MSGID: 1:317/3 641932e4   
   PID: hpt/lnx 1.9.0-cur 2019-01-08   
   TID: hpt/lnx 1.9.0-cur 2019-01-08   
    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.   
      
      
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   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   
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             o Hepatitis_E o Hepatitis_C o Hepatitis o Cirrhosis o   
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   ==========================================================================   
   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   
      
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