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US approves first drug for HIV-prevention

Posted Jul 22 2012 10:30am

The US Food and Drug Administration (FDA) has approved a drug to help prevent HIV transmission.

Truvada, made by Gilead Sciences inc, has been used in the US to help treat HIV since 2004, and it is the first drug to be licensed in the US as a preventative measure. It is aimed at those with a high risk of infection, for example, a partner with HIV who doesn’t want to take antiretroviral drugs or use condoms regularly.

In two clinical trials from 2010, the FDA reports that daily use of Truvada was found to be effective in reducing the risk of HIV infection:

  • By 42% in a study sponsored by the National Institutes of Health of 2,500 HIV-negative gay and bisexual men and transgender women.
  • By 75% in a study sponsored by the University of Washington of 4,800 heterosexual couples in which one partner was HIV positive.

The drug must be taken once-a-day on a long-term basis to help reduce the risk of HIV-1 infection, the most common type. It is a combination of two antiretroviral drugs and works by stopping infected cells replicating.

Health workers and groups in the field have expressed concern that the new use will encourage people to take more risks sexually, and that a drug-resistant form of HIV may develop. However, the FDA says it should be used as part of a comprehensive HIV-prevention plan, which includes regular testing, counselling and condom use.

Debra Birnkrant MD, director of the Division of Antiviral Products at FDA argues that we have come along way in the treatment of HIV. ‘In the 80s and early 90s, HIV was viewed as a life-threatening disease; in some parts of the world it still is. Medical advances, along with the availability of close to 30 approved individual HIV drugs, have enabled us to treat it as a chronic disease most of the time. But it is still better to prevent HIV than to treat a life-long infection of HIV’.

The FDA’s main concern is that overall rates for HIV infection haven’t changed since 2004. ‘The rates of new HIV infections have not significantly changed for a long time. From FDA’s standpoint, this is not acceptable for a serious disease,’ says Birnkrant.

Truvada is currently licensed in the UK for HIV treatment only.

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