P1204 - Efficacy of Bulevirtide in the Treatment of Chronic Hepatitis D Infection: A Systematic Review

Murad Qirem, MD¹, Shahd Yaghi, MD¹, Gowthami Sai Kogilathota Jagirdhar, MD², Byron Okwesili, MD¹, Dema Shamoon, MD³, Mehul Shah, MD¹, Theodore DaCosta Jr, MD^1
1New York Medical College - Saint Michael's Medical Center, Newark, NJ; ²Saint Michaels Medical Center, Newark, NJ; ³Geisinger Community Medical Center, Danville, PA

Introduction: Hepatitis D virus (HDV) is a satellite RNA virus that requires hepatitis B virus (HBV) surface antigen for entry into hepatocytes and for propagation. HDV is estimated to affect around 15 million people worldwide. Long-term coinfection with HBV and HDV is considered to be the most serious type of chronic viral hepatitis.
Currently, there is an absence of approved HDV therapies. However, Bulevirtide is a novel therapeutic agent being studied for treating Hepatitis D. Its mechanism of action is notably specific; it targets and binds to the sodium taurocholate co-transporting polypeptides (NTCP) on hepatocytes. NTCP is a receptor that facilitates the entry of HDV into liver cells. By blocking this entry point, Bulevirtide effectively prevents the virus from infecting new cells and proliferating within the host, blocking the lifecycle of the virus.

Methods: A literature search across PubMed, Embase, and Cochrane identified two clinical trials (N=268), two retrospective cohort studies (N=133), and three prospective studies (N=48). Extracted efficacy outcomes included the number of people who achieved undetectable or ≥2 log10 IU/ml decrease in HDV RNA level, and the number of people who had normalization of the ALT level.

Results: The efficacy of Bulevirtide in treating Hepatitis D was evaluated across the multiple studies included in this systematic review (Table 1) with a total of 419 patients from 7 studies. One study compared Bulevirtide to a placebo. One study compared Bulevirtide and tenofovir disoproxil fumarate (TDF) to TDF alone. Three studies tested the efficacy of Bulevirtide only, and one study Bulevirtide and TDF without a comparison group.
Undetectable or ≥2 log10 IU/ml decrease in HDV RNA level was achieved in a total of 70% (257/370) of people receiving Bulevirtide. Furthermore, normalization of ALT was achieved in 54% (153/280) of people who received Bulevirtide. Two studies compared Bulevirtide to placebo/TDF. Undetectable or ≥2 log10 IU/ml decrease in HDV RNA level was achieved in a total of 67% (127/189) compared to only 4% (3/79) who received a placebo/TDF. Normalization of ALT was achieved in 50% (93/189) of people who received Bulevirtide in compared to 10% (8/79) in patients who received placebo/TDF.

Discussion: Bulevirtide demonstrated substantial efficacy in reducing HDV RNA levels and normalizing ALT levels in patients with Hepatitis D. These findings support Bulevirtide as a promising treatment option for this challenging infection.


Disclosures:


Murad Qirem, MD¹, Shahd Yaghi, MD¹, Gowthami Sai Kogilathota Jagirdhar, MD², Byron Okwesili, MD¹, Dema Shamoon, MD³, Mehul Shah, MD¹, Theodore DaCosta Jr, MD¹. P1204 - Efficacy of Bulevirtide in the Treatment of Chronic Hepatitis D Infection: A Systematic Review, ACG 2024 Annual Scientific Meeting Abstracts. Philadelphia, PA: American College of Gastroenterology.