**ViiV HEALTHCARE REPORTS LONG-ACTING INJECTABLE CABENUVA EFFECTIVELY MAINTAINS VIRAL SUPPRESSION IN ADOLESCENTS LIVING WITH HIV, WITH >97% PREFERRING INJECTIONS OVER DAILY ORAL TREATMENT**

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IMPAACT 2017 (MOCHA) week 96 results show long-acting Cabenuva (cabotegravir + rilpivirine) effectively maintained viral suppression in 94.4% of adolescents aged 12 to <18 years
Additional paediatric data presented at CROI 2026 include IMPAACT 2036 (CRAYON), the first study to provide pharmacokinetic and safety data on long-acting cabotegravir + rilpivirine in children as young as two years

London, 24 February 2026 – ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders,* today announced week 96 and end‑of‑study results from the phase I/II IMPAACT 2017 (MOCHA) study, the first trial to evaluate a complete injectable long‑acting treatment regimen in adolescents living with HIV.¹

Results showed 94.4% of virologically suppressed adolescents aged 12 to <18 years who switched from daily oral HIV treatment to long-acting cabotegravir + rilpivirine (CAB + RPV LA) every two months maintained viral suppression at week 96, with >97% indicating a preference for injections over daily oral therapy at all weeks.

The data were presented today at the 33rd Conference on Retroviruses and Opportunistic Infections (CROI 2026) in Denver, Colorado.

Kimberly Smith, M.D., MPH, Head of Research & Development at ViiV Healthcare, said: “IMPAACT 2017 is a landmark trial and the first to show that the only complete injectable long-acting regimen, cabotegravir + rilpivirine, can maintain virologic suppression in adolescents for nearly two years, with a clear preference for injections over daily pills. For adolescents – one of the most vulnerable and underserved populations in the HIV epidemic – long-acting cabotegravir + rilpivirine offers an important alternative to the daily pill burden and stigma that can come with it. IMPAACT 2017 is a powerful example of ViiV’s commitment to developing innovative treatment options that address individual needs for everyone living with HIV.”

Aditya Gaur, M.D., St. Jude Children’s Research Hospital and co-lead investigator of IMPAACT 2017 (MOCHA) said: “Adolescents living with HIV often face unique developmental, social and adherence challenges, so the dosing flexibility and freedom offered by long-acting injectables is especially important. In IMPAACT 2017, every adolescent who expressed a preference after almost two years of treatment chose the injectable regimen over daily pills. For many, it was the first time in their lives they did not have to take an oral HIV medicine every day, and moving to a brief clinic visit every 2 months can help reduce daily reminders of HIV.”

The International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) Network 2017 / MOCHA is a phase I/II study evaluating a complete injectable regimen of CAB + RPV LA in 144 virologically suppressed adolescents aged 12 to <18 years and ≥35 kg who switched from daily oral ART.

Week 96 and end‑of‑study results showed that CAB + RPV LA given every two months maintained viral suppression (94.4% n=136/144) with no confirmed virologic failures. At all weeks evaluated, >97% (n=138/142; week 8) of participants preferred long-acting injections over daily oral antiretroviral therapy. At week 96, 95% (n=137/144) completed treatment, and preference for injections was 100% (n=135/135).

The long-acting regimen was generally well tolerated, with 42% (n=60/144) experiencing a drug-related adverse event (AE), the most common of which were cough (31.9% n=46), headache (26.4% n=38) and upper respiratory tract infections (20.1% n=29). Of 142 participants with at least one injection, 37% (n=52/142) reported injection site reactions, which were mostly mild to moderate injection site pain that typically resolved within one week. Two drug-related grade 3 AEs and one grade 4 reaction were observed, and all resolved.

These findings show that a complete injectable long‑acting regimen can provide sustained viral suppression and is generally well tolerated for adolescents living with HIV.

IMPAACT 2036 extends CAB + RPV LA to younger children, including those under 20 kg²

Interim data from IMPAACT 2036, an ongoing phase I/II study in virologically suppressed children aged 2 to <12 years and weighing 10 to <40 kg, provide the first pharmacokinetic and safety evidence for CAB + RPV LA in young children, including those weighing less than 20 kg, informing the potential of extending long‑acting injectable treatment to earlier paediatric age and lower weight groups.

Results showed that CAB + RPV LA achieved protocol‑defined pharmacokinetic targets, with plasma concentrations similar to those observed in adolescents and adults receiving long‑acting therapy. No new or unexpected safety signals were seen; grade ≥3 adverse events occurred in 10% (n=6/61) of children, including two drug-related grade 2 and one grade 3 post-injection reaction; all events resolved. Injection site pain was the most common adverse event, reported in 46% (n=28/61) of children, and was limited to grade 1-2.

IMPAACT 2017 (MOCHA; More Options for Children and Adolescents) and IMPAACT 2036 (CRAYON; Cabotegravir and Rilpivirine Long-Acting Injections in Young Children) are supported collaborative studies, sponsored by the Division of AIDS (DAIDS) within the National Institutes of Health (NIH) and conducted by the IMPAACT Network. Both trials are funded with support from ViiV Healthcare and Johnson & Johnson.

CABENUVA (cabotegravir; rilpivirine) extended-release injectable suspensions
Professional Indication and Important Safety Information

INDICATION

CABENUVA is indicated as a complete regimen for the treatment of HIV-1 infection in adults and adolescents 12 years of age and older and weighing at least 35 kg to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine.

IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS

Do not use CABENUVA in patients with previous hypersensitivity reaction to cabotegravir or rilpivirine
Do not use CABENUVA in patients receiving carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifabutin, rifampin, rifapentine, systemic dexamethasone (>1 dose), and St John’s wort

WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions:

Serious or severe hypersensitivity reactions have been reported in association with other integrase inhibitors and could occur with CABENUVA
Hypersensitivity reactions, including cases of drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported during postmarketing experience with rilpivirine-containing regimens. While some skin reactions were accompanied by constitutional symptoms such as fever, other skin reactions were associated with organ dysfunctions, including elevations in hepatic serum biochemistries
Discontinue CABENUVA immediately if signs or symptoms of hypersensitivity reactions develop. Clinical status, including liver transaminases, should be monitored and appropriate therapy initiated. Cabotegravir and rilpivirine oral lead-in may be used to help identify patients who may be at risk of a hypersensitivity reaction

Post-Injection Reactions:

Serious post-injection reactions (reported in less than 1% of subjects) were reported within minutes after the injection of rilpivirine, including dyspnea, bronchospasm, agitation, abdominal cramping, rash/urticaria, dizziness, flushing, sweating, oral numbness, changes in blood pressure, and pain (e.g., back and chest). These events may have been associated with accidental intravenous administration and began to resolve within a few minutes after the injection
Carefully follow the Instructions for Use when preparing and administering CABENUVA. The suspensions should be injected slowly via intramuscular injection and avoid accidental intravenous administration. Observe patients briefly (approximately 10 minutes) after the injection. If a post-injection reaction occurs, monitor and treat as clinically indicated

Hepatotoxicity:

Hepatotoxicity has been reported in patients receiving cabotegravir or rilpivirine with or without known pre-existing hepatic disease or identifiable risk factors
Patients with underlying liver disease or marked elevations in transaminases prior to treatment may be at increased risk for worsening or development of transaminase elevations
Monitoring of liver chemistries is recommended and treatment with CABENUVA should be discontinued if hepatotoxicity is suspected

Depressive Disorders:

Depressive disorders (including depressed mood, depression, major depression, mood altered, mood swings, dysphoria, negative thoughts, suicidal ideation, suicide attempt) have been reported with CABENUVA or the individual products
Promptly evaluate patients with depressive symptoms
Risk of Adverse Reactions or Loss of Virologic Response Due to Drug Interactions:
- The concomitant use of CABENUVA and other drugs may result in known or potentially significant drug interactions (see Contraindications and Drug Interactions)
- Rilpivirine doses 3 and 12 times higher than the recommended oral dosage can prolong the QTc interval
- CABENUVA should be used with caution in combination with drugs with a known risk of Torsade de Pointes

Long-Acting Properties and Potential Associated Risks with CABENUVA:

Residual concentrations of cabotegravir and rilpivirine may remain in the systemic circulation of patients for prolonged periods (up to 12 months or longer). Select appropriate patients who agree to the required monthly or every-2-month injection dosing schedule because non-adherence could lead to loss of virologic response and development of resistance
To minimize the potential risk of developing viral resistance, it is essential to initiate an alternative, fully suppressive antiretroviral regimen no later than 1 month after the final injection doses of CABENUVA when dosed monthly and no later than 2 months after the final injections of CABENUVA when dosed every 2 months. If virologic failure is suspected, switch the patient to an alternative regimen as soon as possible

ADVERSE REACTIONS

The most common adverse reactions in adults (incidence ≥2%, all grades) treated with CABENUVA were injection site reactions, pyrexia, fatigue, headache, musculoskeletal pain, nausea, sleep disorders, dizziness, and rash
The safety of CABENUVA in adolescents is expected to be similar to adults

DRUG INTERACTIONS

Refer to the applicable full Prescribing Information for important drug interactions with CABENUVA, VOCABRIA (cabotegravir), or EDURANT (rilpivirine)
Because CABENUVA is a complete regimen, coadministration with other antiretroviral medications for the treatment of HIV-1 infection is not recommended
Drugs that are strong inducers of UGT1A1 or UGT1A9 are expected to decrease the plasma concentrations of cabotegravir. Drugs that induce or inhibit CYP3A may affect the plasma concentrations of rilpivirine
CABENUVA should be used with caution in combination with drugs with a known risk of Torsade de Pointes

USE IN SPECIFIC POPULATIONS

Pregnancy: There are insufficient human data on the use of CABENUVA during pregnancy to adequately assess a drug-associated risk for birth defects and miscarriage. Discuss the benefit-risk of using CABENUVA during pregnancy and conception and consider that cabotegravir and rilpivirine are detected in systemic circulation for up to 12 months or longer after discontinuing injections of CABENUVA. An Antiretroviral Pregnancy Registry has been established

Lactation: Potential risks of breastfeeding include HIV-1 transmission, developing viral resistance in HIV-positive infants, and adverse reactions in a breastfed infant

For more information, please see full US Prescribing Information for CABENUVA: https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Cabenuva/pdf/CABENUVA-PI-PIL-IFU2-IFU3.PDF

About IMPAACT

The International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) Network is a global collaboration of investigators, institutions, community representatives, and other partners with a mission to improve health outcomes in infancy, childhood, adolescence, pregnancy, and postpartum among those who are impacted by or living with HIV, tuberculosis, and other related complications through the conduct of high-quality clinical trials. IMPAACT’s vision and overall goal is to end the worldwide HIV epidemic among these populations. To achieve this goal, the IMPAACT Network evaluates novel and durable treatments for HIV, TB, and related diseases and conditions, strategies for antiretroviral treatment (ART)-free remission, and strategies to prevent and manage neuropsychological and mental health complications of HIV and its treatment. Overall support and funding for IMPAACT is provided by the National Institute of Allergy and Infectious Diseases (NIAID), with support and co-funding from the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) and the National Institute of Mental Health (NIMH), all components of the United States National Institutes of Health (NIH). The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH. For more information, please visit: www.impaactnetwork.org.

About the National Institutes of Health (NIH)

NIH, the nation’s medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit: www.nih.gov.

About ViiV Healthcare

ViiV Healthcare is a global specialist HIV company established in November 2009 by GSK (LSE: GSK) and Pfizer (NYSE: PFE) dedicated to delivering advances in treatment and care for people living with HIV and for people who could benefit from HIV prevention. Shionogi became a ViiV shareholder in October 2012. The company’s aims are 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.

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*On 20 January 2026, GSK plc and Shionogi & Co., Ltd announced that they have reached agreement together with Pfizer Inc. for the economic interest in ViiV Healthcare Limited currently held by Pfizer to be replaced with an investment by Shionogi. Completion of the transaction is subject to certain regulatory clearances in relevant markets, and is expected to occur during the first quarter of 2026.

References:

A. Gaur et al. Long-Acting Cabotegravir+Rilpivirine in Adolescents: IMPAACT 2017 Week 96 & End of Study Results. Presented at the 33rd Conference on Retroviruses and Opportunistic Infections (CROI). February 2026
M. Archary et al. Safety And Pharmacokinetics of Long-Acting Cabotegravir and Rilpivirine in Young Children 10 - <40kg. Presented at the 33rd Conference on Retroviruses and Opportunistic Infections (CROI). February 2026.