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Associate Professor of Medicine
Division of Infectious Diseases
Emory Center for AIDS Research
Colleen Kelley, MD, MPH: researcher: Gilead Sciences, Moderna, Novavax, ViiV Healthcare.
It is an exciting and dynamic time in HIV prevention. New products, such as long-acting (LA) injectable cabotegravir (CAB), are now available for HIV pre-exposure prophylaxis (PrEP) in addition to daily oral and on-demand regimens. Other LA agents and combination prevention products (eg, to prevent other sexually transmitted infections [STIs], pregnancy, and/or HIV) are under clinical investigation and may become options in the next few years. Having more tools in the toolbox will ensure that our prevention strategies reach more people.
Here, I summarize key updates in the current HIV prevention landscape that have occurred over the past year.
Updated CDC PrEP guidelines now recommend that HIV PrEP be offered to all sexually active people interested in taking it regardless of reported risk behavior. This simplification of the guidelines removes the need for risk assessment during the clinical encounter, which is often fraught with complications and nuance and can be a barrier to PrEP use.
Current options for HIV PrEP include daily oral emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF), daily oral FTC/tenofovir alafenamide (TAF), off-label event-driven (also called on-demand or 2:1:1) FTC/TDF, LA injectable CAB, and the dapivirine vaginal ring—which has not been approved in the United States.
However, all products are not appropriate for all populations at risk of HIV infection, and important differences exist.
Finally, an important update to the CDC PrEP guidelines is that a qualitative or quantitative HIV-1 RNA assay is now recommended for routine PrEP follow-up visits: bimonthly for people receiving injectable CAB and every 3 months for people receiving daily oral FTC/TDF or FTC/TAF. This addition was prompted by delays in HIV diagnosis reported in people who experienced HIV seroconversion while receiving LA CAB or daily oral FTC/TDF as PrEP in clinical trials. Some clinics, especially those in resource-limited settings such as public health departments, have struggled to implement this guidance because of cost. We must ensure that cost is not a barrier to PrEP access and continue to improve access for populations most in need.
LA Injectable PrEP
Since the approval of LA injectable CAB for HIV PrEP in December 2021, we have learned more about its use.
First, large-scale implementation has been complicated because of cost, staffing limitations, and complex insurance coverage and approval processes.
At the AIDS 2022 meeting, updated HIV incidence and pregnancy outcomes were reported for the HPTN084 trial conducted among cisgender women in Sub-Saharan Africa, showing continued low HIV incidence in both PrEP arms (0.18 per 100 patient-years for LA CAB and 1.70 per 100 patient-years for daily FTC/TDF) and no signal for adverse pregnancy outcomes with CAB exposure, although additional data will be needed to better assess pregnancy safety.
The HPTN 083 study also reported no major effects on systemic pharmacokinetics of LA CAB among transgender women using gender-affirming hormone therapy, which is reassuring in this high-need population.
Although PrEP is a powerful HIV prevention tool, we are failing to get it to all of those who need it most, including racial/ethnic minorities and cisgender women with high risk, as well as PWID. In fact, notable inequities in who is using PrEP by race/ethnicity have increased in recent years.
There are many barriers to achieving optimal PrEP access and efficacy, including education, stigma, and healthcare access, and multifaceted intervention approaches will be necessary to ameliorate these barriers and reduce disparities in PrEP use.
Finally, it is important to note that HIV is not the only sexual health issue that people face. Rates of bacterial STIs are increasing.
This year at the AIDS 2022 conference, we heard the positive results of the DoxyPEP study, which showed that postexposure prophylaxis with doxycycline 200 mg taken within 72 hours of sex was effective in reducing rates of chlamydia, syphilis, and gonorrhea among US MSM.
In addition, the world was taken by surprise in 2022 by a large, sexually transmitted monkeypox outbreak that occurred primarily among MSM and transgender people.
As we advance HIV prevention options, it is important to also recognize and use effective prevention interventions for other STIs. Integrating STI prevention and treatment with individualized HIV prevention and treatment is essential to maximize the health benefits of these interventions in an equitable manner.
What are your thoughts on recent changes in the HIV prevention landscape? Have you had success in implementing new options and guideline recommendations in your practice? Join the discussion by posting a comment.