PrEP Developments– New Guidelines and CAB-LA FDA Approval


Be PrEPared for 2022: New Year, New PrEP!

With the new year upon us, there’s never been a better time to join the fight against HIV. With new guidelines from the CDC, FDA approval of the first-ever extended-release injectable version of Pre-Exposure Prophylaxis (PrEP), and generics of the original PrEP medication, HIV prevention has never been easier or more accessible. The CDC estimates that only ¼ of the 1.2 million people who would benefit from PrEP are currently prescribed it, and with these new updates, we move closer to our goal of ending the HIV epidemic for good.

The newest change in the fight against HIV came on December 20th with the approval of the first-ever long-term injectable version of PrEP, cabotegravir extended-release injectable suspension (brand name Apretude). This formulation of a long-studied integrase-inhibitor is delivered by a healthcare professional every two months and provides a fantastic alternative for patients who don’t like the burden of taking daily pills. This new version of PrEP was studied in thousands of individuals in both HPTN 083 and HPTN 084, which even found cabotegravir to be slightly more effective at preventing HIV than the current pills. If given a choice between daily pills or bimonthly injections, the majority of participants preferred the injectable formulation.

In addition to this, the newest CDC guidelines aim to expand access and uptake of PrEP across the nation. First, PrEP has been approved for the prevention of HIV in people who inject drugs. This harm-reduction strategy offers protection for hundreds of thousands of individuals who would otherwise be at risk. Next, the new official CDC PrEP guidelines focused on the importance of making patients aware of their HIV prevention options. Clinicians are now requested to inform ALL sexually active adolescent and adult patients of PrEP, regardless of risk factors. In addition, the CDC outlined the procedure for the on-demand (otherwise known as 2-1-1) method of PrEP for individuals who want the freedom to take PrEP only when needed. By expanding the options available, patients have the freedom to protect themselves against HIV in whatever way works best for them.

Finally, these updates to the types and administration of PrEP are accompanied by new financial regulations ensuring PrEP is accessible to ALL patients, regardless of insurance status. The United States Preventative Services Task Force (USPSTF) gave PrEP its highest level-A recommendation. In addition to signaling the importance of PrEP as a public health tool, this ensures all healthcare plans covered by the Affordable Care Act must provide PrEP with ZERO out-of-pocket costs for patients. The federal government has also pledged to cover the costs for uninsured individuals simply by going to This is accompanied by new generic options for the original Truvada (Emtricitabine/Tenofovir Disoproxil-Fumarate) to help ensure equitable access for everyone.

All these changes point to the importance of biomedical prevention strategies in the fight against HIV. By ensuring all sexually active people are aware of their options, new formulations/dosing methods, and financial protections for patients, it has never been easier for people to find the best PrEP for them.

For training on PrEP or more information on any of the discussed topics, please contact our office at [email protected]

Be PrEPared for 2022 Final

Brandon Mizroch, MD/MBBS

back to top