Tenofovir Disoproxil Fumarate

Years of litigation surrounding Gilead Sciences’ tenofivor-based HIV treatments have come to an end, with the California Supreme Court taking Gilead’s side in a ruling that sets a key precedent for innovative drugmakers. After hearing arguments earlier this summer, the court ruled (PDF) in a 6-1 decision to dismiss thousands of negligence claims against Gilead concerning its older tenofovir disoproxil fumarate (TDF)-based medicine, such as Viread, Truvada and others, as well as its newer products made with tenofovir alafenamide fumarate (TAF), which is in the company's Biktarvy and Descovy. Patients claimed that they would have switched to the safer alternative drug if Gilead hadn’t “unreasonably delayed” bringing it to market, while Gilead maintained that a speedy development and commercialization timeline for a newer product falls outside of its duty of care, regardless of safety profile. With its Aug. 3 ruling, the California Supreme Court agrees with the latter, explaining that imposing a duty of care in this situation would place “extraordinary burdens” on drug manufacturers and risk “distorting research priorities and chilling pharmaceutical innovation in ways that may ultimately undermine, rather than advance, public health and safety,” Justice Joshua Groben wrote in his majority opinion. “What today’s decision declines to do is recognize, for the first time anywhere, sweeping liability for injuries caused by a concededly nondefective drug because the manufacturer allegedly failed to make a different drug available sooner,” Groban continued. “Imposing such liability would create substantial burdens and would risk adverse consequences for pharmaceutical innovation, public health, and patient safety.” For years, plaintiffs have argued that although Gilead's TDF-based medicines are effective in treating HIV, the risk of adverse events such as skeletal and kidney damage should have made the company act faster in developing its safer, lower-dose TAF drug candidate. Several lawsuits have accused Gilead of purposely shelving its TAF development for years in order to drum up continued sales of its earlier drugs before eventually launching the newer medicines, knowingly leaving patients suffering from bone and kidney damage in the meantime. Crucially, the plaintiffs’ acknowledgement that Gilead’s TDF medicines are not defective is the key aspect that creates the unique “duty to innovate” argument that the case hinges on. Gilead has long contended that plaintiffs cannot seek compensation for harm caused by a product that is not proven defective and that it had no duty to disclose information related to a potential alternative treatment when it had not yet been approved. The company emphasized the sweeping stakes of the case when the California appeals court approved the plaintiffs negligence claim in 2024, with Gilead warning of “widespread, negative consequences across all fields of innovation and manufacturing,” a spokesperson told Fierce Pharma at the time. The case ultimately came to question if drugmakers like Gilead have a “duty to innovative” by quickly developing safer or better products. To Gilead’s point, dozens of amicus briefs across industries flooded in to support Gilead and its argument that manufacturers do not have a “duty to innovate,” with other top drugmakers plus those in the automobile and consumer goods sectors such as Lyft and Uber urging the California Supreme Court to reverse course set by the lower courts. Ultimately, the court concluded that drug makers “do not owe a duty of care to users of a non-defective drug when making decisions about whether and when to commercialize an allegedly safer alternative drug,” Groban wrote. The vote, however, wasn’t unanimous, with Justice Kelli Evans, arguing in her dissenting opinion that the decision offers “sweeping immunity” for drugmakers to make products “without accounting for the risk of harm to consumers like plaintiffs here, who are held captive when a drug is both lifesaving and subject to exclusive manufacturing rights.” Groben disagrees, citing the standard legal claims that drugmakers still remain subject to when it comes to FDA-approved products. Gilead called the ruling a victory for all those working to develop improved medical treatments and new medicines,” the company said in a statement , adding that the court’s decision “supports American innovation, allowing companies to continue pursuing breakthroughs for patients and consumers.” “Gilead is proud to have developed innovative, life-saving medicines that continue to be used by millions worldwide to prevent and treat HIV,” the company continued. “We remain committed to ending the HIV epidemic through scientific innovation and a focus on the needs of people with HIV.” In closing out the TDF/TAF litigation chapter, Gilead is simultaneously moving to a new era of HIV treatment altogether with its lenacapavir, a capsid inhibitor that’s separate from the tenofovir-based products of the past. After first hitting the market as a treatment for multi-drug resistant HIV in 2022, the long-acting drug made waves with its first pre-exposure prophylaxis approval last year. Most recently, lenacapavir is angling to be apart of the first complete once-weekly HIV pill in a combination with Merck’s islatravir.

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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