January 17, 2014
Eighteen months after the approval of Truvada (tenofovir/FTC) by the U.S. Food and Drug Administration as a pre-exposure prophylaxis (PrEP) regimen to prevent HIV transmission, the New York state AIDS Institute has released guidelines for health care professionals as to how to approach prescribing PrEP to people who wish to use the drug. Truvada is currently a part of many medication regimens for HIV-positive people, and is among the drugs used as post-exposure prophylaxis (PEP) for those who have had a potential exposure to HIV.
The guidance states that it was released after "studies evaluating the efficacy of PrEP have shown promising results." With the U.S. Centers for Disease Control and Prevention issuing only interim guidance on PrEP for specific populations, New York's guidelines are a welcome sign that adoption of PrEP may finally ramp up across the U.S.
The guidance includes methodology behind PrEP, what medicines are candidates for PrEP (currently only Gilead-produced Truvada), contraindications and considerations, notes on how to do assessments, education, laboratory tests, parameters for follow-up and monitoring and the proper course for discontinuation of a PrEP regimen.
Several key principles in the PrEP guidance include: PrEP as part of a full comprehensive prevention plan; PrEP as a tool for people in serodiscordant relationships; the importance of adherence; and advice on those who use PrEP and choose not to use condoms. On the topic of condom use, the guidance says, "Although consistent condom use is a critical part of a prevention plan, lack of use of barrier protection is not a contraindication to PrEP." Concern about sexual risk and PrEP is a common theme in many discussions around the regimen.
Andy Velez, member of the AIDS Coalition to Unleash Power (ACT UP), which has been calling for the release of these guidelines for some time, said, "It's good that the New York State guidelines have finally been released. But finally is not good enough. This kind of bureaucratic delay has meant that many who could have been prevented from being HIV infected have ended up seroconverting. We are living through the worst new infection numbers among men who have sex with men since the early years of HIV/AIDS. Business as usual on the part of bureaucrats, pharma and service providers is not acceptable. Urgency is the word." ACT UP has begun extensive work around PrEP advocacy as it turns its focus toward HIV prevention as a cornerstone of its agenda.
The Guidance for the Use of Pre-Exposure Prophylaxis (PrEP) to Prevent HIV Transmission is written by the New York state AIDS Institute.
Mathew Rodriguez is the editorial project manager for TheBody.com and TheBodyPRO.com.
Follow Mathew on Twitter: @mathewrodriguez.