Bulevirtide maintains safety, efficacy in HDV-related compensated cirrhosis at 72 weeks
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WASHINGTON — Bulevirtide monotherapy was safe and effective at 72 weeks for patients with hepatitis D virus-related compensated cirrhosis, with virological and clinical responses increasing over time, according to data presented here.
“Until now, administration of pegylated interferon has represented the only therapeutic option [for chronic hepatitis D], but was characterized by suboptimal viral response and significant side effects,” Elisabetta Degasperi, MD, PhD, from the Division of Gastroenterology and Hepatology at the Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico in Milan, told attendees. “Bulevirtide has shown promising results in phase two and phase three studies so that EMA approval was granted in July 2020, for treatment of compensated chronic hepatitis delta.”
She added: “However, data about effectiveness and safety of bulevirtide in patients with compensated cirrhosis beyond week 48 in real world settings are still limited.”
To assess the safety and efficacy of 2 mg bulevirtide up to 72 weeks, Degasperi and colleagues evaluated 86 patients with compensated cirrhosis who were receiving nucleos(t)ide analogue treatment.
Prior to the start of bulevirtide treatment, the researchers noted median ALT levels of 80 (26-383) U/L, albumin 3.9 (2.9-4.7) g/dL, INR 1.2 (1.0-2.4), HDV RNA 5.2 (2.1-7.6) Log IU/mL, qHBsAg 3.7 (0.8-4.5) Log IU/mL, AFP 7 (1-596) ng/mL, with bile acids above normal range in 95% of patients (median 18 [3-306] mol/L).
According to study results, 67% of patients achieved a virological response (HDV RNA 2 Log decline compared with baseline) by week 48 and 69% achieved virological response at week 72. The researchers also noted that HDV RNA was undetectable in 33% of patients by week 72.
Degasperi and colleagues observed ALT normalization in 56% of patients at week 48 and 75% of patients at week 72, with a combined virological and biochemical response reported in 67% of patients at week 48 and 63% of patients at week 72.
In addition to ALT, the researchers observed significant declines for AST, GGT, IgG, gammaglobulins (P<.001 compared with baseline), with albumin values increasing (P<.001), and platelets, LSM and HBsAg levels remaining stable. They observed that bulevirtide was well-tolerated with no patient discontinuation due to adverse events, although an asymptomatic increase in bile acid levels was noted in all patients.
“Our main finding was that [at 72 weeks,] there was a biological response of 75%, a biochemical response of 81% and a combined response of 63%” Degasperi said. “We also showed an improvement of biochemical parameters, liver synthesis and serological non-invasive tests. As expected, there was an increase of bile acids, however, mostly are symptomatic and without major safety issues.”
She added: “Extension of bulevertide monotherapy to 72 weeks is safe and effective in patients with HDV-related compensated cirrhosis, with biological and clinical responses increasing over time.”
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Degasperi E, et al. Extension of bulevirtide monotherapy to 72 weeks in HDV patients with compensated cirrhosis: Efficacy and safety from the Italian multicenter study (HEP4Di). Presented at: The Liver Meeting; Nov. 4-8, 2022; Washington (hybrid).
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