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

ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Shionogi as a shareholder, today announced evidence from the OPERA observational cohort spanning five years of real-world use of Cabenuva (long-acting cabotegravir and rilpivirine [CAB+RPV LA]) for HIV treatment in the U.S. and offering important insights into long-term clinical outcomes for adults living with HIV-1.

The study evaluated treatment durability – defined as maintaining viral suppression over time – and persistence, defined as remaining on therapy in routine care. In HIV care, durability and persistence are important clinical measures to help protect long-term health and prevent drug resistance. Among virologically suppressed adults in the United States who switched from oral antiretroviral therapy (ART) to CAB+RPV LA, after a median treatment duration of 18 months, the data highlight the sustained effectiveness of the long-acting injectable regimen for HIV treatment.

The findings will be presented at IDWeek 2026 in Washington, D.C., to be held October 21–24.

Dr. Ricky K. Hsu, Lead Study Author, National Medical Director, AIDS Healthcare Foundation and Adjunct Associate Clinical Professor at NYU Langone Medical Center, 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.”

The OPERA cohort analysis evaluated 6,955 virologically suppressed adults who switched from a daily oral ART to CAB+RPV LA between January 2021 and December 2025, with follow-up through February 2026. A diverse, real-world population was included in the study: 43% of participants were Black (n=3,002), 32% Hispanic/Latine (n=2,215), 23% aged ≥50 years (n=1,603), 57% (n=3,959) living in the Southern U.S., and 30% with BMI≥30kg/m² (n=2,100).¹

Among 6,362 complete initiators (participants who complete the first two injections ≤67 days apart), 77% (n=4,879) remained in care and on CAB+RPV LA, with a median treatment duration of 18 months (IQR: 9, 31). Among 6,058 complete initiators with follow-up viral load (VL), 94% (n=5,700) of individuals had their last viral load measured at <50 copies/mL, 81% (n=4,891) maintained viral suppression at every visit (<50 copies/mL), and 1% (n=68) experienced confirmed virologic failure.¹

Jean van Wyk, MBChB, MFPM, 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.”

To evaluate treatment persistence, the study used electronic surveys completed by healthcare providers with suspected CAB+RPV LA discontinuations in their patients, and discontinuations were confirmed for 213 individuals. The most common reported reasons for stopping CAB+RPV LA were adherence issues (28%, n=59), loss to care (24%, n=51), and preference for another regimen (15%, n=31).¹

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.

For more information on the company, its management, portfolio, pipeline, and commitment, please visit viivhealthcare.com.

About GSK

GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at gsk.com.

Cautionary statement regarding forward-looking statements

GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described in the “Risk Factors” section in GSK’s Annual Report on Form 20-F for 2025, and GSK’s Q2 Results for 2026.

Reference:

1. 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, 2026; Washington, DC

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