Latest news with #ViiVHealthcare
Yahoo
15-07-2025
- Health
- Yahoo
ViiV's HIV shot preferred, as activists spotlight funding crisis at IAS 2025
ViiV Healthcare's combination injectable human immunodeficiency virus (HIV) medication was preferred over a daily tablet in treatment-naïve patients in a Phase IIIb trial. A global specialist in HIV that is majority owned by GSK, with Pfizer and Shionogi as shareholders, ViiV announced data from the Phase IIIb VOLITION study (NCT05917509) at the International AIDS Society (IAS) conference 2025, taking place from 13 to 15 July in Kigali, Rwanda. In the study, 89% of treatment-naïve HIV patients switched to Cabenuva (a combination treatment of cabotegravir and rilpivirine) following rapid viral suppression with daily Dovato (dolutegravir/lamivudine). Cabenuva is dosed once every two months by a healthcare professional. Patients were initially treated with daily Dovato until they achieved viral suppression. At this point, they were offered the opportunity to change to Cabenuva. The most common reasons cited for choosing Cabenuva were not having to worry about missing a dose each day (80%) and not having to carry medication (68%). ViiV CMO Jean van Wyk said: 'Long-acting injectables provide options that can offer high effectiveness and tolerability, improved adherence, and a preferred dosing schedule compared with daily oral pills. We believe they are a key part of HIV treatment and prevention and will play a critical role in achieving our ambition of ending HIV and AIDS.' Patients were initially treated with daily Dovato until they achieved viral suppression. At this point, they were offered the opportunity to change to Cabenuva. Effectiveness was also sustained with Cabenuva in the real world, with data from several observational studies. In these studies, Cabenuva was shown to address challenges associated with daily oral pills, offering improved treatment satisfaction, high effectiveness and a patient-preferred treatment option that supports long-term virologic control. It also provides better adherence to treatment, something which is a real issue with daily PrEP options due to stigma concerns. GlobalData, the parent company of Clinical Trials Arena, predicts sales of Cabenuva to reach $2.83bn in 2030. ViiV is also investigating an HIV therapy that can be dosed once every four months. In a Phase IIb trial, the therapy was able to suppress viral load below 50 copies per millimetre in blood. Long-acting pre-exposure prophylaxis (PrEP) for HIV has been prominent on the agenda at the IAS 2025 meeting. MSD has initiated two Phase III studies of its monthly oral PrEP candidate, and Gilead is set to report more positive data from its two-Phase III studies of twice-yearly Yeztugo (lenacapavir). On 14 July, the World Health Organization (WHO) endorsed the use of Yeztugo, saying that without a vaccine, it is the 'next best thing'. GlobalData analysts highlighted that the approval of Yeztugo is a 'momentous step in improving PrEP options available for people vulnerable to contracting HIV'. The main topic of conversation at the IAS 2025 conference, however, is the loss of various funding schemes which helped to provide treatment and research into HIV. Funding cuts by Trump's administration are already impacting low-income and middle-income countries, with cases of HIV already rising just six months after the reductions were made. During IAS's opening session, a group of activists took to the stage to vocalise their anger at the loss of funding, as well as some companies removing their diversity policies that recognised patients from LGBTQ+ communities, many of whom are more susceptible to transmitting HIV. The activists chanted 'we will not be erased' as they took to the stage, with several members of the group sharing their views and experiences as HIV patients from the LGBTQ+ community. The conference states it is welcoming of protests and that it 'endorses freedom of speech as an essential principle to end the HIV pandemic as a threat to public health'. "ViiV's HIV shot preferred, as activists spotlight funding crisis at IAS 2025" was originally created and published by Clinical Trials Arena, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site.
Yahoo
14-07-2025
- Health
- Yahoo
ViiV Healthcare data show 89% of treatment-naïve people with HIV choose to switch to long-acting injectable Vocabria + Rekambys from daily pills after achieving rapid viral suppression
Multiple real-world studies show consistent high effectiveness of Vocabria + Rekambys (cabotegravir + rilpivirine LA (CAB+RPV LA)) across a broad range of populations Implementation science data for Apretude (cabotegravir long-acting (CAB LA) for PrEP) demonstrate 95% of participants were happy they switched from oral PrEP to CAB LA LONDON, July 14, 2025--(BUSINESS WIRE)--ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders, today announced data from the phase IIIb VOLITION study demonstrating that 89% (n=129/145) of eligible treatment-naïve people living with HIV opted to switch to long-acting injectable Vocabria + Rekambys (branded as Cabenuva in the US Canada and Australia) following rapid viral suppression with daily Dovato (dolutegravir/lamivudine (DTG/3TC)). Additional real-world data from other studies reinforce CAB+RPV LA's effectiveness across a broad range of populations. Jean van Wyk, MBChB, MFPM, Chief Medical Officer at ViiV Healthcare, said: "Data from the VOLITION study highlight how providing choice in HIV care empowers individuals to choose medicines that meet their evolving everyday needs. ViiV pioneered long-acting injectables for HIV, and we now have over three years of robust real-world evidence demonstrating the impact our portfolio is having today across a broad range of settings and populations. Long-acting injectables provide options that can offer high effectiveness and tolerability, improved adherence, and a preferred dosing schedule compared with daily oral pills. We believe they are a key part of HIV treatment and prevention and will play a critical role in achieving our ambition of ending HIV and AIDS." Data summary from ViiV Healthcare and partner studies at IAS 2025: Empowering choice: 89% of treatment-naïve people with HIV opt for CAB+RPV LA after achieving rapid viral suppression: These new data from the phase IIIb VOLITION study evaluate the experience of treatment-naïve individuals who initiated treatment with daily DTG/3TC pills and were subsequently offered the choice to switch to CAB+RPV LA after achieving viral suppression. Study results showed that participants achieved rapid viral suppression with DTG/3TC (median time to suppression: 4.14 weeks), following which they were offered to switch. At the immediate next study visit (Day of Choice), 89% (n=129/145) of eligible participants chose to switch to CAB+RPV LA, while 11% (n=16) opted to continue DTG/3TC. The most common reasons cited for choosing CAB+RPV LA were not having to worry about missing a dose each day (80%) and not having to carry medication (68%).These findings underscore the efficacy and tolerability of DTG/3TC as a rapid suppression option, and demonstrate the value of offering CAB+RPV LA as a treatment option to meet individual needs and preferences.1 CAB+RPV LA delivers sustained effectiveness and enhanced patient experience in real-world settings: Data from multiple real-world observational studies, including the two-year BEYOND study in the US, the CARLOS study in Germany, the COMBINE-2 cohort across seven European countries, and the OPERA study, consistently reinforce the high effectiveness, favourable outcomes and patient satisfaction associated with CAB+RPV LA.2,3,4,5,6,7 BEYOND is a two-year prospective observational study enrolling people with HIV following the decision to switch to CAB+RPV LA across 27 U.S. sites.2 Among the 308 participants, 97% maintained virologic suppression at Month 24 (at most recent viral load of <50 copies/ml), with infrequent discontinuations due to injection reactions and no new confirmed virologic failures after Month 6. Participants reported reduced stigma and improved treatment satisfaction.3 Similarly, the real-world CARLOS study of 351 participants in Germany, showed 77.5% virologic suppression at Month 24, with high adherence (94.2% on-time injections) and clinically meaningful improvements in treatment satisfaction.4 97.7% of participants maintained virologic suppression at last known viral load at Month 24 or at discontinuation. In Europe, the COMBINE-2 study, evaluating real-world outcomes for 956 virologically suppressed people with HIV initiating CAB+RPV LA across seven European countries, reported 99% virologic suppression at last measured viral load (median follow-up of 10.2 months), with low rates of confirmed virologic failure (0.5%) and high persistence (92% remaining on therapy).5 Real-world evidence focussed on the effectiveness of CAB+RPV LA outside the labelled indication in viraemic patients: The large-scale OPERA study further explored the effectiveness of CAB+RPV LA in treatment-experienced individuals initiating therapy with detectable viral loads and long-standing HIV. Among the 3,304 participants, 11% (368 individuals) initiated with baseline viremia (>50 copies/mL), of these, 88% achieved viral suppression to <50 copies/mL (of n=277/313 with ≥ 1 viral load during follow-up and VL<50 copies/mL at any point during follow-up). A separate analysis also showed that among a diverse group of 105 women initiating CAB+RPV LA with viremia, most achieved viral suppression (of 92 women with ≥1 VL at follow-up, 92% achieved VL <50 copies/mL at any point during follow up), with confirmed virologic failure being rare.6,7 Through these findings, CAB+RPV LA was shown to address challenges associated with daily oral pills, offering improved treatment satisfaction, high effectiveness and a patient-preferred treatment option that supports long-term virologic control. Implementation studies highlight CAB LA for PrEP is highly preferred and easy to implement for key prevention groups: The PILLAR and EBONI studies highlight the high acceptability and feasibility of CAB LA for PrEP for HIV prevention in broad populations, including men who have sex with men (MSM), transgender men (TGM), and Black women (BW).8,9 PILLAR is a phase IV implementation trial assessing the integration of CAB LA for PrEP across 17 clinics in the U.S. among a broad population of MSM and TGM (n=201).8 CAB LA for PrEP was rated highly acceptable (mean 4.6/5 at Month 12) and feasible (mean 4.4/5), with 95% of participants (n=131) who switched from oral PrEP reporting being happy with the choice and 98% recommending CAB LA for PrEP (n=140). Flexible scheduling, reminders, and educational tools supported adherence, while stigma concerns were significantly lower compared to oral PrEP users. Similarly, EBONI, an implementation study evaluating CAB LA for PrEP in Black cis and transgender women, among women's health clinics, across 72 healthcare provider respondents at 15 clinics primary care and infectious disease clinics in the US. Data found CAB LA for PrEP highly appropriate (mean 4.5/5) and feasible (mean 4.4/5) for Black women.9 In addition, clinic capacity to accommodate CAB LA for PrEP tripled within a year without increasing staff or time commitment. The health benefits of two monthly visits included additional opportunities to screen for STIs, screening for comorbidities or providing other health or psychological care. These findings highlight Apretude's potential to support broader PrEP implementation and improve outcomes in underserved populations who may benefit the most across varied clinical settings. Trademarks are owned by or licensed to the ViiV Healthcare group of companies. About Apretude (cabotegravir long-acting for PrEP) 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. 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. 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 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 35kg) 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 35kg) 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 35kg) 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 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 Janssen Sciences Ireland Unlimited Company. 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 Dovato (dolutegravir and lamivudine) Dovato is indicated as a complete regimen to treat HIV-1 infection in adults and adolescents above 12 years of age weighing at least 40kg, in the EU, and weighing at least 25kg in the US, with no antiretroviral (ARV) treatment history or to replace the current ARV regimen in those who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable ARV regimen with no history of treatment failure and no known resistance to any component of Dovato. Please consult the full Summary of Product Characteristics for all the safety information: Dovato 50 mg/300 mg film-coated tablets. 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 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 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 2024, and GSK's Q1 Results for 2025. 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 F. Felizarta, et al. The power of choice: strong preference for CAB+RPV LA following rapid suppression with DTG/3TC in treatment naive people living with HIV. Presented at the International AIDS Society Conference (IAS 2025), 13-17 July, Kigali, RW. 2 F. Felizarta, et al. Perspectives of people living with HIV (PWH) 24 months following a switch to cabotegravir and rilpivirine long-acting (CAB+RPV LA) in an observational real-world US study (BEYOND). Presented at the International AIDS Society Conference (IAS 2025), 13-17 July, Kigali, RW. 3 G. Blick, et al. Clinical outcomes at month 24 after initiation of cabotegravir and rilpivirine long acting (CAB+RPV LA) in an observational real-world study (BEYOND). Presented at the International AIDS Society Conference (IAS 2025), 13-17 July, Kigali, RW. 4 C. Wyen, et al. 24-month outcomes of cabotegravir+rilpivirine long-acting every 2 months in a real‑world setting: effectiveness, adherence to injections, and participant-reported outcomes from people with HIV-1 in the German CARLOS cohort. Presented at the International AIDS Society Conference (IAS 2025), 13-17 July, Kigali, RW. 5 A. Pozniak, et al. High virologic suppression and few virologic failures with Long-Acting Cabotegravir + Rilpivirine in Treatment Experienced Virologically Suppressed Individuals from COMBINE-2 cohort in Europe. Presented at the International AIDS Society Conference (IAS 2025), 13-17 July, Kigali, RW. 6 R. Hsu, et al. Real-world effectiveness of CAB+RPV LA in individuals with HIV viremia at therapy initiation. Presented at the International AIDS Society Conference (IAS 2025), 13-17 July, Kigali, RW. 7 J. Altamirano, et al. Clinical outcomes among women in the OPERA cohort initiating CAB+RPV LA with viral loads ≥ 50 copies/mL. Presented at the International AIDS Society Conference (IAS 2025), 13-17 July, Kigali, RW. 8D. Dandachi, et al. One-year implementation outcomes of cabotegravir long-acting injectable PrEP in men who have sex with men (MSM) & transgender men (TGM): findings from the PILLAR study. Presented at the International AIDS Society Conference (IAS 2025), 13-17 July, Kigali, RW. 9 Z. Tims-Cook, et al. Health care provider experiences after 12 months of implementing cabotegravir long-acting injectable PrEP (CAB LA) for Black women: EBONI study results. Presented at the International AIDS Society Conference (IAS 2025), 13-17 July, Kigali, RW. View source version on Contacts ViiV Healthcare enquiries: Media:Rachel Jaikaran, +44 (0) 78 2352 3755, (London)Nicola André, +44 (0) 7845027166, (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)Lyndsay Meyer, +1 202 302 4595, (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)Jeff McLaughlin, +1 215 751 7002, (Philadelphia)Frannie DeFranco, +1 215 751 3126, (Philadelphia) Error while retrieving data Sign in to access your portfolio Error while retrieving data Error while retrieving data Error while retrieving data Error while retrieving data
Yahoo
14-07-2025
- Health
- Yahoo
ViiV Healthcare extends voluntary licensing agreement with Medicines Patent Pool to enable access to innovative long-acting injectable HIV treatment
Agreement allows manufacturers to develop, manufacture and supply generic long-acting injectable cabotegravir (CAB LA) for treatment in 133 countries Builds on the voluntary licence for CAB LA for HIV pre-exposure prophylaxis (PrEP), enabling increased access to innovative long-acting injectables for HIV treatment LONDON, July 14, 2025--(BUSINESS WIRE)--ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders, today announced an update to their voluntary licensing agreement with the Medicines Patent Pool (MPP) for cabotegravir to include patents relating to its use in a long-acting HIV treatment regimen. The announcement follows updated guidance from WHO recommending long-acting injectable cabotegravir + rilpivirine as an HIV treatment option. Existing generic licensees for prevention will be able to develop, manufacture and supply generic CAB LA, for use in combination with long-acting rilpivirine, subject to required regulatory approvals being obtained, to help enable access to the long-acting treatment in 133 countries worldwide. This includes all least-developed, low-income, lower middle-income and Sub-Saharan African countries, as well as countries where ViiV does not have patent rights for cabotegravir. Deborah Waterhouse, CEO at ViiV Healthcare said: "As leaders in long-acting innovation we're proud to be expanding our voluntary licence with the MPP to now include treatment of HIV in addition to prevention. Long-acting injectables have the potential to transform HIV treatment and we welcome the latest recommendations from WHO to expand treatment options. In line with our mission to ensure no one living with HIV is left behind, we're committed to working with partners like MPP to continue to increase access and reach those most impacted by HIV." Charles Gore, Executive Director at MPP said: "We're delighted to extend the CAB LA licence to cover HIV treatment, reflecting the latest WHO recommendations. Our previous agreement with ViiV for dolutegravir has already enabled the supply of generic DTG-based HIV treatments in 129 countries and we hope that over time a similar coverage can be achieved for CAB LA. CAB LA is a vital addition to the HIV treatment toolbox — especially for people facing adherence challenges with oral regimens. Expanding access to long-acting options like this supports a more person-centred, choice- and needs-driven approach, which is exactly what an equitable and effective HIV response requires." Dr Meg Doherty, Director Global HIV, Hepatitis and STI Programmes said: "The World Health Organization welcomes the expansion of the voluntary licence agreement for long-acting cabotegravir to include HIV treatment. This step is closely aligned with WHO's new recommendation of long-acting injectable antiretrovirals as an alternative for people who are virologically suppressed but face adherence challenges with daily oral regimens. It reflects our commitment to expanding access to innovative, person-centered treatment options that improve outcomes — particularly in underserved regions. This agreement aligns with our global goals to ensure equitable access to essential medicines and improve health outcomes for all. We are committed to supporting countries in implementing these new guidelines and ensuring that no one is left behind." The updated MPP-ViiV agreement is an extension of the voluntary license for cabotegravir for HIV PrEP. ViiV Healthcare has been supporting the generic manufacturers with technical know-how to enable development and access to CAB LA as soon as possible. Through the agreement, the existing licensees, Aurobindo, Cipla and Viatris, will be able to develop, manufacture and supply generic versions of CAB LA, for use in combination with long-acting rilpivirine, for the treatment of HIV-1 infection in adults and adolescents weighing at least 35kg, subject to required regulatory approvals being obtained. Trademarks are owned by or licensed to the ViiV Healthcare group of companies. 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. 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. It should be used in combination with safer sex practices, such as using condoms. Apretude contains the active substance cabotegravir. Please consult the full EU Summary of Product Characteristics for all the safety information: Apretude 600 mg prolonged-release suspension for injection 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 35kg) 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 35kg) 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 EU 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 35kg) 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 EU Summary of Product Characteristics for all the safety information: Rekambys 600mg/900 mg prolonged-release suspension for injection 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 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 About MPP The Medicines Patent Pool (MPP) is a United Nations-backed public health organisation working to increase access to and facilitate the development of life-saving medicines for low- and middle-income countries. Through its innovative business model, MPP partners with civil society, governments, international organisations, industry, patient groups, and other stakeholders to prioritise and license needed medicines and pool intellectual property to encourage generic manufacture and the development of new formulations. To date, MPP has signed agreements with 22 patent holders for 13 HIV antiretrovirals, one HIV technology platform, three hepatitis C direct-acting antivirals, a tuberculosis treatment, a cancer treatment, four long-acting technologies, a post-partum haemorrhage medicine, three oral antiviral treatments for COVID-19 and 16 COVID-19 technologies. MPP was founded by Unitaid, which continues to be MPP's main funder. MPP's work on access to essential medicines is also funded by the Swiss Agency for Development and Cooperation (SDC), Government of Canada, the World Intellectual Property Organization (WIPO) and the Government of Flanders. MPP's activities in COVID-19 are undertaken with the financial support of the Japanese Government, the French Ministry for Europe and Foreign Affairs, the German Agency for International Cooperation, and SDC. 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 2024, and GSK's Q1 Results for 2025. 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 View source version on Contacts MPP enquiries: Media:Gelise McCulloughgmccullough@ +41 79 685 64 36 (Geneva) ViiV Healthcare enquiries: Media:Rachel Jaikaran +44 (0) 78 2352 3755 (London)Nicola André +44 (0) 7845027166 (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)Lyndsay Meyer +1 202 302 4595 (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)Jeff McLaughlin +1 215 751 7002 (Philadelphia)Frannie DeFranco +1 215 751 3126 (Philadelphia) Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Reuters
14-07-2025
- Health
- Reuters
ViiV expands licence to allow generic HIV treatment production for low-income countries
LONDON, July 14 (Reuters) - ViiV Healthcare, the HIV-focused joint venture majority owned by GSK (GSK.L), opens new tab, said on Monday it has expanded its licensing deal with the Medicines Patent Pool to allow generic production of its long-acting injectable HIV treatment cabotegravir. The updated licence, which builds on an earlier agreement covering cabotegravir for HIV prevention, will enable three generic drugmakers to develop and supply the treatment for use in combination with Johnson & Johnson's (JNJ.N), opens new tab rilpivirine in 133 countries, including all low-income, lower-middle income, and Sub-Saharan African nations. ViiV's regimen -- the only approved long-acting injectable treatment for HIV -- is administered once every one or two months, an alternative to daily pills. The World Health Organization last week recommended long-acting cabotegravir and rilpivirine as a treatment option for people who are virologically suppressed but struggle with adherence to oral regimens. The new licence also builds on an existing Medicines Patent Pool agreement covering cabotegravir for pre-exposure prophylaxis (PrEP), signed in 2022. The existing licensees -- Aurobindo ( opens new tab, Cipla ( opens new tab and Viatris (VTRS.O), opens new tab -- will now be able to develop and manufacture generic versions of the long-acting treatment, subject to regulatory approvals. "As leaders in long-acting innovation we're proud to be expanding our voluntary licence to include treatment," said ViiV CEO Deborah Waterhouse. "We're committed to working with partners like MPP to increase access and reach those most impacted by HIV." The announcement comes after Gilead Sciences (GILD.O), opens new tab and the Global Fund to Fight AIDS, Tuberculosis and Malaria last week finalised a separate deal to supply long-acting HIV prevention drug, lenacapavir, to low-income countries at cost -- part of a push to expand access to innovative HIV medicines in the Global South. ViiV is majority-owned by GSK, with Pfizer (PFE.N), opens new tab and Shionogi (4507.T), opens new tab as shareholders.
Business Wire
14-07-2025
- Health
- Business Wire
ViiV Healthcare data show 89% of treatment-naïve people with HIV choose to switch to long-acting injectable
LONDON--(BUSINESS WIRE)--ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders, today announced data from the phase IIIb VOLITION study demonstrating that 89% (n=129/145) of eligible treatment-naïve people living with HIV opted to switch to long-acting injectable Vocabria + Rekambys (branded as Cabenuva in the US Canada and Australia) following rapid viral suppression with daily Dovato (dolutegravir/lamivudine (DTG/3TC)). Additional real-world data from other studies reinforce CAB+RPV LA's effectiveness across a broad range of populations. Jean van Wyk, MBChB, MFPM, Chief Medical Officer at ViiV Healthcare, said: 'Data from the VOLITION study highlight how providing choice in HIV care empowers individuals to choose medicines that meet their evolving everyday needs. ViiV pioneered long-acting injectables for HIV, and we now have over three years of robust real-world evidence demonstrating the impact our portfolio is having today across a broad range of settings and populations. Long-acting injectables provide options that can offer high effectiveness and tolerability, improved adherence, and a preferred dosing schedule compared with daily oral pills. We believe they are a key part of HIV treatment and prevention and will play a critical role in achieving our ambition of ending HIV and AIDS.' Data summary from ViiV Healthcare and partner studies at IAS 2025: Empowering choice: 89% of treatment-naïve people with HIV opt for CAB+RPV LA after achieving rapid viral suppression: These new data from the phase IIIb VOLITION study evaluate the experience of treatment-naïve individuals who initiated treatment with daily DTG/3TC pills and were subsequently offered the choice to switch to CAB+RPV LA after achieving viral suppression. Study results showed that participants achieved rapid viral suppression with DTG/3TC (median time to suppression: 4.14 weeks), following which they were offered to switch. At the immediate next study visit (Day of Choice), 89% (n=129/145) of eligible participants chose to switch to CAB+RPV LA, while 11% (n=16) opted to continue DTG/3TC. The most common reasons cited for choosing CAB+RPV LA were not having to worry about missing a dose each day (80%) and not having to carry medication (68%).These findings underscore the efficacy and tolerability of DTG/3TC as a rapid suppression option, and demonstrate the value of offering CAB+RPV LA as a treatment option to meet individual needs and preferences. 1 CAB+RPV LA d elivers sustained effectiveness and enhanced patient experience in real-world settings: Data from multiple real-world observational studies, including the two-year BEYOND study in the US, the CARLOS study in Germany, the COMBINE-2 cohort across seven European countries, and the OPERA study, consistently reinforce the high effectiveness, favourable outcomes and patient satisfaction associated with CAB+RPV LA. 2,3,4,5,6,7 BEYOND is a two-year prospective observational study enrolling people with HIV following the decision to switch to CAB+RPV LA across 27 U.S. sites. 2 Among the 308 participants, 97% maintained virologic suppression at Month 24 (at most recent viral load of <50 copies/ml), with infrequent discontinuations due to injection reactions and no new confirmed virologic failures after Month 6. Participants reported reduced stigma and improved treatment satisfaction. 3 Similarly, the real-world CARLOS study of 351 participants in Germany, showed 77.5% virologic suppression at Month 24, with high adherence (94.2% on-time injections) and clinically meaningful improvements in treatment satisfaction. 4 97.7% of participants maintained virologic suppression at last known viral load at Month 24 or at discontinuation. In Europe, the COMBINE-2 study, evaluating real-world outcomes for 956 virologically suppressed people with HIV initiating CAB+RPV LA across seven European countries, reported 99% virologic suppression at last measured viral load (median follow-up of 10.2 months), with low rates of confirmed virologic failure (0.5%) and high persistence (92% remaining on therapy). 5 Real-world evidence focussed on the effectiveness of CAB+RPV LA outside the labelled indication in viraemic patients: The large-scale OPERA study further explored the effectiveness of CAB+RPV LA in treatment-experienced individuals initiating therapy with detectable viral loads and long-standing HIV. Among the 3,304 participants, 11% (368 individuals) initiated with baseline viremia (>50 copies/mL), of these, 88% achieved viral suppression to <50 copies/mL (of n=277/313 with ≥ 1 viral load during follow-up and VL<50 copies/mL at any point during follow-up). A separate analysis also showed that among a diverse group of 105 women initiating CAB+RPV LA with viremia, most achieved viral suppression (of 92 women with ≥1 VL at follow-up, 92% achieved VL <50 copies/mL at any point during follow up), with confirmed virologic failure being rare. 6,7 Through these findings, CAB+RPV LA was shown to address challenges associated with daily oral pills, offering improved treatment satisfaction, high effectiveness and a patient-preferred treatment option that supports long-term virologic control. Implementation studies highlight CAB LA for PrEP is highly preferred and easy to implement for key prevention groups: The PILLAR and EBONI studies highlight the high acceptability and feasibility of CAB LA for PrEP for HIV prevention in broad populations, including men who have sex with men (MSM), transgender men (TGM), and Black women (BW). 8,9 PILLAR is a phase IV implementation trial assessing the integration of CAB LA for PrEP across 17 clinics in the U.S. among a broad population of MSM and TGM (n=201). 8 CAB LA for PrEP was rated highly acceptable (mean 4.6/5 at Month 12) and feasible (mean 4.4/5), with 95% of participants (n=131) who switched from oral PrEP reporting being happy with the choice and 98% recommending CAB LA for PrEP (n=140). Flexible scheduling, reminders, and educational tools supported adherence, while stigma concerns were significantly lower compared to oral PrEP users. Similarly, EBONI, an implementation study evaluating CAB LA for PrEP in Black cis and transgender women, among women's health clinics, across 72 healthcare provider respondents at 15 clinics primary care and infectious disease clinics in the US. Data found CAB LA for PrEP highly appropriate (mean 4.5/5) and feasible (mean 4.4/5) for Black women. 9 In addition, clinic capacity to accommodate CAB LA for PrEP tripled within a year without increasing staff or time commitment. The health benefits of two monthly visits included additional opportunities to screen for STIs, screening for comorbidities or providing other health or psychological care. These findings highlight Apretude 's potential to support broader PrEP implementation and improve outcomes in underserved populations who may benefit the most across varied clinical settings. Trademarks are owned by or licensed to the ViiV Healthcare group of companies. About Apretude (cabotegravir long-acting for PrEP) 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. 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. 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 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 35kg) 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 35kg) 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 35kg) 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 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 Janssen Sciences Ireland Unlimited Company. 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 Dovato (dolutegravir and lamivudine) Dovato is indicated as a complete regimen to treat HIV-1 infection in adults and adolescents above 12 years of age weighing at least 40kg, in the EU, and weighing at least 25kg in the US, with no antiretroviral (ARV) treatment history or to replace the current ARV regimen in those who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable ARV regimen with no history of treatment failure and no known resistance to any component of Dovato. Please consult the full Summary of Product Characteristics for all the safety information: Dovato 50 mg/300 mg film-coated tablets. 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 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 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 2024, and GSK's Q1 Results for 2025. References 1 F. Felizarta, et al. The power of choice: strong preference for CAB+RPV LA following rapid suppression with DTG/3TC in treatment naive people living with HIV. Presented at the International AIDS Society Conference (IAS 2025), 13-17 July, Kigali, RW. 2 F. Felizarta, et al. Perspectives of people living with HIV (PWH) 24 months following a switch to cabotegravir and rilpivirine long-acting (CAB+RPV LA) in an observational real-world US study (BEYOND). Presented at the International AIDS Society Conference (IAS 2025), 13-17 July, Kigali, RW. 3 G. Blick, et al. Clinical outcomes at month 24 after initiation of cabotegravir and rilpivirine long acting (CAB+RPV LA) in an observational real-world study (BEYOND). Presented at the International AIDS Society Conference (IAS 2025), 13-17 July, Kigali, RW. 4 C. Wyen, et al. 24-month outcomes of cabotegravir+rilpivirine long-acting every 2 months in a real‑world setting: effectiveness, adherence to injections, and participant-reported outcomes from people with HIV-1 in the German CARLOS cohort. Presented at the International AIDS Society Conference (IAS 2025), 13-17 July, Kigali, RW. 5 A. Pozniak, et al. High virologic suppression and few virologic failures with Long-Acting Cabotegravir + Rilpivirine in Treatment Experienced Virologically Suppressed Individuals from COMBINE-2 cohort in Europe. Presented at the International AIDS Society Conference (IAS 2025), 13-17 July, Kigali, RW. 6 R. Hsu, et al. Real-world effectiveness of CAB+RPV LA in individuals with HIV viremia at therapy initiation. Presented at the International AIDS Society Conference (IAS 2025), 13-17 July, Kigali, RW. 7 J. Altamirano, et al. Clinical outcomes among women in the OPERA cohort initiating CAB+RPV LA with viral loads ≥ 50 copies/mL. Presented at the International AIDS Society Conference (IAS 2025), 13-17 July, Kigali, RW. 8 D. Dandachi, et al. One-year implementation outcomes of cabotegravir long-acting injectable PrEP in men who have sex with men (MSM) & transgender men (TGM): findings from the PILLAR study. Presented at the International AIDS Society Conference (IAS 2025), 13-17 July, Kigali, RW. 9 Z. Tims-Cook, et al. Health care provider experiences after 12 months of implementing cabotegravir long-acting injectable PrEP (CAB LA) for Black women: EBONI study results. Presented at the International AIDS Society Conference (IAS 2025), 13-17 July, Kigali, RW.
