The treatment approved by AIFA is indicated in combination with safe sex practices for pre-exposure prophylaxis
Milan – 40 years after the announcement of the first identification of the virus, HIV infection is a topic we should keep talking about. A big step forward in terms of prevention has recently been made with the approval by AIFA – requested by Mylan Pharmaceuticals Limited, part of the Viatris group – the reimbursement of treatment for pre-exposure prophylaxis (PrEP) of HIV-negative peoplebased on emtricitabine and tenofovir disoproxil. The medicinal product is indicated in combination with safe sex practices for pre-exposure prophylaxis to reduce the risk of sexually transmitted HIV-1 infection in high-risk adults and adolescents.
The scope of this approval was reflected in the press conference entitled “A new era in HIV prevention: PrEP reimbursement historic breakthrough in the fight against infection” promoted by Viatris Italia, which took place in recent days in Milan with the participation of leading exponents of the clinical, institutional and association worlds. The event was an opportunity to take stock of the epidemiological situation of HIV in Italy and in the world, on the progress achieved so far in the prevention and treatment of the infection, as well as on the importance of collaboration between the various players in the field – Institutions, scientific societies, associations, companies – to achieve the goal desired by the World Health Organization of an AIDS-free generation.
In Italia HIV still represents a significant public health problem today, as evidenced by 1,770 new diagnoses per year in 2021, equal to 3 new cases per 100,000. To this is added the alarming data relating to submerged caseswith a growing share since 2015 of people who are diagnosed as HIV-positive late.
“I think PrEP reimbursability can have a positive impact. In the first place, the offer of therapy to prevent HIV infection paid for by the National Health Service, free of charge to the citizen, will allow us to avoid infections and contain the spread of the virus, particularly in sections of the population at risk, with a positive fallout in terms of public health,” said the Prof. Stefano Vella, Professor of Global Health, Catholic University (UCSC), Rome. “Furthermore, the economic impact of pre-exposure prophylaxis compared to the treatment of an HIV-positive person is decidedly lower, also allowing savings for the benefit of public health.”
“Since 1983, the year of the first identification of the virus, we have made countless steps forward in the HIV field and the reimbursement of PrEP represents the most recent step in this journey”, commented the Dr. Andrea Antinori, UOC Director of Viral Immunodeficiencies at INMI Spallanzani in Rome. “The efficacy of PrEP has long been confirmed: if we look at the Australian model, the incidence of HIV observed over a three-year period was 92% lower than the incidence predicted in the absence of PrEP (at least 20 per 1,000 people/year). It is estimated that, with 100% adherence, the incidence drops to zero in at least 5,000 people/year”.
Medicine has made an important progress in the HIV field, making available to patients drugs that are increasingly effective, more tolerated and which simplify adherence to therapy, making the HIV patient equal to a chronically ill person. Antiretroviral therapies, in fact, if taken regularly, make the viraemia no longer detectable in the blood, as also summarized in scientific evidence U=U, Undetectable=Untransmittable, (Undetectable = Untransmittable). However, there are still no drugs to cure and eradicate the virus; moreover, many people discover that they have been infected only late, risking spreading the infection in the meantime.
“This is why it is even more important to have a weapon like PrEP reimbursed to help us contain the spread of HIV in the most fragile population groups with risky behaviors, but also of other sexually transmitted diseases, since those who take PrEP is followed by the infectious disease specialist and must undergo periodic screenings that allow them to be identified early”, said the Prof. Andrea GoriInfectious Diseases Department, “Luigi Sacco” Hospital, University of Milan and President of ANLAIDS Lombard Section.
In this context, however, we must not forget the importance of promoting the correct use of condoms and other preventive strategies in combination with PrEP, such as tests to evaluate HIV positivity, in order to obtain complete prevention and protect the sexual health of all .
“The test to diagnose HIV, the condom, PrEP are all tools for preventing the spread of the HIV virus, not alternative to each other, to be made known especially to young people: at school or in the family there is no discussion of HIV is a topic that is talked about secretly or in whispers, which is still very frightening, while our priority must precisely be an aware sexual education of the youngest”, continues Gori.
In the path towards greater accessibility of treatments and awareness of the population le associations have always played a role at the forefrontrecalling the importance of providing correct information on HIV, of encouraging prevention, early diagnosis in this area and breaking down the still too widespread discrimination.
“Research has done a great deal over the years regarding the HIV virus and AIDS. Today HIV positivity is a condition which, from a clinical point of view, is controllable. The biggest mistake you can make, though, is thinking about this infection as a problem of the past. Precisely for this reason we continue to disseminate the importance of correct information on prevention, of testing as a routine, of access to and adherence to effective drug treatment, always putting the person at the centre. Indeed, HIV is transversal in terms of gender, age and orientation. Aware that if we manage to avoid just one new infection, it was worth it: the reimbursement of PrEP is therefore a fundamental element in this battle “, he reiterated Bruno MarchiniPresident ANLAIDS Onlus – National Association for the Fight against AIDS.
“It’s important to be aware that this success is not an end point,” he said Sandro Mattiolipresident Plus – Italian Network of HIV+ LGBT+ People. “This important milestone requires us to continue working both against stigma – because fear of social prejudice still keeps many people away from testing – and to expand access to medicines with respect to the current distribution and prescription of PrEP medicines. there is still a lot to do! As an association we are committed to spreading the word of the reimbursability of PrEP, clearly conveying the message that the different forms of prevention must be used in combination if we really want to create what the WHO calls “a generation without AIDS”. We continue to look forward to new steps forward in research in this field”.
In achieving the goal of PrEP reimbursement, which positions Italy on a par with other European countries where PrEP was already reimbursed, Viatris, a company historically engaged in the HIV sector to contain the spread of the virus, played a leading role. educate about prevention, promote early diagnosis and provide patients with effective, accessible and high-quality treatments.
“Viatris has made a strong commitment to obtain the reimbursement of PrEP in Italy, to offer equal access to this effective tool to contrast and prevent HIV even to the population groups most exposed to risk and most vulnerable from a social and economic point of view ”, commented the Dr. Laura Borgna, Hospital Care Business Unit and Policy & Market Access Director of Viatris Italia. “In line with what is expressed in the National Plan of Interventions against HIV and AIDS (PNAIDS) we have worked alongside all the actors involved: from institutions to clinicians, from Associations to scientific societies. We believe the reimbursement of PrEP is an important step to help achieve the UN goal of ending the AIDS epidemic by 2030 for an AIDS-free generation.”