FDA approves HIV prevention drug17th July 2012
The US drug regulator has given the green light to a new drug which can reduce the risk of acquiring HIV.
The Food and Drug Administration (FDA) approved Truvada, which is also known as emtricitabine/tenofovir disoproxil fumarate, a drug aimed at reducing the risk of HIV transmission in people who are at high risk, perhaps because they have HIV-infected sexual partners.
Truvada has already been approved for use in combination with other antiretroviral drugs in the treatment of adults and children over 12 who are already infected with HIV.
Individuals will take a daily dose of Truvada to lower their risk of becoming infected, should they be exposed to the virus.
The drug should only be given in conjunction with other prevention methods, included safer sex practices, counseling for risk reduction and regular testing for HIV, the agency said.
According to FDA Commissioner Margaret A. Hamburg, the approval marks an important milestone in the fight against HIV.
She said that around 50,000 US adults and adolescents still become infected every year with HIV in spite of prevention methods that are widely available.
She said both prevention methods and treatments were needed in the continuing battle against the HIV epidemic in America.
Boxes of Truvada will carry a warning alerting healthcare professionals that the drug should only be taken by people who do not have HIV, and who are part of a testing programme every three months.
Individuals whose HIV status is positive or unknown are not to take it, and the FDA strongly recommends against such use, because they will not be using it as part of the designated prevention and risk evaluation strategy, known as REMS.
A training and education programme is being set up to assist prescribers in counselling individuals who are taking or considering Truvada, and will provide information about the importance of sticking to the recommended dose.
According to Janet Woodcock, director of drug evaluation and research at the FDA, the programme aims to educate healthcare professionals and uninfected individuals to help ensure its safe use.
Truvada was approved after two large, randomised, double-blind, placebo-controlled clinical trials in 2,499 HIV-negative men or transgender women who have sex with men and with evidence of high risk behaviour for HIV infection, a group which included sex workers.
Truvada was shown to be effective in reducing the risk of HIV infection by 42% compared with a placebo in this population, but only if it was taken correctly.
Truvada’s manufacturer Gilead Sciences will also be required to evaluate the presence of resistance to Truvada in HIV viral samples from the people who became infected during the trials, the FDA said in a statement on its website.
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Title: FDA approves HIV prevention drug
Author: Luisetta Mudie
Article Id: 22361
Date Added: 17th Jul 2012