New guidelines recommend daily HIV prevention pill for those at substantial risk

May 14, 2014

Dear Colleagues,

Today, CDC and the U.S. Public Health Service released new clinical guidelines recommending that health care providers consider pre-exposure prophylaxis (PrEP) for patients at substantial risk for HIV infection. The strategy of providing daily oral antiretroviral drugs to uninfected individuals prior to HIV exposure, known as PrEP, has been shown to reduce HIV acquisition.

The new guidelines, developed by CDC in partnership with other federal health agencies, public health experts and community leaders, recommend that providers consider PrEP as a prevention option for any patients who meet specified risk criteria. They also underscore the importance of counseling that covers adherence and HIV risk reduction and recommend regular monitoring of HIV status, side effects and toxicities, and risk behaviors.

More specifically, the guidelines recommend PrEP for HIV-uninfected patients with any of the following indications:

• Is in an ongoing relationship with an HIV-infected partner.
• Is not in a mutually monogamous relationship with a partner who recently tested HIV-negative, and who is:
  • A gay or bisexual man who has had sex without a condom or been diagnosed with a sexually transmitted infection within the past six months.
  • A heterosexual man or woman who does not regularly use condoms when having sex with partners known to be at risk for HIV (for example, injecting drug users or bisexual male partners of unknown HIV status).
• Has injected illicit drugs within the past six months and has shared equipment or been in drug treatment within the past six months.

For sexually active people, since no prevention strategy is 100% effective, the guidelines also recommend that physicians encourage patients to use PrEP with other proven prevention strategies, such as condoms, to provide even greater protection than when used alone.

On July 16, 2012, the U.S. Food and Drug Administration approved the combination medication tenofovir disoproxil fumarate plus emtricitabine (TDF/FTC) for use as PrEP among adults at risk for sexually acquired HIV infection.

Over the past several years, CDC has issued interim guidance as trial results in various populations have become available. These new guidelines are the first to offer detailed and comprehensive clinical guidance on PrEP for both sexual and injecting drug use, and replace the interim guidance. They also include a providers’ supplement with additional materials and tools for clinicians who prescribe PrEP.

Today’s guidelines are an important step forward in the fight against HIV as it provides physicians with key information useful to effectively deliver this powerful, new prevention tool. With 2.7 million new infections estimated to occur each year worldwide, and approximately 50,000 in the United States, safe and effective new approaches to prevent HIV are urgently needed to reduce the toll of the disease.

PrEP has the potential to alter the course of the US epidemic, if targeted to populations in need and used as directed. In fact, CDC estimates that as many as 275,000 uninfected gay men and 140,000 discordant heterosexual couples could potentially benefit from this intervention.

Ultimately the role of PrEP in preventing new HIV infections will depend on: its acceptability to users; how effectively it is delivered by health care providers, including support for patients to achieve high medication adherence and to prevent increases in risk behavior; and access to the drug by those at substantial risk of HIV.

CDC is leading a variety of efforts to support PrEP uptake and address these critical issues for delivery in community settings. We are collaborating with the CDC Foundation to launch an implementation pilot program to identify the practical requirements, costs and impact of PrEP delivery in clinical care settings. We continue to provide ongoing support to state and local health departments on the delivery of PrEP in their jurisdictions and are engaged in prevention education efforts to increase awareness of PrEP among clinicians and consumers alike.

Other organizations are also implementing PrEP demonstration projects and research studies in community settings to help determine how PrEP can most effectively be used in the United States.

Yet, in order to realize the promise of PrEP for HIV prevention in the US, we must work collectively to expand uptake and address practical implementation issues. Many groups have critical roles to play:

• HIV prevention organizations can integrate PrEP education into existing programs while those working in clinical settings can play a central role in increasing awareness and uptake of this safe and effective HIV prevention intervention
• Advocates for HIV prevention and care can raise awareness and understanding of PrEP among those populations most at risk and
• Health care providers can prescribe PrEP to those patients with indications for its use

The new guidelines were posted today on CDC’s website. To view the guidelines and provider supplement or learn more about PrEP implementation in the United States, visit www.cdc.gov/hiv/prevention/research/prep/.

CDC will also present Public Health Grand Rounds on PrEP for Prevention of HIV on Tuesday, May 20 at 1:00 PM EDT.

CDC is grateful to its federal and public health partners as well as those health care providers and community leaders who provided input into the development of these guidelines. We are also grateful to you, our prevention partners, for the work you do every day in the fight against HIV.

Sincerely,

/Jonathan Mermin/
Jonathan H. Mermin, M.D., MPH
Director
National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention
Centers for Disease Control and Prevention
www.cdc.gov/nchhstp

/Kenneth G. Castro/
RADM Kenneth G. Castro, M.D.
Commanding Flag Officer,
CDC/ATSDR Commissioned Corps
Acting Director, Division of HIV/AIDS Prevention
NCHHSTP
Centers for Disease Control and Prevention

/Amy Lansky/
Amy Lansky, Ph.D, M.P.H
Deputy Director for Surveillance,
Epidemiology and Laboratory Sciences
Division of HIV/AIDS Prevention
National Center for HIV/AIDS
Viral Hepatitis, STD, and TB Prevention
Centers for Disease Control and Prevention