- Category: Pre-exposure Prophylaxis (PrEP)
- Published on Tuesday, 14 August 2012 00:00
- Written by Press Release
The U.S. Centers for Disease Control and Prevention (CDC) last week issued provisional guidance for the use of tenofovir/emtricitabine (Truvada) pre-exposure prophylaxis -- better known as PrEP -- to prevent heterosexual HIV transmission, adding to earlier guidelines issued for gay and bisexual men. The recommendations stress the importance of a negative HIV test prior to starting PrEP and a comprehensive package of prevention support.
The Food and Drug Administration (FDA) approved Truvada for PrEP on July 16, 2012.
As previously reported, the CDC's interim guidance for men who have sex with men, published in the January 28, 2011, Morbidity and Mortality Weekly Report, was based on findings from the iPrEx trial showing that tenofovir/emtricitabine reduced the risk of HIV acquisition by more than 40% overall in that population, rising to more than 90% for men with blood drug levels indicating good adherence.
Similarly, the heterosexual guidance was based on findings from 2 other large clinical trials, Partners PrEP and TDF2, looking at tenofovir/emtricitabine PrEP in serodiscordant heterosexual couples and heterosexual men and women, respectively, which found that PrEP reduced HIV infection rates by 60% to 75% overall, with protection again rising with good adherence.
Below is an edited excerpt from a recent CDC press release summarizing the new recommendations. The full Interim Guidance for Clinicians Considering the Use of Preexposure Prophylaxis for the Prevention of HIV Infection in Heterosexually Active Adults is available free online in the August 10, 2012, Morbidity and Mortality Weekly Report.
CDC Issues Interim Guidance on Use of Medication to Prevent HIV Infection among Heterosexually Active Adults
Physicians considering the use of anti-HIV medication to reduce the risk of acquiring HIV through heterosexual sex should ensure that patients are confirmed to be uninfected prior to use and provided regular testing and other key prevention services, according to new interim guidance published today by the Centers for Disease Control and Prevention. This strategy, called pre-exposure prophylaxis, or PrEP, may be used by HIV-uninfected individuals to reduce their risk of HIV infection by taking a daily dose of medications that are also used for treating HIV. When used consistently and in combination with other prevention methods, it may offer an additional means to prevent infection for some men and women at very high risk.
The guidance on the use of PrEP among heterosexually-active women and men in the United States was published today in CDC’s Morbidity and Mortality Weekly Report. The guidance is based on the results of two large international clinical trials in which PrEP was found to significantly reduce the risk of HIV infection through heterosexual sex. The guidance supplements existing CDC PrEP interim guidance for men who have sex with men (MSM), and is designed to ensure physicians that may be prescribing PrEP have accurate information and key cautions on its safe and effective use.
"With 50,000 new HIV infections every year in the United States, we urgently need additional prevention options," said Kevin Fenton, MD, director of CDC’s National Center for HIV/AIDS, Viral Hepatitis, STD and Tuberculosis Prevention. "To facilitate the safe and effective use of PrEP as an additional tool, the guidance we’re releasing today gives health care providers information to help them evaluate and support its use for their patients who may be considering this method."
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.
Today’s interim guidance for heterosexually-active women and men includes cautions and recommendations similar to those provided in CDC’s interim guidance on PrEP for MSM (released in January 2011), as well as a number of new recommendations relevant to women of reproductive age and to couples in which one partner is HIV-positive and the other is HIV-negative. The main points of the guidance:
PrEP should be targeted to individuals at very high risk for HIV infection, such as those with a sex partner who is HIV-positive.
It is critical that those using PrEP take the daily medication consistently, as the level of protection has been shown to be closely related to levels of adherence
Concerning women who are pregnant or trying to conceive, health care providers should discuss available information about potential risks and benefits of beginning or continuing PrEP so that an informed decision can be made. While no adverse effects have been found among infants exposed to TDF/FTC during pregnancy, most of the relevant data have been collected among children born to HIV-positive women using the drug for treatment. Data are incomplete for children of HIV-negative women who become pregnant while using PrEP.
PrEP is not a stand-alone solution: It should be delivered as part of a comprehensive package of prevention services, including counseling to reduce risk behavior and encourage adherence to the daily pill regimen, access to condoms, and management of other sexually transmitted infections.
Individuals prescribed PrEP must be confirmed to be HIV negative prior to use, and their HIV status, experience of side effects, adherence, and risk behaviors must be monitored regularly during use.
The full interim guidance is available at http://www.cdc.gov/mmwr/. 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 are anticipated to be published later this year.
"PrEP could help to reduce new HIV infections in the United States, if it is used consistently and effectively in combination with all available prevention strategies," said Jonathan Mermin, MD, director of CDC’s Division of HIV/AIDS Prevention. "Its overall impact will also be determined by acceptability and access among the populations at highest risk and whether programs implemented in community settings can achieve the key requirements for success, including ensuring regular HIV testing, maintaining high levels of medication adherence, and preventing increases in risk behavior."
Demonstration projects and research studies by CDC and others are now underway in several U.S. cities and other countries to begin to assess these and other key implementation questions. Outcomes of these studies of PrEP use in real world settings will help determine how PrEP can most effectively be used in the United States.
DK Smith, MC Thigpen, SR Nesheim, et al. Interim Guidance for Clinicians Considering the Use of Preexposure Prophylaxis for the Prevention of HIV Infection in Heterosexually Active Adults. Morbidity and Mortality Weekly Report 61(31):586-589. August 10, 2012.
CDC National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention. CDC Issues Interim Guidance on Use of Medication to Prevent HIV Infection among Heterosexually Active Adults. Press release. August 9, 2012.