The leading American authority on drug use has green lighted the first ever antiretroviral drug approved to reduce the risk of HIV infection in uninfected people.
The US Food and Drug Administration (FDA) has formally approved Truvada (emtricitabine/tenofovir disoproxil fumarate) for uninfected individuals who are at high risk of HIV infection and who may engage in sexual activity with HIV-infected partners.
British charities have welcomed the news, but currently there are no plans from the Department of Health to ask the National Institute for Health and Clinical Excellence (NICE) to look into the drug and whether it should be made available on the NHS.
The FDA previously approved Truvada to be used in combination with other antiretroviral agents for the treatment of HIV-infected adults and children 12 years or older.
However, now HIV uninfected individuals who are at high risk will take Truvada daily to lower their chances of becoming infected with HIV should they be exposed to the virus.
The FDA stressed that it was approving use of Truvada as part of a comprehensive HIV prevention strategy that included other prevention methods, such as safe sex practices, risk reduction counseling, and regular HIV testing.
Clinicians will be warned that Truvada being used as a pre-exposure prophylaxis should only be used by individuals who are confirmed to be HIV-negative prior to prescribing the drug and at least every three months during use.
The FDA said the drug’s safety and efficacy were demonstrated in two large clinical trials.
In the trials, daily use of Truvada was shown to significantly reduce the risk of HIV infection by 42% in a study sponsored by the National Institutes of Health of 2,499 HIV-negative gay and bisexual men and transgender women, and by 75% in a study sponsored by the University of Washington of 4,758 heterosexual couples in which one partner was HIV positive and the other was not.
FDA commissioner Dr Margaret Hamburg said: “Today’s approval marks an important milestone in our fight against HIV.
“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. New treatments as well as prevention methods are needed to fight the HIV epidemic in this country."
UNAIDS, the Joint United Nations Programme on HIV/AIDS welcomed the move.
A spokesman said: “No single intervention is completely protective in preventing HIV transmission, which is why UNAIDS advocates strongly for combination prevention, including condom use for individuals at high risk of HIV infection.”
Sir Nick Partridge, chief executive of the Terrence Higgins Trust, said: “We have to take every new opportunity to improve the effectiveness of HIV prevention and slow the spread of this epidemic.
“Adding Truvada to our existing range of prevention programmes, including safer sex campaigns, using condoms and regular testing for HIV is an exciting prospect. But we need to know if people at highest risk of infection are prepared to take a pill every day and whether there would be an increase in risk-taking behaviour, which could outweigh the prevention effectiveness of Truvada.”
A spokeswoman for NICE said Truvada was not a drug/treatment that the institute had been asked to look into by the Department of Health at the present time.