HIV, the first monoclonal antibody is available in Italy

HIV, the first monoclonal antibody is available in Italy
HIV, the first monoclonal antibody is available in Italy

It is called ibalizumab and has already been approved in the United States and Europe. It is an innovative molecule to treat HIV infection, even in the case of strains resistant to antiretroviral drugs

Foto: National Cancer Institute|Unsplash

In Italy the first monoclonal antibody long-acting – i.e. that remains in the body for a long time – against human immunodeficiency virus infection (HIV). The marketing of ibalizumab, this is the name of the active ingredient, was approved by the Italian Medicines Agency (Aifa) and published in the Official Journal on October 19th. The monoclonal antibody, which acts in an innovative way, is indicated for the treatment of adults with drug-resistant HIV infection. The announcement took place during the Icar Congress – Italian conference on Aids and clinical research, taking place in Riccione from 21 to 23 October, promoted by the Italian Society of Infectious and Tropical Diseases.

The problem of drug resistance

The human immunodeficiency virus and the disease it causes,Aids, remain one of the major global public health problems: To date, HIV has infected nearly 80 million people and has caused more than 35 million deaths. The advent of antiretroviral therapies, since the nineties, has remarkably improved prognosis of HIV patients, as well as their quality of life. Despite this, there are growing concerns about the development of strains of the virus resistant to available therapies. A 2019 study, in fact, shows that, in the United States, about 25,000 patients are living with a multidrug-resistant HIV infection to treatments, and among these about 12,000 patients need new therapeutic options as all approved drug regimens have failed.

For these reasons, biomedical research has turned towards alternative solutions to antiretroviral drugs, such as monoclonal antibodies. Studies, over the past few years, have shown that monoclonal antibodies offer several benefits for HIV therapy: an innovative mechanism of action, the ability to restore T-cell counts, to cause minimal emergence of resistant strains and a low potential for toxicity compared to other alternative antiretroviral agents.

Among these innovative molecules, the first approved is ibalizumab. It is a recombinant and humanized monoclonal antibody, namely that it was obtained with protein engineering techniques starting from human cells. In particular, the molecule is long-acting (i.e. it stays around longer than other drugs) and is able to blocking HIV infection of CD4 + T lymphocytes (the type of lymphocytes that the virus selectively infects): the antibody, in fact, it binds to the surface of the cells, interfering with the phases following the binding that are used for HIV to enter the lymphocytes; like this prevents viral transmission which occurs through cell-to-cell fusion. The monoclonal antibody, while not actually curing the infection, can reduce the possibility of developing AIDS and HIV-related diseases such as severe infections or cancers.

A story that began in 2018

Trogarzo, this was the commercial name of the molecule already approved by the US regulatory agency, the Fda, in March 2018, and by the European one, the EMA, in September 2019. Now it is also available in Italy (the decision of Aifa that authorizes it was published in the Official Gazette last October 19) and indicated, as stated in the official document “for the treatment of drug-resistant HIV-infected adults for whom a suppressive antiviral regimen would not otherwise be possible“.

This monoclonal antibody attaches to CD4 lymphocytes, preventing the virus from entering the cell“, Says Anna Maria Cattelan, one of the presidents of the Icar congress, at theDire Agency. “This therapeutic approach has been studied for patients with one behind long history of antiretroviral therapy. This is just the beginning, as these monoclonal antibodies could also be used in other settings, such as in initial therapy and even in HIV prevention.”.

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