Maintenance peginterferon therapy and other factors associated with hepatocellular carcinoma in patients with advanced hepatitis C

Anna S. Lok, James E. Everhart, Elizabeth C. Wright, Adrian M. Di Bisceglie, Haeyoung Kim, Richard K. Sterling, Gregory T. Everson, Karen L. Lindsay, William M. Lee, Herbert L. Bonkovsky, Jules L. Dienstag, Marc G. Ghany, Chihiro Morishima, Timothy R. Morgan

Research output: Contribution to journalArticle

146 Citations (Scopus)

Abstract

Background & Aims: Interferon reportedly decreases the incidence of hepatocellular carcinoma (HCC) in patients with chronic hepatitis C. The Hepatitis C Antiviral Long-term Treatment against Cirrhosis (HALT-C) Trial showed that 4 years of maintenance therapy with pegylated interferon (peginterferon) does not reduce liver disease progression. We investigated whether peginterferon decreases the incidence of HCC in the HALT-C cohort over a longer posttreatment follow-up period. Methods: The study included 1048 patients with chronic hepatitis C (Ishak fibrosis scores <3) who did not have a sustained virologic response (SVR) to therapy. They were randomly assigned to groups given a half-dose of peginterferon or no treatment (controls) for 3.5 years and followed up for a median of 6.1 (maximum, 8.7) years. Results: Eighty-eight patients developed HCC (68 definite, 20 presumed): 37 of 515 who were given peginterferon (7.2%) and 51 of 533 controls (9.6%; P = .24). There was a significantly lower incidence of HCC among patients given peginterferon therapy who had cirrhosis, but not fibrosis, based on analysis of baseline biopsy samples. After 7 years, the cumulative incidences of HCC in treated and control patients with cirrhosis were 7.8% and 24.2%, respectively (hazard ratio [HR], 0.45; 95% confidence interval [CI], 0.240.83); in treated and control patients with fibrosis, incidences were 8.3% and 6.8%, respectively (HR, 1.44; 95% CI, 0.772.69). Treated patients with a <2-point decrease in the histologic activity index, based on a follow-up biopsy, had a lower incidence of HCC than those with unchanged or increased scores (2.9% vs 9.4%; P = .03). Conclusions: Extended analysis of the HALT-C cohort showed that long-term peginterferon therapy does not reduce the incidence of HCC among patients with advanced hepatitis C who did not achieve SVRs. Patients with cirrhosis who received peginterferon treatment had a lower risk of HCC than controls.

Original languageEnglish (US)
Pages (from-to)840-849
Number of pages10
JournalGastroenterology
Volume140
Issue number3
DOIs
StatePublished - Mar 2011

Fingerprint

Hepatitis C
Interferons
Hepatocellular Carcinoma
Fibrosis
Maintenance
Incidence
Antiviral Agents
Therapeutics
Chronic Hepatitis C
Confidence Intervals
Biopsy
Disease Progression
Liver Diseases

Keywords

  • Hepatitis C Clinical Trial
  • Interferon Nonresponders
  • Interferon Therapy
  • Liver Cancer

ASJC Scopus subject areas

  • Gastroenterology

Cite this

Lok, A. S., Everhart, J. E., Wright, E. C., Di Bisceglie, A. M., Kim, H., Sterling, R. K., ... Morgan, T. R. (2011). Maintenance peginterferon therapy and other factors associated with hepatocellular carcinoma in patients with advanced hepatitis C. Gastroenterology, 140(3), 840-849. https://doi.org/10.1053/j.gastro.2010.11.050

Maintenance peginterferon therapy and other factors associated with hepatocellular carcinoma in patients with advanced hepatitis C. / Lok, Anna S.; Everhart, James E.; Wright, Elizabeth C.; Di Bisceglie, Adrian M.; Kim, Haeyoung; Sterling, Richard K.; Everson, Gregory T.; Lindsay, Karen L.; Lee, William M.; Bonkovsky, Herbert L.; Dienstag, Jules L.; Ghany, Marc G.; Morishima, Chihiro; Morgan, Timothy R.

In: Gastroenterology, Vol. 140, No. 3, 03.2011, p. 840-849.

Research output: Contribution to journalArticle

Lok, AS, Everhart, JE, Wright, EC, Di Bisceglie, AM, Kim, H, Sterling, RK, Everson, GT, Lindsay, KL, Lee, WM, Bonkovsky, HL, Dienstag, JL, Ghany, MG, Morishima, C & Morgan, TR 2011, 'Maintenance peginterferon therapy and other factors associated with hepatocellular carcinoma in patients with advanced hepatitis C', Gastroenterology, vol. 140, no. 3, pp. 840-849. https://doi.org/10.1053/j.gastro.2010.11.050
Lok, Anna S. ; Everhart, James E. ; Wright, Elizabeth C. ; Di Bisceglie, Adrian M. ; Kim, Haeyoung ; Sterling, Richard K. ; Everson, Gregory T. ; Lindsay, Karen L. ; Lee, William M. ; Bonkovsky, Herbert L. ; Dienstag, Jules L. ; Ghany, Marc G. ; Morishima, Chihiro ; Morgan, Timothy R. / Maintenance peginterferon therapy and other factors associated with hepatocellular carcinoma in patients with advanced hepatitis C. In: Gastroenterology. 2011 ; Vol. 140, No. 3. pp. 840-849.
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AU - Kim, Haeyoung

AU - Sterling, Richard K.

AU - Everson, Gregory T.

AU - Lindsay, Karen L.

AU - Lee, William M.

AU - Bonkovsky, Herbert L.

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AU - Ghany, Marc G.

AU - Morishima, Chihiro

AU - Morgan, Timothy R.

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N2 - Background & Aims: Interferon reportedly decreases the incidence of hepatocellular carcinoma (HCC) in patients with chronic hepatitis C. The Hepatitis C Antiviral Long-term Treatment against Cirrhosis (HALT-C) Trial showed that 4 years of maintenance therapy with pegylated interferon (peginterferon) does not reduce liver disease progression. We investigated whether peginterferon decreases the incidence of HCC in the HALT-C cohort over a longer posttreatment follow-up period. Methods: The study included 1048 patients with chronic hepatitis C (Ishak fibrosis scores <3) who did not have a sustained virologic response (SVR) to therapy. They were randomly assigned to groups given a half-dose of peginterferon or no treatment (controls) for 3.5 years and followed up for a median of 6.1 (maximum, 8.7) years. Results: Eighty-eight patients developed HCC (68 definite, 20 presumed): 37 of 515 who were given peginterferon (7.2%) and 51 of 533 controls (9.6%; P = .24). There was a significantly lower incidence of HCC among patients given peginterferon therapy who had cirrhosis, but not fibrosis, based on analysis of baseline biopsy samples. After 7 years, the cumulative incidences of HCC in treated and control patients with cirrhosis were 7.8% and 24.2%, respectively (hazard ratio [HR], 0.45; 95% confidence interval [CI], 0.240.83); in treated and control patients with fibrosis, incidences were 8.3% and 6.8%, respectively (HR, 1.44; 95% CI, 0.772.69). Treated patients with a <2-point decrease in the histologic activity index, based on a follow-up biopsy, had a lower incidence of HCC than those with unchanged or increased scores (2.9% vs 9.4%; P = .03). Conclusions: Extended analysis of the HALT-C cohort showed that long-term peginterferon therapy does not reduce the incidence of HCC among patients with advanced hepatitis C who did not achieve SVRs. Patients with cirrhosis who received peginterferon treatment had a lower risk of HCC than controls.

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