New HIV PrEP guidelines aim to close gap in prescribing inequality

The CDC is now encouraging physicians to talk to all sexually active adults and adolescents about HIV pre-exposure prophylaxis (PrEP) medications and to prescribe them to anyone who requests them, under a new set of updated guidelines published by the agency in 2021.   

The new recommendations are part of the CDC’s efforts to increase PrEP awareness and use in at-risk populations, and to make it easier for patients to request the drugs without worrying about disclosing potentially stigmatizing behaviors to their healthcare providers. 

PrEP use has increased significantly since the FDA approved the first PrEP medication for HIV prevention in 2012. Out of the 1.2 million people who would benefit from PrEP, only 3% received prescriptions in 2015. In 2020, this number rose to 25% and was accompanied by decreases in new HIV infections, with the CDC estimating that new HIV infections dropped 8% from 2015 to 2019. 

Disparities in PrEP coverage 

Despite advancements in HIV prevention and treatment, HIV still disproportionately affects Black and Hispanic people—the rate of new infections is eight times as high for Black people and four times for Hispanic people, compared to rates of new infections among White people. A key strategy in eliminating HIV is to ensure equitable access to HIV prevention strategies, including PrEP, for everyone who could benefit from these medications.

However, significant racial and ethnic disparities have been documented for PrEP coverage. While Black and Hispanic people make up the largest proportion of people who would benefit from PrEP, they have the lowest rate of PrEP use among all racial and ethnic groups, with the CDC estimating that only 9% of Black people for whom PrEP is recommended received a prescription in 2020. That number is 16% for Hispanic people. 

In addition to racial disparities in PrEP coverage, PrEP use is also unevenly distributed among young people and women. Young people, aged 16-24 were less likely to use PrEP than both the 25-34 and 35-44 age groups and PrEP coverage was three times as high among males (28%) as females (10%). 

Oftentimes, social factors, including transphobia and stigma, stand in the way of ensuring PrEP coverage to all those who need it. A recent study from the CDC found that transgender women were at exceptional risk of developing new HIV infections, with four in 10 transgender women in seven major US cities being HIV-positive. Although a large majority of transgender women (92%) were aware of PrEP medications, only 32% of HIV-negative transgender women reported using PrEP.

The new guidelines seek to close this gap by ensuring that clinicians prescribe PrEP to anyone who wants it without the need for disclosing HIV risk behaviors, with the hope that the discrepancy between PrEP awareness and PrEP use will be eliminated. “PrEP is one of the most powerful tools we have to prevent HIV transmission,” the CDC wrote in a letter to health care providers. "Expanding access to PrEP will be critical to ending the HIV epidemic in the United States."

Additional recommendations 

In addition to continuing to recommend the first-approved PrEP medication, Truvada (emtricitabine-tenofovir), for all genders, the CDC guideline now recommends Descovy, another FDA-approved PrEP medication, for sexually active men and transgender women. The FDA approval for Descovy (emtricitabine-tenofovir alafen) excluded cisgender women. There is also a new section on prescribing intramuscular injections of cabotegravir (CAB), pending FDA approval, every 2 months to sexually active men and women for whom PrEP is recommended. 

The updated guidelines also include changes to HIV testing recommendations. Healthcare providers are now advised to obtain the following for patients who have taken oral PrEP in the past 3 months or those who have received a CAB injection in the past year: a positive antigen/antibody test in addition to a detectable HIV-1 RNA test to start the patient on an HIV treatment regimen and a negative antigen/antibody test with no detection of HIV-1 RNA to continue PrEP prescriptions.

The new guidance did not make any changes to the populations for whom PrEP is recommended or to the section concerning daily dosing regimens for oral PrEP. 

To learn more about the updated CDC guidelines, the full document can be found here.