What the Proposed New CDC Guidelines Say About How PrEP Should Be Administered

Although pharmaceutical companies have been working diligently to develop an HIV vaccine over the last several decades, it will likely be years before one becomes available. That means preventative measures to prevent HIV transmission, like pre-exposure prophylaxis (PrEP), are even more important. However, current guidelines are outdated.

The Centers for Disease Control and Prevention (CDC) have proposed updated PrEP guidelines to include new medication options and expanded access. Read on to learn what we know so far about the newly proposed guidelines.

What is pre-exposure prophylaxis (PrEP)?

We don’t have a human immunodeficiency virus (HIV) cure or vaccine yet, but we do have PrEP medications. With PrEP, people who don’t have HIV can take daily medication to prevent getting an HIV infection. 

PrEP doesn’t protect against other sexually transmitted infections (STI) or pregnancy. It’s meant to be used in addition to safer sex practices — like condoms — and birth control (for people not trying to become pregnant).

Right now, there are two medications FDA-approved for use as PrEP — Truvada and Descovy. Both PrEP medications contain emtricitabine and tenofovir and work just as well at preventing HIV. However, there are a few differences that you should know.

If you’re looking for lower-cost options, only Truvada is available as a generic version. Currently, Descovy is only available as a brand-name medication.

Although both medications contain the same ingredients, tenofovir’s chemical structure in Descovy is slightly different from Truvada, making it safer for kidney and bone health. 

It’s also important to know that certain populations were not studied in Descovy’s clinical trials. Because of this, unlike Truvada, Descovy isn’t approved for PrEP in people at risk for getting HIV through receptive vaginal sex. However, Gilead — the company that makes Truvada and Descovy — reports they’re working on it. 

How does PrEP work?

Antiretrovirals (ARVs) — medications that work against HIV — are used for PrEP. But, Truvada and Descovy alone can’t treat HIV; they can only prevent it. Confusing, we know.

When it comes to treating HIV, providers use a combination of ARVs to lower the amount of virus in the body and prevent it from becoming resistant to medication. A full combination of medications to treat active HIV infection usually means two or more ARVs from two different ARV medication classes. 

Truvada and Descovy both contain two ARVs, but they’re from the same medication class — nucleoside reverse transcriptase inhibitors (NRTIs). NRTIs work by stopping HIV from replicating in the body. 

While they’re not a complete HIV treatment regimen for people with HIV, they’re very good at preventing infection in people who don’t have HIV. 

When you take PrEP medications, your body builds up an ARV storage that’s ready to fight the virus as soon as you’re exposed to it. This fast action can prevent HIV from entering your CD4 T cells — immune system cells that HIV infects and uses to make copies of itself. 

Daily adherence to PrEP is key to building up enough medication in your body to prevent infection. In fact, taking Truvada every day has been shown to lower your risk of getting HIV by 99%. 

ARVs reach certain areas of the body, such as vaginal or rectal tissue, at different speeds. This is one of the reasons your provider may ask about your sex practices before prescribing PrEP. 

Who is currently recommended to get PrEP?

PrEP is an option for anyone who doesn’t have HIV and is at risk for getting HIV through sex or injection drug use. PrEP may also be an option if you’ve used multiple courses of post-exposure prophylaxis (PEP) — medications that are taken after possible HIV exposure. 

According to the 2017 PrEP guidelines, adults at high risk for getting an HIV infection are recommended to take Truvada for PrEP. 

People who inject drugs and share injection equipment are considered to be at high risk for an HIV infection. Additionally, there are certain situations where men who have sex with men (MSM) and heterosexual men and women may be at high risk. These situations include people who:

• Have a sexual partner who has HIV

• Had a recent STI (in the last 6 months)

• Don’t always use condoms

• Work in the commercial sex industry

Who shouldn’t take PrEP?

PrEP is a preventative medication for people who don’t have HIV. If you already have HIV, you shouldn’t use PrEP since it’s not a complete HIV treatment regimen. As mentioned above, treatment regimens require a combination of different ARV medications.

If you already have HIV, using PrEP medications alone can potentially lead to treatment resistance, making it harder to find an effective ARV regimen in the future. 

For this reason, providers use HIV tests and look for acute HIV infection symptoms — fever, sore throat, swollen lymph nodes — to check for an HIV infection before prescribing PrEP.

Additionally, oral PrEP medications might not be an option for people with kidney problems. Tenofovir, one of the ARVs in PrEP, can cause kidney problems and can’t be used in people with slower kidney function.

What are the CDC’s proposed updates to the PrEP guidelines?

There are many proposed updates to the guidelines. However, they haven’t been finalized, so we don’t know exactly what they will look like yet. But for now, let’s focus on what’s currently being proposed regarding PrEP medications and access to care.

What’s changed from the previous guidelines?

As discussed, the previous guidelines were from 2017. Below are a few key differences.

Medications recommended for PrEP

The previous guidelines only recommend Truvada for PrEP. This is because back in 2017, it was the only medication FDA-approved for PrEP. The FDA approved Descovy for PREP in 2019, so the new guidelines add recommendations for using Descovy for PrEP in approved populations. 

The CDC has also added recommendations for using the long-acting injectable ARV, Apretude (cabotegravir). The FDA approved Apretude in late 2021. It became the first and only long-acting injectable medication for PrEP. This medication is injected into your buttock muscle by a healthcare provider and is generally given every 2 months.

Because Apretude is a long-acting injection, it can be a convenient option for people who don't like taking pills, have trouble swallowing them, or have trouble remembering when to take their medications.

Lastly, the new guidelines also provide guidance for on-demand PrEP — Truvada 2-1-1. Truvada 2-1-1 is a nondaily PrEP option for men who have sex with men where you only take Truvada around the time of a sexual event. 

The “2-1-1” means two tablets 2 to 24 hours before sex, then one tablet every 24 hours for 2 days. This dosing schedule isn’t FDA-approved yet, but they’ve included it as an off-label recommendation.

Who should get PrEP

PrEP continues to be a good option for anyone who is at high risk of getting an HIV infection. Unfortunately, not everyone knows it’s an option. Some updates to the guidelines aim to change that. 

The new guidelines use more inclusive verbiage for identifying high-risk individuals. For example, the high-risk individuals’ wording has changed from “MSM and heterosexual men and women” to “adults and adolescents who have had anal or vaginal sex in the last 6 months.” Additionally, there’s expanded guidance for transgender people.

There’s also a strong recommendation for providers to talk about PrEP with all sexually active adults and adolescents so that they know their options. 

Additionally, you might notice these guidelines include sexually active adolescents. In contrast, the previous guidelines only recommended PrEP for adults. This change reflects the FDA’s approval of oral PrEP medications for adolescents who weigh more than 77 lbs (35 kg). 

Lastly, the new guidelines may provide formal recommendations for providing PrEP via telehealth, improving access to care.

When will the new guidelines go into effect?

The CDC hasn’t provided a date as to when they’ll release the new guidelines. As of right now, they’ve taken comments from the public and should be posting responses here shortly. The new guidelines should be posted sometime after that. 

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Written by:

Hope Chang, PharmD, AAHIVP

Hope Chang is a freelance writer and content reviewer for GoodRx. She attended Howard University College of Pharmacy in Washington, D.C. and completed post-graduate residency training at the University of California, Davis Medical Center.

Edited by:

Alyssa Billingsley, PharmD

Alyssa Billingsley, PharmD, is the director of pharmacy content for GoodRx. She has over a decade of experience as a pharmacist and has worked in clinical, academic, and administrative roles.

Reviewed by:

Joshua Murdock, PharmD, BCBBS

Joshua Murdock, PharmD, BCBBS, is a licensed pharmacist in Arizona, Colorado, and Rhode Island. He has worked in the pharmacy industry for more than 10 years and currently serves as a pharmacy editor for GoodRx.

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