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Chronic hepatitis delta (CHD), a severe form of chronic viral hepatitis caused by the hepatitis D virus (HDV), has long posed a significant challenge for treatment. However, recent real-world studies have confirmed the effectiveness of a breakthrough therapy called bulevirtide (BLV) in suppressing viral replication and improving liver function in CHD patients. This marks a significant milestone in the management of this debilitating disease, which has remained difficult to treat for the past 45 years.
Understanding Chronic Hepatitis Delta (CHD) and the Need for Effective Treatment
CHD is characterized by chronic inflammation of the liver, caused by the HDV, an RNA virus that can only infect individuals who are already infected with the hepatitis B virus (HBV). The World Health Organization estimates that nearly 5% of individuals with chronic HBV infection also have HDV co-infection, making it a significant public health concern.
For many years, the only therapeutic option for CHD patients was the off-label use of pegylated-interferon-alpha (PegIFNa), which had suboptimal efficacy and several safety concerns. Therefore, the approval of bulevirtide in 2020 marked a crucial turning point in the management of CHD.
The Effectiveness of Bulevirtide: Real-World Studies Confirm the Breakthrough
Real-world studies conducted on CHD patients treated with bulevirtide outside of clinical trials have demonstrated significant improvements in virological and biochemical response rates, as well as liver function. These findings have been reported in the Journal of Hepatology and its companion journal, JHEP Reports.
Study 1: Bulevirtide Monotherapy in Advanced HDV-Related Compensated Cirrhosis
In a study led by Dr. Pietro Lampertico and his team at Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico in Milan, Italy, the efficacy and safety of bulevirtide monotherapy were evaluated in patients with advanced HDV-related compensated cirrhosis. The study involved 18 patients who received a daily dose of 2mg of bulevirtide for 48 weeks.
The results were promising, with significant virological, biochemical, and combined response rates observed. The liver function of the patients improved, providing hope for the first time in 45 years for individuals with advanced HDV-related compensated cirrhosis.
Study 2: Bulevirtide's Eradication Potential in HDV-Related Compensated Cirrhosis
Dr. Lampertico and his colleagues also presented a case report demonstrating the successful eradication of HDV following a three-year course of bulevirtide monotherapy. The case involved a patient with HDV-related compensated cirrhosis and esophageal varices, who showed
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