BREAKTHROUGH ANTIVIRAL THERAPY FOR CHRONIC HEPATITIS D

For a long period of 46 years since the discovery of the hepatitis D virus antigen by M. Rizzetto in 1977, chronic hepatitis D was considered in conjunction with chronic hepatitis B, classified as chronic hepatitis B with the delta agent. As a result, both viruses were treated with the same low-efficacy therapies, primarily interferon-based treatments, including pegylated interferon-α combined with nucleoside analogues, achieving virological response rates of only around 25 %. For the first time, chronic hepatitis D was recognized as a separate disease entity from chronic hepatitis B in the first Practical Guidelines of the European Association for the Study of the Liveron the management of chronic hepatitis D, published on August 30, 2023. National Russian guidelines on chronic hepatitis D were published earlier, in 2021.

Objective: To present and analyze the first international guidelines on the management of chronic hepatitis D, and to familiarize clinicians with randomized clinical trials evaluating the use of the antiviral drug Bulevirtide in patients with chronic hepatitis D and liver cirrhosis over 10 years.

Materials and Methods: A literature review was conducted using the Medline/PubMed, CyberLeninka, and eLibrary databases.

Results. Unlike chronic hepatitis B or C, liver injury in chronic hepatitis D is more severe and aggressive, with a progressive course, rapid progression to liver cirrhosis with decompensation, and a higher risk of hepatocellular carcinoma. The global prevalence of chronic hepatitis D is heterogeneous due to population migration; according to two major meta-analyses, it is estimated to affect between 12 and 72 million people worldwide.

The use of Bulevirtide since 2014 has marked the beginning of etiological treatment for patients with chronic hepatitis D and liver cirrhosis. Clinical trials have demonstrated the efficacy and safety of Bulevirtide as monotherapy, and even greater efficacy when combined with pegylated interferon-α for 48 weeks or longer.

Conclusions. The EASL guidelines summarize the global experience in treating patients with chronic hepatitis D and liver cirrhosis using Bulevirtide. Between 2019 and 2022, Bulevirtide received regulatory approval in Russia and EU countries.

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