Friday, May 11, 2012

Truvada: A first HIV Prevention pill in queue for FDA approval

Truvada, a pill already approved to treat the HIV infected people since 2004, is expected to move one step further to get the approval for becoming the first official HIV Prevention pill to thwart healthy people from being infected with AIDS causing virus. An advisory panel of experts recently suggested the Food and Drug Administration (FDA) agency that the daily pill Truvada should be made official for preventing the deadly disease in healthy people who are at high risk of HIV contagion. It is the very first time that government advisory committee have suggested to give antiviral medicine to healthy people who are at a risk of exposure to HIV virus through the sexual activity.

Truvada: A first HIV Prevention pill in queue for FDA approval

The Antiviral Drugs Advisory Committee of FDA suggested the approval of pre-exposure prophylaxis (PrEP) drug for the healthy people of three groups: 1) men who have sex with men (gay), 2) heterosexual couples with one HIV-positive partner, and 3) bisexual men. The risk-benefit analysis favored approval of the drug for the people of first group with the strongest yes vote of 19-3 from the Advisory Committee. The Committee voted 19-2 with 1 abstention for the second group and 12-8 with 2 abstentions for the third group, favoring approval for both the groups. The FDA is not required to pursue the suggestions of the advisory committees made up of experts from outside the agency, but it pursues usually.
An ultimate decision for the approval by FDA is anticipated by June 15. If the FDA will give the approval for once-a-day HIV prevention pill, it would be the turning point for the thirty-year combat against a contagion which causes 2.7 million new HIV diseases globally every year, as stated by the United Nations Program on HIV/AIDS.

FDA has already approved this drug in 2004 for the treatment of HIV infections. Therefore, the physicians can prescribe Truvada "off label" for HIV prevention. It has been already utilized ''off-label" as a precautionary drug by high-risk people like man who has sex with man. But, if the FDA will give approval of Truvada as a preventive drug, then the manufacturer company of the drug - Gilead Sciences - would be able to trade the drug for prevention freely.

Prevention & risk reduction
A three-year study presented to the Antiviral Drugs Advisory Committee of FDA reveals that Truvada cuts the risk of acquiring HIV by 42% in healthy bisexual men and gay, when accompanied with counseling and condoms. One other study shows that Truvada cuts the risk of infection by 75% among heterosexual couples, where one partner was HIV-positive and the other was not. These rates of prevention would have been superior if all the participants take the drug every day as directed, the representatives of Gilead told the committee.

Blood tests of the participants showed that majority of them didn’t take the pills on a regular basis, in spite of their involvement in studies which included regular visits with health-care providers. The prevention rates were beyond 90% in the participants, who took the drug regularly.

Truvada is not destined to substitute condoms and other sex-safety measures, but to be utilized with them for further protection.

Why better prevention is required?

Roughly 50,000 new HIV infections occur in the United States every year, that’s why the better methods of prevention are required. Several speakers put emphasis on the fact that the cases of AIDS occurrence has not budged in 15-20 years. That clearly means, the condoms and counseling are not doing much good. Moreover, the sexual partners of many of the newly infected people do not realize that they are HIV-positive.

According to the Centers for Disease Control and Prevention (CDC), men who have sex with men keep on embracing most new infections and the ratio of new infections occurrence in this group raised from 55 % to 61 % from 2007 to 2010. The risk of HIV virus contagion is higher in young black men who have sex with men. According to the CDC, Hispanics and Blacks have a higher risk of deadly disease than whites.
Some members of the advisory committee worried about the risk that people who got HIV contagion while taking Truvada might develop hazardous drug-resistant strains of the virus. However, the committee decided that the advantages of infection prevention prevailed over the risks. There is no word whether the drug will be effective in preventing the HIV infection spread by needle sharing or not. Some committee member alleged that there is not an enough data to provide evidence for the safety and affectivity of drug in African Americans or women.

The approval of FDA would aid to ensure that pills are being utilized more safely and effectively, according to the recommenders of Truvada as a preventive drug. The pills would have to be marked with specific instructions such as which lab tests are necessary for patients for safety reasons. For example, the test for the HIV infection must be done before starting the drug, the reason is that drug-resistant strains of the virus may rapidly develop if the Truvada is taken alone by an HIV-infected patient. Some patients may also require for testifying their kidney function. Truvada even can lead to slight decline in bone density, which may need monitoring.

The approval of FDA may make it more probable that precautionary use of the drug would be covered by insurance that costs around $14,000 a year.

About Truvada

Truvada is composed of two antiviral drugs: Emtriva and Viread. This drug is being used alone for pre-exposure prophylaxis, but it must be used along with other antivirals for the treatment of HIV. It works by aiding to block a chemical in the body, which requires for the multiplication of HIV.
After the approval of Truvada in 2004, it swiftly became one of the top-vending HIV drugs. The expenditure of the drug is around $1,100 per month.
The senior vice president of company at the Foster City, Calif., Andrew Cheng said that the drug should be included to the "existing toolbox" of prevention techniques, including education about clean-needle programs, condom use and safe sex.


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