SAN FRANCISCO — Patients with hepatitis C and cirrhosis who had a sustained response to interferon monotherapy were less likely to develop hepatocellular carcinoma or die of liver-related causes than were patients without a sustained response in a large Italian study, Dr. Savino Bruno reported.
Newer regimens using pegylated interferon plus ribavirin have been shown in separate studies to increase the likelihood of a sustained virologic response, so all patients with hepatitis C virus (HCV) who are candidates for treatment should be given the newer combination therapy—even patients with established cirrhosis, Dr. Bruno said at the annual meeting of the American Association for the Study of Liver Diseases.
Several previous clinical trials of the efficacy of interferon-based therapies in clearing HCV, conducted mostly in Japan, hinted at a slight protective effect from sustained virologic response. This is the first study in a large Western population-based cohort designed to study the protection conferred by sustained virologic response. Such response is defined as undetectable serum HCV-RNA levels 24 weeks after stopping interferon.
In the current study, investigators reviewed data on 1,214 consecutive patients with HCV and Child's class A cirrhosis who were treated with interferon at 23 Italian medical centers from 1992 through 1997. Patients had a mean age of 60 years, 62% were male, and 55% were infected with HCV genotype 1.
The available records showed a sustained virologic response in 16%, and 6% of these developed hepatocellular carcinoma over a mean follow-up period of nearly 8 years.
Among the 84% of patients without a sustained virologic response, 17% developed hepatocellular carcinoma, said Dr. Bruno, head of the liver unit at Fatebenefratelli and Oftalmico Hospital, Milan, and his associates. Dr. Bruno has no relationships with the company that makes interferon.
Only 2% of patients in the sustained virologic response group died of liver-related causes, compared with 12% of patients who did not have a sustained virologic response.
Factors that increased the risk for hepatocellular carcinoma were older age (58 years and up), being male, and not having a sustained virologic response, according to a multivariate analysis.
Lack of a sustained response to treatment doubled the risk of developing cancer and quadrupled the risk for liver-related death. Older age quadrupled the risk for cancer.
Because a sustained response to treatment didn't completely eliminate the risk of hepatocellular carcinoma, especially in older patients, cancer surveillance in these patients must continue, Dr. Bruno said.
The study excluded patients who were coinfected with hepatitis B or HIV.