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The purpose of this study was to report on the clinical usefulness of the Liver Disease Quality of Life Instrument (LDQOL) 1.0, which was prospectively measured in chronic hepatitis B patients. We regularly followed up with patients with chronic hepatitis B between 2008 and 2010 who were enrolled in the study, and the LDQOL 1.0 was filled out until 2015. The reliability and construct validity were evaluated by Cronbach's α values and analysis of variance. Cox proportional hazards models were used to identify questionnaire components associated with death and decompensation. The LDQOL 1.0 scores were compared between groups of patients with different clinical characteristics. A total of 192 patients (27.1% with cirrhosis) were enrolled. The LDQOL 1.0 was reliable with high internal consistency based on the Cronbach's α value. Most of each component was significantly associated with liver disease-related parameters, such as disability days, self-rated severity of liver disease symptoms, and Child-Pugh class. The change in concentration score between the first and last visit significantly predicted death (hazard ratio (HR), 0.44) and decompensation (HR, 0.97; p &lt; 0.05 for both). Patients who achieved complete viral suppression did not show better scores than those who did not. In conclusion, the LDQOL 1.0 was prospectively validated in patients with chronic hepatitis B. Complete viral suppression did not influence the improvement of quality of life scores. The change in concentration scores over time was predictive of death and decompensation.

Validation of the Liver Disease Quality of Life Instrument 1.0 in Patients with Chronic Hepatitis B: A Prospective Study