Cabotegravir/rilpivirine injections administered during home health visit show promise in pilot study

Injectable long-acting cabotegravir/rilpivirine (CAB-LAI) can be administered safely and effectively at home by a trained health care professional, with participants reporting satisfaction, according to the results of a pilot study conducted in South Carolina and presented at IDWeek 2023. However, successful implementation of the program requires significant additional time and effort from clinic staff, as well as that of the nurse who must travel to patients’ homes to administer the injections.

Eric G. Meissner, M.D., Ph.D, an associate professor of medicine in the Division of Infectious Diseases at the Medical University of South Carolina, was the presenter. The research was funded by ViiV Healthcare, the manufacturer of cabotegravir.

Participant Characteristics

Between August 2021 and December 2022, 33 people living with HIV who had been prescribed CAB-LAI were offered the choice of receiving each injection at the Medical University of South Carolina HIV/AIDS clinic in Charleston, at home, or at an infusion center.

Although this was a diverse cohort in terms of age, race, and sex, a majority of participants were Black and a majority were male, with an average age in the 40s. At the time of the IDWeek presentation, 30 participants had completed the study and three remain enrolled.

Study Methods and Results

The first injection was always given at the clinic. For each subsequent injection, participants could choose where to receive it–at home, at the clinic, or at an infusion center. While administration of the medication was covered by the study, the medication itself had to be paid for by the participant’s health insurance. Patient preference therefore was balanced against insurance rules.

The study participants were diverse, in terms of gender, race, age, and geographic location. About the same number of participants chose mostly clinic (18 participants) and home (15 participants). Two participants switched to oral antiretroviral treatment due to an allergic reaction (at-home group) and visit adherence challenges (clinic group), respectively. One participant experienced virologic failure (clinic group) and was switched to a salvage regimen. That person was heavily treatment-experienced with a number of previously unknown resistance mutations.

“To my surprise, the amount of crossover [between clinic and home] was low,” Meissner noted. For participants choosing mostly at-home administration, some injections were given at the clinic during scheduled provider visits.

The home injections were administered by a licensed practical nurse who performed this duty part time. Resulting scheduling difficulties caused one participant who had initially opted for at-home injections to switch to an infusion center.

Prior to the nurse’s visit, a pharmacist discussed refrigeration requirements for the medication with each participant and coordinated the shipping date to make sure the drug was not sent too far in advance but was available on the scheduled injection date. On that date, the LPN communicated with the participant to remove the medication from the refrigerator prior to her arrival.

After drug administration, she remained with the participant for 15 minutes to watch for potential adverse events. As an added safety measure, participants could choose to have an epinephrine pen at home.

None of the home injections occurred outside of the permissible date window for drug administration, while three clinic visits were missed, resulting in target date changes.

Participants who opted for at-home injections often identified convenience as a key consideration for their decision; some also pointed to fear of contracting SARS-CoV-2 at the clinic as a factor. Meanwhile, concerns around temperature requirements for at-home storage were a key consideration for some opting for in-clinic injections..

Post-intervention participant interviews were underway at the time of the presentation, when early signs showed participants of home treatment appeared highly satisfied. In addition, those choosing home administration indicated some frustration at not being able to continue at-home treatment after the study’s end, though these findings are still being analyzed and will be reported at a later time.

Next Steps

This pilot trial provided a workflow for optimizing access to the study drug at home and the researchers are interested in developing a larger initiative to offer this alternative. However, at-home injections require extensive time and coordination by clinic staff, which may be difficult to implement in busy practices. Patients also must be able to store the medication at a specific temperature range at home.

Study Information

Abstract 1027, “At-Home vs. In-Clinic Receipt of Cabotegravir and Rilpivirine Long-Acting: An Implementation Science Trial” was presented by Eric G. Meissner, M.D., Ph.D., at IDWeek 2023 in Boston, Massachusetts.

By Barbara Jungwirth