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As the US Food and Drug Administration moves closer to approving a drug that would reduce the likelihood of contracting HIV, critics and some health campaigners have raised fears that the pre-emptive treatment might actually lead to higher infection rates.
On Thursday an influential advisory panel recommended that the FDA approve Truvada, a drug made by Gilead Sciences that is currently used as part of combination therapy to help slow the progression of HIV. The vote, which came after hours of debate among medical experts, is not binding but the agency usually follows its recommendations.
Truvada is an antiretroviral treatment that is already prescribed by doctors on an “off-label” basis, meaning that is has not yet received FDA approval for that use.
Many opponents of the drug are concerned that it will become a “party drug” that would encourage people who are at risk of contracting HIV to act recklessly. Others worry about dangerous side-effects associated with healthy people taking Truvada and that the virus could mutate, reducing the effectiveness of the treatment.
“I fear that men will take the drug inconsistently, have a false sense of security and increase risky behaviour,” said Joey Terrill, who works in public affairs at the Aids Healthcare Foundation.
Gilead filed last year with the FDA for a new authorised “indication” for “pre-exposure prophylaxis” use of Truvada, which is a core part of HIV treatment around the world. Sales of the drug generate about $3bn a year.
Clinical trials showed that Truvada reduced the risk of contracting HIV in men who have sex with men by 44 per cent, and by 73 per cent among heterosexual couples where one partner was already infected.
Elizabeth Nash, an Aids campaigner, told the FDA panel she thought that 44 per cent was low for an intervention that was intended to be preventive. “It’s hard to think of other preventive measures such as birth control or vaccines where 44 per cent relative efficacy is deemed effective,” she said.
Critics also argue the use of Truvada could lead to drug resistance undermining its value for patients as a result of intermittent use of the medicine, that the studies have not determined the long-term effects of taking the drug and that reliance on Truvada could reduce condom use.
In the developing world, there are fears that patients could be forced to sell or share their medicines with those uninfected but at risk, creating tensions and leaving them without effective treatment.
Gilead has said it is willing to fund substantial HIV prevention programmes to support the use of its medicine to limit new infections around the world.
The company will underwrite testing, condom distribution and lower-cost supplies of the medicine if US regulators extend the use of Truvada.
Howard Jaffe, chairman of the Gilead Foundation, the company’s charitable arm, said the company sought to reach marginalised groups of people at risk of HIV, many of whom are uninsured and unable to access free healthcare in the US or other countries.
The action would mark a highly unusual extension for a pharmaceutical company into supporting public health infrastructure related to a disease, as well as a funding of approaches that potentially reduce the price and total demand for its drug.
“Cost is not going to be an issue,” he said. “We would be very happy to spend a lot of money on testing if it meant there was less HIV. We’re coming at this as citizens of the world, not necessarily as an 800lb gorilla looking to increase our revenues on the backs of people who are HIV positive.”
The US Centers for Disease Control and Prevention estimates that 1.2m people in the US are living with HIV and that there are about 50,000 new cases a year. Gilead projects that the target group of healthy people that would be eligible to take Truvada, which would cost about $14,000 a year, is in the tens of thousands.