Gilead’s Truvada backed in EU for HIV prevention

Gilead’s Truvada (emtricitabine+tenofovir disoproxil) looks set for approval in Europe to reduce risk of HIV infection in high-risk individuals without the disease, after it was given the nod by a top regulatory committee.

The Committee for Medicinal Products for Human Use (CHMP) said Truvada could be used in combination with safer sex practices to reduce risk of sexually acquired HIV-1 among uninfected adults at high risk – a strategy known as pre-exposure prophylaxis, or PrEP.

The drug has been approved and available in this use since 2012 in the US, but has only now gained the same status in the EU.

First approved in Europe in 2005, Truvada is the most prescribed antiretroviral medicine in Europe as part of combination therapy.

Gilead has applied for a label variation based on results of two large placebo-controlled trials of Truvada.

Clinical guidelines in many countries already support use of Truvada with prevention measures such as condoms to prevent sexual transmission of HIV.

Regulatory submissions are pending in Brazil, Taiwan and Thailand. Additionally, within the EU, Truvada is currently available for PrEP in France under a Temporary Recommendation for Use by the French regulatory agency (ANSM).

Clinicians in the UK have been trying to establish the Truvada’s use in PrEP ahead of approval, backed by data from the PROUD study.

But earlier this year attempts to introduce a national scheme were blocked by England’s National Health Service, which ruled that local authorities must commission disease prevention services.

This resulted in plans being drastically scaled back to a handful of pilot sites, in a decision branded as “shameful” by HIV charities.

The CHMP’s decision will be passed on to the European Commission, which will likely rubber-stamp it in the coming weeks.

 

Don't miss your daily pharmaphorum news.
SUBSCRIBE free here.