ViiV Healthcare Reports Five-Year Real-World Evidence Supporting Long-Term Cabenuva Effectiveness in HIV Treatment
ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Shionogi as a shareholder, has announced new real-world evidence from the OPERA observational cohort evaluating five years of experience with Cabenuva (long-acting cabotegravir and rilpivirine [CAB+RPV LA]) for HIV treatment in the United States. The analysis provides insights into treatment durability, viral suppression and persistence among adults living with HIV-1 who switched from daily oral antiretroviral therapy (ART) to a long-acting injectable regimen.
The findings are scheduled to be presented at IDWeek 2026, taking place October 21–24 in Washington, D.C. The analysis draws on data collected between January 2021 and December 2025, with follow-up continuing through February 2026. It included nearly 7,000 adults who had achieved viral suppression before transitioning from oral ART to long-acting cabotegravir and rilpivirine.
The results offer additional evidence on how the injectable regimen performs in routine clinical practice, outside the controlled environment of a clinical trial. Among patients who completed the initial injection phase, most remained in care and continued treatment. Viral load measurements also showed that a high proportion of patients had HIV-1 RNA levels below 50 copies/mL at their most recent measurement.
According to ViiV Healthcare, these observations add to the growing body of clinical and real-world evidence supporting long-acting injectable treatment as an alternative to daily oral medication for eligible people living with HIV.
The analysis assessed two important measures of HIV treatment outcomes: durability and persistence. Treatment durability refers to the ability to maintain viral suppression over time, while persistence describes whether patients remain on their prescribed treatment in routine care. Both measures are important when evaluating long-term HIV management, as maintaining viral suppression helps protect health and reduce the risk of HIV-related complications.
OPERA Cohort Examines Long-Term Treatment Outcomes
The OPERA observational cohort analysis evaluated 6,955 adults with virologically suppressed HIV-1 who switched from daily oral ART to long-acting cabotegravir and rilpivirine between January 2021 and December 2025. Patient follow-up extended through February 2026, allowing researchers to examine treatment experience across a five-year period.
Unlike randomized clinical trials, observational cohort studies use information collected during routine healthcare delivery. These studies can provide insight into how treatments are used in everyday practice, including treatment continuation, viral load outcomes and reasons for discontinuation.
The OPERA analysis focused on patients who were already virologically suppressed when they switched to the injectable regimen. Consequently, its findings primarily inform the experience of this population rather than all people living with HIV-1, including those who have not achieved viral suppression or who may not be suitable candidates for the treatment.
A central objective was to understand whether patients continued receiving CAB+RPV LA and whether viral suppression was maintained after the transition from oral therapy. Researchers also examined reasons for treatment discontinuation to better understand the practical factors that influence long-term use.
Dr. Ricky K. Hsu, lead study author, National Medical Director at AIDS Healthcare Foundation and Adjunct Associate Clinical Professor at NYU Langone Medical Center, highlighted the scale of the analysis and its relevance to clinical practice.
“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,” Hsu said.
He noted that the findings provide encouraging information about persistence with the long-acting regimen. Overall discontinuations were low, and stopping treatment was 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,” Hsu added.
The findings may help healthcare professionals assess the practical benefits and challenges of injectable HIV treatment when discussing options with patients who are considering a change from daily oral medication.
Diverse Patient Population Reflects Routine U.S. HIV Care
The OPERA cohort included a diverse population of adults receiving HIV care across the United States. The demographic profile provides context for interpreting the results and assessing the experience of patients from different age groups, racial and ethnic backgrounds, and geographic regions.
Of the 6,955 adults included in the analysis, 3,002 participants, or 43%, were Black. Hispanic or Latine individuals accounted for 2,215 participants, representing 32% of the cohort. A total of 1,603 participants, or 23%, were aged 50 years or older.
Geographically, 3,959 participants, or 57%, were living in the Southern United States. The analysis also included 2,100 participants, or 30%, with a body mass index (BMI) of at least 30 kg/m².
These characteristics are important because real-world treatment outcomes can be influenced by factors extending beyond a medicine’s pharmacological activity. Access to healthcare, continuity of care, patient preferences, treatment logistics and the ability to attend scheduled appointments can all affect whether patients remain on a regimen.
The inclusion of a large and demographically varied population allows the OPERA analysis to contribute evidence about the use of CAB+RPV LA in routine U.S. healthcare settings. However, demographic representation alone does not establish that outcomes were identical across every subgroup. The reported findings should therefore be interpreted according to the specific populations and endpoints evaluated.
Most Complete Initiators Remained on Long-Acting Treatment
Treatment persistence was one of the principal measures evaluated in the analysis. Researchers assessed persistence among 6,362 complete initiators, defined as participants who completed their first two injections no more than 67 days apart.
Among these complete initiators, 4,879 individuals, or 77%, remained in care and continued CAB+RPV LA. The median treatment duration was 18 months, with an interquartile range of 9 to 31 months.
The median duration indicates that half of the patients had treatment durations at or below 18 months and half had durations at or above that point. The interquartile range describes the middle 50% of treatment durations in the cohort.
The finding that 77% remained in care and on treatment provides a measure of how the injectable regimen was sustained in everyday clinical practice. It also highlights the importance of examining treatment continuation alongside virologic outcomes when evaluating long-term HIV care.
Long-acting injectable therapy offers a different treatment experience from daily oral ART. Instead of taking oral medication every day, eligible patients receive scheduled injections. This can be an attractive option for some individuals who prefer not to take daily pills or who find daily medication routines challenging.
However, injectable treatment also involves practical considerations, including the need to attend healthcare appointments and receive injections according to the prescribed schedule. The OPERA analysis identified adherence-related issues and loss to care among the most frequently reported reasons for discontinuation, illustrating that long-acting treatment does not eliminate every challenge associated with maintaining HIV care.
The persistence results should also be understood in the context of the study definition. The analysis specifically examined complete initiators, rather than treating every individual who began the transition process as part of the same persistence group. This distinction is important when comparing treatment continuation figures across studies.
Viral Suppression Maintained in Most Patients
The analysis also evaluated viral load outcomes among patients who switched to CAB+RPV LA. Viral suppression is a central goal of HIV treatment because it helps preserve immune function, reduce the risk of disease progression and prevent sexual transmission when sustained under established clinical guidance.
Among the 6,058 complete initiators with follow-up viral load measurements, 5,700 individuals, or 94%, had a last measured viral load below 50 copies/mL.
In addition, 4,891 participants, representing 81% of this group, maintained viral suppression at every visit, defined as a viral load below 50 copies/mL. Meanwhile, 68 individuals, or approximately 1%, experienced confirmed virologic failure.
These measures provide complementary information about treatment outcomes. The last available viral load result indicates a patient’s status at the most recent measurement, whereas maintaining suppression at every visit reflects consistency across the available follow-up assessments.
The difference between the two measures is important. A patient may have a viral load below 50 copies/mL at the last measurement without having maintained suppression at every preceding visit. Accordingly, the 94% last-measurement result and the 81% consistent-suppression result describe different aspects of the treatment experience.
The reported 1% rate of confirmed virologic failure also offers insight into an important clinical outcome. Virologic failure occurs when treatment does not maintain the intended level of viral control under the applicable definition. It is clinically significant because inadequate viral suppression can require reassessment of the treatment regimen and evaluation for potential resistance.
The reported outcomes suggest that viral suppression was maintained in most patients in this real-world cohort. Nevertheless, the observational design, the characteristics of the enrolled population and the study’s specific definitions should be considered when interpreting the results. These findings do not establish that every patient will respond similarly or that the injectable regimen is appropriate for all people living with HIV.
Understanding Why Patients Discontinued Treatment
In addition to examining persistence and viral suppression, researchers sought to understand why patients stopped CAB+RPV LA in routine care.
The study used electronic surveys completed by healthcare providers when discontinuation was suspected. Discontinuations were confirmed for 213 individuals, and the analysis identified several commonly reported reasons for stopping treatment.
The most frequently reported reason was adherence-related issues, accounting for 28% of discontinuations, or 59 individuals. Loss to care was the second most common reason, representing 24%, or 51 individuals. Preference for another treatment regimen accounted for 15%, or 31 individuals.
These findings demonstrate that treatment discontinuation can result from several different circumstances. Some patients may have difficulty maintaining the schedule or requirements associated with their treatment, while others may experience interruptions in their relationship with healthcare services. Still others may decide that an alternative regimen better fits their preferences or needs.
The reported reasons also reinforce the importance of individualized HIV care. A treatment that works well for one person may not be the preferred option for another, even when both achieve viral suppression.
Long-acting injectable therapy can reduce the need for daily pill-taking, but patients still need a reliable care pathway for scheduled injections and follow-up. Healthcare teams may therefore need to consider appointment access, continuity of care and patient preferences when determining whether an injectable regimen is appropriate.
The study’s discontinuation findings should be interpreted within the limits of the available survey data. They describe reasons reported for the confirmed discontinuations evaluated and should not automatically be generalized to every patient who discontinued treatment during the broader cohort period.
ViiV Healthcare Highlights the Importance of Real-World Evidence
Jean van Wyk, MBChB, MFPM, Chief Medical Officer at ViiV Healthcare, emphasized the role of long-term observational evidence in understanding treatment performance beyond clinical trials.
“Long-term, real-world evidence is critical to help us better understand the impact of HIV treatment outside of the clinical trial setting,” van Wyk said.
He added that the OPERA analysis demonstrated durable and consistent viral suppression in a large and diverse patient population, alongside 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,” van Wyk said.
“As the leader in long-acting medicines for HIV, we believe LAIs can help bring us closer to ending the HIV epidemic,” he added.
ViiV Healthcare’s focus on long-acting treatment reflects an effort to expand the range of options available to people living with HIV. Treatment choice can be an important component of person-centered care, particularly when patients and healthcare professionals are balancing viral suppression, treatment preferences and the practical demands of long-term medication use.
The OPERA analysis contributes evidence on how CAB+RPV LA performs in routine practice among adults who were virologically suppressed before switching from oral ART. Its findings complement clinical trial evidence by describing treatment continuation, viral load results and reported discontinuation reasons in a real-world population.
Findings to Be Presented at IDWeek 2026
The OPERA cohort results are scheduled for presentation at IDWeek 2026 in Washington, D.C., from October 21 through October 24. The meeting provides a forum for sharing research and clinical developments in infectious diseases.
The five-year analysis offers several key observations: among complete initiators, 77% remained in care and on CAB+RPV LA; 94% of those with follow-up viral load measurements had a last measured viral load below 50 copies/mL; 81% maintained viral suppression at every visit; and approximately 1% experienced confirmed virologic failure.
The study also identified adherence issues, loss to care and preference for another regimen as the most commonly reported reasons for stopping treatment among the confirmed discontinuations examined.
Taken together, the findings add to the real-world evidence base for long-acting cabotegravir and rilpivirine as a treatment option for appropriately selected adults with HIV-1. They also underscore that successful HIV management involves more than the choice of medication: ongoing viral load monitoring, patient preferences, access to care and continuity of treatment remain important considerations.
As long-acting treatment options continue to develop, real-world studies such as OPERA can help clinicians and patients make more informed decisions about available regimens. The findings presented at IDWeek 2026 are expected to contribute further insight into the long-term use of injectable HIV therapy in routine clinical care.
About Cabenuva (cabotegravir + rilpivirine)
Cabenuva is indicated as a complete regimen for the treatment of HIV-1 infection in adults and adolescents 12 years and older and weighing at least 35 kg to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA <50 c/ml) on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine.
The complete regimen combines the INSTI cabotegravir, developed by ViiV Healthcare, with rilpivirine, a non-nucleoside reverse transcriptase inhibitor (NNRTI) developed by Johnson & Johnson. Rilpivirine tablets are approved in the U.S. and when used with cabotegravir is indicated for short-term treatment of HIV-1 infection in adults and adolescents 12 years and older and weighing at least 35 kg who are virologically suppressed (HIV-1 RNA less than 50 copies/mL) on a stable regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine.
INSTIs inhibit HIV replication by preventing the viral DNA from integrating into the genetic material of human immune cells (T-cells). This step is essential in the HIV replication cycle and is also responsible for establishing chronic disease. Rilpivirine is an NNRTI that works by interfering with an enzyme called reverse transcriptase, which stops the virus from multiplying.
Please consult the full Prescribing Information here.
About ViiV Healthcare
ViiV Healthcare is a global specialist HIV company established in November 2009 with GSK (LSE: GSK) and Shionogi as current shareholders. The company is dedicated to delivering advances in treatment and care for people living with HIV and for people who could benefit from HIV prevention. ViiV Healthcare’s aims to take a deeper and broader interest in HIV and AIDS than any company has done before and take a new approach to deliver effective and innovative medicines for HIV treatment and prevention, as well as support communities affected by HIV.