The European Commission has given marketing authorization for Truvada (tenofovir/emtricitabine) as pre-exposure prophylaxis (PrEP) to lower the risk of HIV along with safer-sex practices among adults at high risk of contracting the virus. The approval gives the go-ahead for PrEP in all 28 nations in the European Union.
The approval was based on the results of the iPrEx trial, which proved PrEP’s effectiveness among men who have sex with men (MSM) and transgender women, and the Partners PrEP study, which included mixed-HIV-status heterosexual couples. The most commonly reported side effects in these studies were headache, stomach discomfort and weight loss (Truvada side effects tend to fade after about a month).
First approved in the United States in 2012, PrEP has since been authorized in Australia, Canada, Kenya, Peru and South Africa. Australia’s Pharmaceutical Benefits Advisory Committee recently ruled that the country would not foot the bill for PrEP coverage, however. Meanwhile, an ongoing court battle is raging over whether the National Health Services of England will pay for PrEP in that nation.
To read a press release about the approval, click here.