New guidelines recommend PrEP for those at substantial risk

The US Public Health Service released the first comprehensive clinical practice guidelines for pre-exposure prophylaxis, or PrEP, for use in the prevention of HIV.

The new federal guidelines recommend that PrEP be considered for people who are HIV-negative and at substantial risk for HIV. They include clear criteria for determining a person’s HIV risk and indications for PrEP use. Studies have shown that when taken daily as directed, PrEP can reduce the risk of HIV infection by more than 90%.

“PrEP is a new approach to HIV prevention that requires continuing collaboration between patients and providers, as effectiveness requires adherence to daily medication and regular medical visits for monitoring, counseling and testing,” Dawn K. Smith, MD, MPH, epidemiologist in CDC’s Division of HIV/AIDS Prevention who led the development of the guidelines, said in a press release. “Individuals will have to decide with their doctor if PrEP is right for them, but for some, this may offer a much-needed strategy to help protect themselves from HIV infection.”

PrEP should be considered for HIV-uninfected patients with any of the following indications:

  • Anyone who is in an ongoing sexual relationship with a partner who is HIV-positive.
  • A gay or bisexual man who has had sex without a condom or has been diagnosed with a sexually transmitted infection within the past 6 months, and is not in a mutually monogamous relationship with a partner who recently tested HIV-negative.
  • A heterosexual man or woman who does not always 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), and is not in a mutually monogamous relationship with a partner who recently tested HIV-negative.
  • Anyone who has during the past 6 months injected illicit drugs and shared equipment or been in a treatment program for injection drug use.

The guidelines underscore importance of counseling about adherence and HIV risk reduction, including encouraging condom use for additional protection. In addition, the guidelines recommend regular monitoring of HIV infection status, side effects, adherence, and sexual or injection risk behaviors.

Accompanying the guidelines is a supplement that includes checklists and interview guides to assist clinicians with PrEP prescribing and counseling.

The new guidelines build on interim guidance issued by CDC following the release of research findings on PrEP for men who have sex with men, heterosexuals, and people who inject drugs. In 2012, the FDA approved the drug combination of 300 mg tenofovir disoproxil fumarate and 200 mg emtricitabine (TDF/FTC; Truvada, Gilead) for use as PrEP in combination with safer sex practices.

“While a vaccine or cure may one day end the HIV epidemic, PrEP is a powerful tool that has the potential to alter the course of the US HIV epidemic today,” Jonathan Mermin, MD, MPH, director of CDC’s National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, said in a press release. “These guidelines represent an important step toward fully realizing the promise of PrEP. We should add to this momentum, working to ensure that PrEP is used by the right people, in the right way, in the right circumstances.”

Jonathan Mermin, MD, MPH 

Jonathan Mermin

The guidelines were developed by a federal inter-agency working group led by CDC, and reflect input from providers, HIV patients, partners, and affected communities, according to a CDC press release.

The CDC and other organizations are currently conducting pilot implementation studies and demonstration projects to identify the most effective ways to deliver PrEP in community settings that can reach those at high risk for HIV infection, according to the release.

Click here to view the complete guidelines.

For more information:

USPHS. Preexposure prophylaxis for the prevention of HIV infection in the United States – 2014: A Clinical Practice Guideline. Updated May 14, 2014. Accessed May 15, 2014.

USPHS. Preexposure prophylaxis for the prevention of HIV infection in the United States – 2014: Clinical Providers’ Supplement. Updated May 14, 2014. Accessed May 15, 2014.

Paul A. Volberding, MD

Paul A. Volberding

  • We were very excited several years ago by the impressive data that showed the striking ability of oral medications to prevent HIV acquisition. Taken regularly, the combination of tenofovir with emtricitabine can be a powerful prevention tool. But, we were then concerned with the very slow use of this approach despite FDA approval. The CDC guidelines are extremely important and we really hope that this preventive medication becomes the rule rather than the exception for those who have not been otherwise able to limit their HIV exposure. This could be a key way to finally turn around the numbers getting infected every year in this country. The guidelines are a major step forward in HIV prevention.

    • Paul A. Volberding, MD
    • Infectious Disease News Chief Medical Editor
  • Disclosures: Volberding reports no relevant financial disclosures.