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Mean HBsAg, HBeAg, and HBcrAg reductions of 1.2 log10 IU/mL, 1.7 log10 PEI U/L and 2.0 log10 U/mL, respectively, at
Week 48. These reductions were dose-dependent, independent of co-administration of ETV, and suggest that ALG-000184
may reduce cccDNA levels via both the 1st and 2nd mechanisms of action of CAM-E drugs
1.
Greater mean DNA reductions were observed for ALG-000184 + ETV vs. ETV monotherapy after treatment for 12 weeks;
maximum mean DNA reductions of 6.8 log10 IU/mL for the ALG-000184 + ETV combination were observed at Week 48
2.
Mean DNA reductions were comparable for 300 mg ALG-000184 with or without ETV, indicating ETV did not further impact
DNA lowering. No viral DNA breakthroughs were observed in subjects receiving ALG-000184 monotherapy
3.
4. ALG-000184 with or without ETV was well tolerated with no safety signals identified |
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