US FDA approves first drug shown to reduce risk of HIV infection
A daily pill to protect people at risk of HIV from infection has been approved by the US Food and Drug Administration (FDA), potentially offering a new and powerful weapon in the battle against Aids.
The pill, Truvada, will be available in the US to people at extreme risk of HIV because their partners are infected. But at $14,000 (£9,000) a year, it will be expensive - even though far cheaper than a lifetime of treatment after infection - and those without health insurance are unlikely to get it, the Guardian reports.
However, in the long term, advocates hope it can be offered in Africa and other parts of the developing world.
Truvada is already used for Aids treatment, and Gilead Sciences, the manufacturer, discounts the drug in the developing world, bringing the price as low as $100 a year.
But the FDA announcement of approval ran into an immediate storm within the US as the largest Aids support organisation there accused it of recklessness.
The Aids Healthcare Foundation (AHF) said evidence published recently showed the drug could possibly cause kidney damage.
It also argued Truvada should not be given without an HIV test to ensure the person taking the pills is not already infected - otherwise the virus could become resistant to the drug.
Michael Weinstein, AHF president, called the FDA decision "completely reckless and a move that will ultimately set back years of HIV prevention efforts".
He added: "From the beginning, we believe there was a rush to judgment by government officials and others in favour of such approval despite decidedly mixed studies offered in support.
"The FDA's move today is negligence bordering the equivalence of malpractice which will sadly result in new infections, drug resistance and serious side effects among many, many people."
Trials of the drug were run both in the US and in Africa. The University of Washington's international clinical research centre recruited more than 4,700 discordant couples - in which one partner had HIV but the other did not - in Kenya and Uganda starting in 2008. The Partners PrEP (pre-exposure prophylaxis) study, as it was called, was one of the largest-ever HIV prevention trials.
The study, recently published in the New England Journal of Medicine, found a 75% protection rate in the couples where the uninfected partner took Truvada.
"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 Dr Connie Celum, associate professor of global health and medicine at the university, who led the African trials.
The results were higher than the 42% protection rate found over three years in the US studies, which recruited gay and bisexual men at risk of HIV because of their partners.
In the US and in Africa, participants were given counselling and encouraged to use condoms to protect themselves whether they were given Truvada or not.
The US has 1.2 million people who are HIV-positive and infections are increasing.
"Today's approval marks an important milestone in our fight against HIV," said FDA commissioner Dr Margaret Hamburg in a statement.
"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."
The approval comes within days of the start of the International Aids Conference, a massive event involving scientists and campaigners which takes place every two years and is being held in Washington DC for the first time since 1990, after Barack Obama lifted a ban on people with HIV entering the US.
General side effects of Truvada include diarrhoea, pain and weight loss, but the FDA considered that they were outweighed by the benefit to people who were at high risk of HIV infection.
The FDA wants further data, however, on the effects on women who become pregnant and also on the development of resistance.
It will be important for the drug to be taken consistently - one dose a day - and not sporadically, as this would enable the virus to mutate into a form that is unaffected by the drug.
Truvada is a combination of two antiretroviral drugs used in HIV treatment - emtricitabine and tenofovir.
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