Real-World Study Finds Cabenuva Outcomes Similar to Clinical Trials | IAS 2025

A two-year, real-world study of Cabenuva (cabotegravir and rilpivirine) has found that clinical outcomes are consistent with the phase 3/3b clinical trials, with few discontinuations due to injection reactions/pain and high rates of virologic suppression. There were also low rates of virologic failures, according to a poster presented at the International AIDS Society meeting in Kigali, Rwanda.

Developed by ViiV Healthcare, Cabenuva is a long-acting therapy for patients 12 years and older with HIV to maintain virus suppression. It is approved by the FDA to be given as an intramuscular injection and can be given monthly or every two months.

In the BEYOND trial, 308 people with HIV were enrolled from across 30 sites who began Cabenuva between September 2021 and July 2022. Healthcare providers completed an electronic case report form (eCRF) at baseline and at months 6, 12, and 24 to capture demographics, medical and treatment history, and clinical outcomes.

This analysis of 24-month results includes 257 people with HIV; 211 completed the study and were continuing Cabenuva after 24 months. In the study, 24 people discontinued Cabenuva between month 12 and month 24. An additional 43 participants had discontinued, and 8 had unknown status as of month 12 and did not contribute to this analysis. The most common reasons for treatment discontinuation were other (29%), medication cost/access issues (20%), patient preference (20%) and injection reactions/pain (9%).

At month 24, 98% of participants were receiving Cabenuva every two months and 2% were on monthly dosing, and 97% had a most recent viral load of less than 50 c/mL at month 24. There were no new confirmed virologic failures after month 6.

In a separate analysis of the 24-month results from the BEYOND trial, 95% of people with HIV who switched to Cabenuva had a decrease in the psychological challenges associated with treatment. At 24 months, those who switched from daily antiretroviral treatment had increased treatment satisfaction and fewer concerns. Participants also said having more opportunities to engage with healthcare providers was a benefit.

ViiV had been developing a subcutaneous version of Cabenuva, but last year at the International AIDS Conference, the company announced that it would not continue with trials for this version.

A trial of the subcutaneous version found similar efficacy to the intramuscular injection in maintaining suppression of HIV. The phase 3 FLAIR study demonstrated non-inferior efficacy of switching from daily oral therapy to long-acting Cabenuva.

But many patients in a substudy of the FLAIR trial found the self-injectable to be painful and leading to nodules and reddening of the skin. At week nine, 59% of 85 participants preferred the intramuscular injections, most commonly citing less injection site swelling and fewer nodules, and 34% of 85 participants preferred subcutaneous injection, most commonly citing convenience.

In the FLAIR study, the most common injection site reactions from the subcutaneous injection were pain (48%), nodules (34%) and redness (26%). Five participants withdrew because of injection site reactions from the subcutaneous version.