On December 8, the Centers for Disease Control and Prevention (CDC) released the final version of the updated U.S. Public Health Services guidelines for prescribing HIV pre-exposure prophylaxis (PrEP).
The Food and Drug Administration (FDA) approved Gilead Sciences’ Truvada (tenofovir disoproxil fumarate/emtricitabine) for HIV prevention in July 2012. A second daily PrEP option, Descovy (tenofovir alafenamide/emtricitabine), was approved in 2019 but not for HIV exposure via vaginal sex. The first injectable PrEP option, Apretude, was approved December 20.
The new final guidelines, Preexposure Prophylaxis for the Prevention of HIV Infection in the United States—2021 Update, are very similar to the draft guidelines released for comment in May.
Perhaps most significantly, the guidelines instruct providers to prescribe PrEP when a person asks for it, whether they disclose their risks or not.
“Patients may request PrEP because of concern about acquiring HIV but not feel comfortable reporting sexual or injection behaviors to avoid anticipated stigmatizing responses in health care settings,” the guidelines state. “For this reason, after attempts to assess patient sexual and injection behaviors, patients who request PrEP should be offered it, even when no specific risk behaviors are elicited.”
This goes for people vulnerable to HIV through sex or sharing injection drug equipment. And the CDC made it simple, creating two flow charts to guide clinicians:
The updated guidelines also:
- recommend for clinicians to prescribe daily Truvada to people of all genders;
- add Descovy PrEP as an option for men who have sex with men and transgender women who have anal sex; the FDA hasn’t yet approved Descovy for people exposed to HIV via receptive vaginal sex because early clinical trials didn’t include those individuals;
- reduces the frequency of testing for kidney lab levels from quarterly to twice a year for people over age 50, and annually for people younger than 50;
- call for clinicians to tell every sexually active adolescent and adult about the prevention pill at least once;
- add guidelines on prescribing injectable cabotegravir in anticipation of the FDA’s presumed approval of the drug by the end of January 2022; unlike those taking PrEP pills, those who receive the injections will not require regular lab tests of kidney function or cholesterol levels;
- add guidance for PrEP 2-1-1, or on-demand PrEP before and after sex, using Truvada but not Descovy for men who have sex with men;
- add guidance about how to provide PrEP via telehealth; and
- add a protocol that clinicians can follow for same-day PrEP starts.
The previous PrEP guidelines, released in 2017, didn’t include Descovy, as it hadn’t yet been approved for gay and bisexual men or transgender women. Trials are now underway to evaluate how well it works for people exposed to HIV via vaginal sex. The addition of telehealth guidelines follows the widespread adoption of remote care during the COVID-19 pandemic.
Click here to read the full updated PrEP guidelines.
Click here for more news about PrEP.
Editor’s note: This article was updated to reflect Apretude’s approval.