The drug Truvada has been given its approval by the Food and Drug Administration today to be used as an option for reducing the risk of contracting HIV.

This is the first drug approved by the U.S. government to do so.

Truvada, made by Gilead Sciences, has been used by HIV patients on a daily basis with other drugs for years as part of regimen to keep the virus at bay. In studies, Truvada also proved that when taken in combination with the use of condoms the risk of HIV infection is greatly decreased

• A study sponsored by the National Institutes of Health of HIV-negative gay and bisexual men and transgender women showed a 42 percent less chance of contracting the virus.

• A study by the University of Washington among 4,800 heterosexual couples in which one partner was HIV positive, the chances of contracting HIV dropped 75 percent.

The drug is for high-risk people, such as gay men. The catch? The drug costs approximately $14,000 a year — or about $1,200 a month. How many people can afford this? And are they willing to pay it?

Also, for sex workers — also at high risk of contracting HIV — the cost is simply too much.

There are also arguments that if the drug is made available, gay and bisexual men will begin to indulge in riskier behavior because they may believe that now they have this pill a their disposal, condoms and other safer sex practices are no longer necessary. Bad side effects and drug resistency may result in healthy people taking Truvada, they argue, and lead to more infections.

Others in support of Truvada be made available for HIV prevention counter that gay and bisexual men have show in studies they will continue to know the risks and practice safer sex but simply have another tool in trying to stave the epidemic.

Kevin Fenton, director of the Centers for Disease Control & Prevention's National Center for HIV/AIDS, Viral Hepatitis, STD & TB Prevention, issued a statement this evening:

With 50,000 new HIV infections in the United States each year, additional prevention methods are urgently needed.  The Centers for Disease Control and Prevention applauds the U.S. Food and Drug Administration’s decision to approve the use of Truvada (a combination of 300 milligrams of tenofovir and 200 milligrams of emtricitabine) to reduce the risk of acquiring HIV.  We believe this is an important step that should help ensure that physicians and patients receive the detailed information and educational materials needed to most effectively use this prevention strategy.
 
If delivered effectively and targeted to those at highest risk, pre-exposure prophylaxis (PrEP) could play an important role in our response to the HIV epidemic.  Strong research evidence indicates that PrEP, when used consistently, is safe and effective at reducing the risk of acquiring HIV sexually.  Last year, the Centers for Disease Control and Prevention provided interim guidance for gay and bisexual men who may be considering the use of PrEP, and soon will publish similar guidance for heterosexual men and women.  Key considerations for the use of PrEP include:
 
·         PrEP will not be right for everyone, but for some individuals at high risk for HIV infection, it may provide an important additional prevention tool.
 
·         PrEP must be used consistently to be effective, as the level of protection has been shown to be closely related to levels of medication adherence.
 
·         PrEP should not be thought of a stand-alone solution. It should be provided as part of a comprehensive package of prevention services, including counseling regarding risk reduction and the importance of adherence to daily doses of PrEP medication, ready access to condoms, and diagnosis and treatment of sexually transmitted infections.
 
·         Individuals using PrEP must receive initial and regular HIV testing to confirm they do not have HIV infection, and be monitored for potential side effects.
 
CDC is also leading the development of more detailed U.S. Public Health Service guidelines on the use of PrEP as part of comprehensive HIV prevention programs, which we anticipate will be published later this year.

What are your thoughts?