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Back to Section One | Back to Arts & Entertainment
posted Friday, December 23, 2011 - Volume 39 Issue 51
FDA asked to approve PrEP HIV therapy
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FDA asked to approve PrEP HIV therapy

by Mike Andrew - SGN Staff Writer

Biopharmaceutical giant Gilead Sciences has asked the FDA to approve the antiretroviral drug Truvada as a PrEP HIV prevention therapy.

PrEP, or pre-exposure prophylaxis, is a way to reduce risk of HIV infection among uninfected people with antiretroviral drugs that would otherwise be prescribed for HIV-positive patients.

If approved, Truvada would be the first antiretroviral agent licensed for HIV prevention in uninfected people.

Gilead's application is based partly on data from the Global iPrEx study of men who have sex with men (MSM), the first human efficacy study to prove that PrEP reduces HIV infection risk in HIV-negative people.

iPrEx study results were first reported in the New England Journal of Medicine in November, 2010.

The PrEP drug in question is a single-tablet once-daily combination of emtricitabine (FTC 200 mg) and tenofovir (TDF 300 mg), marketed under the brand name Truvada.

The iPrEx study found that MSM who were prescribed a single daily Truvada tablet experienced an average of 44% fewer HIV infections than those who received a placebo pill.

Among a study sub-set of participants who used the tablet regularly as prescribed, the rate of HIV infection was reduced by more than 90%.

All participants in the iPrEx study received condoms and comprehensive HIV prevention support. The HIV prevention benefits of PrEP were in addition to the benefits obtained from other prevention methods.

'With 2.6 million new HIV infections occurring each year, and fewer than half of people with HIV receiving treatment, the world needs new and effective HIV prevention strategies,' said iPrEx protocol chair Robert Grant, M.D., M.P.H., of the Gladstone Institutes and the University of California at San Francisco.

'Men who have sex with men have borne an enormous burden in this epidemic, and have also been consistently at the head of efforts to help reverse it. The 2,499 men and Transgender women who participated in the iPrEx study in Brazil, Ecuador, Peru, South Africa, Thailand, and the United States have made an historic contribution to the effort to help end this epidemic.'

The iPrEx study was sponsored by the U.S. National Institutes of Health (NIH) and by the Bill & Melinda Gates Foundation.

Two other trials, Partners PrEP and TDF2, involved almost 6000 couples in which one partner was HIV-positive and one HIV-negative.

In Partners PrEP, taking Truvada lowered the risk of HIV infection in the negative partner by 73%, while tenofovir alone cut the risk by 62%. In TDF2, daily Truvada lowered the risk of HIV acquisition by 63%.

Both the iPrEx and Partners PrEP studies found that PrEP is safe, with very low levels of side effects and limited risk of HIV drug resistance.

FEM-PrEP, a fourth trial of Truvada in HIV-negative African women, was stopped by researchers in April 2011 when an independent review panel established that Truvada would not protect these women from HIV.

According to the International AIDS Society, it has not yet been established why the FEM-PrEP results were not consistent with those of the other three studies.

'The data are clearly strong enough to warrant FDA approval of Truvada for HIV prevention,' said Dana Van Gorder, executive director of the AIDS advocacy group Project Inform.

'The decision about whether to approve Truvada for prevention should be made with compassion, based on science rather than ideology, and without judgment regarding the behaviors of people at risk for HIV. We firmly believe in the right of people at risk of becoming infected with HIV to choose PrEP, which has been shown to be effective when used with condoms, as an additional method of HIV prevention.'

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