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Hepatitis B

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Adefovir-resistant HBV ����In patients with no prior exposure to other NA, lamivudine, telbivudine or entecavir may be added. Alternatively, stop adefovir and use tenofovir plus lamivudine or emtricitabine. (III) ����In patients with prior lamivudine resistance in whom lamivudine had been stopped when treatment was switched to adefovir, stop adefovir and use tenofovir plus lamivudine, emtricitabine (II-2) or entecavir (III), but the durability of response to this combination is unknown. Entecavir-resistant HBV ����Use adefovir or tenofovir since they have been shown to have activity against entecavir-resistant HBV in in vitro studies, but clinical data are lacking. (II-3) Table 4. Definition of Response to Antiviral Therapy of Chronic Hepatitis B Category of Response Biochemical (BR) Decrease in serum ALT to within the normal range Virologic (VR) Decrease in serum HBV DNA to undetectable levels by PCR assays, and loss of HBeAg in patients who were initially HBeAg positive Primary nonresponse ��� (not applicable to interferon therapy) Decrease in serum HBV DNA by < 2 log10 IU/mL after at least 24 weeks of therapy Virologic relapse Increase in serum HBV DNA of 1 log10 IU/mL after discontinuation of treatment in at least two determinations more than 4 weeks apart Histologic (HR) Decrease in histology activity index by at least 2 points and no worsening of fibrosis score compared to pretreatment liver biopsy Complete (CR) Fulfill criteria of biochemical and virological response and loss of HBsAg On-therapy During therapy Maintained Persist throughout the course of treatment End-of-treatment At the end of a defined course of therapy Off-therapy After discontinuation of therapy Sustained (SR-6) 6 months after discontinuation of therapy Sustained (SR-12) 12 months after discontinuation of therapy Time of Assessment 7

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