Real-World Outcomes of Opti-Hep-D: An Innovative, Multicentre and Multidisciplinary Program Improving Hepatitis D...

Hepatitis D virus (HDV) infection remains underdiagnosed, and real-world data on screening and linkage to care are limited. We assessed the implementation of Opti-Hep-D, a publicly funded initiative for HDV management in the Spanish region of Catalonia.

In this prospective multicentre study conducted between January 2024 and April 2025, all HBsAg-positive samples underwent reflex anti-HDV and HDV-RNA testing, with subsequent active linkage to care of individuals testing positive. Clinical data were collected in their electronic medical records. Patient characteristics, risk factors, and bulevirtide initiation wereanalysed.

Of 369 581 HBsAg determinations, 6100 were positive. Anti-HDV testing was completed in 5399 (89%), identifying 305 (5.6%) positive individuals. HDV-RNA was assessed in 285 patients, of whom 86 (30%) were viremic. Among 2945 first-time anti-HDV tests, 130 (4.4%) were positive and 26 (20%) were viremic. Notably, 42% of positive patients had no documented risk factors or elevated ALT. HDV prevalence varied across settings (2.3%-14%) and was highest in prisons. Newly diagnosed individuals tended to be younger with milder disease. Among 86 viremic individuals, 95% were successfully linked to care and 43% initiated bulevirtide; 57% remained untreated due to patient-related or reimbursement barriers. No prison inmates received bulevirtide, mainly because of complex social situations.

Large-scale double reflex HDV screening with active linkage to care is feasible and effective in real-world practice and may serve as a model for other healthcare settings. Although care engagement is high, treatment initiation remained limited by structural and social barriers.