At present it is unknown just how effective antiviral therapy is in preventing disease progression in patients with chronic hepatitis B and advanced fibrosis or cirrhosis.
Professor Yun-Fan Liaw and colleagues selected 651 patients with chronic hepatitis B who had histologically confirmed cirrhosis or advanced fibrosis.
The participants were randomly assigned in a 2:1 ration to receive lamivudine (100mg per day) or placebo for a maximum of 5 years.
The researchers assigned 436 participants to receive lamivudine and 215 to receive placebo.
The researchers were using 'time to disease progression' as their endpoint and this was defined by hepatic decompensation, hepatocellular carcinoma, spontaneous bacterial peritonitis, bleeding gastroesophageal varices, or death related to liver disease.
The study was monitored by an independent data and safety monitoring board that also performed the interim analyses of the data.
The researchers terminated the study after a median duration of treatment of 32.4 months because they found that there was a significant difference between treatment groups in the number of end points reached.
|Hepatocellular carcinoma occurred in 3.9% in the lamivudine group and 7.4% in the placebo group.|
|New England Journal of Medicine|
The researchers found that end points were reached by 7.8% of patients receiving lamivudine and 17.7% of those receiving placebo.
The researchers also found that the Child-Pugh score increased in 3.4% of patients receiving lamivudine and 8.8% of those receiving placebo.
However, hepatocellular carcinoma occurred in 3.9% of those in the lamivudine group and 7.4% of those in the placebo group.
The team found that overall, 12% of the patients in the lamivudine group and 18% of the patients in the placebo group reported serious adverse events.
Professor Liaw, speaking on behalf of the team concluded, "Continuous treatment with lamivudine delays clinical progression in patients with chronic hepatitis B and advanced fibrosis or cirrhosis by significantly reducing the incidence of hepatic decompensation and the risk of hepatocellular carcinoma".