Entecavir Reduces HBV DNA More than Adefovir in Chronic Hepatitis B Patients at 48 Weeks

A high HBV DNA level is associated with an increased risk of liver disease progression and complications in patients with chronic hepatitis B. Thus, the aim of antiviral therapy is to rapidly and profoundly reduce the amount of HBV DNA.

In the E.A.R.L.Y. Study, a randomized, open-label, comparative trial, researchers previously demonstrated that entecavir (Baraclude) led to a greater early reduction of HBV DNA at Week 12 compared with adefovir (Hepsera) in HB “e” antigen (HBeAg) positive patients. At the 42nd Annual Meeting of the European Association for the Study of the Liver this week in Barcelona, Spain, they presented Week 48 results from the same study.

In this trial, 69 HBeAg positive, antiviral-naive chronic hepatitis B patients were randomly assigned to receive either 0.5 mg entecavir or 10 mg adefovir once-daily for a minimum of 52 weeks. Mean baseline HBV DNA was 10.26 log₁₀ copies/mL in the entecavir arm and 9.88 log₁₀ copies/mL in the adefovir arm.

Results

• Entecavir demonstrated superior early antiviral activity and viral kinetic profiles compared with adefovir as early as Day 10, with superior reduction in HBV DNA at Week 12 (6.23 vs 4.42 log₁₀ copies/mL; P < 0.0001).
• The mean decrease in HBV DNA from baseline to Week 48 was 7.28 log₁₀ copies/mL in the entecavir arm, compared with 5.08 log₁₀ copies/mL in the adefovir arm.
• At Week 48, 19 patients in the entecavir arm (58%) and 6 in the adefovir arm (19%) achieved undetectable HBV DNA (< 300 copies/mL).
• 25 patients in the entecavir arm (76%) and 20 in the adefovir arm (63%) achieved ALT normalization (1 x ULN).
• 5 subjects receiving entecavir (15%) and 7 receiving adefovir (22%) achieved HBeAg seroconversion.
• Adverse events were comparable in the 2 arms.
• No patients in either arm discontinued due to adverse events.
  

Conclusion

In conclusion, the researchers wrote, “At Week 48, entecavir was observed to result in a greater decrease from baseline in HBV DNA than adefovir (7.28 vs 5.08 log₁₀ copies/mL), with 58% of entecavir-treated patients achieving undetectable HBV DNA compared to 19% of adefovir-treated patients.”

They added that, “Entecavir was well tolerated.”

Alice Ho Miu Ling Nethersole Hospital, Hong Kong, China; China Medical University, Taichung, Taiwan-ROC; Santo Tomas University Hospital, Manila, Philippines; Cipto Mangunkusumo National Central General Hospital, Jakarta, Indonesia; Queen Mary Hospital, Pok Fu Lam, Pok Fu Lam, Hong Kong, China; University of Miami Center For Liver Diseases, Miami, FL; Liver Disease Prevention Center, Division of Gastroenterology and Hepatology, Thomas Jefferson University Hospital, Philadelphia, PA; Toronto General Hospital, Toronto, Ontario, Canada;  Bristol-Myers Squibb Pharmaceutical Research Institute, Wallingford, CT.

04/13/07

Reference  
N Leung, CY Peng, J Sollano, and others. Entecavir (ETV) results in higher HBV-DNA redction vs adefovir (ADV) in chronically infected HBeAg(+) antiretroviral-naive adults: 48 wk results (E.A.R.L.Y. Study). 42nd Annual Meeting of the European Association for the Study of the Liver. April 11 - 15, 2007, Barcelona, Spain.

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