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Gene Stollerman Professor of Medicine
Chief, Division of Infectious Diseases
Northwestern University Feinberg School of Medicine
Babafemi Taiwo, MBBS: consultant/advisor/speaker: Gilead Sciences, GlaxoSmithKline, Johnson & Johnson, ViiV.
The FDA recently approved long-acting injectable cabotegravir, ushering in a new paradigm for HIV pre-exposure prophylaxis (PrEP). Long-acting cabotegravir had superior efficacy to daily oral emtricitabine/tenofovir disoproxil fumarate PrEP in the pivotal clinical trials HPTN 083 and 084 and is expected to expand PrEP access, including to people who would prefer a long-acting approach with less frequent dosing.
At this time, however, long-acting cabotegravir PrEP use is essentially limited to traditional healthcare settings, specifically medical clinics. Several aspects related to the delivery of this option make these settings particularly well suited for rollout, including the need for staff trained in the proper technique for intramuscular gluteal injection as well as the systems and support needed for ongoing monitoring of adherence, HIV status, and sexually transmitted infections (STIs). These settings are also ideal for integrating PrEP into the overall healthcare of persons at risk for acquiring HIV.
To extend long-acting PrEP to all potential candidates, we must improve our ability to reach individuals wherever they routinely access health services in the community. This is because logistical constraints make clinic visits every 2 months for PrEP injections undesirable or even impossible for some individuals. In addition, medical clinics may experience barriers as they integrate and scale up this new PrEP modality into their routine workflow. Although the challenges may be modest with initial introduction of long-acting injectable PrEP, they are likely to increase as the proportion of individuals using this option increases. Broader rollout of this modality can be optimized by making this option available in nontraditional settings such as pharmacies, substance use treatment. centers, or places where individuals go for other routine medical injections (eg, contraceptive care or mental health care).
Several barriers would need to be overcome to successfully deliver long-acting cabotegravir PrEP in nontraditional settings. For example, staff trained in the proper administration of the medication by intramuscular gluteal injection would be needed. In addition, systems would need to be established to ensure that on-PrEP monitoring is not compromised, including adherence, and HIV and STI monitoring. Monitoring for HIV infection could be particularly challenging with recent revisions to the CDC PrEP guidelines that now call for qualitative or quantitative HIV-1 RNA monitoring during PrEP use rather than HIV antibody assays as was previously recommended. Compliance with the new HIV-1 RNA monitoring guidelines would be enhanced in nontraditional settings if easy-to-use, accurate, point-of-care quantitative or qualitative HIV-1 RNA assays were available.
Client privacy also needs to be maintained during long-acting injectable PrEP provision. Settings such as pharmacies and substance use treatment centers already have private spaces designed for providing other injections (eg, vaccinations) and/or patient counseling that can be adapted for PrEP injections. Regular STI screening at all sites of contact, which may include throat or pharyngeal swabs, urine testing, and rectal and/or vaginal swabs, is also a critical component of monitoring during PrEP. Therefore, staff with relevant procedural skills would be needed along with appropriate private spaces for sample collection and access to a laboratory for sample testing. Self-collection of samples may be one option for STI testing, but there is concern that the quality of the sample may be reduced. Finally, collaborative practice agreements or other legal arrangements may be needed to allow PrEP provision in nontraditional healthcare settings, and these requirements vary depending on state laws.
While we wait for the field to better understand how or if long-acting injectable PrEP can be incorporated in nontraditional healthcare settings, we can be encouraged by lessons learned from the rollout of long-acting injectable antiretrovirals for HIV treatment, including evidence that the confidence of healthcare professionals in their ability to effectively deliver long-acting injectable options in clinics tends to increase over time. With this information in mind, we should start considering long-acting cabotegravir PrEP for appropriate individuals in our clinics and incorporate strategies to optimize the client experience and avoid workflow bottlenecks.
In your clinical practice, have you begun offering long-acting injectable cabotegravir PrEP to appropriate individuals at risk of HIV infection? What barriers or challenges have you experienced thus far? Join the discussion by posting a comment and sharing your experiences.