Real-World Data Reinforces Efficacy of Long-Acting HIV Injectable Therapy

WASHINGTON — Long-acting injectable antiretroviral therapy (ART) successfully maintained HIV viral suppression in a real-world cohort, with minimal virologic failure observed over a follow-up period exceeding five years.

In a analysis of the OPERA cohort, 94% of patients who transitioned from oral ART to long-acting cabotegravir/rilpivirine (Cabenuva) and received at least two injections achieved undetectable HIV levels at their most recent viral load test. Of these patients, 81% maintained undetectable viral loads consistently throughout the study, according to findings presented by Ricky Hsu, MD, of NYU Langone Medical Center, at the IDWeek annual meeting.

Confirmed virologic failure occurred in only 1% of cases, defined as two consecutive viral loads of 200 copies/mL or higher, or one such measurement followed by discontinuation of treatment.

“Our data demonstrate that long-acting injectables are highly effective outside of clinical trials,” Hsu stated during a press briefing. “These results may support greater provider confidence by illustrating the therapy’s effectiveness, durability, and sustained patient interest—findings that align closely with previous randomized clinical trials.”

The dual-component regimen remains the sole fully injectable ART option approved as an alternative to daily oral therapy. The FDA first authorized it in 2021 as a monthly treatment, later expanding its dosing interval to every two months for virologically suppressed adults with no history of treatment failure or known resistance to cabotegravir or rilpivirine.

“While this therapy has been available for over five years, it currently accounts for approximately 5% of all HIV prescriptions—a gap underscoring the need to broaden provider adoption,” Hsu observed. “Demonstrating strong real-world performance is critical to expanding access.”

The study addresses earlier concerns about practical barriers such as injection-site reactions and efficacy concerns in non-clinical settings, he noted.

In the OPERA database—a nationwide longitudinal repository covering roughly 14% of U.S. HIV patients—Hsu and team analyzed data from 7,995 ART-experienced adults who initiated long-acting cabotegravir/rilpivirine between January 2021 and December 2025 while maintaining viral suppression (less than 50 copies/mL).

Participants had a median age of 37; 86% were male, 43% identified as Black, and 32% as Hispanic. Nearly 80% had CD4 counts above 500 cells/µL, with a median of 21 months spent on prior regimens. Approximately 87% maintained viral suppression at baseline.

Among 6,362 individuals receiving both initial doses within 67 days of each other, 77% continued with the regimen through the end of the observation period despite any interruptions. Median treatment duration reached 18 months.

“By incorporating insights from routine clinical practice alongside trial data, these findings further affirm the role of cabotegravir plus rilpivirine as an effective, patient-centered approach for people living with HIV,” Hsu concluded in a press release.

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