Opinion on the potential benefits of the concept of HIV/AIDS pre-exposure prophylaxis (PrEP)

This Opinion was adopted by the National AIDS Council at a plenary session on 12 January 2012, by the majority of members present with one abstention.

The Summary of the Opinion is available in pdf format : Click here

 Preamble

There is a widespread consensus, thirty years after the detection of the first cases of AIDS, on the need to drastically reduce the number of new infections in order to stabilize, and subsequently reverse the spread of a pandemic which current prevention measures have failed to contain. Significantly improving the effectiveness of prevention is therefore essential in terms of both the individual and collective benefits it offers. This means that no new avenue for exploring this issue should be excluded.

Pre-Exposure Prophylaxis (PrEP) using antiretroviral (ARV) drugs, which involves proposing antiretroviral therapies to uninfected populations in order to prevent them contracting HIV, is currently the focus of numerous scientific studies, and has generated intense debate. [1] Although there is currently no approved, definitive guidance on this new use of ARV for prevention purposes, interim guidance was issued in January 2011 in the United States of America [2]. More recently, on 15th December 2011, a supplemental New Drug Application (sNDA) for the use of a combination antiretroviral therapy as PrEP was submitted to the U.S. Food and Drug Administration (FDA). Despite the numerous uncertainties which subsist at this preliminary stage, it is important to carefully analyze PrEP, in order to determine whether this strategy could, in the near future, enhance the existing range of means of protection.

This opinion has been produced in response to the letter of mission from the Director General of Health dated 4th March 2011. It works off the hypothesis that the results of scientific studies underway will confirm the benefit of developing a PrEP offering in certain circumstances, and is intended to examine the potential benefits and limitations of this approach in order to anticipate the consequences for prevention as a whole. In accordance with its remit to inform public decision-making, the Council has set itself the triple objective of producing a precise inventory of current knowledge and debate, proposing an interpretation of these that encompasses the multitude of issues involved, and formulating preliminary guidelines on the use of PrEP in France.

Over the last ten years, the use of biomedical tools to prevent HIV transmission has increased dramatically, this is the context in which the new PrEP tool, using antiretroviral drugs, has been introduced. The possibilities opened up by these new approaches have shaken up the prevention paradigm that has been in place since the emergence of the epidemic, resulting in the emergence of the “combination prevention” concept. These new possibilities are intended to develop the necessary synergies between what are known as behavioral, structural and biomedical prevention strategies, the latter incorporating both screening and the different uses of therapies for preventive purposes.

The need to implement this new conception of prevention is all the more urgent given the possible and probable development of PrEP. This new tool, given its own specificities, should be reserved for targeted use in situations where exposure to the risk of HIV infection is highest, rather than for widespread use in the general, uninfected population. Consequently, developing PrEP requires a « personalized » approach, adapted to the specific prevention needs of the individuals concerned, which requires a profound shift in the prevention discourse and offering.

The thinking developed in this opinion follows on from the Council’s work as presented in the opinion dated 9th April 2009, on the use of treatments for preventive purposes for infected persons. It places considerable emphasis on the challenge of reinforcing individuals’ autonomy, helping them to use new prevention methods in conjunction with the range of means already available so they can make informed and reasonable use of these. This should also allow them to build personal prevention strategies adapted to their situation, constraints, desires and practices.

Sommaire

• Preamble [page 1]
• I. Examining PrEP in the context of the redefinition of prevention strategies and (...) [page 2]
• II. PrEP’s potential contribution within the existing range of prevention methods [page 3]
• III. PrEP medical monitoring requirements and cost constitute a new challenge for prevention (...) [page 4]
• IV. A new step toward changing the prevention paradigm [page 5]
• Guidelines for use of PrEP in France [page 6]
• Acknowledgements [page 7]