ViiV Reports 77% Cabenuva Treatment Persistence in U.S. Cohort

ViiV Healthcare reported on October 21, 2026, that 77% of adults who switched to long-acting cabotegravir plus rilpivirine (CAB+RPV LA) in routine U.S. care remained in care and on treatment. Among participants with follow-up viral-load measurements, 94% had a last recorded HIV-1 RNA level below 50 copies/mL. Confirmed virologic failure occurred in approximately 1% of participants in the effectiveness analysis. The findings from the OPERA observational cohort were presented at IDWeek 2026 in Washington, D.C.

The results provide real-world evidence on treatment persistence and viral suppression following a switch from daily oral antiretroviral therapy (ART). However, median treatment duration was 18 months, so the five-year evidence window should not be interpreted as five years of treatment exposure for the typical participant.

Assessing durability and persistence in long-acting HIV treatment

Maintaining viral suppression and remaining on treatment are important considerations in HIV management. Treatment interruptions can increase the risk of viral rebound and may contribute to drug resistance.

Cabenuva combines cabotegravir, an integrase strand transfer inhibitor developed by ViiV Healthcare, with rilpivirine, a non-nucleoside reverse transcriptase inhibitor. It is indicated for eligible adults and adolescents aged 12 years or older who weigh at least 35 kg, have HIV-1 RNA below 50 copies/mL on a stable regimen, have no history of treatment failure, and have no known or suspected resistance to either component.

Randomised clinical trials established the regimen’s efficacy. The OPERA analysis examines outcomes among people who switched from oral ART to long-acting injections in routine clinical practice.

OPERA cohort and study population

The analysis included 6,955 virologically suppressed adults who switched to CAB+RPV LA between January 2021 and December 2025, with follow-up through February 2026.

The cohort included Black adults (43%; 3,002 participants), Hispanic/Latine adults (32%; 2,215), adults aged 50 years or older (23%; 1,603), participants living in the Southern United States (57%; 3,959), and participants with a body mass index of at least 30 kg/m² (30%; 2,100).

Black and Hispanic/Latine adults together represented approximately three-quarters of participants. These characteristics demonstrate the cohort’s demographic composition but do not establish whether outcomes differed between demographic groups.

Treatment persistence and viral suppression

The effectiveness analysis focused on 6,362 complete initiators, defined as participants who received their first two injections no more than 67 days apart.

Among these participants, 4,879 (77%) remained in care and on CAB+RPV LA. Median treatment duration was 18 months, with an interquartile range of 9–31 months.

Among 6,058 participants with follow-up viral-load measurements, 5,700 (94%) had a last recorded viral load below 50 copies/mL. Continuous viral suppression, defined as viral load below 50 copies/mL at every recorded visit, was observed in 4,891 participants (81%). Confirmed virologic failure occurred in 68 participants, approximately 1% of the effectiveness-analysis population.

The difference between the 94% and 81% results is clinically relevant. The first reflects suppression at the last available measurement, whereas the second requires suppression at every recorded visit. These outcomes provide different perspectives on viral control and should not be interpreted interchangeably. The last-measurement result may also not represent participants without follow-up viral-load data.

Why did some participants discontinue treatment?

Healthcare providers were surveyed about suspected discontinuations, with discontinuation confirmed for 213 individuals. The most frequently reported reasons were adherence issues (28%; 59 individuals), loss to care (24%; 51), and preference for another regimen (15%; 31).

Lead author Dr Ricky Hsu of the AIDS Healthcare Foundation said discontinuations were generally low and were not commonly attributed to lack of efficacy or injection-site pain.

The findings highlight the importance of treatment preferences, continuity of care, and attendance at injection appointments. However, reasons were documented for only 213 confirmed discontinuations and cannot explain every case in which participants did not remain on treatment. The announcement did not provide detailed safety, tolerability, or resistance outcomes.

Clinical interpretation and limitations

The high proportion of participants with a suppressed last recorded viral load and the low observed rate of confirmed virologic failure are encouraging. However, the observational design limits conclusions about comparative effectiveness.

The analysis had no concurrent comparison group and included people who were already virologically suppressed before switching. It therefore cannot establish whether injectable therapy performs better or worse than oral ART. Although enrolment spanned January 2021 to December 2025, median treatment duration was 18 months. The findings represent evidence collected over five years, not proof of five years of treatment durability for most participants. The reported virologic failure rate also does not establish whether failures involved treatment-emergent resistance.

Earlier OPERA analyses presented at CROI 2025 reported real-world effectiveness through two years. Independent cohorts, including Spain’s RELATIVITY study, provide complementary evidence from other healthcare settings; their specific findings and follow-up durations should be interpreted according to the published analyses.

Overall, the OPERA findings extend the real-world evidence base for Cabenuva while highlighting that treatment persistence and sustained viral suppression are distinct outcomes. Longer follow-up and more complete safety, resistance, and discontinuation data will help clarify its longer-term performance in routine care.

References

Five years of U.S. real-world evidence reinforce the durable effectiveness and long-term persistence of ViiV Healthcare’s Cabenuva. ViiV Healthcare, October 21, 2026.

Hsu RK, Sension MG, Fusco JS, et al. High suppression and rare virologic failure with long-acting cabotegravir + rilpivirine: real-world evidence over five years from the OPERA cohort. Presented at IDWeek 2026, October 21–24, Washington, D.C.