Real-world studies confirm effectiveness of bulevirtide to treat chronic hepatitis D

Date:
March 20, 2023
Source:
Elsevier
Summary:
In 2020, bulevirtide (BLV) was conditionally approved for
treating chronic hepatitis delta (CHD), an inflammation of
the liver caused by hepatitis D virus (HDV). Now real-world
studies of patients treated outside of clinical trials confirm
that long-term suppressive therapy with BLV monotherapy has the
potential to reduce viral replication and improve liver tests of
these difficult-to-treat patients for the first time in 45 years,
report investigators.


Facebook Twitter Pinterest LinkedIN Email
FULL STORY ==========================================================================
In 2020,bulevirtide (BLV) was conditionally approved for treating chronic hepatitis delta (CHD), an inflammation of the liver caused by hepatitis
D virus (HDV). Now real-world studies of patients treated outside of
clinical trials confirm that long-term suppressive therapy with BLV
monotherapy has the potential to reduce viral replication and improve
liver tests of these difficult-to-treat patients for the first time
in 45 years, report investigators in the Journal of Hepatology and its companion journal JHEP Reports.


==========================================================================
Two of the studies, led by Pietro Lampertico, MD, PhD, Division
of Gastroenterology and Hepatology, Foundation IRCCS Ca' Granda
Ospedale Maggiore Policlinico, Milan, Italy, were designed to assess
the effectiveness and safety of patients with advanced HDV-related
compensated cirrhosis being treated with BLV 2mg monotherapy and the consequences of discontinuing this treatment.

"HDV is the most severe form of chronic viral hepatitis," explained Dr.

Lampertico. "For many years, the only therapeutic option was the off-label administration of pegylated-interferon-alpha (PegIFNa), an approach characterized by suboptimal efficacy, an unfavorable safety profile and
several contraindications." In a study of 18 patients with HDV-related advanced cirrhosis treated with BLV 2 mg/day for 48 weeks, Dr. Lampertico
and colleagues demonstrated significant virological, biochemical and
combined response rates associated with improvement of liver function.

"The efficacy and safety of BLV monotherapy in patients with advanced compensated cirrhosis were unknown before this study. Virological
and biochemical responses to BLV monotherapy that we observed in our difficult-to- treat patients with HDV-related compensated cirrhosis
were similar to those shown in the phase III registration study,"
Dr. Lampertico noted.

In a case report, Dr. Lampertico and co-investigators demonstrated that
HDV could be successfully eradicated from both serum and liver following
a three- year course of BLV monotherapy, despite the persistence
of HBsAg, in a patient with HDV-related compensated cirrhosis and
esophageal varices. During the 72- week off-BLV follow-up, liver biopsy, intrahepatic HDV RNA and hepatitis D antigen were undetectable, less
than 1% of hepatocytes were HBsAg positive and all were negative for
hepatitis B core antigen.

"We were surprised to demonstrate that HDV can be eradicated following
a finite course of an entry inhibitor administered as monotherapy such
as BLV 2mg/day, despite the persistence of HBsAg positivity," commented
Dr. Lampertico.

In a study in JHEP Reports led by PD Dr. med. Katja Deterding, MD,
Department.

of Gastroenterology, Hepatology and Endocrinology at Hannover Medical
School, Hannover, Germany, investigators report the first data from the
largest multicenter cohort of patients to date who were treated with
BLV under real- world conditions, including 50 patients with signs of significant portal hypertension, elevated pressure in the major vein
that leads to the liver.

The retrospective analysis of 114 cases covered 4,289 patient weeks of
BLV treatment. Viral response was observed in 87 cases while hepatic inflammation improved, and treatment was well tolerated. More than 50%
of patients showed a virologic response with less than 10% of patients
not achieving an HDV RNA drop of at least 90% after 24 weeks. An
improvement of biochemical hepatitis activity as measured by the liver
enzyme alanine transaminase (ALT) values was observed regardless of
virologic response. Investigators concluded that treatment was safe and
well tolerated and associated with improvements in liver cirrhosis and
portal hypertension with prolonged treatment.

"In line with other real-world cohorts and clinical trials our real-world
study confirms the antiviral activity of BLV," noted Dr. Deterding. "We
were surprised to see an improvement in biochemical hepatitis activity
even in cases without viral response. Potential explanations for this phenomenon include anti-inflammatory properties of BLV." "This is
the first time that patients with HDV-related chronic advanced liver
disease can be treated with an antiviral therapy since 1977 when HDV
was discovered. Long-term suppressive therapy with BLV 2 mg/day has the potential to improve survival, of these difficult-to-treat patients
for the first time in 45 years," concluded Dr. Lampertico. "We also
found that BLV treatment can be successfully discontinued in some HDV
patients who achieved long-term viral suppression while on therapy."
HDV infection occurs when people become infected with both hepatitis
B and D virus either simultaneously (co-infection) or acquire
the hepatitis D virus after first being infected with hepatitis B (super-infection). According to the World Health Organization, HDV
affects nearly 5% of individuals with a chronic infection resulting
from hepatitis B virus (HBV). Populations that are more likely to have
HBV and HDV co-infection include indigenous populations, recipients of hemodialysis and individuals who inject drugs.

* RELATED_TOPICS
o Health_&_Medicine
# Liver_Disease # Viruses # Infectious_Diseases #
Today's_Healthcare # Patient_Education_and_Counseling #
Chronic_Illness # HIV_and_AIDS # Wounds_and_Healing
* RELATED_TERMS
o Hepatitis_E o Hepatitis_C o Hepatitis o Cirrhosis o
Hepatitis_B o Hepatitis_A o Liver_transplantation o Neurology

========================================================================== Story Source: Materials provided by Elsevier. Note: Content may be edited
for style and length.


========================================================================== Journal Reference:
1. Elisabetta Degasperi, Maria Paola Anolli, Sara Colonia Uceda
Renteria,
Dana Sambarino, Marta Borghi, Riccardo Perbellini, Caroline
Scholtes, Floriana Facchetti, Alessandro Loglio, Sara Monico,
Mirella Fraquelli, Andrea Costantino, Ferruccio Ceriotti, Fabien
Zoulim, Pietro Lampertico.

Bulevirtide monotherapy for 48 weeks in patients with HDV-related
compensated cirrhosis and clinically significant portal
hypertension.

Journal of Hepatology, 2022; 77 (6): 1525 DOI:
10.1016/j.jhep.2022.07.016 ==========================================================================

Link to news story: https://www.sciencedaily.com/releases/2023/03/230320143823.htm

--- up 1 year, 3 weeks, 10 hours, 50 minutes
* Origin: -=> Castle Rock BBS <=- Now Husky HPT Powered! (1:317/3)