Long-Acting PrEP in Europe's Fight Against HIV

The HIV landscape in Europe paints a picture of progress interwoven with persistent challenges. In 2022, the WHO European region saw a rise in HIV diagnoses, reaching 12.4 per 100,000, marking a 4.2% increase from 2021 but a 20.5% drop from 2019.

The UNAIDS 90-90-90 goals, aimed at diagnosing, treating, and achieving viral suppression in 90% of HIV positive individuals by 2020, were not reached in the WHO European region. By 2022, an estimated 3 million people were living with HIV. Of them, around 72% knew their status, 63% were receiving treatment, and 60% had suppressed viral loads, signaling potential challenges in reaching the revised 95-95-95 targets by 2025, and the broader objective to end AIDS by 2030.

As the world marks the 36th World AIDS Day today, Europe stands at the frontlines of the battle against HIV. It requires a comprehensive strategy encompassing health promotion interventions, testing, antiretroviral treatment (ART), and preexposure prophylaxis (PrEP). Experts from the European Centre for Disease Prevention and Control (ECDC) resonated this message at a press conference that presented the latest data on epidemiological trends in Europe and progress toward the 2030 targets.

The Promise of Long-Acting PrEP

PrEP, when used consistently, substantially slashes the risk of HIV acquisition, addressing the initial goal of ensuring 95% of at-risk individuals are aware and protected. Effective PrEP usage among high-risk groups reduces the overall transmission rate, aligning with the second 95 goal. By preventing new HIV infections, it alleviates the strain on treatment systems, allowing for better focus and resources to ensure those on treatment achieve viral suppression, indirectly contributing to the third 95 goal.

France's 2016 rollout of PrEP showcased remarkable outcomes, with adherence rates exceeding 81% and a significant drop in HIV incidence (0.12 per 100 person-years among users vs. 1-2 among non-users). Since then, PrEP in Europe has evolved significantly, introducing long-acting formulations as promising alternatives to daily oral PrEP.

Developing strategies to enhance PrEP accessibility among key populations 'is one of the most challenging issues and there is no quick fix.' Dr Deniz Gökengin, Department of Infectious Diseases and Clinical Microbiology, Ege University in Turkey

Long-acting PrEP abolishes the need for daily pill intake, potentially improving adherence and efficacy compared to daily oral PrEP, which can be inconsistent due to missed doses. In September, the European Commission authorized cabotegravir long-acting injectable (Apretude) and tablets for PrEP, following US Food and Drug Administration approval in December 2021. WHO guidelines released in 2022 advocated for long-acting cabotegravir as a safe and effective HIV prevention approach.

Clinical trials, notably HPTN 084, demonstrated the superiority of long-acting injectable cabotegravir over daily oral emtricitabine/tenofovir disoproxil fumarate in reducing HIV acquisition. It stands as the EU's first HIV prevention option that reduces the necessary doses from 365 daily pills to just six injections per year.

The combination of long-acting cabotegravir and rilpivirine stands as the first long-acting injectable treatment for HIV, maintaining virologic suppression in 87% of participants after transitioning to the combo in the CARISEL study.

A survey including patients with HIV highlighted substantial interest (66%) in switching to long-acting ART, especially among those facing challenges with oral ART.

Accessibility Challenges

However, PrEP faces implementation and access challenges in Europe, with more than 500,000 men who have sex with men expressing the desire for PrEP but encountering limited accessibility (an overall gap of 17.4%, rising to 45% in non-EU and/or Central and Eastern European countries). Disparities persist, with 32% of participants in the European Men-Who-Have-Sex-with-Men Internet Survey (EMIS) unaware of PrEP. In France, only 28% reported PrEP use during their last condomless anal intercourse with a casual partner.

The switch to injectable treatment within the Swiss HIV Cohort study witnessed a low transition rate of less than 3%, primarily among males (82%) with a median age of 48, emphasizing the need to address concerns about injection frequency and tailor treatment options for better satisfaction and adherence among the HIV population.

"Twenty-six countries have made PrEP nationally available and reimbursed, a further 16 countries have generics available but not fully reimbursed, and in 13 countries PrEP is not formally implemented at all. There is a clear West to East gradient contributing to sub-regional disparities in PrEP implementation," said Teymur Noori, MSc, an expert on monitoring an evaluation at the ECDC, speaking to Medscape Medical News. "The challenges for implementation are primarily centered around the cost of the drug itself, the cost of service delivery (STI testing and renal function and bone density monitoring), and challenges on how to deliver a prevention intervention in a healthcare setting."

In countries with the highest number of people on PrEP, it is not reaching women and other key populations beyond men who have sex with men. Teymur Noori, European Centre for Disease Prevention and Control

Developing strategies to enhance PrEP accessibility among key populations "is one of the most challenging issues and there is no quick fix," added Deniz Gökengin, MD, an academic staff member at the Department of Infectious Diseases and Clinical Microbiology, Ege University, Turkey, in an interview with Medscape Medical News.

"Since each key population may have different characteristics, needs, and challenges, countries should first define their key populations who are at most need for PrEP, know their living conditions and behavioral characteristics, as well as their basic and PrEP-related needs," noted Gökengin, who also serves as a clinician in Turkey on HIV/AIDS management.

"Lessons learned from good examples of successful programs for different key populations in different countries across Europe may be used as guidance, and support from international organizations are required to overcome barriers and to move forward quickly," she added.

"In countries with the highest number of people on PrEP, it is not reaching women and other key populations beyond men who have sex with men," said Noori. "What is needed are programs and policies that actively try to create a demand for PrEP in these other groups. One way of doing so is to work with community organizations who know best how to reach out to their communities."

While PrEP and long-acting retrovirals show promise, addressing access disparities calls for a holistic strategy and collective efforts.

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