Transforming HIV prevention in Europe – POLITICO

This article is part of POLITICO Telescope: The New AIDS Epidemic, an ongoing exploration of the disease today.

The world’s battle to end the HIV epidemic is being fought on two fronts. The first involves getting as many people as possible who are living with the virus diagnosed and rapidly onto antiretroviral medication. This reduces the virus inside their bodies to such a low level that it is undetectable and therefore cannot be passed to others. The approach is known as “undetectable = untransmittable” or “U=U*.”

The second front is focused on protecting people from contracting the virus in the first place, even if they have been exposed to it — an approach known as pre-exposure prophylaxis, or PrEP. Taken as prescribed, PrEP makes a person’s body almost entirely resistant to HIV infection.

There is a critical need to bring forward new PrEP options that are informed by and designed for the communities that could benefit from PrEP in Europe.

Jared Baeten MD, PhD, vice president for HIV clinical development at Gilead Sciences

PrEP comprises antiretroviral drugs that can be taken intermittently, around the time someone expects to be sexually active. They protect against the virus in two ways: by increasing the production of antibodies in the cells in the rectal or vaginal lining, making them less receptive to HIV in the first place, and by interfering with the ability of HIV to replicate in the body.

Nearly 5 million people around the world have taken PrEP at least once — including about 2.8 million in Europe — and it has been shown to reduce the incidence of HIV infection during sex by 99 percent. In the European Union, new HIV infections have fallen by about 45 percent since PrEP was licensed in 2016, although this decline is also partly due to U=U.

PrEP as part of combination prevention strategies

Today, PrEP comes primarily in the form of an oral tablet, which has the advantage of being cheap to produce and easy to store. But it is not a universal solution. Because it needs to be taken regularly while someone is sexually active, missing doses or running out can mean becoming susceptible to HIV again. What’s more, in the same way that some bacteria are developing resistance to antibiotics, the HIV that does enter the bodies of people who have paused or discontinued their use of PrEP has a greater chance of being resistant to subsequent antiretroviral medications they may then need.

PrEP taken in tablet form is also an issue for people who need to keep their use of PrEP private, perhaps from family members or partners. Having to take a pill once a day or two or three times a week is something that may be hard to hide from others. And some people, such as migrants, who may not be fully integrated with a country’s health care system, may find it hard to access regular supplies of daily medication. Limitations such as these have prompted the development of alternative, innovative ways for people to protect themselves that are more tailored to their needs and life situations. These include longer-acting drugs that can be injected.

Like existing oral medications, injectable PrEP works by preventing HIV from replicating in a person’s body, but its effect lasts much longer. In September, the EU approved the use of the first intramuscular injectable that can be given every two months. Gilead is, until 2027, running trials of another injectable option, which, once the required efficacy and safety have been demonstrated, could be administered subcutaneously just once every six months. This would be more convenient for many people and more adapted to the circumstances of certain populations, such as migrants, and may therefore lead to better adherence and health outcomes.

HIV continues to be a public health threat across Europe, where in 2022 more than 100,000 people were newly diagnosed with HIV.

Jared Baeten MD, PhD, vice president for HIV Clinical Development at Gilead Sciences

Further ahead — but still in the early stages of development and testing — are patches and implants, which would provide a continuous supply of antiretroviral drugs, and immunotherapies. Immunotherapies would comprise a broad spectrum of naturally produced or manufactured antibodies against HIV, which, in theory, would pre-arm their bodies to resist infection.

As more types of PrEP become available, we will see a greater awareness of its benefits, as more people are able to find the version of PrEP that best suits their living conditions and personal requirements. This is a fundamental principle of “combination prevention,” or innovative interventions that reflect the specific needs of the people they are trying to reach.

Preparing for the future

Despite clear scientific evidence of the benefits of PrEP, there are still some hurdles we need to overcome to make it a powerful tool to end HIV altogether. These include investments and funding in prevention and availability, and programs to combat stigma.

Although the EU licensed PrEP in 2016, availability varies across the bloc. In France, the U.K., Spain, Germany and, more recently, Italy, oral PrEP is available at no cost to those who would benefit from it. In Romania, although PrEP is included in the country’s new HIV National Strategy, it is not yet funded, and it is only available via non-governmental organizations that rely on external funding sources. And in Poland, Hungary and Bulgaria, PrEP is not state funded and there are no current plans to make it so. In many member states, even though PrEP is technically licensed, in practice it can be hard to get hold of, in particular for specific communities, such as women, migrants or trans people. Potential users may find it hard, for example, to access testing or even doctors who are willing to prescribe it.

Another key challenge that health systems and providers face is communicating the importance of PrEP to those who would most benefit, and thereby increase uptake. Many respondents in multiple studies have indicated that they don’t feel HIV is something that affects them, or they have indicated that there is a general stigma in their communities associated with sexual health matters. And some groups that are already discriminated against, such as sex workers, people who inject drugs, and migrants, may be hesitant to engage with health care systems for fear of reprisals. Again, injectable PrEP could help reach such key populations as it will offer a more discreet way of accessing the preventive treatment.

“There is a critical need to bring forward new PrEP options that are informed by and designed for the communities that could benefit from PrEP in Europe,” says Jared Baeten MD, PhD, vice president for HIV clinical development at Gilead Sciences. “At Gilead, we are excited to engage with communities and broader stakeholders to inform our trials efforts and partner with them in our goal to develop person-centered innovations that can help end the HIV epidemic in Europe.”

Europe is leading the world’s efforts toward ending HIV, but, even in the bloc, PrEP usage and availability varies from country to country and demographic to demographic. If the region is to become the first to end the HIV epidemic entirely, the European Commission, the European Parliament and the governments of member states will need to lead the way in fighting stigma, promoting and prioritizing HIV prevention in all its aspects including innovation in therapeutics strengthening the financing and funding of healthcare systems, and establishing effective pathways to zero transmission to end HIV entirely.

“HIV continues to be a public health threat across Europe, where in 2022 more than 100,000 people were newly diagnosed with HIV,” says Baeten. “HIV prevention is critical and has the potential to change the trajectory of the epidemic, but stigma and other barriers limit the impact that PrEP medications can have on reducing HIV infections in Europe. We all have a responsibility to collaboratively partner to make this work.”

_{*U=U is true on two premises: taking HIV medicines as prescribed and getting to and staying undetectable for at least six months prevents transmitting HIV to partners through sex. Undetectable means that the virus cannot be measured by a viral load test (viral load <200 copies/mL)}