Although progress has been made in pre-exposure prophylaxis use, there are still significant barriers for many patients.
As HIV experts turn their attention to addressing barriers in treatment, testing, and prevention, new pre-exposure prophylaxis (PrEP) methods can help, according to a session at the American Society of Health-System Pharmacists (ASHP) 2022 Midyear Clinical Meeting.
Globally, 38.4 million individuals are living with HIV, according to presenter Jerika T. Lam, PharmD, APh, AAHIVP, FCSHP. In a review of 2022 targets for HIV, Lam said the goals thus far have not been met.
For example, at the end of 2021, 85% of HIV-positive individuals knew their status, 75% were on HIV treatment, and 68% were virally suppressed. In 2022, the goal is for 95% of patients to know their status, 95% of those to be on HIV treatment, and 95% to be virally suppressed. With just a few more weeks left in the year, these goals have not been met.
“What this tells us is that there’s a lot of work needed in this space and also in our national and global communities,” Lam said.
The highest rates of new HIV diagnoses in 2019 were seen in the south and US-dependent areas such as Puerto Rico, Guam, and the US Virgin Islands. The lowest rates were seen in the Midwest.
To address these gaps, the CDC has proposed a 3-fold plan for ending the HIV epidemic, including a focus on high-incidence geographic areas; an emphasis on early diagnosis, immediate treatment, and engagement; and an expansion of PrEP. Although significant progress has been made in PrEP usage, Lam said there is still a long way to go.
“We were at a dismal 20%, and now we have to step up and try to achieve the goal of 50% to bring down the new HIV infection rates,” she said.
There is an incredible gap between those likely to benefit from PrEP and those who actually use it, Lam explained. An estimated 1.2 million Americans could benefit from its use, but as of 2019, just approximately 23% received PrEP. Notably, 80% of those who could benefit from PrEP are aware of it and 60% are willing to use it, but just around 20% do so.
Some barriers to PrEP use include concerns about adverse effects, lack of knowledge, struggling to keep up with the medication regimen, socio-economic factors, stigma, and factors of daily life. Lam said it is important to remember that not all patients have the same resources, such as smartphones or apps that can help with medication adherence.
“I’d say one of the biggest reasons for non-adherence is forgetfulness,” Lam said. “We all have smart phones, we all have apps…not all of these individuals have these resources available to them.”
Lam also reviewed currently available PrEP options, including Truvada (Gilead) and Descovy (Gilead).
Truvada is approved for individuals with a creatinine clearance of greater than 60 mL/min and adolescents weighting more than 35 kg. A generic formulation is available as well. Importantly, Lam said all patients should be screened for hepatitis B prior to initiation of any PrEP medication.
Notably, Truvada has been studied as an option for on-demand PrEP in the ANRS IPERGAY trial. In this trial, patients took 2 tablets with food between 2 and 24 hours before sex, followed by 1 tablet 24 hours later and another tablet 48 hours after sex. This is called the 2-1-1 strategy, and the study found that this regimen was somewhat protective for individuals having an anticipated sexual event.
However, Lam emphasized that the CDC recommends daily PrEP use for all patients. The 2-1-1 strategy, while somewhat effective for men who have sex with men (MSM), is only potentially appropriate for those who would find event-driven PrEP more effective than a daily regimen and who are able to plan or delay that sexual event for at least 2 hours.
Descovy has been approved by the FDA for MSM as well as trans women and adolescents who have a creatinine clearance greater than 30 mL/min. Notably, it is not approved for cisgender women and has not been studied for on-demand PrEP.
Emerging PrEP options may make adherence easier for patients who struggle with a daily regimen. Cabotegravir, a long-acting injectable PrEP option, was approved by the FDA in 2021 as a 600 mg intramuscular injection for adults and adolescents weighing 35 kg or more.
It is administered as 2 injections in the first month followed by 1 injection every 2 months. Additionally, prior to the first injection, patients may receive an optional oral cabotegravir 30 mg daily for 4 weeks.
Lab testing is critical for long-acting injectable PrEP, Lam said. Before each injection patients should be tested for HIV, and every 4 months they should be tested for gonorrhea-chlamydia and syphilis.
Lam J, and Cocohoba J. PrEParing For a New Kind of HIV Prevention. Presented at: American Society of Health-System Pharmacists 2022 Midyear Clinical Meeting. December 6, 2022.