{Reference Type}: Journal Article {Title}: Characterizing Hepatitis Delta in Spain and the gaps in its management. {Author}: Rodríguez-Tajes S;Palom A;Giráldez Gallego Á;Moreno A;José Urquijo J;Rodríguez M;Alvarez-Argüelles M;Diago M;García-Eliz M;Fuentes J;Sapiña Pérez AMM;Castillo P;Casado M;Pérez Campos E;Muñoz R;Hernández-Conde M;María Morillas R;Granados R;Miquel M;Morillas Ariño MJ;García-Retortillo M;Antonio Carrión J;María Moreno J;Montón C;González-Santiago JM;Lorente S;Cabezas J;Mateos B;Vázquez-Rodríguez S;Díaz-Fontenla F;María Pinazo J;Delgado M;Pérez-Palacios D;Horta D;Fernández Marcos C;López C;Luis Calleja J;Fernández I;García-Samaniego J;Forns X;Buti M;Lens S; {Journal}: Gastroenterol Hepatol {Volume}: 0 {Issue}: 0 {Year}: 2024 Jun 20 {Factor}: 5.867 {DOI}: 10.1016/j.gastrohep.2024.502222 {Abstract}: OBJECTIVE: Chronic hepatitis D (CHD) is a severe form of chronic viral hepatitis. The estimated HDV prevalence in Spain is around 5% of patients with hepatitis B. Reimbursement of new antiviral therapies (Bulevirtide, BLV) was delayed in our country until February 2024. We aimed to characterize the clinical profile of patients with HDV/HBV infection in Spain and current barriers in their management at the time of BLV approval.
METHODS: Multicenter registry including patients with positive anti-HDV serology actively monitored in 30 Spanish centers. Epidemiological, clinical and virological variables were recorded at the start of follow-up and at the last visit.
RESULTS: We identified 329 anti-HDV patients, 41% were female with median age 51 years. The most common geographical origin was Spain (53%) and East Europe (24%). Patients from Spain were older and had HCV and HIV coinfection probably associated to past drug injection (p<0.01). HDV-RNA was positive in 138 of 221 assessed (62%). Liver cirrhosis was present at diagnosis in 33% and it was more frequent among viremic patients (58% vs 25%, p<0.01). After a median follow-up of 6 (3-12) years, 44 (16%) resolved infection (18 spontaneously and 26 after Peg-INF). An additional 10% of patients developed cirrhosis (n=137) during follow-up (45% had portal hypertension and 14% liver decompensation). Liver disease progression was associated to persisting viremia.
CONCLUSIONS: One-third of the patients with CHD already have cirrhosis at diagnosis. Persistence of positive viremia is associated to rapid liver disease progression. Importantly, barriers to locally determine/quantify HDV-RNA were present.