By Cheryl Lathrop
BOSTON -- November 2, 2009 -- Telbivudine provided effective viral suppression and had a favourable safety profile over 4 years in patients with hepatitis B e antigen (HBeAg)-positive and HBeAg-negative chronic hepatitis B (CHB), researchers noted here at the Liver Meeting 2009, the 60th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD).
At the conclusion of the 2-year GLOBE study -- a phase 3 trial of telbivudine versus lamivudine in 1,367 adults in which telbivudine demonstrated superior efficacy -- subjects had the option of continuing telbivudine treatment for a 2-year extension period to evaluate the efficacy and safety of 3 and 4 years of continuous telbivudine treatment.
Yuming Wang, Xinan Hospital, Chongqing, China, and colleagues reported the findings from the GLOBE 2-year extension study in a poster session here on October 31. This open-label, phase 3b clinical trial comprised adults with chronic hepatitis B who were previously treated in either GLOBE or one of the feeder studies (010, 015, 018, 019, 2301). This poster presentation, however, covered data from only the subjects that had been in the previous GLOBE study, as it provided data for subjects that received telbivudine for 4 continuous years.
A total of 484 subjects continued into the extension study; 58 subjects discontinued due to efficacy and 27 had major protocol deviations, leaving 399 subjects (213 HBeAg-positive, 186 HBeAg-negative) for analysis.
Of the 213 HBeAg-positive subjects, 22% (n = 46) were hepatitis B virus (HBV)-DNA positive; 4% (n = 7) of the HBeAg-negative subjects were HBV-DNA positive. In all, 93% (n = 371) completed 3 years of treatment and 83% (n = 331) completed 4 years.
For HBeAg-positive subjects, 79% (n = 168) achieved undetectable HBV DNA with 51% cumulative HBeAg seroconversion after 4 years of treatment. For HBeAg-negative subjects, 84% (n = 156) achieved undetectable HBV DNA and 91% alanine aminotransferase (ALT) normalisation after 4 years of treatment.
"Continued telbivudine treatment for 4 years is an effective treatment option for chronic hepatitis B patients," the authors concluded. "The favourable telbivudine safety profile reported [at] 2 years remained unchanged over 4 years. No cases of rhabdomyolysis or lactic acidosis were reported."
GLOBE was the largest registration trial of patients with chronic hepatitis B ever conducted and the first global registration trial to include chronic hepatitis B patients from China, where the disease is endemic.
[Presentation Title: Efficacy and Safety Outcomes After 4 Years of Telbivudine Treatment in Patients With Chronic Hepatitis B (CHB). Abstract 482]
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