The ongoing phase III trial is evaluating the drug in the treatment of 332 Chinese patients. According to Idenix, mainland China has the largest population affected by the hepatitis B virus of any nation with 120 million infected (nearly one out of every ten people in China) and 30 million chronic sufferers.
These data, together with one-year data from the international phase III GLOBE study, were included in a recent regulatory submission to Chinese health authorities for marketing approval of telbivudine.
“These data suggest that telbivudine, if approved in China, may become an important new treatment option for the millions of Chinese patients with this potentially life-threatening disease,” said Dr Jinlin Hou, director of the Hepatology Unit and Department of Infectious Diseases at Nanfang Hospital, China and a principal investigator in the study.