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Fact Sheet

Pre-Exposure Prophylaxis (PrEP) for HIV Prevention: Promoting Safe and Effective Use in the United States

February 2011

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Developing Formal U.S. Public Health Service Guidelines on PrEP Use

CDC is the lead federal agency in developing U.S. Public Health Service guidelines, in collaboration with other federal health agencies. The guidelines will be based on a full review of trial data and other research, and will incorporate input from providers, HIV prevention partners, and affected communities. The guidelines will help ensure both physicians and MSM have accurate information to guide decisions about the use of PrEP.

Topics to be addressed in the guidelines will include:

  • Guidance on how to assess which populations of MSM may benefit most from PrEP
  • Procedures for health care providers to assess whether PrEP is appropriate for individual patients (e.g., methods for evaluating patients' risk behavior)
  • Recommended support services to help ensure adherence to the daily PrEP regimen
  • Recommended risk reduction counseling to prevent inadvertent increases in risk behavior (known as "risk compensation" or "disinhibition"), as well as to provide referrals to -- and/or transition individuals to -- other, more effective prevention interventions
  • Procedures for initial HIV testing and health screening, as well as ongoing monitoring for side effects, clinical toxicities, HIV infection, and possible drug resistance among those who become infected despite taking PrEP

Maximizing the Potential Benefits of PrEP in the U.S.

The iPrEx trial findings offer a new tool to help combat HIV among MSM, one of the hardest hit populations in the U.S. and many areas of the world.

We will have to carefully consider how to most effectively use this tool in combination with other prevention strategies to reduce the continuing toll of HIV and AIDS. There are a significant number of HIV-positive individuals in the U.S. and around the world who do not have access to antiretroviral drugs to treat their infection, and we know that treatment not only benefits infected individuals, but can also reduce transmission of HIV to others. But, we also know that treatment alone will not end the epidemic. With 2.7 million people becoming infected annually worldwide, including approximately 56,000 in the U.S., we must capitalize on every available prevention tool.

Ultimately, the impact of PrEP on the U.S. HIV epidemic will depend on difficult decisions and many things that remain unknown, including the feasibility, cost, and impact of this strategy in real-world settings.

Available data suggest that PrEP, used strategically and effectively among MSM, could have a positive impact on the U.S. epidemic and be cost-effective, but only if certain conditions are met, including:

  • Reaching the MSM at highest risk for HIV infection
  • Effectively delivering PrEP in tandem with effective risk reduction counseling, condoms, and other prevention tools as were delivered in the trial setting. This will be critical to prevent increases in risk behavior that could offset the benefits of PrEP
  • Identifying ways to achieve the high levels of adherence needed for maximum protection

CDC's Next Steps

CDC will be implementing a range of activities to promote the effective and strategic use of PrEP in the U.S. In addition to developing public health guidelines, CDC will:

  • Develop updated risk reduction messages for MSM that address PrEP and other proven HIV prevention strategies
  • Adapt national HIV surveillance and program monitoring systems to help evaluate the use and impact of PrEP in the U.S.
  • Examine potential program costs, impact, and cost-effectiveness compared to other interventions
  • Communicate guidance to providers and MSM through multiple information channels

CDC has also identified other activities that could help address remaining research questions and is currently exploring all avenues to identify resources to support them. Key among these is the need for demonstration projects in clinics serving MSM to assess feasibility, acceptability, and the impact of PrEP in real-world settings. It will also be critical for public and private sector partners to begin to collectively address the significant financial barriers that may place PrEP out of reach for many MSM at highest risk for HIV infection.

Given the urgency of addressing the HIV epidemic among gay and bisexual men in this nation, CDC is working to maximize the impact of this important new intervention in combination with all available HIV prevention strategies.

For more information on PrEP and HIV prevention, please visit

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This article was provided by U.S. Centers for Disease Control and Prevention. Visit the CDC's website to find out more about their activities, publications and services.
See Also
More on HIV Medications for HIV Prevention


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