Patent ID: 8211633

Claim:
A method for determining whether a hepatitis B test virus from a human patient exhibits reduced sensitivity to entecavir relative to a wild-type hepatitis B virus, the method comprising: (a) screening a nucleic acid molecule from the test virus for entecavir-resistance mutations, wherein the nucleic acid molecule comprises a nucleic acid sequence that encodes a reverse transcriptase domain of a DNA polymerase, the mutations being combinations of mutations selected from the list consisting of: (i) mutations at codon positions 180, 202, and 204; and (ii) mutations at codon positions 180, 184, and 204; (b) wherein codon positions 180, 184, 202, and 204 correspond to position 106, 110, 128, and 130, respectively of SEQ ID NO:2; (c) wherein the mutation at position 180 is a substitution to methionine, the mutation at codon position 184 is a substitution to glycine, isoleucine, proline, cysteine, alanine, phenylalanine, or methionine, the mutation at position 202 is a substitution to cysteine, and the mutation at codon position 204 is a substitution to isoleucine or valine, and (d) wherein the presence of mutations corresponding to (i) or (ii) indicates that the test virus exhibits reduced sensitivity to entecavir.