Bulevirtide monotherapy is safe and well tolerated in patients with chronic hepatitis D (CHD): An integrated safety analysis of 48-week data

Asselah, T.; Lampertico, P.; Aleman, S.; Bourliere, M.; Streinu-Cercel, A.; Bogomolov, P.; Morozov, V.; Stepanova, T.; Lazar, S.; Suri, V.; Manuilov, D.; Mercier, R.C.; Tseng, S.; Ye, L.; Flaherty, J.F.; Osinusi, A.; Brunetto, M.; Wedemeyer, H.

doi:10.1016/j.dld.2023.01.145

Cited by 2 publications

(6 citation statements)

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“…88 No serious AEs related to bulevirtide and no AEs leading to discontinuation were reported. 88 A study of bulevirtide in combination with tenofovir disoproxil fumarate (TDF) showed 54, 50, and 77% of patients on 2, 5, and 10 mg of bulevirtide with TDF, respectively, achieved undetectable HDV RNA at 24 weeks. 89 At 48 weeks of bulevirtide monotherapy, the combined primary endpoint response (> 2 log 10 decrease in HDV RNA or undetectable RNA and ALT normalization) rate was 45% for 2 mg and 48% for 10 mg, suggesting no advantage associated with the higher dose.…”

Section: Therapymentioning

confidence: 96%

“…In clinical trials, bulevirtide as monotherapy and in combination with PegIFN-2a through 24 weeks of therapy resulted in high rates of viral decline: HDV RNA decline was −2.32 and −3.81 log 10 IU/mL, respectively. 88 Among patients receiving bulevirtide 2 mg as monotherapy for 24 weeks, 55% had a virologic response, 53% had a biochemical response, and 37% had a combined response. 88 No serious AEs related to bulevirtide and no AEs leading to discontinuation were reported.…”

Section: Therapymentioning

confidence: 98%

“…88 Among patients receiving bulevirtide 2 mg as monotherapy for 24 weeks, 55% had a virologic response, 53% had a biochemical response, and 37% had a combined response. 88 No serious AEs related to bulevirtide and no AEs leading to discontinuation were reported. 88 A study of bulevirtide in combination with tenofovir disoproxil fumarate (TDF) showed 54, 50, and 77% of patients on 2, 5, and 10 mg of bulevirtide with TDF, respectively, achieved undetectable HDV RNA at 24 weeks.…”

Section: Therapymentioning

confidence: 98%

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Hepatitis Delta Infection: A Clinical Review

Pearlman

2023

Semin Liver Dis

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First discovered over 40 years ago, the hepatitis delta virus (HDV) is a unique RNA virus, requiring hepatitis B virus (HBV) antigens for its assembly, replication, and transmission. HBV and HDV can be acquired at the same time (coinfection) or HDV infection can occur in persons with chronic HBV (superinfection). Screening guidelines for HDV are inconsistent. While some guidelines recommend universal screening for all people with HBV, others recommend risk-based screening. Estimates of the global HDV prevalence range from 4.5% to 14.6% among persons with HBV; thus, there may be up to 72 million individuals with HDV worldwide. HDV is the most severe form of viral hepatitis. Compared to HBV monoinfection, HDV coinfection increases the risk of cirrhosis, hepatocellular carcinoma, hepatic decompensation, mortality, and necessity for liver transplant. Despite the severity of HDV, there are few treatment options. Pegylated interferon (off-label use) has long been the only available treatment, although bulevirtide is conditionally approved in some European countries. There are many potential treatments in development, but as yet, there are few effective and safe therapies for HDV infection. In conclusion, given the severity of HDV disease and the paucity of treatments, there is a great unmet need for HDV therapies.

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Section: Therapymentioning

confidence: 96%

Section: Therapymentioning

confidence: 98%

Section: Therapymentioning

confidence: 98%

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Hepatitis Delta Infection: A Clinical Review

Pearlman

2023

Semin Liver Dis

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“…and HBV has been consistently demonstrated in various clinical trials. [65][66][67][68][69] Among these trials, some patients were randomized to receive BLV monotherapy. Patients receiving BLV 10 mg monotherapy achieved 68-72% HDV RNA ≥2 log 10 IU/ml reduction or clearance at week 24.…”

Section: Both Hbv and Hdv Life Cycledirected Therapiesmentioning

confidence: 99%

“…Of those who had a liver biopsy at week 48, 43.8% of them (21/48 patients) had negative intrahepatic HDV RNA. 65,[67][68][69] BLV monotherapy demonstrated consistent efficacy in reducing HDV RNA and is capable of inducing HDV RNA clearance. However, BLV in combination therapies achieved even better efficacy results against HDV RNA.…”

Section: Both Hbv and Hdv Life Cycledirected Therapiesmentioning

confidence: 99%

Future anti‐HDV treatment strategies, including those aimed at HBV functional cure

Tan

Lee

Huang

et al. 2022

Liver International

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HDV is a defective virus that uses the HBV surface antigen to enter hepatocytes. It is associated with an accelerated course of liver fibrosis progression and an increased risk of hepatocellular carcinoma. Negative HDV RNA 24 weeks after the end of therapy has been proposed as an endpoint but late relapses make this endpoint suboptimal, hence HBsAg loss appears to be more appropriate. Current HBV antiviral agents have poor activity against HDV hence the search for improved therapy. Drugs only active against HDV, such as lonafarnib, have shown efficacy in combination with nucleoside analogues and peginterferon, but do not lead to HBsAg loss. HBsAg loss sustained 24 weeks after the end of therapy with negative HBV DNA is termed functional cure.

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Bulevirtide monotherapy is safe and well tolerated in patients with chronic hepatitis D (CHD): An integrated safety analysis of 48-week data

Cited by 2 publications

References 0 publications

Hepatitis Delta Infection: A Clinical Review

Hepatitis Delta Infection: A Clinical Review

Future anti‐HDV treatment strategies, including those aimed at HBV functional cure

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