The long-term treatment with Epivir-HBV (lamivudine) delayed disease progression in chronic hepatitis B patients with advanced fibrosis or cirrhosis by significantly reducing the rate of liver complications including the development of liver cancer, according to the results of a study published in the New England Journal of Medicine. Treatment with lamivudine was associated with an approximate 50 per cent reduction in disease progression during the treatment period, a release from GlaxoSmithKline said.
The large, controlled, multi centred study reports results of a 651 patient, double-blind, placebo-controlled clinical trial that was conducted at multiple centres in Asia-Pacific countries.
Results showed that During the time when patients received treatment for a median of 32 months only 8 per cent of lamivudine-treated patients had defined events indicating disease progression in advanced chronic hepatitis B as compared with 18 per cent of patients receiving placebo; among the individual disease endpoints, 3 per cent of the lamivudine group saw an increase in the Child-Pugh score (a scoring system to assess liver function), compared with 9 per cent of those patients on placebo; hepatocellular carcinoma (liver cancer) occurred in 4 per cent of lamivudine treated patients and in 7 per cent of placebo recipients.
"These results are clinically important and signal hope for many patients," stated professor Y F Liaw of Chang Gung Memorial Hospital and University, Taipei, Taiwan. He added, "They show that lamivudine is not only an effective treatment for chronic hepatitis B, but that it can also delay development of serious life-threatening complications associated with disease progression. These results underscore the importance of lamivudine treatment in delaying the progression of this serious disease."
Epivir-HBV is approved in the US for the treatment of chronic hepatitis B associated with viral replication and active liver inflammation in adults and children ages 2-17 years.