The initiative comes after AIFA approved bulevirtide as a new treatment for HDV. “This drug will make it possible to treat patients who previously could not receive any therapy even without interferon – underlines Alessio Aghemo, Aisf secretary -. Now we need to bring out the undeclared and treat patients with advanced disease as a matter of urgency”.
A few weeks ago theAifa approved the reimbursement of a new drug, boulevardswhich will improve the survival and quality of life of patients with Delta hepatitis. Faced with this novelty, the hepatologists of theItalian Association for the Study of the Liver (Aisf) and infectious disease specialists Italian Society of Infectious and Tropical Diseases (Simit) have developed a joint documentjust released, to provide practical recommendations to the medical profession in the paths of diagnosis and treatment. Presentation of the Document “Aisf and Simit operational indications for the diagnosis and clinical management of patients with Delta hepatitis” it took place yesterday, March 16, during the 55th Aisf Congress, which ends today.
LARGE SUBMERGED AND RAPID DISEASE PROGRESSION – Delta hepatitis occurs only in people with hepatitis B, but it is particularly virulent and is characterized by the large submerged disease that is hard to bring out. Even in liver centers there is often little training for a disease for which simple blood tests are sufficient to diagnose it. It is estimated that there are 10-20 million infected people worldwide and that about 10% of patients with hepatitis B also have Delta. In Italy it is estimated that there are about 10-15 thousand people affected by HDV. For hepatitis B, in Italy, vaccination has been mandatory since 1991, therefore the virus is almost absent in the under 40 population, but is found in other age groups and in subjects not born in Italy.
AISF AND SIMIT TOGETHER AGAINST HDV – “AIFA’s decision represents a turning point and provides a very important tool – underlines the professor Alessio Aghemo, AISF secretary -. Delta hepatitis, in fact, is not only the most serious form of existing viral hepatitis, with the ability to cause cirrhosis and hepatocellular carcinoma with much higher rates than other hepatitis, but it is above all a pathology against which therapeutic tools have so far been limited. . This new drug will make it possible to treat patients who previously could not receive any therapy even without interferon. Now, in addition to having full awareness of it and a widespread culture, it is necessary to bring out the underground of those who are affected by the virus but are not aware of it and to treat patients with advanced disease as a matter of urgency”.
“The document produced by Aisf and Simit offers a series of indications on the correct diagnostic, therapeutic and follow-up management of patients with HDV infection – explains Professor Massimo Andreoni, scientific director Simit –. It is a work of easy consultation, which will be a valid point of reference for all the doctors involved. The document is divided into a few key points. First of all, there are indications to facilitate the diagnosis: data from the Piter register coordinated by Iss, Aisf and Simit show that 26% of the Hbv cohort has not been tested for HDV, with serious risks given the rapid course of the disease. Second, the paper addresses disease severity stratification through non-invasive methods. Finally, it explains how to treat the patient with the antiviral therapies available, now enriched by a new therapeutic tool that allows us to fight the virus with unprecedented results”.
THE POSITIVE RESULTS OF THE NEW TREATMENT – Several studies have confirmed the validity of the recently approved treatment. As reported in the paper, administration of bulevirtide monotherapy for 48 weeks normalizes transaminases in approximately 50% of patients, reduces viraemia in approximately 70% of patients, completely suppresses viral replication in approximately 20% of cases, and induces a combined response in 30-50% of patients. The treatment also reduces the viral load in the liver; in 50% of cases the antigen is no longer detectable in liver biopsy tissue. Similar results are also reported in patients with compensated cirrhosis and portal hypertension.
“The availability of a targeted treatment on HDV represents a research success – underlines the professor Vincent Calvaruso, member of the Sisf Scientific Committee -. Bulevirtide is a first class inhibitor which prevents Hbv and HDV from entering the hepatocyte. This treatment can also be performed in advanced stages of the disease. Clinical trials and real life studies have confirmed the good results, with the reduction of inflammation and fibrosis and, in the long term, beneficial effects on the prevention of hepatic decompensation and hepatocellular carcinoma, with an important increase in survival. The hope is that this new therapeutic option will stimulate greater attention to a pathology that requires a standardization of screening procedures to bring out the undeclared and arrive at the diagnosis”.
THE 55th AISF CONGRESS IN ROME – The 55th National Congress of the Italian Association for the Study of the Liver is underway in Rome, at the Auditorium della Tecnica Congress Center (viale Umberto Tupini, 65). In addition to the news on Delta hepatitis, the subject of discussion between hepatologists and other specialists in the lectures and symposia will be, among the various topics, the new guidelines for hepatocellular carcinoma, other hepatitis, unpublished studies on NASH and NAFLD, the national registry on primary biliary cholangitis, microbiota and chronic liver diseases, liver cancer in autoimmune diseases.
Nurse Times editorial team
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