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AssigneesRheinishche Friedrich-Wilhelms-Universitaet Bonn, Universitaet Zu Koeln, Justus-Liebig-Universitaet Gissen
InventorsOliver Schildgen, Martin Vogel, Bertfried Matz, Juergen Rockstroh, Rolf Kaiser, Martin Daeumer, Martin Helm, Lutwin Weitner, Carl Knud Schewe, Wolfram Gerlich
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The present invention relates generally to the field of Hepatitis B variants exhibiting a reduced sensitivity to nucleoside analogues both in vivo and in vitro. More in particular, reverse transcriptase mutant rt I233V is provided. Present invention provides assays and methods for detecting such variant, which assays are useful in monitoring anti-viral therapeutic regimes and adjusting patient therapy. A diagnostic kit for detecting the presence of an HBV variant in a biological sample has also been described. Finally, the use of a pharmaceutical composition to cure a subject suffering from a HBV infection, which HBV is resistant to lamuvidine and/or adefovir has been provided, which pharmaceutical composition comprises the nucleoside analogue tenofovir.
A method of detecting Hepatitis B virus (HBV) variant in a biological sample, said HBV variant comprising at least one nucleotide mutation in the DNA polymerase gene at codon position 233 which results in a substitution of an isoleucine to any other amino acid, said method comprising the step of detecting the presence of a HBV polynucleic acid or a fragment of a HBV polynucleic acid in a biological sample, said HBV polynucleic acid or said fragment comprising a nucleotide mutation at codon position 233 that results in an amino acid substitution of an isoleucine of the DNA polymerase gene in the HBV variant to any other amino acid in the HBV variant, or the step of detecting the expression product of said HBV polynucleic acid or said fragment comprising said amino acid substitution.
A method of detecting Hepatitis B virus (HBV) variant in a biological sample, said HBV variant comprising at least one nucleotide mutation in the DNA polymerase gene at codon position 233 which results in a substitution of an isoleucine to any other amino acid, said method comprising the step of detecting the presence of a HBV polynucleic acid or a fragment of a HBV polynucleic acid in a biological sample, said HBV polynucleic acid or said fragment comprising a nucleotide mutation that results in an amino acid substitution of an isoleucine of the DNA polymerase gene in the HBV variant to any other amino acid in the HBV variant.
A method for detecting a drug-resistant HBV-variant present in a biological sample, said variant being resistant to an antiviral drug, except of tenofovir, said HBV variant comprising at least one nucleotide mutation in the DNA polymerase gene at codon 233 which results in an iso-leucine to any other amino acid substitution rtI233X, said method comprising the step of detecting the presence of a HBV polynucleic acid comprising a nucleotide mutation that results in an amino acid substitution rtI233X of the DNA polymerase gene in the HBV variant, or a fragment of said HBV polynucleic acid comprising said nucleotide mutation, wherein the presence of said HBV polynucleic acid indicates resistance of an HBV virus present in said biological sample to an antiviral drug.
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