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In the Media

article imageFDA panel backs first breakthrough drug in HIV prevention

In a move that could lead to a new milestone in the worldwide AIDS epidemic, an advisory panel to the Food and Drug Administration has for the first time backed a drug to prevent HIV infection in healthy people.
"Today is an exciting day for HIV prevention," Dr. Kenneth Mayer of the nonprofit Fenway Institute said after the committee voted, according to Reuters.
"Although (Truvada) is not a panacea, this approach can prevent many new infections and could dramatically impact HIV transmission worldwide," he said.
According to the New York Times, on Thursday, after evaluating studies of the once-a-day pill and hearing scientific presentations, the panel recommended that Truvada be prescribed for people at high risk of infection, like gay men who have multiple sex partners, especially those who do not always use condoms, and people in relationships with someone who is H.I.V.-positive.
Young black men who have sex with other men are at highest risk.
Matthew Rose, a membership coordinator for the National Lesbian & Gay Journalists Association, who described himself to the panel as “a young, H.I.V.-negative black man” gave the advisory panel a glimpse into those at highest risk, the Times reported.
Growing up gay in Washington, D.C., he said, young men have their sexual debut at 16 and are H.I.V.-positive by 25. Facing that reality, many want another layer of protection, Rose said.
He said he and many of his friends were excited about the prospect of a preventive drug:
“I ask you to give my community another option,” he told the panel. “We’re not saying it will end the epidemic. But give people options and choices that will work for them, things science tells us will give us a chance.”
And what does science say? Tests show that new drug Truvada, if taken daily, can reduce the chance of contracting the virus by 44 per cent.
Studies from 2010 showed that Truvada, which contains two antiviral drugs and sold by Gilead Sciences, based in Foster City, Calif. , reduced the risk of HIV in healthy gay men - and among HIV-negative heterosexual partners of people who are HIV positive - by between 44% and 73%, the BBC reported.
Though it is used alone for prevention, it must be taken along with other antivirals to treat H.I.V.
First approved in 2004, it quickly became one of the best-selling H.I.V. drugs.
Reuters reports that nearly 1.2 million Americans are infected with HIV. But clinical research, which shows Truvada to be effective at preventing the spread of HIV among people who take the pill daily, has raised hopes that the United States could stem the growth of a national HIV epidemic that has stubbornly generated 50,000 new infection cases a year for the past two decades.
But not everyone is excited. Take Dr. Lauren Wood of the National Cancer Institute for instance. Wood said she voted against all preventive applications because clinical studies did not measure the dangers of drug-related renal problems among black people, who are among the hardest impacted by HIV infection and the most susceptible to kidney problems linked to AIDS drugs.
"I don't think that is adequate when you're talking about the population that is most at risk," she told Reuters.
Others cringe at Truvada's $14,000 a year price tag. They think people may now treat it like a "a party drug" for weekend use, raising the danger of increasing HIV drug resistance and making the treatment harder to obtain for people who are infected with HIV.
Still, many say the widespread benefits outweigh the harm.
"This brings us closer to a watershed for global HIV prevention efforts," said Mitchell Warren, executive director of the Aids Vaccine Advocacy Coalition, after the vote, according to the BBC.
The FDA is expected to make its decision by 15 June.
article:324628:22::0
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