EU regulators have approved Gilead Science’s Truvada for pre-exposure prophylaxis (PrEP), making it the first drug licensed in Europe to reduce the risk of HIV transmission through sexual intercourse.
The EU approval of Truvada (emtricitabine and tenofovir disoproxil) for PrEP comes four years after the drug got a green light from the US FDA for reducing sexual transmission of HIV to uninfected adults.
The EMA’s decision means that Truvada may help slow down a recent uptick in new HIV diagnoses, which hit a new peak of 30,000 in 2014. According to HIV specialist Professor Jean-Michel Molina of the Hôpital Saint Louis in Paris, almost all (94%) of new infections are 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,” he said.
Truvada was first approved by the EMA in 2005 and is currently the most prescribed antiretroviral medicine in Europe as part of HIV combination therapy, with sales approaching $3.5bn worldwide last year.
After a slow start in the US, Truvada’s use for PrEP has risen dramatically over the past two years, with Gilead reporting that prescribing rates tripled between 2014 and 2015, and have continued to rise this year.
Gilead’s chief operating officer Kevin Young said recently that an estimated 60,000 to 70,000 people in the US were using Truvada for PrEP in the second quarter, accounting for approximately one-third of Truvada demand.
“This is encouraging, as we know Truvada has an important role to play as part of comprehensive HIV prevention for many at-risk individuals,” he noted. The drug is also approved for PrEP in Australia, Canada, Kenya, Peru and South Africa.
Gilead is in the process of rolling out a replacement product for Truvada that swaps tenofovir disoproxil for tenofovir alafenamide (TAF), a different form of the compound that is more potent and so can be given at a lower dose, reducing the risk of side effects affecting the bones and kidneys.
The new emtricitabine/TAF-based product – called Descovy – was approved in the US and EU earlier this year. Gilead has said it is data from animals suggesting that Descovy has equivalent activity to Truvada as PrEP, but has not yet decided what clinical evidence would be required to support approval.
As there are some differences between Truvada and Descovy in terms of metabolism and the distribution of the active drug around the body, Descovy should not be prescribed off-label for PrEP, according to HIV advocacy organisation AVAC.
Meanwhile, Gilead’s arch-rival in the HIV treatment market, ViiVHealthcare, recently reported the first data from trials of its integrase inhibitor cabotegravir for PrEP. The drug could provide the option of a monthly or bi-monthly injectable PrEP regimen rather than taking daily tablets.