Cabotegravir/Rilpivirine

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--(BUSINESS WIRE)--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 ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); 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 1 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. 2 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. 3 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. 4 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. 5 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. 6 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. 7 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. 8 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. 9 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. Contacts ViiV Healthcare enquiries: Media: Kate Senter +44 (0) 77 9670 7446 (London) Melinda Stubbee +1 919 491 0831 (North Carolina) GSK enquiries: Media: Tim Foley +44 (0) 20 8047 5502 (London) Sarah Clements +44 (0) 20 8047 5502 (London) Kathleen Quinn +1 202 603 5003 (Washington DC) Alison Hunt +1 540 742 3391 (Washington DC) Investor Relations: Constantin Fest +44 (0) 7831 826525 (London) James Dodwell +44 (0) 20 8047 2406 (London) Mick Readey +44 (0) 7990 339653 (London) Steph Mountifield +44 (0) 7796 707505 (London) Sam Piper +44 (0) 7824 525779 (London) Jeff McLaughlin +1 215 751 7002 (Philadelphia) Frannie DeFranco +1 215 751 3126 (Philadelphia)

Detailed phase 3 results suggest the two-drug combination of Gilead Sciences’ lenacapavir and Merck & Co.’s islatravir has what it takes to become the first complete weekly pill for the treatment of HIV. Two Islend clinical trials confirmed that a once-weekly, single-tablet combination of islatravir and lenacapavir (ISL/LEN) matches daily treatments like Gilead’s Biktarvy at maintaining HIV viral suppression, according to data slated for presentation at the 26th International AIDS Conference in Rio de Janeiro, Brazil. Positioned to become the first complete weekly oral HIV treatment, ISL/LEN combines a major scientific leap with the promise of meeting diverse patient needs, Jared Baeten, M.D., Ph.D., Gilead’s clinical development lead in virology, said in an interview with Fierce Pharma. “Many people living with HIV struggle with adherence,” Baeten said. “Once-a-week pills take […] the psychological challenges of HIV adherence from seven days a week to one.” The weekly ISL/LEN pill was efficacious and well tolerated at least up to Week 48 in the two Islend trials. In the Islend-1 study among 607 participants who already had their HIV well under control with Biktarvy, no individuals who switched to ISL/LEN had detectable HIV of at least 50 copies/mL at Week 48, compared with one (0.3%) case in those who remained on Biktarvy. Patients who got ISL/LEN saw their CD4+ T-cell count changed by an average minus 10 cells/μL, compared with minus 18 cells/μL in the control arm. The patients started the trial with CD4 counts at around 740 cells/μL, well above the 500 cells/μL threshold considered normal. As for Islend-2, that study enrolled 626 individuals who were virologically suppressed by various daily regimens. At Week 48, one (0.3%) ISL/LEN recipient and four (1.3%) patients who continued their standard treatments had HIV RNA levels reach 50 copies/mL or above. Average change in CD4 counts was minus 45 cells/μL with ISL/LEN and minus 8 cells/μL with daily orals. As the researchers noted in an abstract, the ISL/LEN group had higher baseline CD4 counts, while the two groups’ numbers converged at Week 48. The FDA once temporarily placed several Merck studies of islatravir on clinical hold in 2021 after some patients had experienced notable declines in total lymphocyte and CD4 T-cell counts. As Baeten pointed out, the safety signal was triggered by high dose levels of islatravir that was significantly higher than used in the Islend trials. In both Islend trials, investigators reported “no between-group differences” in lymphocyte counts at Week 48, according to their abstracts. In both trials, ISL/LEN demonstrated a safety profile that’s comparable to daily orals. All study arms had treatment-emergent adverse events of any grade in the high-70s percentage range. The rate of any-grade adverse events deemed treatment-related was 13.5% and 13.2% for ISL/LEN and Biktarvy, respectively, in Islend-1; and 18.5% and 0.3% for the weekly pill and control arm, respectively, in Islend-2. Treatment-related serious adverse reactions or treatment-related problems leading to discontinuation were generally low across both trials, in the low single digits or below. Before ISL/LEN’s clinical success, GSK already introduced the world’s first complete long-acting HIV treatment, Cabenuva, which replaces daily pills with injections given once a month or every two months. Still, many patients prefer taking pills over injecting themselves, Baeten noted. On the flip side, many patients who’re comfortable taking pills every day may stick with their daily routine. What ISL/LEN offers is another option, he said. “We are laser-focused on getting enough options to patients so that every one of them can find the thing that’s going to work for them for the long term because HIV treatment is a decades-long exercise,” Baeten said. While ISL/LEN could offer a once-weekly treatment option, the California pharma is developing new antivirals in the hopes of matching lenacapavir’s six-month dosing capability. In one approach, Gilead is launching two phase 3 studies in the Daybreak program combining lenacapavir with two broadly neutralizing antibodies, teropavimab and zinlirvimab. The positive HIV treatment readout comes as Gilead is making commercial inroads for lenacapavir, an HIV capsid inhibitor, as a twice-yearly PrEP injection for HIV prevention. Approved by the FDA a year ago under the brand name Yeztugo , the long-acting injectable booked $166 million in sales in the first quarter. At AIDS 2026, Gilead provided updated results from the landmark Purpose trials for Yeztugo through a year of open-label extension that Baeten said reinforce the drug’s profile. Of 4,417 cisgender women enrolled in the Purpose 1 trial who were eligible to join the open-label stage following the original randomized blinded phase, 95% chose to start or continue Yeztugo. There were zero HIV infections among all those individuals during the 52 weeks of follow-up. By comparison, one infection was reported in a woman who switched from blinded Yeztugo to Gilead’s daily PrEP Truvada during the open-label phase. In Purpose 2, which enrolled cisgender men and gender-diverse individuals, a similar 95% of participants opted to take Yeztugo during the open-label phase. One case of HIV occurred in a person who received all Yeztugo injections on time. Despite that additional case, Yeztugo still boasts the lowest chance of breakthrough infection as seen in a PrEP clinical trial, Baeten said. All told, in Purpose-2, there were four HIV infections for Yeztugo over 5,295 person-years of follow-up so far. Typically, in this population, the expected HIV incidence rate is around 3% to 5% per year, the Gilead exec noted. The fact that 95% of participants chose to take Yeztugo is in itself “a striking number,” Baeten noted. Besides, adherence to timely injections was high, at 96% and 92%, respectively, at week 52 between the two trials. “Adherence is the Achilles’ heel of PrEP, and lenacapavir, by being an injection of just twice a year, takes much of that adherence out of people’s hands,” Baeten said. Both Gilead and researchers are evaluating in various studies how best to keep adherence to Yeztugo high, Baeten noted. For its part, Merck recently got FDA approval for islatravir, a nucleoside reverse transcriptase translocation inhibitor (NRTTI), as part of a daily combination with doravirine under the brand name Idvynso . After failing to turn islatravir into a PrEP option because of the dosing strength problem, Merck is developing a follow-on NRTTI, alimatravir (MK-8527), as a potential once-monthly oral pill for PrEP. Trying to build its own once-weekly oral treatment without Gilead’s lenacapavir, the New Jersey pharma is investigating pairing islatravir with an NNRTI called ulonivirine in phase 2.