“The reimbursement” of bulevirtide is very important “because about 5% of those with hepatitis B with Delta virus (HDV) infection may have the first targeted therapeutic option” capable of causing “a drastic reduction in the risk of progressing to cirrhosis and complications”. This is how Vincenza Calvaruso, Associate Professor in the Gastroenterology Section of the University of Palermo, comments on the approval of the Italian Medicines Agency (Aifa) for the Gilead antiviral, the first specific drug for the treatment of chronic Delta hepatitis, the most severe and more rapidly progressing viral hepatitis, with significantly higher rates of progression to cirrhosis and hepatocellular carcinoma (Hcc) than monoinfection with hepatitis B virus (Hbv).
“Bulevirtide is an entry inhibitor drug – explains Calvaruso – it blocks a specific receptor of the liver cell (hepatocyte) preventing the entry of the hepatitis B virus (Hbv) and Delta (Hdv). It is the first molecule to have a specific efficacy for the Delta virus which, since it cannot actually enter the cell, cannot infect others”. It is “an extremely effective drug. Compared to the treatment we had up to now, that is interferon – adds Calvaruso – it allows us to normalize the transaminases, improve the inflammation of the frigate and the risk of progression of the disease”. In treated patients – explains a company note – the drug demonstrated 70% virological response, 50% biochemical response, and 45% combined response. “The data is promising – underlines the expert – because it also allows us to treat patients with advanced disease, severe fibrosis and compensated cirrhosis”.
“We have a multi-center Italian study – recalls Calvaruso – which showed us how the drug is safe and effective even in patients with advanced disease. Achieving the reduction of viraemia in at least 70% of cases and the improvement of inflammation and transhumanaxis is fundamental to the risk of progression towards cirrhosis of these patients which is unfortunately very high. These patients – explains the professor – have an 80% risk of progressing to cirrhosis. It is a dangerous infection for these subjects – she points out – having a drug that blocks the replication of the virus means changing the natural history of these patients. It is essential – says Calvaruso – that there is also reimbursement for virus markers, that is, for everything needed to monitor this disease”.
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