In patients with chronic Hepatitis C who do not have a response to antiviral treatment, the disease may progress to cirrhosis, liver failure, hepatocellular carcinoma, and death.
Whether long-term antiviral therapy can prevent progressive liver disease in such patients remains uncertain.
Dr Adrian Di Bisceglie and colleagues from Missouri, USA conducted a randomized, controlled trial of peginterferon alfa-2a at a dosage of 90 µg per week for 4 years.
Compared with no treatment, in 1050 patients with chronic Hepatitis C and advanced fibrosis who had not had a response to previous therapy with peginterferon and ribavirin.
|39% in the treatment group had at least one serious adverse event|
|New England Journal of Medicine|
The patients, who were stratified according to stage of fibrosis, were seen at 3-month intervals and underwent liver biopsy at about 2 and 4 years after randomization.
The primary end point was progression of liver disease, as indicated by death, hepatocellular carcinoma, hepatic decompensation, or, for those with bridging fibrosis at baseline, an increase in the Ishak fibrosis score of 2 or more points.
The researchers randomly assigned the patients to receive peginterferon or no therapy for 4 years.
The level of serum aminotransferases, the level of serum Hepatitis C virus RNA, and histologic necroinflammatory scores all decreased significantly with treatment.
However, the team noted no significant difference between the groups in the rate of any primary outcome.
The percentage of patients with at least one serious adverse event was 39% in the treatment group, and 32% in the control group.
Dr Di Bisceglie’s team commented, “Long-term therapy with peginterferon did not reduce the rate of disease progression in patients with chronic Hepatitis C and advanced fibrosis, with or without cirrhosis, who had not had a response to initial treatment with peginterferon and ribavirin.”