CABENUVA DEMONSTRATES SUPERIORITY TO DAILY ORAL THERAPY IN ADOLESCENTS LIVING WITH HIV, AS ViiV HEALTHCARE HIGHLIGHTS NEW LONG-ACTING INJECTABLE DATA AT AIDS 2026

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Superiority data from LATA, together with OPERA findings, add to the clinical and real-world evidence base for long-acting injectable Cabenuva
Six-month follow-up CLARITY data further reinforce a more favourable injection experience with long-acting cabotegravir compared with lenacapavir after a single dose; additional studies showcase high real-world adherence and a preference for Apretude among previous oral PrEP users
EXTEND 4M explores a new investigational intramuscular cabotegravir formulation dosed three times a year for HIV prevention, as part of broader long-acting pipeline data

London, 29 July 2026 – ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Shionogi as a shareholder, today announced data to be presented this week at the 26^th International AIDS Conference (AIDS 2026) in Rio de Janeiro, Brazil. Multiple studies span long-term outcomes, real-world use, injection experience, adherence and future long-acting options for HIV treatment and prevention.

Jean van Wyk, MBChB, MFPM, Chief Medical Officer at ViiV Healthcare, said: “The data presented at AIDS 2026 underscore the depth and breadth of evidence ViiV Healthcare has generated for long-acting injectables across HIV treatment and prevention. With OPERA, real-world evidence from nearly 6,800 adults in routine care shows Cabenuva maintained high and comparable virologic suppression to daily oral therapy, helping us better understand how it performs outside clinical trials and supports people over time. Together with clinical and patient-reported data, this evidence provides a trusted foundation for the next generation of innovation, shaped by people affected by HIV and designed to deliver impact at scale.”

Superiority data from LATA, together with OPERA findings, add to the clinical and real-world evidence base for cabotegravir + rilpivirine (CAB+RPV LA) in long-acting HIV treatment.

Week 96 results from the LATA trial, led by University College London, showed CAB+RPV LA dosed every two months was superior to daily oral dolutegravir/tenofovir disoproxil fumarate/lamivudine (DTG/TDF/3TC) in 476 virologically suppressed adolescents aged 12 to 19 years living with HIV in Kenya, South Africa, Uganda and Zimbabwe.¹

Confirmed viral rebound occurred in 0.9% (n=2/235) of adolescents receiving CAB+RPV LA versus 6.4% (n=15/241) receiving daily oral therapy.
94% (n=215/228) reported that long-acting injections were much easier to take than daily oral therapy.
The findings contribute to evidence in an adolescent population, where adherence and retention in care can be challenging.

New real-world data from the US-based OPERA cohort showed CAB+RPV LA dosed every two months maintained virologic suppression comparable to daily oral bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) in nearly 6,800 virologically suppressed adults living with HIV.²

89% (n=3,655/4,095) of individuals receiving CAB+RPV LA and 83% (n=2,239/2,699) receiving BIC/FTC/TAF had viral load <50 copies/mL, at a median follow-up of 15 months and 22 months, respectively.
Confirmed virologic failure risk was low and comparable in both groups, occurring in 1% (n=46) of individuals receiving CAB+RPV LA and 2% (n=46) receiving BIC/FTC/TAF.

Six-month follow-up data from CLARITY reinforce a more favourable injection experience with long-acting cabotegravir (CAB LA) versus lenacapavir (LEN) after a single dose; additional studies showcase high real-world adherence and a preference for CAB LA for PrEP among previous oral PrEP users.

The phase I CLARITY study compared participant experience after a single intramuscular dose of CAB LA and a single subcutaneous dose of LEN in 63 participants without HIV-1. Building on earlier Day 22 findings published in Advances in Therapy, follow-up data show injection site reactions (ISRs) were less visible with CAB LA compared with LEN through six-months.^3,4

70% (n=42/60) rated the CAB LA injection experience as “very acceptable” or “totally acceptable,” compared with 37% (n=22/60) for LEN LA.
No healthcare professionals reported challenges with administration and patient management with CAB LA, whereas 3/4 had difficulty with LEN LA administration and 2/4 had difficulty managing participants on LEN LA.

Additional late-breaking participant-reported outcomes from an Injection-Site Reaction Assessment (ISRA) analysis at six months following dosing, showed CAB LA was associated with shorter lasting and less bothersome ISRs, with lower interference with daily activities.⁵

90% (n=54/60) of LEN participants continuing to report nodules after six-months, compared to only 20% with CAB LA (n=12).
No severe CAB-associated ISRs were reported, while 11/54 (20%) of LEN LA-associated nodules were reported as severe.
At Day 90, 92% of participants receiving CAB LA (n=56/61) reported they were not bothered by ISRs, compared with 58% receiving LEN LA (n=36/62).
No participants receiving CAB LA reported being “quite a lot” or “very much bothered” by ISRs, compared with 12% (n=7/60) receiving LEN LA.
These findings highlight the importance of ISRs in the injection experience in including patient-provider consideration that visible, persistent or bothersome ISRs may affect people’s daily lives.

CAPTIVATE found strong preference for CAB LA for PrEP among people with prior oral PrEP experience and positive provider experiences delivering CAB LA for PrEP in US clinical practice.^6,7The study included 241 PrEP users and 36 healthcare providers across 18 US sites.

Among participants with prior PrEP / oral PrEP experience, 97% (n=185/190) preferred CAB LA for PrEP, compared to daily oral PrEP (2%).
Nearly all participants reported feeling protected from HIV (99%; n=239/241) and less worried about acquiring HIV (99%; n=238), as well as feeling more in control of their life (91%; n=219) because they use CAB LA for PrEP.
Among healthcare providers, 89% (n=16/18) reported a positive overall opinion of administering CAB LA for PrEP in their practice. Prescribers cited benefits of regular injection visits, including assurance of adherence (89%), more frequent STI testing (72%) and opportunities to address other health needs (61%)
These findings support CAB LA for PrEP as a preferred option for those who value control and engagement with their broader care, as well as convenience.

PrEPFACTS showed that people using CAB LA for PrEP had high adherence to their dosing schedule, in a large US real-world analysis of 2,913 people.⁸

Overall adherence was high, with a median proportion of days covered (PDC) of 1.00 (IQR: 0.96-1.00), indicating high coverage during measured follow-up.
89% (n=2,588) were covered by PrEP for at least 90% of the measured period.
Most continuation injections were given within recommended timeframes, including 85% (n= 9,798/11,476) within 67 days and 96% (n=11,009/11,476) within 90 days.
These findings add to real-world evidence that people can maintain adherence with CAB LA for PrEP, an important factor for maintaining protection.

EXTEND 4M baseline data describe diverse enrolment in the first study of a new investigational intramuscular cabotegravir formulation dosed three times a year for HIV prevention, representative of those who could benefit from PrEP in the real-world.

Baseline data from the phase IIb EXTEND 4M registrational study include 229 participants aged 16 years and older enrolled across 27 US sites in regions with significant HIV transmission among subpopulations disproportionately affected by HIV.⁹

Participants include 45% assigned female sex at birth, 32% Black or African American participants and 37% Hispanic/Latine participants.
28% of participants had previous oral PrEP use.
The study will assess pharmacokinetics, safety and tolerability, designed to support a potential HIV prevention option that could reduce clinic visits while maintaining regular screening and care. Data is expected to be presented at a future medical congress.

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

APRETUDE (cabotegravir) extended-release injectable suspension
Professional Indication and Important Safety Information

INDICATION

APRETUDE is indicated for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection in adults and adolescents weighing at least 35 kg who are at risk for HIV-1 acquisition. Individuals must have a negative HIV-1 test prior to initiating APRETUDE (with or without an oral lead-in with oral cabotegravir) for HIV-1 PrEP.

IMPORTANT SAFETY INFORMATION
BOXED WARNING: RISK OF DRUG RESISTANCE WITH USE OF APRETUDE FOR HIV-1 PRE-EXPOSURE PROPHYLAXIS (PrEP) IN UNDIAGNOSED HIV-1 INFECTION

Individuals must be tested for HIV-1 infection prior to initiating APRETUDE or oral cabotegravir, and with each subsequent injection of APRETUDE, using a test approved or cleared by the FDA for the diagnosis of acute or primary HIV-1 infection. Drug-resistant HIV-1 variants have been identified with use of APRETUDE by individuals with undiagnosed HIV-1 infection. Do not initiate APRETUDE for HIV-1 PrEP unless negative infection status is confirmed. Individuals who acquire HIV-1 while receiving APRETUDE for PrEP must transition to a complete HIV-1 treatment regimen.

CONTRAINDICATIONS

Do not use APRETUDE in individuals:
- with unknown or positive HIV-1 status
- with previous hypersensitivity reaction to cabotegravir
- receiving carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifampin, and rifapentine

WARNINGS AND PRECAUTIONS
Comprehensive Management to Reduce the Risk of HIV-1 Infection:

Use APRETUDE as part of a comprehensive prevention strategy, including adherence to the administration schedule and safer sex practices, including condoms, to reduce the risk of sexually transmitted infections (STIs). APRETUDE is not always effective in preventing HIV-1 acquisition. Risk for HIV-1 acquisition includes, but is not limited to, condomless sex, past or current STIs, self-identified HIV risk, having sexual partners of unknown HIV-1 viremic status, or sexual activity in a high prevalence area or network. Inform, counsel, and support individuals on the use of other prevention measures (e.g., consistent and correct condom use; knowledge of partner[s] HIV-1 status, including viral suppression status; regular testing for STIs)
Use APRETUDE only in individuals confirmed to be HIV-1 negative. HIV-1 resistance substitutions may emerge in individuals with undiagnosed HIV-1 infection who are taking only APRETUDE, because APRETUDE alone does not constitute a complete regimen for HIV-1 treatment. Prior to initiating APRETUDE, ask seronegative individuals about recent (in past month) potential exposure events and evaluate for current or recent signs or symptoms consistent with acute HIV-1 infection (e.g., fever, fatigue, myalgia, skin rash). If recent (<1 month) exposures to HIV-1 are suspected or clinical symptoms consistent with acute HIV-1 infection are present, use a test approved or cleared by the FDA as an aid in the diagnosis of acute HIV-1 infection
When using APRETUDE, HIV-1 testing should be repeated prior to each injection and upon diagnosis of any other STIs
Additional HIV testing to determine HIV status is needed if an HIV-1 test indicates possible HIV-1 infection or if symptoms consistent with acute HIV-1 infection develop following an exposure event. If HIV-1 infection is confirmed, then transition the individual to a complete HIV-1 treatment
Counsel individuals without HIV-1 to strictly adhere to the recommended dosing and testing schedule for APRETUDE

Potential Risk of Resistance with APRETUDE:

There is a potential risk of developing resistance to APRETUDE if an individual acquires HIV-1 either before, while taking, or following discontinuation of APRETUDE. To minimize this risk, it is essential to clinically reassess individuals for risk of HIV-1 acquisition and to test before each injection to confirm HIV-1–negative status. Individuals who are confirmed to have HIV-1 infection must transition to a complete HIV-1 treatment. If individuals at continuing risk of HIV-1 acquisition discontinue APRETUDE, alternative forms of PrEP should be considered and initiated within 2 months of the final injection of APRETUDE

Long-Acting Properties and Potential Associated Risks with APRETUDE:

Residual concentrations of cabotegravir may remain in the systemic circulation of individuals for prolonged periods (up to 12 months or longer). Take the prolonged-release characteristics of cabotegravir into consideration and carefully select individuals who agree to the required every-2-month injection dosing schedule because non-adherence or missed doses could lead to HIV-1 acquisition and development of resistance

Hypersensitivity Reactions:

Serious or severe hypersensitivity reactions have been reported in association with other integrase inhibitors and could occur with APRETUDE
Discontinue APRETUDE immediately if signs or symptoms of hypersensitivity reactions develop. Clinical status, including liver transaminases, should be monitored and appropriate therapy initiated

Hepatotoxicity:

Hepatotoxicity has been reported in a limited number of individuals receiving cabotegravir with or without known pre-existing hepatic disease or identifiable risk factors
Clinical and laboratory monitoring should be considered and APRETUDE should be discontinued if hepatotoxicity is suspected and individuals managed as clinically indicated

Depressive Disorders:

Depressive disorders (including depression, depressed mood, major depression, persistent depressive disorder, suicidal ideation or attempt) have been reported with APRETUDE
Promptly evaluate patients with depressive symptoms

Risk of Reduced Drug Concentration of APRETUDE Due to Drug Interactions:

The concomitant use of APRETUDE and other drugs may result in reduced drug concentration of APRETUDE
Refer to the full Prescribing Information for steps to prevent or manage these possible and known significant drug interactions, including dosing recommendations. Consider the potential for drug interactions prior to and during use of, and after discontinuation of APRETUDE; review concomitant medications during use of APRETUDE

ADVERSE REACTIONS

The most common adverse reactions (incidence ≥1%, all grades) with APRETUDE were injection site reactions, diarrhea, headache, pyrexia, fatigue, sleep disorders, nausea, dizziness, flatulence, abdominal pain, vomiting, myalgia, rash, decreased appetite, somnolence, back pain, and upper respiratory tract infection.

DRUG INTERACTIONS

Refer to the full Prescribing Information for important drug interactions with APRETUDE
Drugs that induce UGT1A1 may significantly decrease the plasma concentrations of cabotegravir

USE IN SPECIFIC POPULATIONS

Lactation: Assess the benefit-risk of using APRETUDE to the infant while breastfeeding due to the potential for adverse reactions and residual concentrations in the systemic circulation for up to 12 months or longer after discontinuation
Pediatrics: Not recommended in individuals weighing less than 35 kg

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

Trademarks are owned by or licensed to the ViiV Healthcare group of companies.

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 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.

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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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References:

M. B. Dangarembiz, et al. Eight-weekly injectable cabotegravir and rilpivirine is superior to daily oral tenofovir disoproxil fumarate/lamivudine/dolutegravir in adolescents living with HIV in sub-Saharan Africa: LATA 96-week results. Presented at the 26th International AIDS Conference (AIDS 2026). July 2026.
R. Hsu, et al. Comparable virologic effectiveness with long-acting cabotegravir + rilpivirine vs. daily bictegravir/emtricitabine/tenofovir alafenamide in the US-based OPERA Cohort. Presented at the 26th International AIDS Conference (AIDS 2026). July 2026.
E. R. Elliot, et al. Long-Acting Cabotegravir Injections Are More Acceptable Than Long-Acting Lenacapavir Injections After One Dose: Results From the CLARITY Randomized Crossover Study. Adv Ther. 2026. https://doi.org/10.1007/s12325-026-03703-3
K. L. Nelson, et al. Participant and Provider Experiences With Long-Acting Cabotegravir vs Lenacapavir Injections: Results From the CLARITY Study. Presented at the 26th International AIDS Conference (AIDS 2026). July 2026.
L. Dupont-Benjamin, et al. Presence, Severity, Interference With Usual and Daily Life Activities and Bothersomeness of Injection Site Reactions With Cabotegravir vs Lenacapavir: Insights From Participant Reported Outcomes in the CLARITY Study. Presented at the 26th International AIDS Conference (AIDS 2026). July 2026.
M. Brizzi, et al. Real-world experience using cabotegravir long-acting for HIV-1 pre-exposure prophylaxis in the united states from cross-sectional surveys and retrospective chart reviews: results from the CAPTIVATE study. Presented at the 26th International AIDS Conference (AIDS 2026). July 2026.
K. Visnyei, et al. Operational insights for long-acting cabotegravir for HIV-1 pre-exposure prophylaxis: findings from the CAPTIVATE United States healthcare provider survey. Presented at the 26th International AIDS Conference (AIDS 2026). July 2026.
G. F. Herman, et al. Real-world utilization and adherence of cabotegravir long-acting for HIV pre-exposure prophylaxis in the United States: Updated results from the PrEPFACTS study using healthcare administrative claims data. Presented at the 26th International AIDS Conference (AIDS 2026). July 2026.
C. Acuipil, et al. Baseline demographics in the phase 2b registrational EXTEND 4M trial: evaluating a novel every-4-month cabotegravir formulation in a population who could benefit from PrEP. Presented at the 26th International AIDS Conference (AIDS 2026). July 2026.