Bulevirtide 2 mg has been approved and reimbursed by the Italian Medicines Agency (Aifa), the first specific drug for the treatment of chronic Delta hepatitis, the most severe and most rapidly progressing form of viral hepatitis, with progression rates towards cirrhosis and hepatocellular carcinoma ( Hcc) significantly higher than mono-infection with Hbv. Gilead Sciences announces it in a note. Bulevirtide 2 mg is indicated for the treatment of chronic hepatitis delta virus infection in plasma (or serum) HDV-RNA positive adult patients with compensated liver disease. Bulevirtide – details the note – has also received the attribution of the conditional therapeutic innovativeness requirement, which provides for its inclusion in the lists of innovative drugs.
Bulevirtide, administered 2 mg subcutaneously daily – details the note – is the first specific treatment approved for this serious form of hepatitis, since the discovery of the HDV virus in 1977. Delta hepatitis is the most aggressive form of hepatitis, the one with the fastest progression and with a higher risk of evolution towards cirrhosis and further complications, such as hepatic decompensation and hepatocellular carcinoma. Given the very particular nature of the HDV virus, chronic Delta hepatitis can only occur in people already affected by hepatitis B. In Italy the prevalence of this double infection concerns about 5-9% of subjects infected with the hepatitis B virus Bulevirtide belongs to the so-called ‘entry inhibitor’ class of drugs: by blocking the Ntcp receptor which allows the virus to enter liver cells and be transmitted to other liver cells, it prevents the infection from spreading in the liver.
“With bulevirtide, the first drug approved against Delta hepatitis 45 years after its discovery – declares Pietro Lampertico, full professor of Gastroenterology at the University of Milan and director of the Gastroenterology and Hepatology Unit of the Milan Polyclinic – we are witnessing to a revolution in the treatment of this disease which is the most serious form of chronic viral liver disease. The phase III pivotal study demonstrated the efficacy and safety of this drug which, administered as monotherapy for 48 weeks, achieved 70% virological response, 50% biochemical response, and 45% combined response. With this drug, we can finally respond to the clinical priorities of suppressing viraemia and normalizing transaminases, conditions that could slow down the progression of the disease towards cirrhosis, liver decompensation and hepatocellular carcinoma”.
Chronic Delta hepatitis, due to its greater aggressiveness compared to other forms of hepatitis and its rapid progression – continues the note – has a higher risk of evolution towards cirrhosis and other serious liver complications, with a significant impact on people with this infection. HDV virus infection can only occur in patients who are also HBsAg positive; this is because Delta hepatitis is a so-called “defective” or “satellite” virus, ie it needs another virus, the so-called helper, hepatitis B (Hbc), to infect liver cells. Worldwide, an estimated 10 million people are currently co-infected with HBV/HDV viruses, but the infection, for which there are no other approved treatment options, remains underdiagnosed globally.
“The recognition of reimbursement for bulevirtide represents an important new milestone in viral hepatitis for Gilead Sciences,” said Cristina Le Grazie, executive director of medical affairs at Gilead Sciences. “Gilead has been passionately committed to the fight against hepatitis for more than 20 years, contributing to the development of medicines, such as those for hepatitis C, that have truly changed the future for patients. And now with bulevirtide, Gilead brings a concrete treatment opportunity for a disease for which there were no specific therapies until now”.
Bulevirtide 2 mg received conditional approval from the EMA in July 2020 for the treatment of patients with compensated chronic Delta hepatitis (Chd). Bulevirtide also obtained the designation of orphan drug, confirmed in May 2020 by the review conducted by the Comp (Committee for orphan medicinal products) on the basis of the necessary criteria according to the European Regulation of orphan medicinal products, and benefited from the support of the PRIority MEdicines scheme (Prime ) the EMA platform for early and enhanced dialogue with developers of promising new medicines addressing unmet medical needs, as the first approved treatment in Europe for adults with chronic HDV and compensated liver disease.