HIV Pill Truvada Is A Step Closer To FDA Approval Favor For Prevention

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By Laura Matthews | May 11, 2012 1:04 AM EST

Truvada, a pill used to treat HIV, is a step closer to getting the approval of the United States Food and Drug Administration as a drug used to prevent the spread of the virus that causes AIDS.

"The individual at risk may be spared infection with a serious and life-threatening illness that requires lifelong treatment," Reuters quoted the FDA report as saying.

If the FDA gives the green light to Gilead Sciences' Truvada, it will be the first drug approved for HIV prevention. The agency said it appears to be safe and effective for HIV prevention.

US News reported that an advisory panel to the FDA supports Truvada as a way to help prevent the spread of HIV in high-risk individuals such as highly sexually active gay or bisexual men, or the partners of those already infected with HIV.

The advisory panel will be meeting Thursday to decide whether or not to recommend Truvada as a preventive measure for at-risk people. Though the FDA is not required to follow the panel's advice, it usually does so, the Associated Press reported.

More Than 1 Million Americans Infected With HIV

The U.S. Centers for Disease Control and Prevention estimates that 1.2 million Americans are living with HIV. Moreover, one in five are unaware of their infection. Approximately 50,000 Americans are infected with HIV each year.

The HIV virus attacks the human immune system and if left untreated, develops into the fatal disease known as AIDS.

Truvada, which may be the greatest breakthrough in the last 30 years of HIV / AIDS research, is a combination of two HIV-fighting drugs, tenofovir (Viread) and emtricitabine (Emtriva). It does have potential disadvantages: it is expensive and may cause side effects, according to US News.

Some patient advocacy groups say the pill is another option along with condoms and other prevention measures.

"If we're going to reduce the more than 50,000 new HIV infections in this country each year, we need to increase the available options for people," said Ronald Johnson, AIDS United's vice president, as reported by the AP.

Bloomberg reported that the study cited by the FDA said that Truvada reduced the risk of HIV as much as 94 percent for people who regularly took the pill.

Michael Weinstein, president of the Los Angeles-based AIDS Healthcare Foundation, told Bloomberg that it is difficult to get their HIV positive patients to adhere to a pill regimen. He worries that widespread use of the drug could lead to less condom use.

AIDS Healthcare Foundation provides medical care for 130,000 people worldwide. "Counting on adherence is not going to work," said Weinstein.

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