Table 7:
Primary non-response | Less than 2-log10 IU/mL decrease in HBV DNA measured at 6 months of treatment, most commonly related to non-adherence to medication |
Genotypic resistance | Mutation of HBV DNA polymerase known to decrease the efficacy of the antiviral agent |
Phenotypic resistance | Defined by an in vitro assay demonstrating decreased inhibition of viral replication in the presence of the specific mutation in the polymerase gene |
Viral breakthrough | Increase in HBV DNA of 1 log10 IU/mL or greater above the nadir, measured in two consecutive samples 1 month apart, occurring after the first 3 months of therapy; this is commonly because of genotypic resistance, but it may also be the result of lack of adherence |
Clinical or biochemical breakthrough | A rise in ALT from its nadir during treatment associated with a rise in HBV DNA of 1 log10 IU/mL or greater; it may also be the result of either genotypic resistance or lack of adherence |
ALT = alanine aminotransferase; HBV DNA = viral load