Background and aims
Hepatitis delta (HDV) infection runs a more progressive course than that of hepatitis B (HBV). If left untreated, HDV is associated with an earlier onset of hepatic disease such as cirrhosis, liver failure, and liver cancer compared to HBV. Pegylated interferon (PEG-IFN) is used off-label as a standard treatment for HDV in the United States. Data evaluating HDV treatment patterns is limited. This study describes treatment rates and distribution of provider specialties in management of HDV in the US.
Using the All-Payer Claims Database, adults (≥18 years) with ≥1 inpatient claim or ≥2 outpatient claims ≥30 days apart for HDV infection based on ICD-9/10-CM diagnosis codes were identified from 1/1/2015 to 12/31/2019. First date of HDV diagnosis was defined as the index date. Patients were required to have ≥12 months of continuous enrolment before and after their index date. Treatment patterns for antiviral therapies were assessed over the 12-month post-index period (follow-up). Physician specialty was assessed at diagnosis and during follow-up.
Among the 9, 376 patients identified with HDV during the study period, 6, 719 met inclusion criteria; only 0.1% received treatment with PEG-IFN within the follow-up period. Additionally, only 8.8% were on HBV-specific antiviral therapy including tenofovir disoproxil fumarate (5.3%), entecavir (2.9%), and tenofovir alafenamide (1.0%). The majority (53.0%) of HDV patients were diagnosed by primary care physicians (PCPs), followed by gastroenterology (GI, 9.3%), obstetrics-gynecology (OBGYN) (4.7%), infectious diseases (ID, 2.4%), and hepatology (0.6%) physicians. During the follow-up period, 62.1% of patients were managed by PCPs, while 12.1%, 4.4%, 2.9%, and 2.7% were seen by GI, OBGYN, ID, and hepatology physicians, respectively.
In a large national US cohort representing ∼80% of the insured population, most patients with HDV were diagnosed and cared for by PCPs without specialty referral, and <20% were cared for by specialty providers. Rates of HBV-specific antiviral treatment among HDV patients were <10%, and very few patients were treated with PEG-IFN, the current standard of care for HDV. There is a critical need for greater awareness of the importance of ensuring HDV patients are appropriately treated, and for vigorous efforts to ensure that appropriate healthcare providers are made aware of new HDV therapies in a timely manner.