Clin Gastroenterol Hepatol. 2013 Dec 6. pii: S1542-3565(13)01840-5. doi: 10.1016/j.cgh.2013.11.033. [Epub ahead of print]
Oze T, Hiramatsu N, Yakushijin T, Miyazaki M, Yamada A, Oshita M, Hagiwara H, Mita E, Ito T, Fukui H, Inui Y, Hijioka T, Inada M, Katayama K, Tamura S,Yoshihara H, Inoue A, Imai Y, Hayashi E, Kato M, Miyagi T, Yoshida Y, Tatsumi T, Kasahara A, Hamasaki T, Hayashi N, Takehara T; the Osaka Liver Forum.
Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine, Suita, Osaka, Japan.
Abstract
BACKGROUND & AIMS: In patients with chronic hepatitis C virus (HCV) infection, lack of sustained virologic response (SVR) 24 weeks after the end of interferon therapy is a significant risk factor for hepatocellular carcinoma (HCC). Although many pre-treatment factors are known to affect HCC incidence, less is known about post-treatment factors- many change during the course of interferon therapy.
METHODS: We performed a prospective study, collecting data from 2659 patients with chronic hepatitis C without a history of HCC who had been treated with pegylated interferon (Peg-IFN) plus ribavirin from 2002 through 2008 at hospitals in Japan. Biopsies were collected before treatment; all patients received Peg-IFN plus ribavirin for 48-72 weeks (HCV genotype 1) or 24 weeks (HCV genotype 2). Hematologic, biochemical, and virologic data were collected every 4 weeks during treatment and every 6 months after treatment. HCC was diagnosed based on angiography, computed tomography, and/or magnetic resonance imaging findings.
RESULTS: HCC developed in 104 patients during a mean observation period of 40 months. Older age, male sex, lower platelet counts and higher levels of α-fetoprotein at baseline, and lack of an SVR were significant risk factors for HCC. The cumulative incidence of HCC was significantly lower in patients without SVRs who relapsed than those with no response to treatment. Levels of α-fetoprotein 24 weeks after the end of treatment (AFP24) were significantly lower than levels of α-fetoprotein at baseline in patients with SVRs and those who relapsed, but not in non-responders. Post-treatment risk factors for HCC among patients with SVRs included higher AFP24 and older age; among those without SVRs, risk factors included higher AFP24, integrated level of alanine aminotransferase, older age, and male sex. AFP24 (>10 ng/ml, 10-5 ng/ml, and then <5 ng/ml) was a better predictor of HCC incidence than pre-treatment level of AFP among patients with and without SVRs.
CONCLUSIONS: In patients with chronic HCV infection, levels of α-fetoprotein decrease during interferon therapy. High post-treatment levels of α-fetoprotein predict HCC, regardless of whether patients achieve an SVR. UMIN: C000000196, C000000197.
Copyright © 2013 AGA Institute. Published by Elsevier Inc. All rights reserved.
KEYWORDS: AFP, AFP24, ALT, ALT24, CH-C, CT, EOT, HCC, HCV, IFN, MRI, NR, Peg-IFN, PreAFP, PreALT, SVR, alanine aminotransferase, alanine aminotransferase levels at 24 weeks after the end of treatment, alanine aminotransferase levels at the start of treatment, alpha-fetoprotein, alpha-fetoprotein levels at 24 weeks after the end of treatment, alpha-fetoprotein levels at the start of treatment, chronic hepatitis C, computed tomography, end of treatment, hepatitis C virus, hepatocellular carcinoma, i-ALT, integrated alanine aminotransferase value after the end of treatment, interferon, liver cancer, magnetic resonance imaging, non-response, outcome, pegylated interferon, response to therapy, risk factor, sustained virologic response
PMID: 24321207 [PubMed - as supplied by publisher]
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