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HIV pre-exposure prophylaxis considered by EMA


The European Medicines Agency has released a reflection paper on the use of medicines to prevent the transmission of HIV for public consultation.

The paper gives recommendations on how pharmaceutical companies should study medicines for the pre-exposure prophylaxis (PrEP) of HIV.

It includes information on medicines taken by mouth and on topical medicines, such as vaginal gels.

It emphasises the fact that the use of PrEP should form part of an integrated approach to reducing an individual’s risk of contracting HIV.

The use of medicines to prevent HIV transmission has been studied for many years. This reflection paper sets out a consolidated position based on this research, which has culminated in the positive results of two studies using anti-HIV medicines to reduce the likelihood of catching HIV.

One of these was carried out in women with a vaginal gel containing tenofovir and another in men taking Truvada (tenofovir / emtricitabine) tablets.

The publication of the reflection paper follows assessment of comments received on a concept paper, which was released for consultation in early 2011.

The Agency also hosted a workshop on this topic in July 2011 involving academics, representatives from the World Health Organisation, the African Institutional Body and patients’ associations.

The Agency is continuing to follow scientific developments in this area, giving scientific advice as requested and following consultations that culminated in this reflection paper.

The paper states that the Agency is prepared to evaluate future marketing authorisation applications for PrEP.

The public consultation is open until 30 June 2012.


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