There will no doubt be big celebrations at Gilead after it got the final seal of approval to market its Truvada for the prevention of HIV in the US, making it the first pill OK'd to protect against infection with the disease.
Despite some opposition to the move, the US Food and Drug Administration has given the green light for Truvada (emtricitabine and tenofovir) to reduce the risk of HIV infection in high-risk, uninfected individuals who may engage in sexual activity with infected partners.
The move came as no real surprise, however, as the agency's advisory committee had voted in favour of approving the drug back in May, based on data from several clinical studies showing it to be safe and effective for HIV pre-exposure prophylaxis (PrEP), with one trial showing 43% fewer infections in patients given Truvada compared with the placebo group.
As part of the approval, Gilead has developed a Risk Evaluation and Mitigation Strategy (REMS) with the FDA to help ensure safe use of Truvada for PrEP as part of a comprehensive prevention strategy for the disease.
And to further support the safe use of Truvada for PrEP, Gilead said it will also provide vouchers for free HIV testing and condoms, an opt-in service for regular reminders about HIV testing, and subsidised HIV resistance testing for any individual who becomes HIV-positive while taking its drug.
"Today’s approval marks an important milestone in our fight against HIV," commented FDA Commissioner Margaret Hamburg. "Every year, about 50,000 US adults and adolescents are diagnosed with HIV infection, despite the availability of prevention methods and strategies to educate, test, and care for people living with the disease."
“It is exciting to consider the potential impact of this new HIV prevention tool, which could contribute to significantly reducing new HIV infections as part of a combination HIV prevention strategy," said Connie Celum, Professor of Global Health and Medicine at the University of Washington.
However, opinion over the use of Truvada - which has been on the markets as a treatment for HIV since 2004 - for disease prevention is somewhat divided.
The AIDS Healthcare Foundation argues that its availability for PrEP would actually increase HIV infections, and notes that recent research has linked one of the components of Truvada - tenofovir - to a significant risk of kidney disease and damage, whereas simply using a condom is 95% effective and carries no such risk.
“Widespread use of PrEP has all the makings of a public health disaster – increased HIV infections, drug resistant strains of HIV, and tens of thousands of damaged kidneys," Michael Weinstein, AHF’s president, said earlier this year.
GlobalData also previously said it anticipates FDA approval could "significantly increase" sales of the Truvada, which are about $2.88 million a year, given that the Centre for Disease Control estimates that 415,000 in the US alone are at high risk for contracting HIV.