No benefit of extended hepatitis C therapy for some

NEW YORK (Reuters Health) - In patients with advanced chronic hepatitis C infection who have not responded to prior therapy with the standard combination drug treatment -- peginterferon and ribavirin -- prolonged low-dose, or "maintenance" therapy does not reduce the rate of disease progression, new research shows.

Patients who do not respond to initial antiviral therapy are at increased risk for progression to cirrhosis, liver failure, liver cancer, and ultimately, death, Dr. Adrian M. Di Bisceglie, from Saint Louis University School of Medicine, and colleagues note. Although some patients are put on extended peginterferon treatment to prevent disease progression, the effectiveness of this approach is unclear.

The Hepatitis C Antiviral Long-Term Treatment against Cirrhosis (HALT-C) trial included 1,050 patients who were randomly assigned to receive low-dose peginterferon therapy or to no treatment for 3.5 years after they did not respond to standard peginterferon and ribavirin therapy.

The patients were evaluated at 3-month intervals and liver biopsies were performed after 1.5 and 3.5 years. The results are reported in The New England Journal of Medicine.

Although blood levels of the liver enzyme protein aminotransferase and hepatitis C virus, as well as tests scores measuring liver tissue destruction and inflammation, fell significantly with peginterferon therapy, disease progression still occurred and was about the same in both groups: 34.1 percent of the treatment group and 33.8 percent of the control group.

The rate of serious adverse events was higher, but not significantly different, in the peginterferon group compared with the untreated group: 38.6 percent vs. 31.8 percent.

The authors conclude "that long-term maintenance therapy with half-dose peginterferon is ineffective" in preventing disease progression and is not recommended for patients with advanced chronic hepatitis C infection who do not respond to standard treatment with peginterferon and ribavirin.

SOURCE: The New England Journal of Medicine, December 4, 2008.