Feb 4, 2011
CDC releases interim HIV PrEP guidelines
Interim guidelines for the prescription of pre-exposure prophylaxis (PrEP) to prevent HIV infection were recently released by the United States Centers for Disease Control and Prevention (CDC). The guidelines were developed in response to the results from the iPrEx clinical trial, which were released in late 2010. That study showed that over the course of about one year, a daily pill called Truvada was safe and partially effective in reducing the risk of HIV infection among HIV-negative men who have sex with men (MSM) who are at high risk for HIV transmission. This was the first study to show that PrEP taken orally could prevent HIV transmission in people. The iPrEx results were promising but left many unanswered questions about the safety and effectiveness of PrEP.
Truvada is already approved for the treatment of HIV infection. However, Truvada has not been approved for the prevention of HIV infection. Because it is legal for healthcare providers to prescribe medications for any medical use that they see fit, it is now possible for some HIV-negative people to access Truvada for PrEP. This has led to concerns that inappropriate use of PrEP may put some people at increased risk of HIV infection or may cause other harms. The CDC interim guidelines contain information for healthcare providers who elect to prescribe PrEP on the basis of the preliminary results from the iPrEx study. The interim guidelines were not released to encourage the use of PrEP, but rather to reduce possible harm if PrEP is requested and prescribed. The CDC plans to release more comprehensive guidelines regarding the use of PrEP in the near future.
According to the interim guidelines, for Truvada to be safe and potentially effective in reducing the risk of HIV infection, it needs to be:
- targeted to MSM at high risk for HIV infection, who are not consistently using other prevention strategies. PrEP should not be used by women or men who have sex with women.
- taken every day.
- delivered as part of a comprehensive set of prevention services. PrEP is not as effective as using condoms.
- accompanied by monitoring of HIV status, side effects, adherence, and risk behaviors at regular intervals. PrEP must not be taken by someone who is or becomes infected with HIV.
The prescription and use of PrEP is challenging and demanding for both doctors and their patients. Even if the guidelines are followed, many concerns remain. The guidelines also highlight the dangers of obtaining anti-HIV medications to use as PrEP from sources other than a doctor. If anti-HIV medications are obtained in this manner, it is unlikely that PrEP will be used in a way that follows the guidelines and is safe and effective.
For more information about PrEP and related issues, see these resources:
CDC Interim Guidelines
CATIE Fact Sheet on PrEP
CATIE news article on iPrEx study
CATIE Fact Sheet on Truvada