Abstract and Introduction
In July 2020, the entry inhibitor bulevirtide was approved in the European Union for the treatment of chronic hepatitis delta virus (HDV) infection. We describe the first 48 weeks of bulevirtide therapy in eight patients (n = 7 male, n = 1 female; n = 3 compensated cirrhosis) treated at our centre. Median ALT values declined from 82 to 34 U/L after 48 weeks. Median HDV RNA dropped from 13 380 000 to 3135 copies/ml. One patient showed no significant response and was discontinued at week 16. Overall, we observed a favourable safety profile and a marked biochemical and virological response in the majority of our patients.
Hepatitis D virus (HDV), termed delta hepatitis, is a satellite virus of Hepatitis B virus (HBV). Synchronous infection mostly leads to viral clearance, while metachronous infection generally causes chronic HBV/HDV coinfection, which is associated with rapid progression to severe liver disease and hepatocellular carcinoma. Estimations vary between 12 million and about 70 million people worldwide living with HBV/HDV. The coinfection poses a relevant public health challenge in numerous countries.
Effective drug therapy options for chronic hepatitis B/D virus infections are still needed. Until 2020, interferon-alpha was the only available therapy and only approved for the treatment of chronic HBV infection. With serious side effects, poor tolerability and a limited efficacy of about 30%, it remains an ineffective option for the majority of patients.
Thus, there is a high medical need for new therapeutic options in chronic hepatitis B/D, and several new concepts have been tested in the last years. The first drug that has been granted provisional approval so far is bulevirtide (trade name Hepcludex, former denomination Myrcludex B, company name Myr GmbH, Burgwedel, DE; since December 2020 Gilead). The drug blocks the sodium/bile salt cotransporter NTCP (Na+−taurocholate cotransporting polypeptide), which is also the entry receptor for Hepatitis B and D viruses. In July 2020, bulevirtide (2 mg/day s.c.) was provisionally approved in the European Union for the treatment of chronic hepatitis B/D. In Germany, it received market approval in September 2020 for all HBV/HDV coinfected patients with compensated liver disease. An early access program allowed for a therapy start with bulevirtide around 6 weeks before market approval. Here, we describe the first real-life treatment experience with bulevirtide at a German tertiary referral center.
Liver International. 2022;42(11):2403-2407. © 2022 Blackwell Publishing