The European preexposure prophylaxis revolution

Area of Science:

• Public Health
• Epidemiology
• HIV Prevention

Background:

• The European HIV epidemic disproportionately affects key populations, including men who have sex with men (MSM) and transgender women.
• Existing HIV prevention strategies require enhancement to address the ongoing transmission rates.
• The transition of pre-exposure prophylaxis (PrEP) from clinical trials to routine practice presents implementation challenges.

Purpose of the Study:

• To review the European HIV epidemic context.
• To analyze the challenges in integrating pre-exposure prophylaxis (PrEP) into routine clinical practice.
• To evaluate the effectiveness of oral PrEP in European trials.

Main Methods:

• Analysis of data from two European clinical trials of oral PrEP (tenofovir/emtricitabine).
• Comparison of HIV incidence in trial participants versus anticipated incidence based on surveillance data in MSM.
• Review of current HIV prevention services and regulatory landscapes in European Member States.

Main Results:

• Oral PrEP (tenofovir/emtricitabine) demonstrated high and consistent reduction in HIV incidence among gay and other MSM and transgender women.
• HIV incidence in the control groups was unexpectedly high, indicating a significant unmet need for effective prevention.
• Gilead has not yet submitted a marketing authorization application for TDF/FTC as PrEP in Europe.

Conclusions:

• There is an urgent need to make PrEP accessible to key populations in Europe as a vital additional prevention tool.
• Despite the lack of specific regulatory approval for PrEP, some countries are already utilizing TDF/FTC for post-exposure prophylaxis.
• European Member States must identify key populations and integrate PrEP services within comprehensive prevention packages, considering diverse healthcare delivery models.