CDC says all sexually active patients should be told about HIV PrEP
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The CDC on Wednesday recommended that all sexually active adult and adolescent patients be informed about HIV PrEP.
In an updated clinical practice guideline, the CDC also added a recommendation for prescribing long acting cabotegravir for PrEP, which is not yet approved by the FDA.
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The new recommendations were originally released as a draft update in May.
“I’m delighted to see the updated CDC PrEP guideline, which has been needed for quite a while,” Infectious Disease News Editorial Board Member Melanie A. Thompson, MD, principal investigator at the AIDS Research Consortium of Atlanta and former chair of the HIV Medicine Association, told Healio.
The CDC added a new section about prescribing intramuscular injections of cabotegravir every 2 months for sexually active men, women and transgender people who report sexual behaviors “that place them at substantial ongoing risk of HIV exposure and acquisition.”
In May, ViiV Healthcare announced that it was initiating a rolling submission with the FDA for long-acting injectable cabotegravir based on study findings showing that injections of the medication given every 8 weeks prevented HIV infection.
Cabotegravir is already part of the first FDA-approved long-acting injectable regimen for HIV treatment, Cabenuva, which also includes rilpivirine. According to the CDC, FDA approval of cabotegravir for PrEP is anticipated in “late 2021.”
Including cabotegravir in the new guidance means recommendations will be immediately available when the drug becomes available, Thompson said.
“It is striking to me that the CDC is now willing to be ahead of the curve by addressing the use of injectable cabotegravir for PrEP even before FDA approval — a very unusual and welcomed approach for CDC.”
Other updates included:
- a simplified determination of indications for PrEP use for sexually active-active people with a flow chart assessing indication in place of boxes;
- revised HIV testing to include two algorithms — one for assessing HIV status in people with no recent history of antiretroviral exposure starting PrEP and the other for assessing HIV status at follow-up visits while persons are taking, or have recently taken, PrEP;
- the inclusion of emtricitabine/tenofovir alafenamide (FTC/TAF) as an FDA-approved PrEP option for sexually active men and transgender women (cisgender adolescent girls and women were left out of the research for FTC/TAF);
- guidance for initiating PrEP via telehealth, called “Tele-PrEP;”
- guidance for same-day initiation of PrEP;
- procedures for off-label prescribing of FTC/tenofovir disoproxil fumarate to men who have sex with men on a “2-1-1” or “on-demand” nondaily regimen and their follow-up care;
- a section on primary care considerations for PrEP users, and;
- expanded guidance for transgender persons.
Thompson said the most important new recommendation is that all sexually active adults and adolescents be told about PrEP.
“This recommendation seems simple but could have dramatic impact on ending the HIV epidemic if fully implemented,” Thompson said.
According to Thompson, current data show that only a small proportion of people who could benefit from PrEP are actually using it. This rate is even lower among people with the highest rates of new HIV infection, including racial and ethnic minorities, cis- and transgender women and people who inject drugs.
“We need to vastly expand awareness and usage of PrEP, which will be 10 years old in 2022,” she said.
Unfortunately, Thompson said that even with this expanded guidance, implementation will be challenging because it “demands a whole-of-health-care approach to the training of health care workers.” She said the training should also include a “status neutral” approach to HIV testing to ensure that those testing negative are given appropriate and thorough education and care that includes offering PrEP.
“It also requires realizing that our broken health services are now struggling from a workforce decimated by COVID, and that the old way of doing things simply may not work in 2021 and beyond,” she said.
The recommendations should be seen as a “call to action for paradigm shifts in medical education, HHS agency requirements for receipt of federal funds, mechanisms for delivery of PrEP, health care provider licensing requirements and funding streams to ensure coverage of PrEP,” Thompson said.
“The CDC has done its job, but the implementation plan needs to occur at a higher level,” she said.
Thompson said a key to implementing changes will be learning from the 2006 CDC guidance for HIV testing in health care settings, which recommended routinely offering HIV testing to sexually active adults.
“Implementation of this guidance has been a colossal failure, mostly ignored by those on the frontlines of care,” Thompson said. “We should learn from this failure and resolve that we simply cannot afford to fail again. If we want to end the HIV epidemic, it will take much more than a guideline, even a welcomed and well-crafted one.”
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CDC. Preexposure prophylaxis for the prevention of HIV infection in the United States – 2021 update. https://www.cdc.gov/hiv/pdf/risk/prep/cdc-hiv-prep-guidelines-2021.pdf. Accessed on Dec. 8, 2021.
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