Clinical Advances in Liver, Pancreas, and Biliary TractIncidence of Hepatocellular Carcinoma and Associated Risk Factors in Hepatitis C-Related Advanced Liver Disease
Section snippets
Patients and Methods
The design of the HALT-C Trial has been described previously.18, 19 Briefly, patients with detectable HCV RNA at 10 clinical centers had to meet the following criteria for enrollment: failure to have achieved a sustained virologic response after previous interferon treatment with or without ribavirin, the presence of advanced hepatic fibrosis on liver biopsy (Ishak fibrosis score, ≥3), no history of hepatic decompensation or HCC, and the absence of defined exclusion criteria (eg, liver disease
Results
A total of 1050 patients were randomized between January 2001 and August 2004. Forty-five patients were excluded for the following reasons: (1) prevalent HCC, defined as HCC diagnosed within 12 months after enrollment (n = 5); (2) patients who had less than 12 months follow-up after enrollment (n = 38); and (3) patients with a diagnosis of presumed HCC who were followed for at least 24 months and did not show radiologic or clinical progression of their liver masses (n = 2). The characteristics
Discussion
The major objective of the HALT-C Trial was to determine whether long-term treatment with peginterferon would reduce progression of hepatitis C, including the development of HCC. Support for the possibility that maintenance therapy might inhibit disease progression had come from a 2-year study of interferon maintenance therapy in a US population.23 Additionally, several early reports suggested that interferon therapy reduced the development of HCC in Japanese and Italian patients with chronic
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H.L.B.'s current address is Carolinas Medical Center, Charlotte, North Carolina.
The authors disclose the following: Financial relationships of the authors with Hoffmann–La Roche, Inc, are as follows: A. S. Lok is a consultant; T. R. Morgan is a consultant, on the speaker's bureau, and receives research support; A. M. Di Bisceglie is a consultant, on the speaker's bureau, and receives research support; R. K. Sterling is a consultant, on the speaker's bureau, and receives research support; G. T. Everson is a consultant, on the speaker's bureau, and receives research support; K. L. Lindsay is a consultant and receives research support; W. M. Lee receives research support; H. L. Bonkovsky receives research support. Authors with no financial relationships related to this project are L. B. Seeff, T. M. Curto, J. L. Dienstag, M. G. Ghany, C. Morishima, and Z. D. Goodman. Potential investigator conflict of interest was disclosed to study participants.
Supported by the National Institute of Diabetes and Digestive and Kidney Diseases (contract numbers are listed in Appendix 1); the National Institute of Allergy and Infectious Diseases (NIAID); the National Cancer Institute; the National Center for Minority Health and Health Disparities; General Clinical Research Center grants from the National Center for Research Resources, National Institutes of Health (grant numbers are listed in Appendix 1); and by Hoffman–La Roche, Inc, through a Cooperative Research and Development Agreement (CRADA) with the National Institutes of Health.
This is publication No. 34 from the HALT-C Trial Group.
The HALT-C Trial was registered with clinicaltrials.gov (NCT00006164).