TY - JOUR
T1 - Maintenance peginterferon therapy and other factors associated with hepatocellular carcinoma in patients with advanced hepatitis C
AU - Lok, Anna S.
AU - Everhart, James E.
AU - Wright, Elizabeth C.
AU - Di Bisceglie, Adrian M.
AU - Kim, Haeyoung
AU - Sterling, Richard K.
AU - Everson, Gregory T.
AU - Lindsay, Karen L.
AU - Lee, William M.
AU - Bonkovsky, Herbert L.
AU - Dienstag, Jules L.
AU - Ghany, Marc G.
AU - Morishima, Chihiro
AU - Morgan, Timothy R.
N1 - Funding Information:
Funding Supported by the National Institute of Diabetes and Digestive and Kidney Diseases (contract numbers are listed in the acknowledgments). Additional support was provided by the National Institute of Allergy and Infectious Diseases , the National Cancer Institute , the National Center for Minority Health and Health Disparities , and General Clinical Research Center and Clinical and Translational Science Center grants from the National Center for Research Resources , National Institutes of Health (grant numbers are listed in the acknowledgments). The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Center for Research Resources or the National Institutes of Health. Additional funding to conduct this study was supplied by Hoffmann-La Roche, Inc , through a Cooperative Research and Development Agreement with the National Institutes of Health.
PY - 2011/3
Y1 - 2011/3
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.
AB - 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.
KW - Hepatitis C Clinical Trial
KW - Interferon Nonresponders
KW - Interferon Therapy
KW - Liver Cancer
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U2 - 10.1053/j.gastro.2010.11.050
DO - 10.1053/j.gastro.2010.11.050
M3 - Article
C2 - 21129375
AN - SCOPUS:79952316752
SN - 0016-5085
VL - 140
SP - 840-849.e1
JO - Gastroenterology
JF - Gastroenterology
IS - 3
ER -