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Projects / Programmes source: ARIS

Pre-exposure Prophylaxis for HIV Prevention Among Men Who Have Sex with Men in Slovenia

Research activity

Code Science Field Subfield
3.01.00  Medical sciences  Microbiology and immunology   

Code Science Field
B007  Biomedical sciences  Medicine (human and vertebrates) 

Code Science Field
3.01  Medical and Health Sciences  Basic medicine 
Keywords
HIV, MSM, PrEP, Slovenia
Evaluation (rules)
source: COBISS
Researchers (6)
no. Code Name and surname Research area Role Period No. of publicationsNo. of publications
1.  50154  Manja Kordiš  Microbiology and immunology  Researcher  2018 - 2020 
2.  32966  Blaž Pečavar  Microbiology and immunology  Researcher  2018 - 2020  52 
3.  51507  Maja Pleško  Microbiology and immunology  Researcher  2018 - 2020 
4.  11347  PhD Janez Tomažič  Microbiology and immunology  Head  2018 - 2020  412 
5.  50050  Gabriele Turel  Microbiology and immunology  Researcher  2018 - 2020  30 
6.  30546  Tomaž Vovko  Microbiology and immunology  Researcher  2018 - 2020  78 
Organisations (1)
no. Code Research organisation City Registration number No. of publicationsNo. of publications
1.  0312  University Medical Centre Ljubljana  Ljubljana  5057272000  77,480 
Abstract
Pre-exposure Prophylaxis (PrEP) is daily or event-driven use of tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) to prevent HIV infection. Several clinical studies have shown its efficacy and safety in the population of men who have sex with men (MSM) at high-risk for HIV infection. Most notably, the PROUD and IPERGAY trials, found a 86% reduction in the rate of HIV acquisition if PrEP was used in addition to other means of risk reduction. In the United States PrEP was approved by the Food and Drug Administration (FDA) in July 2012. The World Health Organization (WHO) endorses PrEP as part of a combination strategy to prevent HIV infection since 2015. Recommendation towards using TDF/FTC was issued by the European Medicines Agency (EMA) in 2015 and has been approved by the European Commission in combination with safer sex practices in August 2016. Free of charge PrEP is provided to people at high-risk of HIV infection as part of the public health service in France and Norway. In the United Kingdom PrEP will be available in 2017 as part of a large scale clinical trial, as will happen also in many other European countries - we hope also in Slovenia. Slovenia has a low incidence of HIV infections as compared to other European Union (EU) countries. From 2006 to 2016, the number of new HIV diagnosis per year ranged from 33 in 2006 to a maximum of 65 in 2016 (National Institute of Public Health - NIJZ 2016). Sex between men is the predominant mode of transmission  (NIJZ 2016). The steady increase in the number of new HIV infections among men who have sex with men (MSM) over the past 10 years (NIJZ), changed attitude of MSM towards HIV infection (effective treatment!), changes in sexual behaviour (use of mobile applications to find sexual partners, recreational drug use, etc.), long-term individual, epidemiological and financial consequences of HIV infection and known efficacy of pre-exposure prophylaxis (PrEP) when combined with other forms of preventive measures, support the implementation of PrEP to lower the number of new HV infections. With the introduction of PrEP we would engage at risk MSM into medical care and could, in addition to chemoprophylaxis (PrEP), influence and improve the basic behavioural prevention measures (condom/lubrican use, safe sex practices, etc.), as well as regularly test them for other sexually transmitted infections (STI). The purpose of this study is to evaluate the feasibility, acceptability and safety of HIV PrEP in preventing HIV infection among MSM at highest risk in Slovenia. The data obtained in the study would clarify the role of HIV PrEP in Slovenia and would guide the decision on PrEP implementation into national HIV preventing guidelines.
Significance for science
The main value of this study is not to advance science but to assess the feasibility, acceptability and safety of HIV PrEP in preventing HIV infection among MSM at higher risk for HIV infection in Slovenia. Data obtained in the study would clarify the role of HIV PrEP in Slovenia and thereby help in the decision to include PrEP in national HIV prevention guidelines. In addition, the results of the study will be published in the relevant international journal and will inform our colleagues abroad, especially Professor Jean-Michel Molina, MD, PhD (Paris, France), who is a pioneer of PrEP in Europe and has already shown interest in our project.
Significance for the country
Although the project is not directly associated with economic growth, it is very relevant to the economy in terms of preventing long-term consequences of HIV to the individual and society. Prevention is one fo the basic principles of medicine! At first glance, prevention of HIV infection is simple: use a condom, know your partner well, etc. Unfortunately, real life is more complicated and for this reason combined HIV prevention has been developed. PrEP is an important element of such prevention. Treatment of people who are already infected with HIV, especially afeer they have developed AIDS (20% of newly diagnosed patients in Slovenia!) is significantly more expensive compared to hIV Prevention with PrEP. According to the results of the PROUD and Ipergay studies, PrEP needs to be administred to 15 MSM with higeh risk behavior in order to prevent one infection within a year. The "cost versus benefit" score is fully in favor of PrEP, which is finacially very effective.
Most important scientific results Annual report 2018
Most important socioeconomically and culturally relevant results
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