By Mary Welch
BioChem Pharma Inc. reported that patients who underwent Phase II trials in Asia for lamivudine, an oral treatment for hepatitis B (HBV), have found that efficacy can be sustained for at least two years.
Discovered by BioChem Pharma, of Laval, Quebec, lamivudine is 3TC, which is approved forAIDS, and now is targeted of HBV. Lamivudine studies have shown it produces significant reduction in replication of HBV. This reduction in viral load slows the body's immune response and lessens the progressive damage to the liver that leads to cirrhosis and liver cancer.
HBV is a potentially fatal liver disease, with some 350 million people being long-term carriers of the virus. About one-third of those 350 million are expected to develop serious progressive liver disease. HBV is the ninth most common cause of death worldwide.
FDA Filing Expected This Quarter
The study, done with 334 patients, showed that most patients treated continuously with lamivudine had substantially reduced levels of viral replication, with 52 percent maintaining undetectable levels of the virus through the end of the second year.
At one year of therapy, the seroconversion rate was 17 percent in lamivudine-treated patients, compared to 4 percent in the placebo group. After two years, 27 percent of lamivudine patients showed seroconversion. Seroconversion is an immune response to the virus that is thought to predict long-lasting remission of the disease.
These patients also had continued normalization of ALT levels, which suggests that liver inflammation was also reduced during the second year of treatment. ALT is an enzyme that circulates in the bloodstream at increased levels with ongoing liver inflammation.
"This is the longest trial to date and it's clear that the patients continued to show important improvements," said Michelle Roy, BioChem's director of corporate communications.
BioChem Pharma and its partner Glaxo Wellcome plc, of London, have filed for approval in China, Canada and Europe. A filing with the FDA will take place by next month, Roy said.
BioChem Pharma invented the antiviral agent and licensed worldwide rights, excluding North America, to Glaxo Wellcome. In North America, lamivudine will be produced by a joint venture of the two firms and sold in Canada by them. In the U.S., Glaxo Wellcome will sell lamivudine upon approval. *