By Marie Rosenthal, MS
Health care teams from a variety of HIV clinics in the United States reported that optimal implementation of long-acting cabotegravir-rilpivirine (CAB + RPV LA; Cabenuva, ViiV Healthcare) was achieved within one to three months, according to a presentation at the International AIDS Society Conference 2021 (IAS 2021), held virtually.
Although the idea of a long-acting antiretroviral therapy (ART) is appealing to some patients with HIV, there was concern among health care providers because it would require regular clinic visits for the injections and additional resources in the clinical setting, according to Maggie Czarnogorski, MD, the head of innovation and implementation science at ViiV Healthcare, who presented the health care staff data from the CUSTOMIZE (Cabotegravir plus Rilpivirine long acting in the US To Optimize and Measure Implementation and Experience) trial.
“Perceived barriers to implementation among health care staff decreased substantially from baseline to month 12,” Dr. Czarnogorski said.
The CUSTOMIZE trial was initiated in 2019, to identify ways to successfully integrate the monthly injections of CAB + RPV LA, which come as a co-pack of two injectable medications, ViiV Healthcare’s cabotegravir and Janssen’s rilpivirine. They are dosed every four weeks.
The multicenter, single-arm study, which lasted one year, looked at the extent of acceptability, appropriateness, feasibility, fidelity and sustainability of using the long-acting ART in a variety of clinical settings, including private practices, university clinics, federally qualified health centers and integrated health care systems. These centers served various patient demographic groups throughout the country. The study, which involved 115 people living with HIV and 24 health care providers, evaluated both qualitative and quantitative measures.
A suite of educational items, training aids, treatment and resource planning tools, appointment reminders, and patient-directed support items were made available as part of this study.
Patients with HIV and staff from each site (physician/primary care practitioner, nurse/medication administration personnel, administrator/clinic manager) were surveyed and interviewed during the study.
Regardless of clinic type, most of the health care staff (96%; n=22/23) either agreed or completely agreed that the long-acting regimen was feasible to implement in their clinics, and most (78%; n=18/23) felt that optimal implementation was achieved with only minor adjustments to clinic logistics required.
At the beginning of the study, health care staff were concerned that patients would not be able to keep their monthly appointments because they forgot or transportation was an issue. They were concerned about flagging missed visits, clinic flow, rescheduling missed injections, treatment failures due to nonadherence, managing other patient needs and patient injection soreness. By week 12, most of these issues were less concerning, according to Dr. Czarnogorski.
“Adaptations to implementation strategies were made throughout the study through month 12 and best practices were identified by clinical type,” she said, adding that “some themes and adaptations included changes to infrastructure such as extending clinic hours, increased coordination with other departments such as pharmacy, and finding available room space for injections.”
Key strategies for successful implementation of the therapy included good staff communication, teamwork and the use of a web treatment planner. In addition, keys to improving patient adherence were good communication about the dosing window, a reminder system and designated staff to track appointments.
“The health care staff were most positive about communication and least positive about strategic planning and organizational capacity,” Dr. Czarnogorski said.
By the end of the study, 70% of health care staff said the monthly visits were actually beneficial to patients. “The benefits of monthly visits included improving patient engagement and relationship with the provider discussing and/or screening for sexually transmitted infections, and monitoring high-risk patients such as those with diabetes and hypertension,” she said.
Trial participants with HIV agreed that the long-acting regimen was acceptable and appropriate to implement, with most (97%; n=99/102) expressing interest in continuing to receive the long-acting regimen over daily oral therapy after the study ended at month 12.
Findings from people living with HIV in the CUSTOMIZE trial showed that at month 12:
- 74% reported that nothing interfered with their ability to receive the monthly injection;
- 87% found monthly clinic visits very or extremely acceptable;
- 92% reported they preferred the long-acting regimen to their previous daily oral regimen;
- 97% reported they would continue with CAB + RPV LA after the study; and
- 93% found the time spent in clinic to receive the injections to be very or extremely acceptable.
In addition to assessing the implementation of the ART, CUSTOMIZE examined the safety and efficacy of the regimen. Over the course of the study, findings showed that 100% of participants with available viral load results maintained viral suppression (<50 copies/mL; n=102), and there were no virologic failures. Injection site reactions were the most common overall adverse event, reported in 72% (78/109) of participants who received at least one injection through month 12.
An analysis of the impact of the COVID-19 pandemic on implementation outcomes in CUSTOMIZE was also conducted. Most patients (74%) reported few barriers to monthly injection appointments even during COVID-19.
A corresponding trial in Europe, CARISEL, is examining the implementation of CAB + RPV LA, dosed every two months in certain European health care settings. Initial results from the CARISEL study are expected later this year, according to ViiV Healthcare.
