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In spite of heavy criticism, FDA has approved the use of Truvada for preventing HIV/AIDS in uninfected, high-risk individuals. Truvada is currently used in combination with other drugs to treat HIV-infected individuals.

AIDS or acquired immune deficiency syndrome is the advanced stage of infection with HIV (human immunodeficiency virus), which is usually contracted by engaging in unprotected sex or by needle sharing.

In 2004, a drug called Truvada was approved by the US Food and Drug Administration (FDA) to treat people who have already been infected with HIV. Recently, however, the drug also earned FDA approval for use to prevent HIV transmission and AIDS in healthy or uninfected individuals

This move was met with criticisms from many health experts who believe that this may compromise the effectiveness of other methods of AIDS prevention, particularly the practice of safe sex.

HIV/AIDS, Still a Global Issue

HIV infection and AIDS continue to be a growing health issue all over the world.

The US Centers for Disease Prevention and Control (CDC) estimates that there are about 50,000 people who are newly infected with the virus annually.

Most of these individuals are gay or bisexual males, with blacks or African/Americans being affected eight times more than white individuals.

In 2011, about 2.5M new cases of HIV infection were reported worldwide, with 34M people already living with the disease. About 30M people have died of AIDS since the worldwide epidemic began in the 1980s. More than one million Americans have been diagnosed with AIDS and more than half a million have died of the disease since then. The biggest burden of the disease affects the Africans, but people from Asian, Eastern European and Latin American countries are also significantly affected.

Not all people who have been infected with HIV have AIDS and it may take several years for HIV-infected individuals to develop AIDS. Although there is still no cure for HIV infection and AIDS, drug treatment can help people maintain a healthy life.

Furthermore, a new drug called Truvada, which has been used to treat HIV patients, is now being prescribed to highly susceptible but healthy individuals to prevent HIV transmission as well as AIDS.

What is Truvada?

Truvada is the trade name of a prescription drug that combines two anti-HIV medicines (emtricitabine and tenofovir disoproxil fumarate) in one tablet.

It is not a new drug; it has been used since it was approved by the FDA in 2004, to treat people infected with HIV. Emtricitabine (trade name, Emtriva) is a nucleoside reverse transcriptase inhibitor while tenofovir disoproxil fumarate (trade name, Viread) is a nucleotide reverse transcriptase inhibitor. These nucleoside analogue reverse transcriptase inhibitors are also called NRTIs, and are very similar, except that the latter is chemically preactivated, making it more easy for the body to use. 

These drugs work by helping to prevent the virus from multiplying in the cells of the body and by decreasing the number of virus in the body.

Truvada is used in combination with other HIV medications to control the infection. However, it does not cure HIV or AIDS. By reducing the virus load in the body, Truvada helps the immune system to work better, thus reducing one’s risk of acquiring new infections (opportunistic infection) or cancer.
 

Can Truvada Prevent HIV/AIDS?

Last year, FDA approved the use of Truvada to prevent HIV transmission in people who are healthy but at high risk for the disease.

These include uninfected men who engage in sex with other men, uninfected partners of people who test positive for HIV, and others who may be at risk for infection through sexual intercourse.

Factors that increase one’s risk for HIV infection include practicing unprotected sex, having sex with more than one partner, having a sexually transmitted disease or STD, drug abuse, and alcoholism.

Other factors such as unknown HIV status, prostitution, and incarceration may also increase one’s risk for acquiring the virus.

The decision to approve Truvada for use as a preventive drug for HIV/AIDS came after a few studies published in the New England Journal of Medicine in 2012, showed its effectiveness in preventing HIV transmission.  Three clinical trials were conducted in different places in Africa, where heterosexual transmission of the virus is common. Each trial compared the ability of Truvada to reduce the rate of HIV transmission versus that of a placebo.  Participants were counseled about safe sexual practices and HIV risk reduction.

One study conducted in Uganda and Kenya involved almost 5,000 married couples where one spouse was HIV-positive.

Researchers found that virus transmission was reduced up to 75% among those who received the drug early in the study, so that couples who were initially given placebo were given the drug instead, thus ending the study.

Another study conducted in Botswana involved healthy, unmarried men and women. Those who took the drug were more than 60% less likely to acquire the disease than those who received placebo. The last study conducted in South Africa, Kenya, and Tanzania involved healthy women who were either married or unmarried. Although the drug did not seem to reduce HIV transmission among those who used it, it was found that compliance for drug intake was low after blood tests showed that only a few women actually took the drug. The trial was discontinued.

FDA warns that Truvada does not always prevent infection with HIV. It must be used in combination with safe sexual practices (i.e., use of condoms). In addition to this, one must avoid sharing needles, razors, or toothbrushes to reduce the risk of HIV infection.

What the Critics Say

One of the biggest critics of the move to approve Truvada as a prophylactic drug for HIV/AIDS is the AIDS Healthcare Foundation, which believes that this quick-fix solution may detract people from using proven methods of disease prevention, which includes safe sex practices, particularly condom use. Critics also point out that the pill has many dangerous side effects, such as bone loss, liver damage and lactic acidosis. The pills are also very expensive, and one will spend about $ 1,100 monthly for a once-daily dose of the drug, according to Gilead Sciences, its manufacturer. 

The company recommends that when prescribing Truvada as part of a comprehensive strategy to prevent HIV, healthcare providers must counsel uninfected people to adhere to dosing instructions and to undergo screening for HIV infection regularly.

Sources & Links

  • Morin, M. Truvada pill urged for AIDS prevention after promising studies. Los Angeles Times. http://www.latimes.com/health/la-sci-hiv-prevention-20120712,0,3763131.story#axzz2j6VqQnoB
  • WebMD. HIV and AIDS. http://www.webmd.com/hiv-aids/guide/sexual-health-aids
  • CDC. Statistics Overview. http://www.cdc.gov/hiv/statistics/basics/index.html
  • Doheny, K. FDA Panel OKs Truvada as First HIV-Preventive Drug. WebMD.http://www.webmd.com/hiv-aids/news/20120510/fda-panel-oks-truvada-first-hiv-preventive-drug
  • AIDSinfo.Emtricitabine / Tenofovir Disoproxil Fumarate. http://aidsinfo.nih.gov/drugs/406/emtricitabine---tenofovir-disoproxil-fumarate/0/patient
  • Photo courtesy of Fersolieslava by Wikimedia Commons : commons.wikimedia.org/wiki/File:Truvada_pill_flask.jpg
  • Photo courtesy of Wheeler Cowperthwaite by Flickr : www.flickr.com/photos/wcowperthwaite/5774582962/

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