Long-term outcome after antiviral therapy of patients with hepatitis C virus infection and decompensated cirrhosis

Clinical Gastroenterology and Hepatology
PII: S1542-3565(10)01109-2
doi:10.1016/j.cgh.2010.10.036
© 2010 AGA Institute. Published by Elsevier Inc. All rights reserved

Article in Press

Angelo Iacobellis, MD, Francesco Perri, MD, PhD, Maria Rosa Valvano, MS, Nazario Caruso, MD, Grazia Anna Niro, MD, Angelo Andriulli, MD

AffiliationsCorrespondence: Angelo Andriulli, Division of Gastroenterology, “Casa Sollievo della Sofferenza” Hospital, IRCSS, viale Cappuccini 1, 71013 San Giovanni Rotondo, Italy, Phone: +39 0882 410263. Fax: +39 0882 835411.

Received 27 May 2010; received in revised form 19 October 2010; accepted 22 October 2010. published online 18 November 2010.

Accepted Manuscript

Abstract

Background & Aims
We evaluated the long-term outcomes following antiviral therapy of patients with decompensated cirrhosis and hepatitis C virus (HCV) infection.

Methods
Seventy-five patients with HCV infection and decompensated cirrhosis received therapy with peginterferon alfa-2b and ribavirin. We compared adverse-event profiles and mortality rates between patients with or without sustained virological responses (SVRs). The mean follow-up time off therapy was 51±18 months (range 3–78 months).

Results
Seven patients with HCV genotypes 1 or 4 (16%) and 17 patients with genotypes 2 or 3 (55%) achieved SVRs. The mean survival times were 53 months among patients that did not achieve SVRs (95% confidence interval [CI], 48–59 months) and 73 months among those that did achieve SVRs (95% CI, 67–80 months) (P=0.004). During the study, 25 patients died (2 with and 23 without SVRs). In the follow up period, 8/24 patients with SVRs (33.3%) and 49 of 51 without SVRs (96.1%) experienced further events of decompensation (P<0.0001). The hospital re-admission rates for patients with and without SVRs were 7.4 and 56 per 1000 person-months, respectively (ratio of 7.5 without/with SVR; 95% CI, 4.0–16.0; P<0.0001). At the end of the follow-up period, the incidence of hepatocellular carcinoma was not associated with clearance of HCV.

Conclusions
Among patients with cirrhosis that is secondary to HCV infection and who have progressed to a stage of liver decompensation, an SVR following anti-viral therapy is a positive prognostic factor.

Keywords: liver disease, clinical trial, chronic hepatitis, peg-IFN

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