Reality Check: Bulevirtide for HBV/HDV coinfection, dynamics of virological parameters and liver-stiffness

Background HDV is the most aggressive form of chronic viral hepatitis with a high risk for the development of liver cirrhosis and its complications. Until 2020 treatment with interferon-alpha was the only therapeutic-option for HBV/HDV-coinfection, with serious side effects and limited efficacy. Bulevirtide is a synthetic lipopeptide that blocks HBV/HDV uptake into hepatocytes by binding to the NTCP-receptor. There are few reports of its clinical use from Germany and little experience on treatment dynamics and efficacy in a real-life settings. We present clinical and virological data on our first 12 patients treated with bulevirtide.

Methods Since 11/2020 12 HDV-infected patients with active hepatitis started bulevirtide-treatment. Median age (4 female, all HDV-genotype 1) was 43. Five patients had compensated liver cirrhosis, ten patients received NUC-therapy and eight patients had a history of previous interferon treatment. Every 30 days HDV-RNA, HBV-DNA, HBsAg, ALT/AST, and bile-acids as well as liver-stiffness were tested.

Results Median baseline-parameters were: HDV-RNA 597.000 IU/ml, ALT 117 U/l, AST 64 U/l, bile acids 11,5 umol/l, platelets 160x1000/ul, HBsAg 23.074 IU/ml, liver-stiffness 10kPa. At the time of analysis (range of treatment-duration two-ten months) five patients achieved normalisation of transaminases, . Median HDV-RNA was reduced by 1,35 log (2,8% of baseline HDV) - or 28% after three months of treatment and median liver- stiffness decreased to 7,7KPa.

Conclusion Real- life data in patients with advanced liver disease demonstrate a favorable safety profile, good patient compliance, and improvement of biochemical and virological parameters as well as liver damage regression for most patients.

Publikationsverlauf

Artikel online veröffentlicht:
26. Januar 2022