Rilpivirine Hydrochloride

The Ask Us Europe survey, led by an academic team in London, and supported by ViiV Healthcare, found 81% of respondents living with HIV recalled having a treatment review, but only 45% had discussed long-acting injectable Vocabria and Rekambys 93% of respondents expressed interest in future long-acting treatment options, with greatest interest in injectable options dosed two or three times a year London, 29 July 2026 – ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Shionogi as a shareholder, today announced new data revealing a gap between interest in long-acting HIV treatment options and the conversations taking place in clinics. The data also highlight inequities in whether long-acting treatment is being discussed during consultations across different demographic groups of people living with HIV in Europe. These findings highlight the need for more proactive, equitable care that ensures people can access options aligned to their needs and preferences. The data come from Ask Us Europe, a community co-produced online survey of more than 1,900 people living with HIV across 18 European countries. Results were presented at the 26th International AIDS Conference (AIDS 2026) in Rio de Janeiro, Brazil. Professor Chloe Orkin, Director of the SHARE Research Collaborative at Queen Mary University of London and Principal Investigator of the Ask Us Europe study, said: “Designing the study with people living with HIV across Europe, the Ask Us Europe study has allowed lived experience to shape the questions we ask and the solutions we recommend. These findings show that many people who could benefit from long-acting treatment are not having these conversations with their healthcare providers, and eligibility alone does not guarantee access. Proactive, open dialogue, and shared decision-making, are essential to ensure people can access the care that is right for them.” Long-acting HIV treatment conversations are not reaching everyone equally An equity analysis from the survey showed conversations about long-acting injectable Vocabria + Rekambys (cabotegravir + rilpivirine (CAB+RPV LA)) and treatment review discussions varied across social and demographic groups, including by age, ethnicity, education and time since diagnosis.1 Among participants who had had a treatment optimisation discussion with their healthcare provider (81% (n=1549/1911)), only 45% (n=558/1246) reported that they had discussed CAB+RPV LA. 19% (n=362/1911) of respondents said they did not ever recall having a treatment review discussion. Respondents aged over 55 years were less likely to have discussed CAB+RPV LA with their healthcare provider than those under the age of 55. These findings show the need for more proactive and equitable conversations in clinic, so people living with HIV can understand the treatment options available to them. Jean van Wyk, MBChB, MFPM, Chief Medical Officer, said: “The Ask Us Europe study shows why community-led research is essential to improving care. By involving people living with HIV and translating their experiences into real-world evidence, these findings highlight a clear gap between the treatment options people want and the conversations they are having with their clinicians. At ViiV Healthcare, we are committed to supporting clinical academic partners and the HIV community to help close that gap, so open dialogue and shared decision-making become part of everyday HIV care.” Strong interest in long-acting HIV treatment options Further data from the survey revealed strong interest in CAB+RPV LA and potential future long-acting HIV treatment options, with greatest interest in future injectables dosed two or three times a year.2 93% (n=1,656/1,782) of respondents expressed interest in future long-acting treatment modalities, with the highest interest in injectables dosed two or three times a year (77% (n=1,371). 68% (n=1,207) expressed interest in monthly orals, and 56% (n=1,000) in weekly orals, while implants (40% (n=721)) and patches (34% (n=604)) were the least favoured. Among those who had ever received CAB+RPV LA, 89% (n=250/282) were interested in future long-acting injectables dosed two or three times a year, while only 20% (n=56) expressed interest in weekly oral options. These findings underscore the importance of developing a range of treatment options that reflect different preferences and needs of people living with HIV. Unmet needs among transgender, non-binary and gender diverse respondents In a sub-analysis of the survey, transgender, non-binary and gender-diverse people living with HIV (n=162) reported greater unmet social support needs and higher interest in CAB+RPV LA compared to cisgender respondents.3 Transgender, non-binary and gender-diverse respondents were more likely to have complex support needs than cisgender respondents (60% (n=97/162) vs 47% (n=809/1,724)), including domestic violence services, drug and alcohol support, meal and foodbank access, and peer support. Transgender people also had higher levels of complex support needs that were unmet compared to cisgender people. 14% (n=23/162) had ever received CAB+RPV LA. Among those not receiving CAB+RPV LA (n=139), 65% of transgender, non-binary and gender-diverse respondents were interested in it.4 Interest in CAB+RPV LA among transgender, non-binary and gender-diverse respondents was driven primarily by adherence concerns, accidental HIV status disclosure, and polypharmacy. Transgender, non-binary and gender-diverse respondents were also more likely to report missed doses including missing a dose by mistake (40% vs 22%) and not taking pills for more than three days (11% vs 5%). These findings highlight the need for HIV care that combines innovation with additional social and clinical support to help improve adherence, quality of life and wellbeing in diverse populations. About Vocabria (cabotegravir) Vocabria injection is indicated - in combination with rilpivirine injection - for the treatment of Human Immunodeficiency Virus type 1 (HIV-1) infection in adults and adolescents (at least 12 years of age and weighing at least 35 kg) who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen without present or past evidence of viral resistance to, and no prior virological failure with agents of the non-nucleoside reverse transcriptase inhibitors (NNRTI) and integrase inhibitor (INI) class. Vocabria tablets are indicated - in combination with rilpivirine tablets - for the short-term treatment of HIV-1 infection in adults and adolescents (at least 12 years of age and weighing at least 35 kg) who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen without present or past evidence of viral resistance to, and no prior virological failure with agents of the NNRTI and INI class for: oral lead-in to assess tolerability of Vocabria and rilpivirine prior to administration of long acting Vocabria injection plus long-acting rilpivirine injection. oral therapy for adults who will miss planned dosing with Vocabria injection plus rilpivirine injection. Vocabria tablets are only indicated for treatment of HIV-1 in combination with rilpivirine tablets, therefore, the prescribing information for Edurant (rilpivirine) tablets should also be consulted for recommended dosing. Please consult the full Summary of Product Characteristics for all the safety information: Vocabria 400mg/600 mg prolonged-release suspension for injection and Vocabria 30 mg film-coated tablets About Rekambys (rilpivirine) Rekambys is indicated - in combination with cabotegravir injection - for the treatment of HIV-1 infection in adults and adolescents (at least 12 years of age and weighing at least 35 kg) who are virologically suppressed (HIV-1 RNA < 50 copies/mL) on a stable antiretroviral regimen without present or past evidence of viral resistance to, and no prior virological failure with, agents of the NNRTI and INI class. Rekambys should always be co-administered with a cabotegravir injection. The prescribing information for cabotegravir injection should be consulted for recommended dosing. Rekambys may be initiated with oral lead-in or without (direct to injection). Please consult the full Summary of Product Characteristics for all the safety information: Rekambys 600mg/900 mg prolonged-release suspension for injection About the Ask Us Europe Study The Ask Us Europe study is an equity-focused, co-produced, mixed-methods study from the SHARE Collaborative in partnership with 18 community members, the European AIDS Treatment Group (EATG) and the UK Community Advisory Board (UK-CAB). The study was designed to capture the real-world perspectives and experiences of people living with HIV on antiretroviral therapy, with a focus on treatment discussions, access to innovation and support needs. Between July 2025 and January 2026, 1,825 people living with HIV completed the online survey across 18 European countries and languages, recruited via social media and community/ clinical networks. The study is led by Principal Investigator Professor Chloe Orkin and is funded by ViiV Healthcare. For more information, please visit: shareresearch.org.uk/ask-us-study/. 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. 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. Registered in England & Wales: GSK plc ViiV Healthcare Limited No. 3888792 No. 06876960 Registered Office: 79 New Oxford Street ViiV Healthcare Limited London GSK Medicines Research Centre WC1A 1DG Gunnels Wood Road, Stevenage United Kingdom SG1 2NY References: ViiV Press Releases & Company Statements For our corporate press office, email: Kate Senter OR call +44 7796 707446 For US-specific media enquiries, email: Rachel Jaikaran OR call +1 9193578932

For Media and Investors only 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 26th 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.6,7 The 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. 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 integrase strand transfer inhibitor (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 US 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 Apretude (cabotegravir long acting) Apretude is a medicine used for preventing sexually transmitted HIV-1 infection (pre-exposure prophylaxis or PrEP) in adults and adolescents weighing at least 35 kg who are at high risk of being infected. It should be used in combination with safer sex practices, such as using condoms. Apretude contains the active substance cabotegravir. Please consult the full Summary of Product Characteristics for all the safety information: Apretude 600 mg prolonged-release suspension for injection 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. 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. Registered in England & Wales: GSK plc ViiV Healthcare Limited No. 3888792 No. 06876960 Registered Office: 79 New Oxford Street ViiV Healthcare Limited London GSK Medicines Research Centre WC1A 1DG Gunnels Wood Road, Stevenage United Kingdom SG1 2NY References: For our corporate press office, email: Kate Senter OR call +44 7796 707446 For US-specific media enquiries, email: Rachel Jaikaran OR call +1 9193578932 Reporting of side effects If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in the package leaflet. You can also report side effects directly via the GSK Reporting Tool link https://gsk.public.reportum.com/. By reporting side effects, you can help provide more information on the safety of this medicine. 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