The European Commission (EC) has granted marketing authorisation for US-based Gilead Sciences’ once-daily Truvada to reduce the risk of sexually acquired HIV-1 infection.
In 2005, this anti-retroviral medicine was approved by the European Medicines Agency for use in combination with other anti-retroviral agents to treat the infection in adults aged 18 years and above.
With the authorisation in place, Truvada can be marketed for pre-exposure prophylaxis (PrEP) within all 28 countries of the European Union.
University of Paris professor Jean-Michel Molina said: “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 a known cause transmitted through sexual contact.
“Truvada for PrEP provides an additional prevention tool, which when used with safer-sex practises, will help uninfected adults at high risk of HIV protect themselves against the virus.”
The authorisation is based on the results of two placebo-controlled trials of Truvada, the pre-exposure prophylaxis initiative (iPrEX) and partners PrEP, sponsored by the US National Institutes of Health and the University of Washington, respectively.
The studies highlighted the most commonly reported side effects such as headache, stomach discomfort and weight loss.
Gilead Sciences research and development executive vice-president and chief scientific officer 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.”
The medicine alone does not constitute a complete regimen for the treatment of HIV-1 and should not be used in individuals with unknown or positive HIV-1 status.
Truvada is also authorised for PrEP in Australia, Canada, Kenya, Peru, South Africa and the US.