BACKGROUND AND AIMS: The impact of bulevirtide in patients awaiting liver transplantation (LT) for decompensated liver disease and/or hepatocellular carcinoma (HCC) is unclear. We assessed clinical, virological, and biochemical responses to bulevirtide in patients with chronic hepatitis delta virus (HDV) awaiting LT and compared outcomes with a cohort of similar untreated patients. METHODS: Consecutive HDV-infected patients waiting for LT since bulevirtide approval were included. Patients receiving 2 mg of bulevirtide daily had clinical, biological, and virological data collected at baseline, Week 24, Week 48, at LT, and post-LT. Patients not receiving bulevirtide had data collected at baseline, LT, and post-LT for comparison. RESULTS: Forty-one patients from nine LT centers were included. In the bulevirtide group (20 patients
mean age 52.8 ± 9.98 years
75% male), 65%, 10% and 25% were Child-Pugh A, B and C, respectively. Fifteen completed 48 weeks of therapy. At 48 weeks, median HDV RNA decreased by 2.56 log IU/mL (p = 0.004). Virological and biochemical responses were obtained in 73.3% and 66.6% of patients. Twelve patients (60%) underwent LT. No serious adverse events occurred. Bulevirtide improved liver function, enabling one (7.1%) HCC patient to undergo chemoembolization while on the WL and leading to delisting of three (15%) other patients. In untreated patients (mean age 42.9 ± 7.9 years
76.2% Child-Pugh C), none were delisted. Three-month transplant-free survival was 76.9% in the bulevirtide group versus 36.7% (p = 0.007) in the control group. CONCLUSIONS: Bulevirtide demonstrates safety and efficacy in HDV-infected patients listed on the LT waiting list and may potentially improve pre-transplant outcomes.