Romero-Gómez MD 6, Inmaculada Fernandez MD 7, Javier Garcia-Samaniego MD 8, Javier Fuente MD 9, Ricard Solá MD 10, Ricardo Moreno-Otero MD 11 and Ramón Planas MD 12 on behalf of the Group for the Assessment of Prevention of Cirrhosis Complications and Virological Response (APREVIR)

1 Hospital Universitario Fundación Alcorcón, Madrid, Spain
2 Hospital Clinic I Provincial, Badalona and IDIBAPS, Ciberehd, Badalona, Spain
3 Hospital Universitario Gregorio Marañón Ciberehd, Madrid, Spain
4 Hospital Ramón y Cajal, Madrid, Spain
5 Hospital Clínico Universitario, Valencia, Spain
6 Hospital de Valme Ciberehd, Sevilla, Spain
7 Hospital Universitario 12 de Octubre, Madrid, Spain
8 Hospital Carlos III Ciberehd, Madrid, Spain
9 Hospital Miguel Servet, Zaragoza, Spain
10 Hospital del Mar, Badalona, Spain
11 Hospital Universitario de La Princesa, Madrid, Spain
12 Hospital Germans Trias i Pujol, Ciberehd, Badalona, Spain

Correspondence: Conrado M. Fernández-Rodríguez, MD, Hospital Universitario Fundación Alcorcón, Av Budapest-1, 28922, Madrid, Spain. E-mail: cfernandez@fhalcorcon.es

Received 4 September 2010; Accepted 11 March 2010; Published online 10 August 2010.

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 (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 × 105 (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 log10 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.

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