Sustained HBeAg Response Occurs with Both Telbivudine and Lamivudine

Hepatitis B “e” antigen (HBeAg) loss and seroconversion are considered important markers in the treatment of chronic hepatitis B.

In a study presented at the 42nd Annual Meeting of the European Association for the Study of the Liver this week in Barcelona, Spain, researchers assessed the durability of HBeAg response among participants in the GLOBE Study, a randomized Phase III trial comparing telbivudine (Tyzeka) vs lamivudine (Epivir-HBV).

The trial enrolled 921 patients with HBeAg positive chronic hepatitis B from 20 countries. At baseline, subjects had HBV DNA levels greater than 6 log₁₀ copies/mL, alanine aminotransferase (ALT) levels 1.3-10 times the upper limit of normal, and compensated liver disease. After 1 year, participants were eligible to discontinue treatment if they had HBV DNA levels below 5 log₁₀ copies/mL and had exhibited HBeAg loss for at least 24 weeks; these patients then continued scheduled study visits for post-treatment follow-up.

Results

• Post-treatment durability of HBeAg response among patients who discontinued treatment is presented in the table below.
• 134 of 458 patients receiving telbivudine (29%) and 123 of 463 patients receiving lamivudine (27%) were eligible to discontinue treatment; however, due to investigator recommendations, only 23% did so.
• At week 104, more than 80% of patients in both the telbivudine and lamivudine arms exhibited sustained HBeAg responses.
• The median duration off-treatment was 35.2 weeks in the telbivudine and 29.1 weeks in the lamivudine arm.
• Patients who relapsed had a slightly higher mean HBV DNA level (2.7 vs 2.3 log₁₀ copies/mL) at the time of discontinuation.
• Relapsers also had a shorter mean duration of treatment (64 vs 75 weeks).
  
  

 Conclusion

In conclusion, the investigators wrote, “In HBeAg-positive patients [who] discontinued [treatment] for efficacy in the GLOBE trial, sustained HBeAg responses were observed in > 80% of patients [receiving] both telbivudine and lamivudine following a median duration of 33 weeks off-treatment.”

Groupe Hospitalier Pitie-Salpetriere, Paris, France; Phramongkutklao Hospital, Bangkok, Thailand; Bundang CHA Hospital, Gyeonggii-Do, South Korea; National University Hospital, Singapore, Singapore; University Of Toronto, Toronto, Ontario, Canada; Huashan Hospital, Medical Center of Fudan University, Shanghai, China; University Of Calgary, Calgary, Alberta, Canada; University College, London, UK; Saarland University Hospital, Homburg-Saar, Germany; Idenix Pharmaceuticals, Cambridge, MA.

04/13/07

Reference  
T Poynard, A Chutaputti, SG Hwang, and others. Sustained Off-Treatment HBeAg Response in Telbivudine and Lamivudine Treated HBeAg-Positive Patients from the GLOBE Study. 42nd Annual Meeting of the European Association for the Study of the Liver. April 11 - 15, 2007, Barcelona, Spain.

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