Long-acting CAB plus RPV effective for HIV suppression, preferred over daily oral ART

Long-acting (LA) cabotegravir (CAB) plus rilpivirine (RPV) is supported as a preferred treatment option for patients with HIV infection due to its effectiveness and ability to maintain virologic suppression, according to study findings published in Open Forum Infectious Diseases.

Treatment guidelines were updated in 2024 to recommend use of LA CAB plus RPV among individuals with HIV and a history of antiretroviral therapy (ART) adherence challenges.

The findings come from an ongoing, 2-year, prospective, real-world evidence study comprising adult patients enrolled across 27 sites in the United States between 2021 and 2022. Eligible study patients (N=308) were those who initiated LA CAB plus RPV for HIV treatment. The primary outcomes of this interim analysis were virologic suppression and confirmed virologic failure at 12 months, defined as an HIV viral load below 50 copies/mL and 2 consecutive HIV-1 RNA measurements of at least 200 copies/mL or treatment discontinuation after a single measurement of at least 200 copies/mL, respectively.

Among patients included in the analysis, the median age was 45 (range, 18-80) years, 87% were men, 48% were White, the median BMI was 27.9 (range, 16.9-57.5) kg/m², and the median duration of antiretroviral therapy (ART) was 9.9 (range, 0.1-35.7) years. Overall, 56% of the population reported use of 1 or 2 prior 2 ART regimens.

The majority (76%) of the population reported use of LA CAB Plus RPV that was consistent with labeling, defined as initiating treatment while virologically suppressed and having no history of virologic failure or documented resistance to either of its ART components.

Overall, the most commonly cited primary motivations for switching to LA CAB plus RPV among study patients were fatigue with daily oral ART (27%) and a desire for a more consistent treatment option (21%). More than half (52%) of the population initiated the LA ART regimen at once-monthly dosing schedules, and 48% received the treatment every 2 months. At 12 months, 97% of patients reported adherence to the 2-month dosing schedule.

Further analysis showed 72% of patients initiated LA CAB plus RPV within 7 days of the targeted treatment date. In the real-world post hoc analysis, the adherence rates were 91% and 88% among patients whose use of the LA ART regimen was consistent and inconsistent with labeling, respectively. Of 65 LA CAB plus RPV injection dosing visits that were missed by 12 months, the researchers noted oral therapy was used as a bridge for 46% of them.

Among patients with baseline virologic suppression whose use of LA CAB plus RPV was consistent (n=155) or inconsistent (n=31) with labeling, 97% and 90%, respectively, maintained virologic suppression through 12 months of treatment. All patients (n=13) with HIV viremia at baseline, whose use of LA CAB plus RPV was inconsistent with labeling, achieved virologic suppression through 12 months. Overall, 7 patients experienced virologic failure with the LA ART regimen.

Study limitations include potential recall bias and the possibility of missing, inaccurate, or incomplete data. There also may have been bias related to patient experience, as patients were motivated and planned to switch to LA CAB plus RPV prior to study enrollment.

According to the researchers, “Participants using CAB+RPV LA had high adherence, experienced improvements in challenges related to HIV-1 treatment after 12 months, and reported multiple benefits of additional clinic visits.”

By Jessica Nye, PhD

References:

Dandachi D, Garris C, Richardson D, et al. Clinical outcomes and perspectives of people with HIV-1 12 months after initiation of long-acting cabotegravir and rilpivirine in an observational real-world US study (BEYOND). Open Forum Infect Dis. Published online April 19, 2025. doi:10.1093/ofid/ofaf220