Brussels, 22/07/2016 (Agence Europe) - The European Medicines Agency sees no objection to extending the marketing authorisation for Truvada. The Committee for Medicinal products for Human Use (CHMP) took the view on Thursday 21 July that this medicine could also be used as part of a prevention strategy.
The CHMP opinion will now be sent to the European Commission which has the final say on the matter.
Truvada is a medicine produced by American laboratory Gilead. It contains two active substances, emtricitabine and tenofovir disoproxil. It has been used in the EU since 2005 in combination with at least one other antiviral medicine to treat adults infected with HIV-1. Gilead recently applied for an extension of Truvada's marketing authorisation introducing the prevention element.
In its recommendation, the CHMP recommends that the Commission give its approval. It based its decision on two main studies “which showed substantial reductions in the risk of HIV-1 infection when Truvada was used as PrEP” (pre-exposure prophylaxis). PrEP corresponds to preventive treatment: it is aimed at people who do not have HIV but who are at high risk of HIV infection. Taking Truvada, in combination with safer sex practices (such as using condoms) would, in the view of the CHMP, reduce the risk of infection in the event of exposure to the virus.
The two studies are: the iPrEx study which found that Truvada reduced the risk of HIV infection by 42% in HIV-negative men or transgender women who have sex with men and who were considered at high risk of HIV infection; and the Partners PrEP trial, in which Truvada reduced the risk of becoming infected by 75% in the heterosexual partners of HIV-positive men and women.
The CHMP notes adverse events, similar to those seen with Truvada used for the treatment of HIV-1 infection, including diarrhoea, nausea, tiredness, headache and dizziness.
If the Commission decides to grant the extension, each member state will take a decision on price and reimbursement of Truvada based on the potential role/use of this medicine in the context of its national health system. (Original version in French by Sophie Petitjean)