EU approves Gilead's Truvada for HIV prevention

Gilead's Truvada (emtricitabine+tenofovir) has been approved in its HIV prevention use in Europe, but it is unclear whether the treatment will be funded in the UK and several developed countries.

The European Commission has granted a marketing authorisation for once-daily Truvada in combination with safer sex practices to reduce risk of sexually acquired HIV-1 infection among uninfected adults at high risk – a strategy known as pre-exposure prophylaxis (PrEP).

Truvada can now be marketed in all 28 EU countries, subject to national regulatory authority approval of required pharmacovigilance materials in each country.

Professor Jean-Michel Molina, of the Hôpital Saint Louis in Paris and University of Paris 7, said: “In the past thirty years, we have seen significant progress in the way we treat HIV – however infection rates have continued to rise.”

Approval is based on results of two large placebo-controlled trials, in which the most commonly reported side effects included headache, stomach discomfort and weight loss.

Side effects were consistent with Truvada's use as part of an HIV treatment regimen.

However several countries, including the UK, are unwilling to use public money to subsidise Truvada in HIV PrEP.

In the UK, the government indicated that it would fund a national Truvada PrEP scheme, based on findings of the separate PROUD study.

But England's National Health Service (NHS) has scaled these plans down to a handful of pilot projects, saying that local authorities must fund preventive health services such as PrEP.

NHS England has also challenged a High Court ruling that there is nothing to stop the NHS paying for the drug.

In Australia, Truvada PrEP will not be taxpayer subsidised after it failed to receive a recommendation to the Pharmaceutical Benefits Scheme earlier this month.

Press reports show that in Canada, only Quebec reimburses Truvada in HIV PrEP, despite a positive, fast review, from the regulator Health Canada. In the US, where it has been available since 2012 for PrEP, Truvada is usually covered through either Medicaid or insurance.