After the many failures in trials, has the idea of a preventive vaccine against HIV been abandoned or is there something new on the horizon? Who can you turn to for help? What is PrEP for? On the occasion of World AIDS Day, we asked some specialists to answer ten questions that can help clarify why, while waiting for a vaccine, today people with HIV, if treated early with antiretroviral drugs, they have a life expectancy similar to that of those who have never come into contact with the virus and it is essential to do more tests to reach an early diagnosis. The theme chosen for World Day this year is “Remember and commit”, which urges us to keep alive the memory of the victims of the epidemic and to strengthen the commitment to fight it. After almost four years of monopoly of attention on the Covid pandemic, attention must also be brought back to the silent HIV pandemic, which still afflicts 38 million people around the world. Just 20 years ago, the HIV/AIDS pandemic seemed unstoppable, with 2.5 million new infections and 2 million deaths per year due to AIDS worldwide.
HIV, one in ten people still without diagnosis (in the European area) by Salute editorial staff 28 November 2023
How far along are the new studies for an mRNA vaccine?
After the interruption of the Mosaico study, which used different components of the HIV virus as antigens with the aim of inducing the broadest possible immune response against different viral subtypes, researchers from all over the world have united by deciding not to abandon the idea of arriving at the discovery of an effective vaccine sooner or later. In particular, we are awaiting the first data from two studies that are testing the immunogenicity and safety of vaccines against HIV and which use the same vaccination platform as Covid. “We are working on the development of an mRNA vaccine – he explains Antonella Castagnahead of the Infectious Diseases department of the San Raffaele Hospital in Milan -, but the trial is still in phase 1, with the aim of evaluating its safety and ability to induce an immune response by producing largely neutralizing antibodies”. In essence we are trying to understand if other vaccination platforms can overcome the obstacles encountered so far despite knowing that finding an effective vaccine against HIV is much more difficult than against Covid.
And the African vaccine?
The study on the first African vaccine, financed by the European Union, has already entered its final stages. It investigates two combined vaccines and the concomitant use of one of the two drugs used for PrEP, to test the effectiveness of the vaccine while also offering protection to prevent HIV infection. The clinical trial began enrollment in December 2020 and enrolled the last of its 1,512 participants in March 2023. “This is the PrEPVacc study – specifies Castagna – which uses a DNA-based vaccination platform offering all study participants for the first six months also PrEP, i.e. pre-exposure therapy which significantly reduces the risk of becoming HIV positive”. Participants are tested and receive counseling every four to eight weeks and will be monitored until October 2024. For PrEPVacc to be considered a success, the vaccine being tested will need to achieve an efficacy of at least 70%. In addition to PrEPVacc, there are more than 20 vaccine trials underway, studying different technologies to protect against HIV.
What is PrEP?
While waiting for a vaccine to arrive, a lot can be done thanks to pre-exposure prophylaxis, PrEP, also because finally last May the Italian Medicines Agency approved the reimbursement of these treatments for pre-exposure prophylaxis (PrEP) of HIV negative people, based on emtricitabine and tenofovir disoproxil. The medicine is indicated in combination with safe sexual practices for pre-exposure prophylaxis to reduce the risk of sexually transmitted HIV-1 infection in high-risk adults and adolescents. “These therapies – explains Castagna – have demonstrated significant effectiveness and a risk reduction of over 80% in people at high risk of contracting the infection”.
HIV is still among us, we must never forget it by Mara Magistroni 01 November 2023
What are “long acting” therapies?
Another recent innovation is that of therapeutic regimens to be administered at very large intervals without this reducing the ability to control the infection. “In Europe, but not yet in Italy, for prevention – continues the infectious disease specialist from San Raffaele in Milan – the long-acting drug cabotegravir has been approved, which is injected every two months and which has demonstrated superior efficacy to emtricitabine /daily oral tenofovir in reducing the risk of acquiring HIV. Cabotegravir plus rilpivirine, however, is already available in Italy for therapy with two intramuscular injections every 2 months”. Furthermore, the drug lenacapavir has recently been available in Italy and has obtained reimbursement approval from the Italian Medicines Agency for the treatment of adults with multi-resistant HIV infection. “Lenacapavir – underlines Castagna – is a long-acting molecule, progenitor of a new class of antiretroviral drugs: its multistage action inhibits the HIV capsid at several points in the life cycle of the virus, thus preventing its replication It is available both in oral form and with subcutaneous injections and is administered only twice a year. For prevention, however, phase 3 trials are still underway.”
What is the epidemiological situation?
However, while research is moving rapidly towards increasingly effective and easy-to-administer therapeutic solutions, much still remains to be done in terms of early diagnosis and awareness, given that the ECDC, the European Center for Disease Prevention and Control, reports that diagnoses, half of which are late, have increased by 4.2% and that one European citizen in 10 is HIV positive, but doesn’t know it. Looking at Italy, the slight increase in the last two years post-Covid does not affect the ongoing trend since 2012 which sees the incidence decreasing with 1,888 new diagnoses and 403 new cases of AIDS in 2022. The data coming from the Institute Health authorities report a higher incidence of new HIV diagnoses in the 30-39 age group, while until four years ago it was found in the 25-29 age group. According to the new data, 58% of new diagnoses are people who have a CD4 count (the cells of the immune system that are attacked by the virus) less than 350 mm per microliter of blood. 42% of these “late presenters” already have the infections that define acquired immunodeficiency syndrome.
Why is it important to get tested for HIV?
Therefore, what is most worrying is the figure of two thirds of late diagnoses, sometimes already in AIDS, to which we can add an estimated 140 thousand hidden patients unaware of the infection. “The points on which we need to intervene are easier access to tests and the fight against stigma – he says Cristina Mussini, councilor of the Italian Society of Infectious and Tropical Diseases and professor of Infectious Diseases at the University of Modena and Reggio Emilia -. The tests are already free, anonymous and fast, but access must be facilitated, also involving local places such as emergency rooms and family doctors, who can further investigate the lifestyle of their patients and understand any potentially harmful behaviours. risk. The sexual history of individuals, in fact, must not be a taboo, but must fall within the scope of the patient’s knowledge; at the same time, we need campaigns that fight stigma.”
Where to get tested for HIV?
And precisely to meet the need to diagnose as early as possible, on the occasion of World AIDS Day, the Italian Red Cross renews its commitment to combating the spread of HIV through prevention and screening activities promoted by 183 CRI Committees all over Italy. Furthermore, 77 Committees will open their offices to welcome citizens who want to undergo a free HIV test thanks to the establishment of the LoveRED points. This initiative is part of the broader LoveRED campaign which aims to promote sexual education aware of the importance of prevention. At the CRI offices, anyone who decides to undergo the test will be provided with an assistance service provided by healthcare personnel and CRI volunteers, with information on sexually transmitted infections (STIs), with particular attention to HIV, risk behaviours, information on HIV testing, methods of execution and interpretation of results. The distribution of rapid saliva tests for self-administration, which can be carried out independently, is also planned.
Who should you contact for advice?
Also providing a realistic picture of the HIV epidemic in Italy is the Aids toll-free phone of the Istituto Superiore di Sanità. The latest data relating to the period from January to November this year show a collapse in the number of calls arriving at the number 800 861 061 which, on the occasion of World Day, will expand its activity from 9.00 to 19.00. Compared to the 90s when over 50 thousand phone calls were recorded per year, the current figure has been 8,048, 86% of which were made by men and 14% by women in an age range between 20 and 39 years. The HIV test was carried out at least once in 27.5% of cases and several times in 36.4%. The analysis of the data also made it possible to highlight that in 21.6% of phone calls the person declared that they had never taken the test. In 13.4% of phone calls, psycho-social issues are addressed, including those relating to advice on legal matters (privacy protection, social security and assistance, civil disability, transnational mobility for people living with HIV).
HIV and Aids in Italy in 2022, ISS data: more infections among heteros and women 17 November 2023
Why is it important to talk to doctors?
That it is necessary to talk about HIV again also emerges from the data of the survey conducted by Elma Research on 500 patients as part of the awareness campaign “HIV. Shall we talk about it?” (www.hivneparliamo.it), promoted by Gilead Sciences with the patronage of 16 Italian patient associations, the Italian Society of Infectious and Tropical Diseases (SIMIT) and the Italian Conference on AIDS and Antiviral Research (ICAR). 40% of people living with HIV learn of the infection by chance and as many as 2 out of 10 postpone communication, mainly due to fear of judgment and marginalization.
Why is adherence to therapy important?
The lack of adherence to therapies still weighs on the quality of life: “From the Elma Research survey it emerges that around 30% of patients are unable to comply with it – he explains Andrea Gori, of the Infectious Diseases department, Luigi Sacco Hospital, University of Milan and president of Anlaids Lombardia -. Adhering to the therapy means drastically reducing the probability of the appearance of mutations of the virus that can cause resistance to anti-HIV drugs, i.e. a reduced or absent capacity for the effectiveness of the therapy itself. Not only. Those who follow the therapeutic indications also protect others, since by eliminating the replication of the virus, they do not transmit the infection and are no longer contagious. A revolutionary and at the same time very simple concept that translates into U=U (Undetectable?Untransmittable) that is to say “I take care, not infected”.