LONDON, Aug 23 (APM) - Gilead's Truvada has been approved in Europe in a new use to reduce the risk of HIV infection, four years after it was authorised in that indication in the U.S., it has been announced.

The European Commission has approved once-daily Truvada (emtricitabine/tenofovir disoproxil) in combination with safer sex practices to reduce the risk of sexually acquired HIV-1 infection among uninfected adults at high risk, a strategy known as pre-exposure prophylaxis or PrEP, the U.S. pharma said in a late Monday statement.

Truvada was approved in Europe in 2005 for use in combination with other antiretrovirals for HIV-1 infection treatment in adults. Gilead said it is the most prescribed antiretroviral medicine in Europe as part of combination therapy.

The statement quoted professor Jean-Michel Molina of Hôpital Saint Louis in Paris and University of Paris 7 as saying:
"In the past 30 years, we have seen significant progress in the way we treat HIV. However, infection rates have continued to rise. In 2014, we saw the highest number of newly diagnosed cases in the European Union ever recorded, with 94% of those with known cause transmitted through sexual contact.

"Truvada for PrEP provides an additional prevention tool, which when used with safer-sex practices will help uninfected adults at high risk of HIV protect themselves against the virus."

Gilead's chief scientific officer Dr Norbert Bischofberger said: "The approval of Truvada for PrEP represents an important step forward in addressing the incidence of HIV in Europe. When taken as directed and used in combination with other prevention strategies, Gilead believes Truvada for PrEP can have a meaningful impact on public health by helping to reduce HIV transmission rates across Europe."

Approval is based on the results of two large placebo-controlled trials of Truvada, the Pre-Exposure Prophylaxis Initiative (iPrEX) and Partners PrEP, sponsored by the U.S. National Institutes of Health and the University of Washington respectively. In these studies, the most commonly reported side effects included headache, stomach discomfort and weight loss. The incidence and types of side effects were consistent with Truvada's safety and tolerability profile when used as part of an HIV treatment regimen.

Worldwide, clinical guidelines support the use of PrEP, in combination with other existing prevention measures such as condoms, to prevent the sexual transmission of HIV in adults at high risk of HIV infection.

Gilead said Truvada should not be used in individuals with unknown or positive HIV-1 status, as Truvada alone does not constitute a complete regimen for the treatment of HIV-1 and HIV-1 resistance mutations have emerged in individuals with undetected HIV-1 infection who are only taking Truvada.

As well as Europe, Truvada is also authorised for PrEP in Australia, Canada, Kenya, Peru, South Africa and the U.S.

Almost 50,000 people have taken Truvada in HIV PrEP in the U.S., according to pharma company data presented at the 2016 AIDS meeting in Durban, it was announced last month (APMMA 48833). The antiretroviral was authorised in PrEP in the U.S. in July 2012

In France, Truvada has been authorised in this indication under an temporary access scheme (RTU) since December 2015 (APMMA 45268).

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