January 27, 2011

Dear Advocates,

Today the US Centers for Disease Control and Prevention issued interim guidance on pre-exposure prophylaxis (PrEP) as an HIV prevention strategy for gay men and other men who have sex with men (MSM). These interim guidelines address key considerations for health care providers considering daily oral TDF/FTC as PrEP for their MSM clients. With this interim guidance in place, US agencies and organizations should now move swiftly to design and implement demonstration projects in key high-incidence settings. These projects would gather additional needed data on PrEP for HIV prevention and lay the groundwork for eventual introduction of PrEP as an additional HIV prevention strategy.

This update summarizes some of the key points of the CDC interim guidance which includes this important statement: “PrEP has the potential to contribute to effective and safe HIV prevention for MSM if 1) it is targeted to MSM at high risk for HIV acquisition; 2) it is delivered as part of a comprehensive set of prevention services, including risk-reduction and PrEP medication adherence counseling, ready access to condoms, and diagnosis and treatment of sexually transmitted infections; and 3) it is accompanied by monitoring of HIV status, side effects, adherence, and risk behaviors at regular intervals.”

Advocates’ input is needed to map out next steps in the US and to discuss the relevance of these interim guidelines for other countries. We hope you will join us for a teleconference on “Translating PrEP Research into Practice”. The call will feature debate and discussion with brief remarks from key discussants on what needs to happen next to translate the iPrEx trial results outside of clinical trial settings. Please join us on Tuesday, February 8 from 10 to 11am US Eastern time (visit www.timeanddate.com to confirm the time in your area).

Click here to register for the call.

As we provide this update on an important biomedical advance, AVAC also offers condolences and steadfast support to Ugandan gays and lesbians who lost a leader and shining light with the brutal and senseless murder of David Kato. There will be no end to AIDS without an end to homophobia, stigmatization and human rights abuses worldwide.

More on the CDC interim guidance
When a new public health strategy is identified, national and international public health agencies review the evidence and provide guidance. These guidance statements help shape policy and guide eventual introduction. The guidance published by the US CDC in this week’s Morbidity and Mortality Weekly Report (MMWR) is described as an interim tool for clinicians who may want to consider oral TDF/FTC as PrEP for some of their clients. CDC and other federal agencies are working on a more complete set of US Public Health Service guidelines for PrEP use in MSM, which are expected later this year.

Key statements in the MMWR include:

• “Until the safety and efficacy of PrEP is determined in trials now under way with populations at high risk for HIV acquisition by other routes of transmission, PrEP should be considered only for MSM.” Details on other trials available here.
• “The iPrEX trial results provide strong evidence that support for adherence to the prescribed medication regimen must be a routine component of any PrEP program.” The guidelines also specify the need for “PrEP medication adherence counseling” and the “support [of] PrEP medication at each follow-up visit, more often if inconsistent adherence is identified.”
• PrEP is an HIV prevention intervention and should only be given to individuals who are HIV-negative. “To minimize the risk for drug resistance, PrEP should not be started in persons with signs or symptoms of acute viral infection unless HIV-uninfected status is confirmed by HIV RNA testing or a repeat antibody test performed after the viral syndrome resolves.” And guidelines indicate the need to “document negative HIV antibody test(s) immediately before starting PrEP medication.”
• PrEP is not meant for everyone. The CDC’s interim guidance states, “For MSM whose behaviors place them at high risk for HIV infection and who do not use other effective prevention methods consistently, PrEP might reduce their risk for HIV infection.”
• The effects of long-term use of TDF/FTC as PrEP is still unknown, so regular monitoring is critical. CDC notes, “Health-care providers and patients should be aware that HIV prevention is not a labeled indication for the use of Truvada and that its long-term safety in HIV-uninfected persons is not yet known. Health-care providers should report any serious adverse events resulting from prescribed TDF/FTC for PrEP to the Food and Drug Administration’s MedWatch.”

The CDC’s interim guidance is an important step in thinking about the implications of the iPrEx results. Please join us for the teleconference on February 8, and make your voice heard in this critical debate and discussion about the ways forward. To register for the teleconference, click here.

This teleconference is the first in a series of calls that AVAC has planned in the coming weeks and months. These calls will build on the current issue of Px Wire, which outlines some of the important questions and next steps in biomedical HIV prevention research.

Please join us! If you have any questions in advance, please send them to avac@avac.org.

Best,
AVAC