Bulevirtide treatment of hepatitis D in Germany: multicentre real-world experience

Dietz, Christopher; Tacke, Frank; Zöllner, Caroline; Demir, Münevver; Schmidt, Hartmut; Schramm, Christoph; Willuweit, Katharina; Lange, Christian; Denk, Gerald; Weber, Sabine; Berg, Christoph; Grottenthaler, Julia M; Merle, Uta; Olkus, Alexander; Zeuzem, Stefan; Sprinzl, Kathrin; Berg, Thomas; Bömmel, Florian van; Herta, Toni; Seufferlein, Thomas; Zizer, Eugen; Dikopoulos, Nektarios; Thimme, Robert; Galle, Peter R.; Sprinzl, Martin; Lohse, Ansgar W.; Wiesch, Julian Schulze zur; Kempski, Jan; Geier, Andreas; Reiter, Florian P.; Hofmann, Wolf Peter; Kahlhöfer, Julia; Maasoumy, Benjamin; Port, Kerstin; Cornberg, Markus; Wedemeyer, Heiner; Deterding, Katja

doi:10.1016/s0168-8278(22)01943-2

Cited by 4 publications

(3 citation statements)

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“…No serious adverse events were reported; fatigue ( n = 7), pruritus ( n = 3) and injection site reaction ( n = 1) were the most common side effects. De novo decompensation occurred in two cases 15 . Germany also reported long‐term outcomes at Weeks 52, 56 and 68 in three patients receiving BLV 2 mg/day monotherapy.…”

Section: Blv Monotherapymentioning

confidence: 90%

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Bulevirtide‐based treatment strategies for chronic hepatitis delta: A review

Degasperi

Lampertico

2023

Journal of Viral Hepatitis

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Chronic hepatitis Delta (CHD) is a rare and severe form of chronic viral hepatitis.Until recently, the only therapeutic approach has been the off-label use of a 48 weeks course of PegInterferon alpha (PegIFNα), that was characterized by suboptimal efficacy and burdened by significant side effects that limited treatment applicability in patients with advanced liver disease. In July 2020, European Medicines Agency (EMA) conditionally approved the entry inhibitor Bulevirtde (BLV) at the dose of 2 mg/day for the treatment of adult patients with compensated CHD. Efficacy and safety of BLV in CHD have been evaluated in clinical trials either as monotherapy or in combination with PegIFNα. These results were confirmed by real-life studies, which also evaluated long-term BLV monotherapy in patients with advanced compensated cirrhosis. Notwithstanding these promising results there are still several issues to be addressed, such as the optimal duration of the treatment, the rates of off-therapy responses, as well as the long-term clinical benefits. This review summarizes updated and current literature data about clinical trials and real-life studies with BLV monotherapy and/or in combination with PegIFNα.

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Section: Blv Monotherapymentioning

confidence: 90%

“…De novo decompensation occurred in two cases. 15 Germany also reported long-term outcomes at Weeks 52, 56 and 68 in three patients receiving BLV 2 mg/day monotherapy. All patients achieved a virological response at Week 24, that was maintained throughout Week 68 in two cases, while the other experienced HDV RNA breakthrough at Week 40.…”

Section: F I G R Ementioning

confidence: 98%

Bulevirtide‐based treatment strategies for chronic hepatitis delta: A review

Degasperi

Lampertico

2023

Journal of Viral Hepatitis

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“…Bulevirtide was shown to be active against all HDV genotypes in a recent in vitro study 176 . Several recent studies analyzed real-life data to assess VR after BLV monotherapy in patients with CHD, and the response ranged from 15% to 54% 177–180 . There is an ongoing phase III trial evaluating the efficacy and safety of bulveritide in patients with CHD, NCT03852719.…”

Section: Bulevirtidementioning

confidence: 99%

Hepatitis delta: Epidemiology to recent advances in therapeutic agents

et al. 2023

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Hepatitis D virus (HDV) was first described in 1977 and is dependent on the presence of hepatitis B surface antigen (HBsAg) for its entry into cells and on the human host for replication. Due to the envelopment with the hepatitis B virus (HBV) envelope, early phases of HDV entry resemble HBV infection. Unlike HBV, HDV activates innate immune responses. The global prevalence of HDV is estimated to be about 5% of HBsAg positive individuals. However, recent studies have described a wide range of prevalence between 12 to 72 million individuals. Infection can occur as super-infection or co-infection. The diagnosis of active HDV infection involves screening with anti HDV antibodies followed by quantitative PCR testing for HDV RNA in those who are HBsAg positive. The diagnostic studies have evolved over the years improving the validity and reliability of the tests performed. HDV infection is considered the most severe form of viral hepatitis and the HDV genotype may influence the disease course. There are eight major HDV genotypes with prevalence varying by geographic region. HDV treatment has been challenging as HDV strongly depends on the host cell for replication and provides few, if any viral targets. Better understanding of HDV virology has led to the development of several therapeutic agents currently being studied in different phase II and III clinical trials. There is increasing promise of effective therapies that will ameliorate the course of this devastating disease.

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