Twenty percent of patients taking the immune system enhancing drug Zadaxin in a phase III clinical trial in Japan were deemed cured of hepatitis B by the end of the 18-month study, according to the drug's maker, SciClone Pharmaceuticals.
"The results of this study compare favorably to published data from other approved hepatitis B therapies," a SciClone spokesperson said.
Lamivudine, a widely used drug for the treatment of hepatitis B, produced a seroconversion of the hepatitis B e-antigen in 16 percent of Asian patients after 12 months of therapy in a separate study, according to SciClone.
Adefovir dipivoxil, the newest hepatitis B drug approved by the U.S. and European regulatory authorities, produced a seroconversion of the hepatitis B e-antigen in 12 percent of patients after 12 months of therapy in another trial, SciClone reported.
Patients with chronic hepatitis B who demonstrate a sustained seroconversion are widely considered to be cured of their chronic hepatitis B.
"We are extremely pleased with the data from our phase 3 hepatitis B clinical trial in Japan," said Dr. Eduardo Martins, vice president of medical affairs of SciClone. "These results are even more impressive when we consider that this study included some of the more difficult to treat hepatitis B patients.
"Upon entry into this study, 39 percent of patients had failed prior therapy with interferon and 24 percent of patients had severe liver fibrosis," Martins added.
Martins said that 27 percent of patients had negative hepatitis B viral DNA at the end of the 18-month study, and 23 percent of patients had a successful interruption of replication of the hepatitis B virus.
Other sources: SciClone