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A RANDOMISED DOUBLE-BLIND PHASE II STUDY OF LAMIVUDINE (LAM) COMPARED TO LAMIVUDINE PLUS ADEFOVIR DIPIVOXIL (ADV) FOR TREATMENT NAìVE PATIENTS WITH CHRONIC HEPATITIS B (CHB) : WEEK 52 ANALYSIS
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J.J.Y. Sung*, 1 J.Y. Lai, 2 S. Zeuzem, 3 W.C. Chow, 4 E. Heathcote, 5
R. Perrillo, 6 C. Brosgart, 7 M. Woessner, 8 S.A. Scott, 9 F.M. Campbell, 9
*Presenting Author
1Prince Of Wales Hosp, Hong Kong, 2Princess Margaret Hosp, Hong Kong, China 3Univ Hosp, Hamburg, Germany 4Singapore General Hosp, Singapore, 5Toronto Western Hosp, ON, Canada 6Alton L.Oschner Clinic, LA, USA 7Gilead Sciences Inc., CA, USA 8GlaxoSmithKline, NC, USA 9GlaxoSmithKline, Middlesex, UK
Background: Both LAM and ADV have proven efficacy and safety in CHB patients. In vitro data suggest they have additive/synergistic activity and may be more effective in combination for treatment-na•ve CHB patients. Methods: 115 patients were randomised to LAM (100mg od) and ADV (10mg od) or LAM and ADV-placebo (PLA) for 104 weeks. Primary-endpoint was HBV-DNA time-weighted average change from baseline to W16 (DAVG16). Secondary-endpoints included: ALT-normalisation, HBV-DNA reduction, HBeAg/HBsAg loss, incidence of viral-breakthrough and YMDD mutant HBV.
Results: Groups were similar at baseline. Of 112 patients, mean age 36-years, 79% male, 64% Asian, 34% Caucasian, 96% HBeAg-positive, 96% ALT>ULN, 98% HBV-DNA positive (Roche-COBAS). (insert table here)
LAM monotherapy had a significantly higher incidence of ALT-normalisation at W48 and W52. However, median ALT was similar in both groups throughout Year-1. Both regimens were well tolerated with similar safety profiles. Serious AEÕs: 4/55 (7%) in LAM and 1/58 (2%) in LAM+ADV group.Conclusions: During Year-1, LAM+ADV did not enhance the antiviral, biochemical or serological outcome compared to LAM in treatment-na•ve CHB patients. An increased incidence of YMDD mutant HBV and viral-breakthrough was observed in the LAM group. Clinical benefit of LAM+ADV may not become apparent until Year-2.
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