New guidelines focus on PrEP use against HIV
Executive Summary
The Centers for Disease Control and Prevention (CDC) has issued clinical guidance for use of anti-HIV drugs in uninfected patients who are at substantial risk of infection. Research indicates that pre-exposure prophylaxis (PrEP) can reduce HIV infection rates. When taken daily as directed, PrEP can reduce the risk of HIV infection by more than 90%.
• The guidelines solidify interim PrEP guidance issued in 2012 by CDC and the 2012 approval by the Food and Drug Administration of 300 mg tenofovir disoproxil fumarate and 200 mg emtricitabine for use as PrEP with safer sex practices.
• The guidelines emphasize HIV testing before PrEP is prescribed, as well as at three-month intervals during use.
The Centers for Disease Control and Prevention (CDC) has issued clinical guidance for use of anti-HIV drugs in uninfected patients who are at substantial risk of infection.1,2 Research indicates that pre-exposure prophylaxis (PrEP) can reduce HIV infection rates; when taken daily as directed, PrEP can reduce the risk of HIV infection by more than 90%.3
The guidelines solidify interim PrEP guidance issued in 2012 by the CDC and the 2012 approval by the Food and Drug Administration of 300 mg tenofovir disoproxil fumarate and 200 mg emtricitabine for use as PrEP in combination with safer sex practices. (Contraceptive Technology Update reported on both events. See "Check interim guidance for PrEP in men, women," October 2012, p. 113.)
"HIV infection is preventable, yet every year we see some 50,000 new HIV infections in the United States," said CDC Director Tom Frieden, MD, MPH, in a statement accompanying the guidance release. "PrEP, used along with other prevention strategies, has the potential to help at-risk individuals protect themselves and reduce new HIV infections in the U.S."
According to the CDC guidance, PrEP should be considered for HIV-uninfected patients with any of the following indications:
• anyone who is in an ongoing sexual relationship with an HIV-infected partner;
• a gay or bisexual man who has had sex without a condom or has been diagnosed with a sexually transmitted infection within the past six 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, within the past six months, injected illicit drugs and shared equipment or been in a treatment program for injection drug use.1
CDC expands uptake
PrEP has the potential to alter the course of the epidemic in the United States, if targeted to the right populations, for use in the right way and in the right circumstances, says Dawn Smith, MD, MPH, a CDC medical epidemiologist who led the development of the guidelines. To realize the promise of PrEP in the United States, public health officials must expand uptake and address practical implementation issues, she notes.
The CDC is leading efforts on multiple fronts to support PrEP uptake and address critical issues for its delivery in community settings, according to Smith. As part of those efforts, the agency is conducting an implementation pilot study to examine the practical requirements, costs, and impact of PrEP at four federally qualified health centers in Houston, Philadelphia, Newark, and Chicago. The pilot will look specifically into services provided by health centers that serve adults at substantial risk of acquiring HIV infection, such as gay and bisexual men, heterosexual women and men, and people who inject drugs, states Smith.
How can you integrate PrEP into your practice? Visit the CDC web site, http://1.usa.gov/1fzbtkI, for a variety of online resources. At this site, clinicians can download the current guidance, as well as a supplement that includes checklists and interview guides to assist with PrEP prescribing and counseling. (Click on the publication’s title under the heading "Pre-exposure Prophylaxis.")
Consistent with FDA labeling, the guidelines emphasize the importance of HIV testing before PrEP is prescribed, as well as at three-month intervals during patient use. Such testing ensures that anyone on PrEP who becomes infected with HIV can discontinue PrEP use to minimize the risk that the virus could become resistant to the drugs. Such patients then can begin receiving HIV treatment.
Because no prevention strategy for sexually active people is 100% effective, the CDC guidance encourages patients taking PrEP to use other effective prevention strategies to further reduce their risk, including:
• using condoms consistently and correctly;
• getting HIV testing with partners;
• choosing less risky sexual behaviors, such as oral sex;
• for people who inject drugs, getting into drug treatment programs and using sterile equipment.
While a vaccine or cure might one day end the HIV epidemic, PrEP is a powerful tool that has the potential to alter the course of the U.S. HIV epidemic today, stated Jonathan Mermin, MD, MPH, director of CDC’s National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention in a statement accompanying the guidance release.
"These guidelines represent an important step toward fully realizing the promise of PrEP," said Mermin. "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."
- Centers for Disease Control and Prevention. Preexposure Prophylaxis for HIV Prevention in the United States -- 2013: A Clinical Practice Guideline. Accessed at http://1.usa.gov/1n3IJzr.
- Centers for Disease Control and Prevention. Preexposure Prophylaxis for the Prevention of HIV Infection in the United States -- 2014. Clinical Providers’ Supplement. Accessed at http://1.usa.gov/1n0f0If.
- Baeten JM, Donnell D, Ndase P, et al. Antiretroviral prophylaxis for HIV prevention in heterosexual men and women. N Engl J Med 2012; 367(5):399-410.
