With the ink barely dry on iPrEx -- still tricky to type -- along come "interim" guidelines from the CDC on pre-exposure prophylaxis (PrEP).
Based on the results [iPrEx], CDC and other U.S. Public Health Service (PHS) agencies have begun to develop PHS guidelines on the use of PrEP for MSM at high risk for HIV acquisition in the United States as part of a comprehensive set of HIV prevention services. Completing the guidelines and obtaining expert input and public comment will take several months before they can be published. Concerns exist that without early guidance, various unsafe and potentially less effective PrEP-related practices could develop among health-care providers and MSM beginning to use PrEP in the coming weeks and months.
Since government organizations often move at glacial speed, the rapidity with which this appeared is truly impressive.
Some initial points worth emphasizing:
This is just for TDF/FTC. Sure, other drugs might work -- but let other studies determine that first.
This is only for MSM at high risk for HIV. Yes, this was the group studied in iPrEx, and should be the predominant population treated. But if you knew of a heterosexual female at high risk (let's say through domestic violence with a known HIV positive partner), would you exclude her?
It is critical to exclude established or acute HIV infection before starting PrEP. The boxed recommendations at the bottom of the report are quite clear about this. Certainly this will increase the use of HIV RNA as a diagnostic test, and makes the combined HIV antibody/antigen assay seem much more valuable.
Most people getting PrEP are at risk for other STIs. Screen them appropriately.
Ongoing assessments of adherence, safety, and HIV serostatus are critical. PrEP only works if people take it, and continuing dual therapy if HIV is acquired could rapidly lead to resistance.
Intermittent PrEP cannot be supported. Here I think the guidelines will not be widely followed, at least based on anecdotal discussions I have had with certain providers. But I understand why they needed to say this -- intermittent PrEP hasn't been proven effective -- yet.
Give a maximum of a 90 day supply. Important not to continue prescribing the drug without periodic monitoring, as noted above. I wonder where they came up with 90 days? Did they consult the rules?
I still want to know how they got this guidance out so fast -- suspect they were working on it behind the scenes, awaiting publication of the study. Regardless, this is a timely release indeed, and the larger "comprehensive" set of guidelines on HIV prevention promise to be very interesting.
Paul Sax is Clinical Director of Infectious Diseases at Brigham and Women's Hospital. His blog HIV and ID Observations is part of Journal Watch, where he is Editor-in-Chief of Journal Watch AIDS Clinical Care.
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