Telbivudine Provides Superior HBV Suppression Compared with Adefovir through 76 Weeks

At the 42nd Annual Meeting of the European Association for the Study of the Liver this month in Barcelona, Spain, researchers reported results from a 1-year randomized trial of telbivudine (Tyzeka) vs adefovir (Hepsera), followed by 24 additional weeks of open-label telbivudine.

The study enrolled 135 adults with HBeAg positive chronic hepatitis B with HBV DNA levels greater than 6 log₁₀ copies/mL and serum ALT levels 1.3-10 x the upper limit of normal.

Patients were randomly assigned (2:1) to received adefovir or telbivudine for 24 weeks. Then, adefovir recipients were secondarily randomized (1:1) to either continue adefovir or switch to telbivudine after Week 24. The primary endpoint was HBV DNA reduction at Week 24. After Week 52, most patients received telbivudine in an open-label extension trial. The effect of switching from adefovir to telbivudine in patients with suboptimal response to adefovir (HBV DNA > 3 log at 24 or 52 weeks) was analyzed.

Results

• At Week 24, the mean HBV DNA reduction from baseline was significantly greater with telbivudine than with adefovir (decrease of 6.30 vs 4.97 log₁₀ copies/mL).
  
  
• Mean HCV viral load decreased sharply in adefovir-treated patients after switching to telbivudine at Week 24.
  
  
• Among the 78% of patients in the adefovir group with suboptimal response at Week 24, those who switched to telbivudine experienced an additional 2.1 log₁₀ mean reduction between Week 24 and Week 52, compared with 0.9 log₁₀ for patients who remained on adefovir.
  
  
• Similarly, among adefovir recipients with persistent suboptimal response at Week 52, a 2.1 log₁₀ decrease in viral load occurred between Week 52 and Week 76 after switching to telbivudine.
  
  
• In patients receiving continuous telbivudine, the mean HBV DNA reductions from baseline were:
  
  
• 6.3 log¹⁰ at Week 24;
• 6.8 log₁₀ at Week 52;
• 7.2 log₁₀ at Week 76.
  
  
• Serum HBV DNA was undetectable (< 300 copies/mL) in 39% of patients at Week 24, 60% at Week 52, and 72% at Week 76.

Conclusion

“Telbivudine provided greater and more rapid antiviral effects compared with adefovir through 1 year of treatment,” the investigators concluded. “For patients with suboptimal response to adefovir, switching from adefovir to telbivudine after 24 or 52 weeks provided a substantial additional reduction of serum HBV DNA that persisted through week 76.”

Hopital Beaujon, Clichy, France; Prince Of Wales Hospital, Hong Kong-SAR, China; University Of Hong Kong, Hong Kong-SAR, China; Pusan National University Hospital, Busan, South Korea; Severance Hospital, Seoul, South Korea; Tri-Service General Hospital, Taipei, Taiwan-ROC; Toronto Western Hospital, Toronto, ON, Canada; University of Calgary, Calgary, AB, Canada; Novartis Pharmaceuticals, East Hanover, NJ; Idenix Pharmaceuticals, Cambridge, MA.

04/20/07

Reference 
P Marcellin, HLY Chan, C-L Lai, and others. 76 week follow up of HBeAg positive chronic hepatitis B patients treated with telbivudine, adefovir or switched from adefovir to telbivudine. 42nd Annual Meeting of the European Association for the Study of the Liver. Barcelona, Spain. April 11-15, 2007.

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