Antiviral Drug-Resistant HBV: Standardization of Nomenclature and Assays and Recommendations for Management
Anna S. Lok, Fabien Zoulim,Stephen Locarnini, Angeline Bartholomeusz, Marc G. Ghany, Jean-Michel Pawlotsky, Yun-Fan Liaw, Masashi Mizokami, and Carla Kuiken, and the Hepatitis B Virus Drug Resistance Working Group
Abstract Substantial advances have been made in the treatment of chronic hepatitis B in the past decade. Approved treatment sfor chronic hepatitis B have expanded from just one agent to a total of six agents: standard interferon(IFN), pegylated IFN, lamivudine (LAM), adefovirdipivoxil (ADV), entecavir (ETV), and telbivudine(LdT). In addition to the four approved nucleos(t)ideanalogues (NAs) for chronic hepatitis B, tenofovirdisoproxil fumarate (TDF), the pro drug of tenofovirand the coformulation of TDF and emtricitabine, approved treatments for human immunodeficiency virus(HIV) infection, have activity against hepatitis B virus(HBV).Although NAs are more convenient than IFN-based therapies and have fewer side effects, sustained viral supperssionis usually not achieved after withdrawal of a 48-week course of NA therapy, necessitating long, and in many cases, indefinite treatment. Unfortunately, a long duration of NA treatment is associated with an increase ingrisk of development of drug resistance. Antiviral resistance and poor adherence are the most important factor sin treatment failure. Thus, there is a need to standardizenomenclature relating to HBV antiviral resistance, and to define genotypic, phenotypic, and clinical resistance to NA therapy. In this review, we propose definitions of terminologies, briefly describe available methods for detecting and quantifying drug resistance, and discuss the interpretation of drug resistance data and its current and future application in clinical practice.
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