(IN BRIEF) ViiV Healthcare has received approval from China’s National Medical Products Administration (NMPA) for Vocabria (cabotegravir) in combination with Rekambys (rilpivirine), marking the first complete long-acting HIV-1 injectable treatment in China. This approval allows people living with HIV in China to reduce their treatment dosing from 365 to 12 or 6 times per year after initiation. The move is seen as critical in addressing the HIV epidemic in China, where an estimated 1.045 million people live with HIV.
(PRESS RELEASE) LONDON, 27-Oct-2023 — /EuropaWire/ — GSK plc (LSE/NYSE: GSK) announced that ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders announced that the National Medical Products Administration (NMPA) of China has approved ViiV Healthcare’s Vocabria (cabotegravir injection) used in combination with the Janssen Pharmaceutical Companies of Johnson & Johnson’s Rekambys (rilpivirine long-acting injection) for the treatment of HIV-1 infection. Prior to the recent marketing authorisation for rilpivirine long-acting injection, cabotegravir injection and tablets were approved in China in July 2023.
Cabotegravir injection is indicated in combination with rilpivirine long-acting injection for the treatment of human immunodeficiency virus type-1 (HIV-1) infection in adults who are virologically suppressed, on a stable antiretroviral (ARV) regimen without present or past evidence of viral resistance to, and no prior virological failure with, agents of the non-nucleoside reverse transcriptase inhibitor (NNRTI) and integrase inhibitor (INI) classes. Vocabria (cabotegravir) tablets are approved for use in combination with rilpivirine tablets (trade name Edurant) as an optional oral lead-in before initiating injections or as oral therapy for those who will miss planned injection doses.
By the end of October 2020, there were an estimated 1.045 million people living with HIV in China.[1] Advancements in treatment mean many people living with HIV can now live long and healthy lives, however, some may still struggle with daily oral HIV medication. It may act as a constant reminder of HIV, be a cause of fear that their HIV status will be accidently disclosed or create challenges with adherence.
Deborah Waterhouse, CEO of ViiV Healthcare, said: “At ViiV Healthcare, we are proud to be able to offer innovative solutions that meet the evolving needs of people living with HIV. The approval of cabotegravir injection and rilpivirine long-acting injection marks a step forward in helping to change the treatment experience for some people living with HIV in China who may have challenges with daily HIV therapies. We look forward to working closely with our partners in China to make this treatment available to those who could benefit from a long-acting regimen, part of our commitment to ensuring no person living with HIV is left behind.”
This approval is based on data from three pivotal trials: the ATLAS (Antiretroviral Therapy as Long-Acting Suppression) and FLAIR (First Long-Acting Injectable Regimen) studies, and the phase IIIb ATLAS-2M study, which collectively included more than 1,200 participants from 16 countries. ATLAS and FLAIR demonstrated the efficacy and safety of cabotegravir and rilpivirine compared to standard-of-care oral regimens, while ATLAS-2M showed that once every two month dosing had comparable efficacy to once monthly.[2], [3], [4] In ATLAS, 92.5% of participants receiving long-acting therapy and 95.5% of those receiving oral therapy remained virally suppressed at week 48 (adjusted difference: -0.3%; 95% confidence interval [CI]: -6.7% to 0.7%), meeting the criterion for non-inferiority.[2] In FLAIR, 93.6% of participants receiving long-acting therapy and 93.3% of participants receiving oral therapy remained virally suppressed at week 48 (adjusted difference: 0.4%; 95% CI: −3.7% to 4.5%), meeting the criterion for non-inferiority.[3] In the pooled analysis of ATLAS and FLAIR most long-acting recipients (83%) experienced injection site reactions, which decreased in incidence over time. Injection site reactions led to the withdrawal of 6 (1%) participants. The serious adverse event rate was 4% in each arm.[5] In ATLAS-2M, cabotegravir plus rilpivirine long-acting every eight weeks was non-inferior to dosing every four weeks (adjusted difference: 0.8%; 95% CI: -0.6% to 2.2%) after 48 weeks of treatment. The safety profile was similar between dosing groups, with 844 (81%) of 1,045 participants having adverse events (excluding injection site reactions); no treatment-related deaths occurred.[4]
ViiV Healthcare’s mission is to leave no person living with HIV behind. As the only pharmaceutical company solely focused on HIV and AIDS, ViiV Healthcare is working to deliver a broad range of treatments that meet the needs of a wide variety of people living with HIV. The long-acting regimen approved on the 18 October 2023 was developed in collaboration between ViiV Healthcare and Janssen. This builds on ViiV Healthcare’s industry-leading portfolio which is centred on delivering innovative medicines for the HIV community.
About cabotegravir
Cabotegravir is an integrase strand transfer inhibitor (INSTI) developed by ViiV Healthcare for the treatment of HIV-1 in virologically suppressed adults. It is approved as a long-acting formulation for use in combination with a rilpivirine long-acting formulation in the US, the EU and in other countries.
INSTIs, like cabotegravir, 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 infection.
About rilpivirine and rilpivirine long-acting
Rilpivirine is a non-nucleoside reverse transcriptase inhibitor (NNRTI) that works by interfering with an enzyme called reverse transcriptase, which in turn stops the virus from multiplying. It is approved as Edurant, an oral formulation, for the treatment of HIV-1 infection in combination with other antiretroviral agents in antiretroviral treatment-naïve patients 12 years of age and older and weighing at least 35kg with a viral load ≤100,000 HIV RNA copies/mL. It is also approved as Rekambys, a long-acting formulation that is indicated, in combination with cabotegravir injection, for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults 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.
Administration and dosing of cabotegravir and rilpivirine
Cabotegravir injection used in combination with rilpivirine injection is a complete long-acting regimen dosed once monthly or once every two months for the treatment of HIV-1 in adults who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral (ARV) regimen without present or past evidence of viral resistance to, and no prior virological failure with, agents of the non-nucleoside reverse transcriptase inhibitor (NNRTI) and integrase inhibitor (INI) classes. Cabotegravir and rilpivirine should be administered intramuscularly (IM) at two separate, gluteal injection sites by a healthcare professional at the same appointment. Prior to the initiation of the injections, cabotegravir and rilpivirine oral tablets can be taken as oral lead-in for approximately one month (at least 28 days) to assess tolerability to the medicines.
For once-monthly dosing, each person will receive a loading dose that includes one 600 mg injection of cabotegravir and one 900 mg injection of rilpivirine administered intramuscularly in the gluteal site. Then, each month after that, each person will receive one 400 mg injection of cabotegravir and one 600 mg injection of rilpivirine.
For once every two months dosing, each person will receive a loading dose that includes one 600 mg injection of cabotegravir and one 900 mg injection of rilpivirine, which is repeated one month later. Then, every two months after that, each person will receive one 600 mg injection of cabotegravir and one 900 mg injection of rilpivirine as a continuation dose.
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 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 are at risk of acquiring HIV. 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 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/company.
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 under Item 3.D ‘Risk factors” in the company’s Annual Report on Form 20-F for 2022, and Q2 Results for 2023.
References
[1] Jun-Jie X, Meng-Jie H, Yong-Jun J, et al. Prevention and control of HIV/AIDS in China: lessons from the past three decades. Chinese Medical Journal 2021; 134(23):2799-2809.
[2] Swindells S, Andrade-Villanueva J-F, Richmond G, et al. Long-acting cabotegravir and rilpivirine for maintenance of HIV-1 suppression. New England Journal of Medicine 2020; 382:1112-1123.
[3] Orkin C, Arasteh K, Hernandez-Mora MG, et al. Long-acting cabotegravir and rilpivirine after oral induction for HIV-1 infection. New England Journal of Medicine 2020; 382:1124-1135.
[4] Overton ET, Richmond G, Rizzardini G, et al. Long-acting cabotegravir and rilpivirine dosed every 2 months in adults with HIV-1 infection (ATLAS-2M), 48-week results: a randomised, multicentre, open-label, phase 3b, non-inferiority study. The Lancet 2020; 396(10267):1994-2005.
[5] Rizzardini G, Overton ET, Orkin C, et al. Long-Acting Injectable Cabotegravir + Rilpivirine for HIV Maintenance Therapy: Week 48 Pooled Analysis of Phase 3 ATLAS and FLAIR Trials. J Acquir Immune Defic Syndr 2020; 1;85(4):498-506.
Media Contact:
Tim Foley
Vice President, Global Corporate Media Relations
corporate.media@gsk.com
+44 (0)20 8047 5502
SOURCE: GlaxoSmithKline plc
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- Dispatch.d Offers Unique US Market Entry Services for European Impact Brands
- CSA Research’s New Localization Intelligence Analyzer, powered by LocHub, Helps Organizations Improve their Website’s Effectiveness for Global Customers
- Customer Data Platform Industry Accelerated During Pandemic: CDP Institute Report
- Digi Communications N.V. announces that two of its subsidiaries entered into two facility agreements
- Introducing Cap Expand Partners, Helping Business Leaders Break International Barriers
- Hong Kong’s Innovation and Technology Venture Fund Becomes Strategic Financial Investor of Ignatica
- Cure for prostate cancer on the horizon
- Fanpictor signs multi-year partnership with Royal Belgian Football Association
- Fanpictor unterzeichnet mehrjährige Partnerschaft mit dem Königlich Belgischen Fussballverband
- Fanpictor signe un partenariat pluriannuel avec la Royal Belgian Football Association
- Fanpictor firma una colaboración de varios años con la Real Federación Belga de Fútbol
- Fanpictor firma una partnership pluriennale con la Royal Belgian Football Association
- Fanpictor tekent meerjarige partnership met Koninklijke Belgische Voetbalbond
- Launch of the New Akenza Platform
- De zelflerende algoritme DBLG1®: eenvoudig te gebruiken voor een optimale en gepersonaliseerde behandeling van diabetes type 1
- Launch of the Anna Lindh Foundation Virtual Marathon for Dialogue!
- Digi Communications N.V. announces the exercise of stock options by the Executive Director of the Company pursuant to the decision of the Company’s general meeting of shareholders dated 30 April 2020 and in accordance with the stock option plan approved at the level of the Company in 2017
- New research unlocks long tail growth opportunity for the tech industry
- Digi Communications NV announces the availability of the instructions on the 2020 share dividend payment
- Digi Communications NV announces that conditional stock options were granted to several Directors of the Company based on the approval of the general meeting of shareholders from 18 May 2021
- Digi Communications N.V. Announces the Company’s General Shareholders Meeting resolutions adopted on 18 May 2021 approving, amongst others, the 2020 Annual Accounts
- Digi Communications N.V. (“Digi”) announces the Q1 2021 Financial results
- Digi Communications NV announces Investors Call for the Q1 2021 Financial Results
- Digi Communications N.V. announces an Amendment to the 2021 Financial Calendar
- Fastpayhotels Hits an Industry Milestone by Connecting 500 Hotels Per Day Through DerbySoft Technology
- 4 ways to build a more flexible supply chain
- Join the world's leading virtual CBD event for FREE
- DEEPENING STRATEGIC RELATIONSHIP BETWEEN UBC AND PIONEERING DECENTRALISED PLATFORM, MANYONE
- Mono Solutions recognizes Norwegian small business agency with best website 2021 award
- Mono Solutions and Xrysos Odigos unlock new opportunities for small businesses
- Behind the scenes of a 10,000-people online conference: creating a live-event atmosphere and leveraging cybersecurity software
- Largest Supply Chain for Face masks, FFP2, FFP3 and cloth masks
- TRANSMAR AND TRANSMETRICS SIGN DEAL FOR STATE-OF-THE-ART LOGISTICS COLLABORATION
- Amendment of Digi Communications N.V. Financial Calendar for 2021
- 4iG and Digi Communications NV’s Romanian subsidiary have entered into a term sheet with regards to a potential acquisition by 4iG of DIGI Group’s Hungarian operations
- “Building Healthy Relationships and Enhancing Gender Equality”: Young women from Cyprus, Egypt, Lebanon and Jordan come together
- Bring Ventures investit dans Crossborderit (CBIT), DDP et une solution de commerce électronique
- Bring Ventures investiert in Crossborderit (CBIT), eine DDP (geliefert verzollt) und E-Commerce Lösung
- Bring Ventures invests in Crossborderit (CBIT), DDP and ecommerce solution
- Lionspeed GP with Patrick Kolb and Lorenzo Rocco joins forces with CarCollection Motorsport in 2021
- Eurekos, ein klassenbester LMS-Anbieter, hat seine Position im renommierten Fosway 9-Grid™ für Lernsysteme verbessert
- Eurekos, en førsteklasses LMS-udbyder, har forstærket sin position på den prestigefyldte Fosway 9-Grid™ for læringssystemer
- Eurekos, ein erstklassiger LMS-Anbieter, hat seine Position auf dem renommierten Fosway 9-Grid™ für Lernsysteme weiter ausgebaut
- Digi Communications N.V. announces Share transaction made by an executive director of the Company with class B shares
- Digi Communications N.V.: Announces an Amendment to the Financial Calendar for 2021
- Ideanomics Invests $13M in Italian EV Motorcycle Company, Energica
- DigiSky and Asman Technology Announce Global Reseller Agreement
- Neowintech - O Marketplace Da Sua Próxima Solução Financeira
- Neowintech - Il Marketplace per la tua prossima soluzione finanziaria
- PIONEERING DECENTRALISED SECURE MESSAGING PLATFORM MANYONE ANNOUNCES STRATEGIC RELATIONSHIP WITH UNIVERSITY COLLEGE LONDON CENTRE BLOCKCHAIN TECHNOLOGY
- Digi Communications NV announces the release of the 2020 Preliminary Financial Results
- Fraunhofer IGD develops automated robotic arm to scan cultural objects in 3D, now cooperating with Phase One
- Adapt Fast or Disappear – Choosing the Right Supplier
- Digi Communications NV announces Investors Call for the 2020 Preliminary Financial Results
- A URSAPHARM Arzneimittel e a CEBINA anunciam uma parceria com vista a reaproveitar o anti-histamínico azelastina para combater a COVID-19
- URSAPHARM Arzneimittel et CEBINA annoncent un partenariat pour reconvertir l'antihistaminique azélastine afin de lutter contre la COVID-19
- URSAPHARM Arzneimittel y CEBINA anuncian una colaboración para readaptar el antihistamínico azelastine para combatir la COVID-19
- URSAPHARM Arzneimittel and CEBINA announce partnership to repurpose the antihistamine azelastine to combat COVID-19
- ANIL UZUN Will Launch Bass Guitar Lessons Series on Youtube
- Henrik Stampe Appointed CEO for Mono Solutions
- Anna Mossberg leder Nordens största privata AI-lab i Sverige: "Utan AI riskerar svenska företag att förlora sin konkurrensfördel."
- What COVID-19 has taught us about manufacturing & the importance of a digital online marketplace
- Digi Communications N.V. announces: the Supreme Court of Hungary dismissed the Company’s appeal related to the 5G Tender procedure
- Customer Data Platform Industry to Reach $1.5 Billion in 2021: CDP Institute Report
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GreenMantra Technologies Announces Exclusive Distribution Relationship with HARKE GROUP