CDC releases draft update for HIV PrEP guidance
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The CDC released a draft of revised clinical practice guidelines for HIV PrEP and took feedback from clinicians via two webinars held May 24 and 25.
“The main changes surround the soon-to-be-approved availability of long-acting PrEP injectables with cabotegravir used as intramuscular injections every 8 weeks,” Infectious Disease News Chief Medical Editor Paul A. Volberding, MD, professor emeritus of medicine at the University of California, San Francisco, explained to Healio.
ViiV Healthcare announced this month that it has initiated a rolling submission of a new drug application for long-acting cabotegravir PrEP on the heels of positive findings from multiple clinical trials.
“It’s becoming clear that this may be preferred over oral PrEP for some and may reduce adherence challenges,” Volberding said. “The new guidelines should be of value in helping clinicians and their patients prepare for this new approach — again facilitating more PrEP coverage.”
Additions to the clinical practice guidelines include:
- a new section on prescribing bimonthly injections of cabotegravir for PrEP for sexually active men and women, pending FDA approval;
- a recommendation to inform all sexually active adults and adolescents about 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, but a study is in the works);
- guidance for initiating PrEP via telehealth, which the draft calls “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.
Kenneth H. Mayer, MD, medical research director and cochair of The Fenway Institute and professor of medicine at Harvard Medical School, said the new guidance is important because it encourages primary care providers to discuss PrEP with sexually active Americans, and new guidance for 2-1-1 PrEP and tenofovir alafenamide FTC/TAF “prepares the stage” for injectable PrEP once it is FDA approved.
“I think more guidance for primary care providers about how to discuss sexual and substance use risks, and a listing of resources needed for a successful PrEP program will be helpful,” Mayer told Healio.
“For example, many providers are unsure about how to pay for all the parts of the PrEP package — for example, monitoring labs, as well as medications — and tables of where to look in each state will be helpful,” Mayer said. “It will also be helpful to provide useful links for providers to programs that can enhance their ability to deliver culturally competent care to key populations.”
Other changes include:
- Sections were reordered and revised to describe guidance applicable to all PrEP patients and those applicable to only specific patients.
- Sections were added for oral and injectable PrEP.
- Boxes were replaced with flow charts for assessing PrEP indications.
- The HIV testing algorithm was revised to clarify preferred and less preferred options, harmonize with the acute infection section of HHS’s HIV Treatment Guidelines, and revise the frequency of assessing estimated creatinine clearance (eCrCL) by baseline age.
- Renal function should now be assessed every 6 months for daily oral PrEP users aged older than 50 years who have an eCrCL less than 90 mL per minute at PrEP initiation,
- Follow-up visits should now be conducted every 12 months to assess renal function in all patients.
- A new table was added for cabotegravir injection PrEP.
- In the section regarding follow-up visits for at 2 months beginning with the third injection and pregnancy testing, the language was revised to “persons with childbearing potential” to be more inclusive.
- A flowchart is now used for assessing indications for PrEP in sexually active persons, people who inject drugs and clinical determination of HIV status for PrEP provision.
- The viral load cutoff for potential false positive tests was changed from 3,000 copies/mL to 10,000 copies/mL to align with HHS treatment guidelines.
- A primary care health measures table was added to guide testing/screening.
“The guidelines also address other barriers, including HIV testing and monitoring for potential PrEP toxicity, including renal function testing, where experience has shown an extremely low incidence of problems — especially in the majority with no kidney disease at PrEP initiation,” Volberding said. “Overall, the new guidelines are a very useful update and will hopefully be widely followed.”
Reference:
Federal Register. CDC draft 2021 update to the HIV preexposure prophylaxis clinical practice guideline and supplement; webinars. https://www.federalregister.gov/documents/2021/05/13/2021-10094/cdc-draft-2021-update-to-the-hiv-preexposure-prophylaxis-clinical-practice-guideline-and-supplement. Accessed May 25, 2021.
Perspective
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I believe these changes will be critical to increase awareness, acceptance and access to PrEP. With newer medications on the horizon, including the long-acting injectable cabotegravir, as well as the availability of better-tolerated medications including TAF, these changes and updates are timely, as far as incorporating the best available current evidence base, as well as providing guidance to actually improve, increase and facilitate implementation of PrEP.
With COVID propelling telehealth to the forefront, adaptations for provision of PrEP via expansion to telehealth are an important, welcome and necessary component of these updated draft guidelines. Long-acting PrEP, broadly, would help to ease the compliance aspect of PrEP — we know that PrEP, just like any medication, is only good if it’s taken, so the easier it is logistically, and the lesser the barriers to accessing PrEP, and the need for monitoring overall, the better.
In the setting of the COVID-19 pandemic, efforts in the HIV arena have slowed down in general. We can’t afford to lose our focus on PrEP as a robust tool — as we strive to meet our goal of ending the HIV epidemic.
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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 May 26, 2021.
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