A US observational study of nearly 7,000 adults with HIV-1 found high rates of viral suppression and continued treatment after switching to long-acting injectable Cabenuva.

Real-world study tracks treatment persistence

ViiV Healthcare has reported five years of real-world evidence on Cabenuva, a long-acting combination of cabotegravir and rilpivirine, in adults with HIV-1 who switched from daily oral antiretroviral therapy (ART).

The analysis used data from the OPERA observational cohort and included 6,955 adults who were virologically suppressed before switching treatment between January 2021 and December 2025. Follow-up continued until February 2026.

Among 6,362 people who completed the initial two injections within 67 days of each other, 77% remained in care and on Cabenuva. Median treatment duration was 18 months, with an interquartile range of nine to 31 months.

The findings were announced by ViiV Healthcare, the HIV-focused company majority owned by GSK, ahead of their presentation at IDWeek 2026 in Washington, DC, from 21–24 October.

Viral suppression maintained in most participants

Among 6,058 complete initiators with follow-up viral load measurements, 94% had a last recorded viral load below 50 copies/mL. A total of 81% maintained viral suppression below this threshold at every recorded visit, while 1% experienced confirmed virologic failure.

The cohort included a diverse population: 43% of participants were Black, 32% were Hispanic or Latine, 23% were aged 50 or older, and 30% had a body mass index of at least 30 kg/m². More than half lived in the southern US.

Ricky Hsu, lead study author and national medical director at AIDS Healthcare Foundation, said: “By evaluating nearly 7,000 individuals in routine clinical care, this analysis gathered over the five-year OPERA study adds to and strengthens the clinical and real-world evidence base for long-acting cabotegravir and rilpivirine. The data offer vital, highly encouraging insights around treatment persistence with the long-acting therapy, showing that overall discontinuations were low and not commonly attributed to a lack of therapeutic efficacy or injection site pain. These are important insights for healthcare providers as they consider the full breadth of treatment options available to their patients.”

Reasons for stopping treatment

Healthcare providers completed surveys to investigate suspected treatment discontinuations, which were confirmed for 213 individuals. The most commonly reported reasons for stopping Cabenuva were adherence issues, accounting for 28% of confirmed discontinuations, followed by loss to care at 24% and preference for another treatment regimen at 15%.

Jean van Wyk, chief medical officer at ViiV Healthcare, said: “Long-term, real-world evidence is critical to help us better understand the impact of HIV treatment outside of the clinical trial setting. In this analysis gathered over five years from the OPERA cohort, cabotegravir and rilpivirine demonstrated durable and consistent viral suppression within a large and diverse patient population, with high persistence in routine care. These findings showcase the important role a long-acting injectable (LAI) can play in treatment adherence for people living with HIV and underscore the value of providing options in addition to daily oral regimens. As the leader in long-acting medicines for HIV, we believe LAIs can help bring us closer to ending the HIV epidemic.”

The findings provide information on how long-acting HIV treatment performs in routine clinical practice. However, the observational design does not establish that Cabenuva is more effective than daily oral ART. Participants were already virologically suppressed when they switched, and the median treatment duration was 18 months.

Cabenuva is approved in the US as a complete treatment regimen for eligible adults and adolescents aged 12 and older who weigh at least 35 kg and meet specified criteria, including viral suppression on a stable antiretroviral regimen and no known or suspected resistance to either component.