Randomised clinical trial: the benefit of combination therapy with adefovir and lamivudine for chronic hepatitis B

Alimentary Pharmacology and Therapeutics, 04/04/2012

Extended combination therapy with lamivudine and adefovir is associated with a high rate of long–term virological and biochemical response. Adefovir monotherapy appears to be less effective mainly because of poor initial response and the ultimate development of antiviral resistance.

Methods

  • Patients with chronic hepatitis B with and without previous lamivudine therapy were randomised to receive adefovir alone (10 mg/daily) or adefovir and lamivudine (100 mg/daily) for up to 192 weeks.
  • Study endpoints were :
    • Maintained virological (HBV DNA <500 copies/mL), biochemical and histological response
    • Loss of HBeAg
    • Loss of HBsAg.

Results

  • A total of 41 patients were enrolled, including 31 HBeAg -positive and 31 treatment-naive subjects.
  • 30 patients remained on assigned therapy at 192 weeks.
  • The percentage of patients achieving a combined maintained response was higher in the combination than the monotherapy arm, both at week 48 (59% vs. 26%, P = 0.06) and 192 (68% vs. 31%, P = 0.03).
  • At week 192, 76% of the combination vs. 36% of the monotherapy group had loss of HBeAg (P = 0.03).
  • One patient receiving adefovir cleared HBsAg.
  • Adefovir resistance developed in 6 of 19 (32%) monotherapy but none of 22 combination treated patients (P = 0.03).

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