Health care providers can successful integrate the administration of ViiV Healthcare’s experimental monthly long-acting injectable antiretroviral (ARV) regimen Cabenuva (cabotegravir/rilpivirine) into their practices, while people with HIV can succeed on the regimen in a real-world setting.
These are the findings of the CUSTOMIZE trial, which included 105 people with HIV who started Cabenuva at eight clinic sites. The study is the first to analyze the integration of the monthly treatment, which must be injected into the muscle by a health care worker, in standard clinical practice—as opposed to in a regimented clinical trial.
Cabenuva has been approved in Canada, but the U.S. Food and Drug Administration (FDA) expressed concerns about the regimen’s manufacturing process. ViiV is working with the FDA to address these concerns in hopes of securing an approval.
Findings from the study were presented at the recent virtual IDWeek conference.
The participants all entered the study with a fully suppressed viral load thanks to an oral ARV regimen and then switched to Cabenuva during the trial. While people in this study received Cabenuva injections monthly, recent studies have shown that injections every other month are equally effective at suppressing HIV.
Ninety-one percent of the participants reported upon entering the study as well as four months later that they either agreed or completely agreed that Cabenuva was both appropriate for and acceptable to them.
Upon entering the study, 33% of the participants reported hiding their oral ARVs from others, and 22% reported having difficulty remembering to take their medications. The top reason for wanting to switch to monthly injectable treatment, reported by 83% of the participants, was the desire for a “more convenient treatment option.”
After four months, 84% of the participants reported that attending monthly clinic visits was either very or extremely acceptable to them, and 66% reported experiencing no logistical challenges in receiving their injections.
When they started the study, 58% of the participants said that pain at the injection site was their primary concern about taking Cabenuva. But after four months, just 28% reported actually experiencing such pain.
Four months into the study, 95% of the participants’ injections were provided within seven days, whether prior to or following, the scheduled dates.
Interviews with 24 physicians, nurses and clinic administrators indicated a high level of confidence that they could adjust their practices to accommodate providing ongoing monthly injections of Cabenuva to their patients.
To read a press release about the study, click here.