Long-term use of bulevirtide is linked to a lower rate of liver decompensation in patients with hepatitis D virus (HDV)-related cirrhosis, according to a 3-year retrospective study presented at The Liver Meeting 2026.
The research, which compared 431 patients treated with the antiviral against 298 historical control subjects, found that de novo decompensation occurred in 3.0% of the treated group compared with 11.3% of those who did not receive the medication, according to Medscape.
“Bulevirtide monotherapy is able to reduce the risk of de novo liver decompensation in patients with HDV-related cirrhosis,” said Elisabetta Degasperi, MD, of Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico in Milan, Italy, who served as the study’s lead author.
While the study showed a lower rate of liver-related events—a composite of decompensation and hepatocellular carcinoma (HCC)—the impact of the drug on HCC risk specifically remains unclear. The study reported that HCC occurred at a rate of 7.3% in the bulevirtide group versus 3.6% in the control group, a difference that was not statistically significant. Overall survival rates also showed no difference between the two groups.
“This study is of high clinical relevance as it provides what may represent the strongest evidence to date that bulevirtide is associated with a decrease in adverse liver outcomes,” said Joseph K. Lim, MD, of the Yale School of Medicine in New Haven, Connecticut.
Despite the findings, experts said that the study carries limitations due to its retrospective design and the use of historical control groups. Dr. Lim pointed out that the reliance on inverse probability of treatment weighting is “subject to unmeasured and residual confounding.”
He also said that the lack of difference in HCC rates raises questions regarding whether the outcome was a result of the study’s follow-up duration or the level of virologic suppression achieved.
Dr. Degasperi indicated that her team intends to extend the follow-up period and perform future comparisons using a more contemporary control group “to overcome the potential limitations of historical control groups.”
“The primary implication of these findings is that it further strengthens the principle that virologic suppression is associated with an improvement in liver outcomes,” Dr. Lim said. “From a clinical perspective, this provides patients and clinicians with greater confidence that HDV treatment can meaningfully improve patient outcomes.”
