Bulevirtide monotherapy ‘may prevent decompensation but not HCC’ in HDV, cirrhosis
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Key takeaways:
- The 2-year cumulative incidence of new HCC was similar between untreated patients vs. bulevirtide-treated patients (3.7% vs. 6.6%).
- However, decompensation was higher in the untreated group (3.9% vs. 9.1%).
Over 2 years, bulevirtide monotherapy reduced the risk for decompensation and mortality, but not hepatocellular carcinoma, among patients with hepatitis D virus and compensated cirrhosis compared with untreated patients.
“Bulevirtide, the first-in-class entry inhibitor, has been approved by EMA for treatment of compensated chronic hepatitis delta,” Elisabetta Degasperi, MD, PhD, of the division of gastroenterology and hepatology at Foundation IRCCS Ca’ Granda Ospedale Maggiore Policlinico, said at EASL Congress. “In phase 2 and 3 clinical trials and real-life studies, bulevirtide monotherapy yielded high rates of virological and biochemical response, also in patients with cirrhosis.
“However, the impact of bulevirtide on hard clinical outcomes, such as decompensation and HCC, remains unknown,” Degasperi continued.
In a case-control, real-life study, researchers evaluated the impact of bulevirtide monotherapy on liver-related events and mortality in patients with HDV-related cirrhosis among 176 treated patients (median age, 49 years; 59% men) from a retrospective, multicenter European study vs. a historical cohort of 140 untreated patients (median age, 40 years; 78% men). Outcomes of interest included liver-related events and overall mortality compared via inverse probability treatment weighing- adjusted analysis.
At baseline, the treated cohort had an alanine transaminase of 77 U/L, an albumin level of 4 g/dL, 100% with a CPT score A and 55% with varices; the untreated cohort had an ALT of 102 U/L, albumin of 4 g/dL, 94% with a CPT score A and 46% with varices. Median follow-up was 15 months and 91 months, respectively.
According to study results, among patients treated with bulevirtide monotherapy, 77% achieved virological response, 63% a biochemical response and 51% a combined response at 2 years. The cumulative incidence of de-novo HCC was similar between the untreated group and treated group (6.6% vs. 3.7%); however, decompensation rates were higher in the untreated group (9.1% vs. 3.6%).
Results from inverse probability treatment weighing-adjusted analysis showed treated patients had a “significantly decreased risk” for liver-related events of all types (HR = 0.38; 95% CI, 0.24-0.6) and decompensation (HR = 0.32; 95% CI, 0.16–0.63). The risk for HCC was similar between groups.
Degasperi reported overall there were few liver-related events, with four deaths in each group.
“Additionally, five patients from the bulevirtide- treated cohort underwent liver transplantation and most deaths were non-liver related,” she added.
In addition, the overall survival was similar between the two groups and the risk of all-cause deaths “were comparable”, researchers reported.
“This preliminary analysis suggests that a 24-month course of bulevirtide monotherapy may prevent decompensation but not HCC in patients with compensated HDV-related cirrhosis,” Degasperi, said. “Additional studies with larger cohorts and extended follow-up are needed in order to confirm this data.”
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Degasperi E, et al. Bulevirtide monotherapy prevents liver decompensation and reduces mortality in patients with HDV-related cirrhosis: A case control study with propensity score weighted analysis. Presented at: EASL Congress; June 5-8, 2024; Milan (hybrid).
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