OBJECTIVE: The burden of illness of HBV is significant in Asia-Pacific, not only because of its high prevalence, but also because of its HRQOL decrement. Despite the importance of HRQOL in HBV, there are no disease-targeted instruments currently available. We are therefore developing a new, disease-targeted HRQOL instrument in HBV. This presentation describes the candidate items and scales resulting from our initial content validation process. METHODS: “Content validity” is the degree to which an instrument contains a representative range of items and scales relevant to the disease under study. In order to establish content validity for our evolving instrument, we initially conducted a systematic review to identify published HRQOL instruments in chronic liver disease and related conditions. We then convened a panel of five hepatologists experienced in HBV. Using a semi-structured protocol, we elicited the domains perceived as most relevant in HBV, and asked the panel to comment on the relevance of the items from systematic review. Finally, in concert with three psychometricians, we developed a conceptual model of the scales in HBV. RESULTS: We selected five scales on the basis of their content validity and potential responsiveness (i.e. ability to detect HRQOL change after successful treatment); 1) Anticipation Anxiety/Psychological Well Being (e.g. fear of cancer/cirrhosis);2) Disease Stigma/Social Well Being (e.g. embarrassment, concern for job); 3) Sexual Well Being/Intimacy (e.g. transmission concern, impact on sexuality); 4) Daily Functioning (e.g. impact on diet or medication use); and 5) Vitality/Physical Well Being (e.g. feeling worn out, low energy). CONCLUSIONS: Five scales may capture HRQOL in HBV across a range of psychological, social, and physical factors. The breadth and depth of symptoms in HBV highlights the significant HRQOL burden of this condition. Future research will test these scales with patient focus groups, and will prospectively measure the psychometrics of our evolving instrument.