Immediate-type hypersensitivity reaction to bulevirtide in a female patient with HBV/HDV-associated compensated cirrhosis

HDV-coinfection leads to accelerated progression of liver disease in patients with chronic hepatitis B. While vaccination against HBV represents the most important preventive measure for HDV-infection, until recently treatment options for HBV/HDV-coinfection were limited to the off-label use of pegylated interferon (PEG-IFN). Recently, bulevirtide - a new HDV hepatocyte entry-inhibitor - has been licensed for the treatment of HBV/HDV coinfection in Europe. While studies and first real-life data report good drug tolerability and safety, larger cohort data will be needed to discover potential rare adverse events. Our patient is a 35-year old woman of Romanian descent with HBV/HDV-associated compensated cirrhosis (Child Pugh A, no esophageal varices). The patient had been treated with tenofovir (TDF) and PEG-IFN since July 2018 and June 2019, respectively. Due to progressive thrombocytopenia and anemia as well as persisting HDV-viremia under this treatment, PEG-IFN was stopped and the patient was started instead with bulevirtide while continuing on TDF in December 2020. After unremarkable subcutaneous application of the first dose of bulevirtide 2mg at our outpatient clinic, the patient continued self-administered daily treatment according to current recommendations. Six days after initiation of treatment (i.e. after her sixth dose), the patient attended our outpatient clinic again for an unscheduled visit. She reported progressive pruritus and swelling of the upper extremities, of the face and lips as well as dyspnea starting after the third injection of bulevirtide, indicative of type-1 allergic reaction. Treatment with bulevirtide was stopped immediately and the patient recovered fully without any further medical or pharmaceutical intervention. A positive prick- and intracutaneous skin test reaction confirmed an immediate hypersensitivity response induced by injections of bulevirtide in this patient. While no immediate-type hypersensitivity reactions to bulevirtide have been reported in clinical trials and first real life applications, informing patients about this potential life-threatening adverse event seems warranted.

Publication History

Article published online:
01 September 2021