The US FDA has granted accelerated approval to bulevirtide for the treatment of chronic hepatitis delta virus (HDV) infection in adults without cirrhosis or with compensated cirrhosis. Clinical evidence The approval is supported by data from a clinical trial involving 100 patients with chronic HDV infection. At week 48, bulevirtide achieved a combined endpoint of undetectable HDV RNA and alanine aminotransferase (ALT) normalization in 48% of patients. Further analysis showed a virologic response in 76% of participants and ALT normalization in 56%.
The treatment demonstrated sustained efficacy over time. At week 94, the combined response rate increased to 56%, with virologic response and ALT normalization rates of 82% and 64%, respectively. These benefits were maintained through week 144, when the combined response, virologic response, and ALT normalization rates were 54%, 76%, and 60%,…
