Characteristics, Treatment Patterns, and Clinical Outcomes of Chronic Hepatitis B Across 3 Continents: Retrospective Database Study

Abstract

Introduction: The prevalence of chronic hepatitis B virus (HBV) infection is high in many countries; however, robust, real-world epidemiological data are lacking. This study describes the prevalence, characteristics, treatment patterns, and long-term clinical outcomes of patients with chronic HBV infection in the US, Germany, and Taiwan.

Methods: This was a retrospective cohort analysis of three healthcare/insurance claims databases. Individuals were identified as patients with chronic HBV infection if their records contained HBV diagnostic codes from 1 January 2010 to 31 December 2012 (Germany and Taiwan) or 1 January 2013 (USA). Included patients were indexed on 1 January 2013. Patients' demographics, clinical characteristics, and healthcare utilisation were described. Treatment patterns and long-term clinical outcomes over follow-up (to 31 December 2016 or loss to follow-up) were estimated.

Results: The prevalence of chronic HBV infection was 0.10%, 0.17%, and 2.39% in the US, Germany, and Taiwan respectively. Prevalence was very low in children, increased rapidly in adulthood, and peaked in 50- < 65 year olds before declining in the elderly. More US (16.6%) and German (15.4%) patients were HIV ± HCV coinfected than in Taiwan (4.1%). Baseline clinical characteristics and healthcare utilisation were broadly similar between countries. In total, 19.2%, 11.1%, and 5.9% of non-coinfected adult patients received treatment at index in the US, Germany, and Taiwan, respectively; most frequently with nucleos(t)ide analogue monotherapy (94.4%, 97.2%, 99.8% of treated patients, respectively) and rarely with interferons (0.27%, 1.63%, and 0.06%, respectively). Untreated Taiwanese patients were more likely to remain untreated than elsewhere, and treated Taiwanese patients were less likely to persist with therapy. Generally, the cumulative incidence of long-term clinical outcomes was lowest in Germany.

Conclusion: This study provides a contemporary, real-world, intercontinental snapshot of chronic HBV infection. Long-term sequelae occurred in all populations, and treatment levels were low, suggesting an unmet need for (or access to) effective treatments.

Keywords: Epidemiology; Hepatitis B virus; Prevalence; Sequelae; Therapeutics.

Fig. 1

Study design schematic. Avg average, Decomp decompensated liver disease, HCU healthcare utilisation, HIV human immunodeficiency virus, HDV hepatitis delta virus, LTX liver transplant, Rx treatment, Re-Init re-initiation

Fig. 2

Patient data flow in each country

Fig. 3

Age-specific point prevalence of chronic HBV infection in 2013 (all patients). HBV hepatitis B virus

Fig. 4

Treatment patterns of NCIA patients. A At index; B amongst those initiating treatment during follow-up. Note: The proportions in ‘Treatment’ charts from panel A (US and Taiwan) and panel B (Taiwan) do not equal 100.0%, and the proportions in ‘NA monotherapy’ charts from panel A (US and Germany) and panel B (Taiwan) do not equal exactly the corresponding proportion in the ‘Treatment’ charts due to rounding to one decimal place. 3TC lamivudine, ADF adefovir, ENT entecavir, IFN interferon, IFN-a interferon alpha, LdT telbivudine, NA nucleos(t)ide analogue, NCIA non-coinfected adults, PEG-IFN pegylated interferon, TDF tenofovir disoproxil fumarate

Fig. 4

Treatment patterns of NCIA patients. A At index; B amongst those initiating treatment during follow-up. Note: The proportions in ‘Treatment’ charts from panel A (US and Taiwan) and panel B (Taiwan) do not equal 100.0%, and the proportions in ‘NA monotherapy’ charts from panel A (US and Germany) and panel B (Taiwan) do not equal exactly the corresponding proportion in the ‘Treatment’ charts due to rounding to one decimal place. 3TC lamivudine, ADF adefovir, ENT entecavir, IFN interferon, IFN-a interferon alpha, LdT telbivudine, NA nucleos(t)ide analogue, NCIA non-coinfected adults, PEG-IFN pegylated interferon, TDF tenofovir disoproxil fumarate

Fig. 5

Persistence to treatment status among NCIA patients. A Untreated at index; B treated with NAs at index; C–E untreated at index who initiated during follow-up in the US (C), Germany (D) and Taiwan (E). NCIA non-coinfected adults

Fig. 6

Longitudinal treatment patterns in NCIA patients who remained in the study for 2 years. A US; B Germany; C Taiwan. The nodes (vertical bars) represent the order of treatments prescribed in the year, and the width of the links (horizontal connectors) represents the proportion of patients moving from one treatment state to another. Lines of therapy prescribed ≥ 1% are presented here. A adefovir, B telbivudine, E entecavir, I interferon, L lamivudine, NCIA non-coinfected adults, P pegylated interferon, T tenofovir, U untreated

Fig. 7

Long-term clinical outcomes in NCIA patients by index treatment status. A Cirrhosis; B decompensated liver disease; C hepatocellular carcinoma. NA nucleos(t)ide analogues, NCIA non-coinfected adult