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Head of Department of Infectious Diseases and Tropical Medicine
Full Professor of Infectious Diseases
Infectious Diseases Clinics, University Hospital
University of Modena and Reggio Emilia
Cristina Mussini, MD: consultant/advisor/speaker: AbbVie, Angelini, Gilead Sciences, GlaxoSmithKline, Janssen, MSD, Pfizer, Roche, ViiV Healthcare; researcher: Gilead Sciences, Janssen, MSD, ViiV Healthcare.
The advent of safe and effective long-acting (LA) HIV therapy provides people with HIV the opportunity to receive a complete HIV treatment regimen without having to take 1 or more pills every day—a first in the history of HIV therapy. Likewise, LA HIV pre-exposure prophylaxis (PrEP) enables people at risk for HIV to receive a biomedical prevention option that does not involve a daily pill. Although LA HIV prevention and treatment approaches are not for everyone, for some, they are everything. One of the most significant benefits provided by LA HIV treatment is a reduction in the stigma felt by many people with HIV: Taking a pill every day, however simple, is for some a stark reminder that they have a disease that has been stigmatized by society for decades. Currently available LA antiretroviral therapy (ART) removes that daily reminder as well as the need to keep HIV treatments in one’s home. In the case of PrEP, a daily oral pill can also serve as a constant reminder that someone is living at risk of HIV infection. It is also important to keep in mind that PrEP with LA cabotegravir was demonstrated to provide significantly greater protection against HIV infection vs daily oral emtricitabine/tenofovir disoproxil fumarate.
Yet, new paradigms never emerge without challenges. Healthcare professionals (HCPs) who are well versed in the tried-and-true treatments may be resistant to change and experience understandable hesitancy related to a major shift in treatment and prevention provision. Although this fear of change stems from a bedrock principle in medical care—do no harm—it is important to recognize that advances in care can be implemented safely and ultimately hold the potential to improve lives.
Reassurance From Implementation Studies: CUSTOMIZE and CARISEL
Concerns have been expressed regarding the need for increased clinic capacity to accommodate the provision of in-clinic intramuscular injections every 1-2 months for individuals who switch to LA ART or who initiate or switch to LA HIV PrEP. These concerns are certainly legitimate, particularly in the current environment of healthcare work force shortages in some countries. Large centers that may have a considerable number of individuals interested in and eligible for switching to LA HIV therapy may need a dedicated staff member to provide the injections. However, we can look to results from 2 key implementation studies to inform on the impact of incorporating LA HIV care into practice, CUSTOMIZE and CARISEL.
The hybrid type III implementation-effectiveness phase IIIb CUSTOMIZE trial used quantitative surveys and semistructured interviews at baseline, Month 4, and Month 12 to gather HCP (physicians, nurses, injectors, administrators) and patient perspectives on incorporation of monthly LA cabotegravir plus rilpivirine as an HIV switch regimen option across 8 US clinics of varying types (private practice, federally qualified health center, university clinic, AIDS Healthcare Foundation, health maintenance organization). Support provided to participating clinics included facilitation via monthly phone meetings and an implementation tool kit that included materials to support both HCP and patient education.
Overall HCP scores for acceptability, appropriateness, and feasibility of implementing LA cabotegravir plus rilpivirine were high throughout the study and across clinic types. At Month 12, 30% of HCPs reported the need for infrastructure changes such as modified clinic hours to accommodate early/late injection visits, refrigerator purchases, additional space designated for injections, and increased interdepartmental coordination. Of note, anticipated implementation barriers decreased from baseline to Month 12. For example, 81% of HCPs identified patients’ ability to keep monthly appointments as a barrier at baseline vs only 39% at Month 12. Key facilitators of successful implementation reported by HCPs included teamwork among clinic staff, use of a web-based treatment planner, having a designated individual track appointment scheduling, and clear communication with patients. For 78% of HCPs, optimal implementation was reached within 1-3 months.
The hybrid type III implementation-effectiveness phase IIIb CARISEL trial used surveys and semistructured interviews to gather HCP (primarily physicians and nurses) and patient perspectives on incorporation of LA cabotegravir plus rilpivirine administered every 2 months as an HIV switch regimen option across 18 clinics in Europe. Similar to findings from the CUSTOMIZE trial, anticipated implementation barriers decreased among HCPs over time, with more than 50% reporting increase in staff workload (54%) and scheduling, staff, and storage (57%) as anticipated implementation barriers at Month 1 vs only 25% reporting staffing and workload concerns as barriers at Month 5.
Perspectives of patient participants in CUSTOMIZE and in CARISEL also demonstrated high acceptability, with 92.0% of participants (n = 102) preferring LA injections over daily oral tablets at Month 12 and 97.0% (n = 99) planning to continue the LA regimen going forward in CUSTOMIZE and 91.2% of participants reporting that they felt “very” or “extremely positive” about the LA regimen at Month 4 in CARISEL.
A particularly notable aspect of CUSTOMIZE and CARISEL is that both studies were conducted during the COVID-19 pandemic. The demonstrated feasibility of LA HIV treatment during a time of major global disruption in healthcare services provides additional reassurance for implementation during more “normal” times.
It Is Okay to Start Slowly
Another important consideration when it comes to assessing the effect of implementing LA HIV care in your own clinic is the fact that only a subset of individuals will be eligible for and interested in LA options. Therefore, you will not be in the position of suddenly needing to see all your patients every 1-2 months. In fact, it is okay to start slowly as you begin identifying the most appropriate individuals for these strategies and start having discussions with those individuals to assess their interest. When having those conversations, we should provide as much information as possible about the regimen, clearly explain the dosing and scheduling requirements, and then allow them to carefully consider if this option is appropriate for them.
In addition to beginning slowly with patient numbers that will be feasible for your clinic setting, it is also helpful if you can identify locations outside of the main clinic or hospital, ideally with extended or flexible service hours where people can obtain their injections. Several aspects of medical care where I practice in Italy facilitate the implementation of LA HIV therapy, including the fact that we already see patients once every 2 months for HIV treatment monitoring and medication provision and that we have outpatient organizations that offer the possibility for injections to be administered outside of the hospital.
I expect that this is just the beginning of a new generation of LA HIV treatment and prevention options, with various strategies under investigation to further reduce the burden of care. To meet the needs of those who are interested in and able to receive new LA treatment and prevention strategies, it is important that we strive to overcome our resistance to change and not be an obstacle to this care. By learning from implementation studies, carefully selecting the most appropriate patients for LA options, and having clear and open discussions with our patients, we can make sure that this new paradigm fulfills the promise of expanding options to improve the lives of people with or at risk of HIV.
Have you begun offering a switch to LA HIV treatment for appropriate patients in your clinical practice? What about LA PrEP (if it is available in your region)? If not, what are the barriers standing in your way? Join the discussion and share your experiences by posting a comment.