Abstract
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. 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. 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], 0.24-0.83); in treated and control patients with fibrosis, incidences were 8.3% and 6.8%, respectively (HR, 1.44; 95% CI, 0.77-2.69). 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). 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.
Highlights
Hepatocellular carcinoma (HCC) is the sixth most common cancer and the third most common cause of cancer death in the world.[1]
Because presence of esophageal varices at randomization was a strong risk factor for hepatocellular carcinoma (HCC) in a previous analysis of Hepatitis C anti-viral long-term treatment against cirrhosis (HALT-C) Trial outcomes,[5] we examined the effect of their presence and development more closely, based on results from the baseline and year-3.5 upper endoscopies
It has been suggested that the limited duration of follow-up in these reports may not have been sufficient to observe a clinical benefit of peginterferon as chemoprevention for HCC;[8] in this vein, retrospective studies have suggested that a benefit of interferon in reducing the occurrence of HCC may not be observed for 5 years or more.[9]
Summary
Hepatocellular carcinoma (HCC) is the sixth most common cancer and the third most common cause of cancer death in the world.[1]. In an earlier analysis of the HALT-C Trial data, we showed that maintenance peginterferon reduced HAI compared to no treatment.[4] To determine whether the effect of peginterferon on prevention of HCC was related to its effect in decreasing hepatic inflammation, we analyzed 426 patients in the peginterferon group and 416 in the control group who had repeat liver biopsies at 1.5 years.
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