Viral variants and uses therefor

Details Viral variants and uses therefor Viral variants and uses therefor

C - Chemistry, Metallurgy

12

N

C12N 15/36 (2006.01) A61K 39/29 (2006.01) C07K 14/02 (2006.01) C12N 7/01 (2006.01) C12N 15/54 (2006.01) G01N 33/576 (2006.01)

Patent

CA 2309379

The present invention relates generally to viral variants exhibiting reduced sensitivity to particular agents including nucleoside analogues and immunological mediators such as immunoglobulins and immune cells. More particularly, the present invention provides hepatitis B virus (HBV) variants which exhibit a level of replication fitness in the presence of a nucleoside analogue similar to or greater than in the absence of the nucleoside analogue. The detection of such HBV variants is important in the management of therapeutic protocols including the selection of appropriate agents for treating HBV infection. In particular, the present invention contemplates a method of treating HBV infection including a method for identifying a need to change or otherwise alter an existing therapeutic regimen. Furthermore, the method of treatment further encompasses selecting an anti-viral agent or combination of anti-viral agents which would be less likely to result in development of resistance to anti-viral therapy. The method of this aspect of the present invention is predicated in part on monitoring the development in a subject of an increased HBV load in the presence of a nucleoside analogue. This may be manifested by an increase in HBV DNA levels compared to levels in patients prior to treatment. The recognition of such increased viral load and/or DNA levels is indicative of the development of a variant HBV resistant to said nucleoside analogue and an immune mediated response. The clinician is then able to modify an existing treatment protocol or select an appropriate treatment protocol accordingly. The present invention further provides the use of nucleoside analogue-resistant HBV variants which exhibit a similar or increased replication fitness in the presence of the nucleoside analogue compared to in the absence of the nucleoside analogue to screen for medicaments to treat HBV infection.

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