Disease Progression in Adults With Hepatitis Delta Virus vs. Hepatitis B Virus Monoinfection in Inpatient and Outpatient Settings in Italy
Author(s)
Pietro Lampertico, MD, PhD1, Valentina Perrone, M.Sc.2, Luca Degli Esposti, PhD2, Melania Leogrande, M.Sc.2, Chong H Kim, MPH, MS, PhD3, Marvin Rock, MPH, DrPH3.
1Division of Gastroenterology and Hepatology, Foundation IRCCS Ca’ Granda Ospedale Maggiore Policlinico and CRC “A. M. and A. Migliavacca” Center for Liver Disease, Department of Pathophysiology and Transplantation, University of Milan, Milan, Italy, 2CliCon S.r.l. Società Benefit, Health, Economics & Outcomes Research, Bologna, Italy, 3HEOR-Global Value and Access, Gilead Sciences, Inc., Foster City, CA, USA.
1Division of Gastroenterology and Hepatology, Foundation IRCCS Ca’ Granda Ospedale Maggiore Policlinico and CRC “A. M. and A. Migliavacca” Center for Liver Disease, Department of Pathophysiology and Transplantation, University of Milan, Milan, Italy, 2CliCon S.r.l. Società Benefit, Health, Economics & Outcomes Research, Bologna, Italy, 3HEOR-Global Value and Access, Gilead Sciences, Inc., Foster City, CA, USA.
OBJECTIVES: Hepatitis delta virus (HDV) infection occurs as a coinfection with hepatitis B virus (HBV) and is the most severe form of viral hepatitis. This study compared rates of disease progression between adults with HDV vs HBV monoinfection (HBV-only) in inpatient and outpatient settings in Italy.
METHODS: Administrative databases were screened for patients aged ≥18 years with an inpatient or outpatient claim (ICD-9-CM or exemption codes) between 01/01/2009 and 30/06/2022. Patients diagnosed with HDV or HBV-only (no HDV claim) during the inclusion period (01/01/2010-30/06/2021) with continuous capture for ≥12 months pre- and post-index date (diagnosis date) were included. Inverse probability of treatment weighting was calculated via propensity scores (probability of HDV vs HBV-only given covariates at baseline). Fine and Gray's subdistribution hazard model was used to assess risk of progression to severe liver disease or death, accounting for competing risks.
RESULTS: Among 17,670 patients, 11,187 were included (HDV, n = 686; HBV-only, n = 10,501). The mean (SD) age (years) was similar between cohorts (HDV, 55.7 [16.2]; HBV-only, 55.8 [16.4]; P = .845), as was the male-to-female ratio (~2:1). Patients with HDV were more likely to progress from noncirrhotic disease (NCD) to compensated cirrhosis (CC; hazard ratio, 95% CI; 1.48, 1.09-2.00), NCD to liver transplantation (LT; 3.44, 1.12-10.58), CC to decompensated cirrhosis (DCC; 3.21, 1.52-6.76), CC to LT (9.72, 2.39-39.49), DCC to hepatocellular carcinoma (HCC; 2.71, 1.24-5.95), DCC to LT (4.27, 1.92-9.46), and HCC to LT (7.97, 2.63-24.17) vs patients with HBV-only (all P-values <.05).
CONCLUSIONS: In Italy, patients with HDV have a significantly increased risk of progressing to greater liver disease severity vs patients with HBV-only, emphasising the need for earlier HDV diagnosis and targeted interventions to delay progression and reduce liver-related morbidity.
METHODS: Administrative databases were screened for patients aged ≥18 years with an inpatient or outpatient claim (ICD-9-CM or exemption codes) between 01/01/2009 and 30/06/2022. Patients diagnosed with HDV or HBV-only (no HDV claim) during the inclusion period (01/01/2010-30/06/2021) with continuous capture for ≥12 months pre- and post-index date (diagnosis date) were included. Inverse probability of treatment weighting was calculated via propensity scores (probability of HDV vs HBV-only given covariates at baseline). Fine and Gray's subdistribution hazard model was used to assess risk of progression to severe liver disease or death, accounting for competing risks.
RESULTS: Among 17,670 patients, 11,187 were included (HDV, n = 686; HBV-only, n = 10,501). The mean (SD) age (years) was similar between cohorts (HDV, 55.7 [16.2]; HBV-only, 55.8 [16.4]; P = .845), as was the male-to-female ratio (~2:1). Patients with HDV were more likely to progress from noncirrhotic disease (NCD) to compensated cirrhosis (CC; hazard ratio, 95% CI; 1.48, 1.09-2.00), NCD to liver transplantation (LT; 3.44, 1.12-10.58), CC to decompensated cirrhosis (DCC; 3.21, 1.52-6.76), CC to LT (9.72, 2.39-39.49), DCC to hepatocellular carcinoma (HCC; 2.71, 1.24-5.95), DCC to LT (4.27, 1.92-9.46), and HCC to LT (7.97, 2.63-24.17) vs patients with HBV-only (all P-values <.05).
CONCLUSIONS: In Italy, patients with HDV have a significantly increased risk of progressing to greater liver disease severity vs patients with HBV-only, emphasising the need for earlier HDV diagnosis and targeted interventions to delay progression and reduce liver-related morbidity.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
EPH64
Topic
Epidemiology & Public Health
Topic Subcategory
Public Health, Safety & Pharmacoepidemiology
Disease
Infectious Disease (non-vaccine), Rare & Orphan Diseases