Real-World Epidemiology, Clinical and Economic Burden of Chronic Hepatitis B in Japan: A Retrospective Study Using JMDC Claims Database.

INTRODUCTION: Chronic hepatitis B (CHB) is one of the world's major healthcare problems, especially in the Western Pacific regions. This study describes the prevalence, incidence, treatment profiles and clinical and economic burden of chronic hepatitis B patients in Japan using the Japan Medical Data Center (JMDC) Claims Database. METHODS: This is a retrospective observational study. Prevalence cases were identified as patients with ≥ 1 inpatient or ≥ 2 outpatient CHB diagnoses and ≥ 2 records for hepatitis B tests or ≥ 1 prescription for CHB treatment between January 2010 and December 2019. Newly diagnosed CHB patients were defined as patients diagnosed from 2010 to 2018 with no history of the disease up to 2 years prior to the diagnosis. The index date is defined as the first CHB diagnosis day. We only used patients' data with ≥ 1-year post-index date. RESULTS: We identified 13,061 CHB prevalent cases (2010-2019), yielding a crude period prevalence of 0.32%. Newly diagnosed CHB patients (n = 1973; median age 52 years) were followed for a median period of 3.1 years, during which 15% received a CHB treatment. Entecavir was the most common first treatment (66%). During this period, 3.4% of the patients developed compensated cirrhosis (CC), 1.5% decompensated cirrhosis (DC) and 3.0% hepatocellular carcinoma (HCC). Around 43.3% of CHB patients were hospitalized at least once. Hospitalizations, treatment rates, serologic testing and screening for liver diseases increased as the severity of the disease progressed. The average total healthcare cost was 870,568 JPY (7779 USD) per person per year. DC and HCC resulted in the highest management costs. CONCLUSIONS: Chronic hepatitis B represents a high clinical and economic burden for patients and caregivers, given its morbidity and associated costs.

Clinical Outcomes and Quantitative HBV Surface Antigen Levels in Diverse Chronic Hepatitis B Patients in Canada: A Retrospective Real-World Study of CHB in Canada (REVEAL-CANADA).

BACKGROUND: Hepatitis B surface antigen (HBsAg) loss is associated with improved clinical outcomes for individuals with chronic hepatitis B (CHB); however, the effects of varying HBsAg levels on clinical outcomes in diverse cohorts are understudied. METHODS: In this cross-sectional, multicentre, retrospective study, the data on adult subjects enrolled in the Canadian HBV Network with CHB seen from 1 January 2012 to 30 January 2021 with the treatment and virologic data within 1 year of HBsAg testing were analyzed. Patients were tested for HBsAg using qualitative (for HBsAg-negative samples) and/or commercial quantitative assays. Fibrosis or hepatic necroinflammation was determined by the liver stiffness measurement (LSM). The baseline data were summarized using descriptive statistics and compared by using univariable/multivariable analyses. RESULTS: This study included 844 CHB patients, with a median age of 49.6 years (IQR 40.1-60.5), and 37% were female. In total, 751 patients (78.6%) had known ethnicity data, and 76.7% self-reported as Asian, 11.4% as Black, 6.8% as White, and 4.8% as other. Among the 844 patients, 237 (28.0%) were HBsAg (-) (1000 IU/mL. Overall, 80% (682) had known HBeAg status at the last follow-up, and the majority (87.0%) were HBeAg-negative. In addition, 54% (461/844) had prior antiviral therapy, 19.7% of which (16.3, 23.7, n = 91) were HBsAg (-). The treated patients had a lower risk of cirrhosis (16.46, 95% CI 1.89-143.39, p = 0.01) or HCC (8.23, 95% CI 1.01-67.39, p = 0.05) than the untreated patients. A lower proportion of the HBsAg-loss group had cirrhosis (5.7% vs. 10.9%, p = 0.021) and HCC (0.9% vs. 6.2%, p = 0.001). CONCLUSION: In this retrospective, ethnically diverse cohort study, CHB patients who received antiviral therapy and/or had HBsAg loss were less likely to develop cirrhosis and HCC, confirming the results of the studies in less diverse cohorts. No association was found between the qHBsAg level and fibrosis determined with LSM. Individuals who achieved HBsAg loss had low-level qHBsAg within 1 year of seroclearance.

Preferences of Patients with Chronic Hepatitis B - A Discrete Choice Experiment on the Acceptability of Functional Cure.

BACKGROUND: Current antiviral therapies for chronic hepatitis B (CHB) rarely achieve functional cure, thus often requiring lifelong therapy. A therapy achieving functional cure in a significant percentage of patients could change the treatment landscape substantially. However, the acceptability of functional cure by patients is unknown, especially if associated with additional treatment burden. METHODS: A Discrete Choice Experiment (DCE) including patients with CHB was performed between 2018 and 2019 in Germany. Patient inclusion criteria were confirmed CHB; age of at least 18 years; no history of hepatocellular carcinoma; no HIV or HCV/HDV co-infection. The final DCE included the following attributes: route of administration (oral administration by tablets; subcutaneous injection + tablets; intramuscular electroporation + tablets), side effect frequency (0/1/3 days per month), functional cure (1%/30%/50% of patients), frequency of physician visits (monthly, half-yearly) and travel time to treating physician (15/45 min). RESULTS: The main analysis sample consisted of 108 patients with CHB (mean age: 49.1 years, female: 37.0%, average time since CHB diagnosis: 14.0 years, 52.8% with Hepatitis B surface antigen (HBsAg) chronic HBV infection). High efficacy was found to be the main driver of decisions for/against the presented treatment options (impacted 57% of patients' decisions), followed by therapy regimen (17%), safety profile (12%) and number of physician visits (11%). Latent class analysis revealed first insights into different decision patterns, with age, gender and previous side-effect experience affecting patients' decisions. CONCLUSION: In comparison to all other treatment-related attributes such as therapy regimen or safety profile, patients with CHB showed a strong preference towards a scenario where a substantial number of patients benefit from sustained disease remission, which mimics functional cure.