GSK to present updates on its industry-leading infectious disease portfolio at IDWeek 2022
Issued: London UK
For media and investors only
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First presentation of RSV Older Adult vaccine candidate’s pivotal phase III efficacy and safety data
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New data showing Shingrix efficacy and safety over ten years
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Results on implementation of long-acting HIV treatment, Vocabria/Rekambys, in clinical setting
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Breadth of data presented demonstrates GSK’s expertise and commitment to preventing and treating infectious diseases
GSK plc (LSE/NYSE: GSK) will share updates on its industry-leading infectious disease pipeline and portfolio with 33 abstracts accepted for the Infectious Disease Society of America’s IDWeek 2022 annual meeting in Washington, DC, US from 19-23 October 2022. This will include the first presentation of the results from the 25,000-participant pivotal AReSVi-006 phase III trial which is investigating the efficacy and safety of GSK’s respiratory syncytial virus (RSV) vaccine candidate for adults aged 60 years and above. The abstract summarising the efficacy data from AReSVi-006 has been accepted for oral presentation on 20 October 2022 at 1.45pm ET.
Reinforcing the strength of GSK’s portfolio of vaccines, data from an extension study exploring the efficacy and safety of Shingrix over ten years will also be shared for the first time, providing further evidence on the duration of protection for adults aged 50 years and over. This long-term follow-up study from two previous phase III clinical trials (ZOE-50 and ZOE-70), which initially demonstrated up to 97% efficacy[1], [2], [3] in adults aged 50 years and older, will be presented on 20 October 2022 at 12.15pm ET.
Submissions also include presentations from ViiV Healthcare, the global specialist HIV company majority-owned by GSK, with Pfizer, Inc. and Shionogi & Co., Ltd. as shareholders, which will consist of abstracts from the company’s diverse portfolio of innovative licensed treatment and prevention options. ViiV Healthcare will share results from its pioneering implementation science program that aims to identify successful methods of integrating its medicines for HIV treatment in the clinical setting. The CARISEL study evaluates the best approaches to implementing Vocabria/Rekambys (cabotegravir, rilpivirine; marketed as Cabenuva in the US) administered every two months into clinical practice in Europe. Clinical results will be presented at IDWeek followed by primary results of the study at HIV Glasgow.
Tony Wood, Chief Scientific Officer, GSK said: “We are proud to share new and exciting data from across our infectious disease portfolio at this year’s IDWeek 2022 – leading with our RSV vaccine candidate for older adults, long-term data on Shingrix to prevent shingles, and implementation data and real-world evidence from our established HIV treatment portfolio. Discovering and developing innovative vaccines and medicines against infectious diseases is a key focus for us, and our longstanding expertise means we are uniquely placed to help protect people.”
GSK ID Week data summary
In addition to the pivotal phase III efficacy data, GSK will share three additional abstracts for its RSV OA vaccine candidate. One from a trial exploring co-administration of the RSV OA vaccine candidate with flu vaccination, and two from a phase III immunogenicity and safety trial.
A further 17 abstracts by ViiV Healthcare have been accepted as poster and oral presentations, including data from the OPERA cohort comparing real-world safety and effectiveness data in virologically suppressed adults taking Dovato (dolutegravir, lamivudine) with those taking a bictegravir- or dolutegravir-based 3-drug regimen.[4]
Four abstracts have been accepted as poster presentations on Xevudy (sotrovimab), including data from the Fair Health study, a retrospective claims database analysis of high-risk patients with COVID-19.
Another six abstracts have been accepted as poster presentations for gepotidacin, a potential first-in-class antibiotic.
GSK and ViiV Healthcare sponsored and supported studies to be presented at ID Week 2022 include:
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Abstract Title |
First author |
Presentation |
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A Respiratory Syncytial Virus (RSV) Prefusion F Protein Candidate Vaccine (RSVPreF3 OA) is Efficacious in Adults ≥ 60 Years of Age (YOA) |
Michael G. Ison |
Oral |
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A Candidate Respiratory Syncytial Virus (RSV) Prefustion F Protein Investigational Vaccine (RSVPreF3 OA) Is Immunogenic when Administered in Adults ≥ 60 Years of Age: Results at 6 Months after Vaccination |
Tino F. Schwarz |
Poster |
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Safety and Reactogenicity of an Investigational Respiratory Syncytial Virus (RSV) Prefusion F Protein Vaccine for Adults ≥ 60 Years of Age (RSVPreF3 OA): an Interim Analysis at 6 Months after Vaccination
|
Tino F. Schwarz |
Poster |
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Immunogenicity, reactogenicity and safety of a Respiratory Syncytial Virus prefusion F (RSVPreF3) candidate vaccine co-administered with the seasonal quadrivalent influenza vaccine in older adults |
Reynaldo Chandler MD |
Poster |
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Long-term Protection Against Herpes Zoster (HZ) by the Adjuvanted Recombinant Zoster Vaccine (RZV): Interim Efficacy, Immuno and Safety Results at Approximately 10 Years after Initial Vaccination |
Anne Strezova |
Poster |
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Real-World Effectiveness of Sotrovimab for the Early Treatment of COVID-19 in the US
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Carolina M. Reyes |
Poster |
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Safety, Tolerability, and Viral Pharmacodynamics of the IgG Monoclonal Antibody Sotrovimab Administered via Intramuscular Injection for the Treatment of Early Mild-to-Moderated COVID-19
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Jennifer Han |
Poster |
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Viral Resistance Analysis in the COMET-PEAK Study: Sotrovimab Treatment in Participants With Mild-to-Moderate COVID-19
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Jill Walker |
Poster |
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Resistance Analysis in the COMET-TAIL Study: Participants With Mild-to-Moderate COVID-19 Treated with Intramuscular or Intravenous Sotrovimab
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Maria L. Agostini |
Poster |
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Analysis of Co-Resistance Among Escherichia coli Urine Isolates from Female Outpatients in the United States
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Keith S.Kaye, MD, MPH |
Poster |
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Analysis of Co-Resistance Among Klebsiella pneumoniae Urine Isolates from Female Outpatients in the United States
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Keith S.Kaye, MD, MPH |
Poster |
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Prevalence, Regional Distribution, and Trends of Antimicrobial Resistance Among Female Outpatients with Urine Klebsiella pneumoniae Isolates: A Multicenter Evaluation
|
Keith S.Kaye, MD, MPH |
Poster |
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Patient Perceptions of Treatment Success in Uncomplicated Urinary Tract Infection
|
Ashish V. Joshi, PhD |
Poster |
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Activity of Gepotidacin Tested Against Molecularly Characterized Escherichia coli Isolates Resistant to Commonly Used Oral Therapies for UTI in the US (2019-2020)
|
Rodrigo E. Mendes, PhD |
Poster |
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Activity of Gepotidacin Against Escherichia coli Isolates from Community-acquired Urinary Tract Infections Collected Between 2019-2021 in the United States |
Rodrigo E. Mendes, PhD |
Poster |
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Systematic Literature Review of Real-world Experience with the 2-Drug Regimen Dolutegravir and Lamivudine in People with HIV Who Would Not Have Met Inclusion Criteria for the Phase 3 Clinical Program |
J. Slim |
Poster |
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Efficacy and Safety of Switching to DTG/3TC in Virologically Suppressed PLWH by Age, Including Those Aged ≥65 Years: Pooled Results from the TANGO and SALSA Studies |
M. Prakash |
Poster |
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Suppressed Switch to DTG/3TC 2-Drug Regimen vs BIC- or DTG-Based 3-Drug Regimens |
G. Pierone |
Hot Zone Poster* |
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Effectiveness and Durability of Dolutegravir (DTG) Based Regimens in Older People Living with HIV (PLWH) from the Veterans Aging Cohort Study (VACS) |
L. Yan |
Poster |
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Real World Treatment Experience of Treatment-Naive People with HIV Who Initiated Treatment with Single Tablet Dolutegravir/Lamivudine in a Test and Treat Setting in the US |
J. Kuretski |
Poster |
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Real World Treatment Experience of Single Tablet Dolutegravir/Lamivudine in Those Naive to Treatment with Baseline Viral Loads ≥100,000 Copies/mL in the US |
P. Benson |
Poster |
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A Real-world Observational Study on HIV-Infected Patients Who Switched from Nevirapine + 2 Nucleoside Reverse Transcriptase Inhibitors to Dolutegravir/Lamivudine in British Columbia, Canada |
J. de Wet |
Poster |
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CARISEL: A Hybrid III Implementation Effectiveness Study of Implementation of Cabotegravir Plus Rilpivirine Long Acting (CAB+RPV LA) in EU Health Care Settings; Key Clinical and Implementation Outcomes by Implementation Arm |
S. de Wit |
Oral |
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Phase 3/3b Experience with Long-Acting Cabotegravir and Rilpivirine: Efficacy and Safety Outcomes Through Week 96 by Race |
P. Patel |
Oral |
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Real-world Use of Long-Acting Cabotegravir + Rilpivirine in the US: Effectiveness in the First Year |
M. G. Sension |
Oral |
|
US Healthcare Provider Perspectives on the Initiation of Cabotegravir and Rilpivirine Long-Acting (CAB+RPV LA) in an Observational Real-world Study (BEYOND) |
R. Hsu |
Poster |
|
Awareness and Interest in PrEP Options Among US Cisgender Women – A National Survey |
T. Poteat |
Oral |
|
PrEP Interest and Preferences Among US Black and Hispanic Men – A National Survey |
T. Poteat |
Poster |
|
Relative Patient Preferences for Starting Daily, On-Demand, and Long-Acting Injectable HIV Pre-exposure Prophylaxis Among US Men Who Have Sex with Men, 2021-2022 |
T. Sanchez |
Hot Zone Poster |
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Durability and Effectiveness of Fostemsavir in Heavily Treatment-Experienced People with HIV |
R. K. Hsu |
Hot Zone Poster |
|
An Increase in Single-Tablet Regimen (STR) Utilisation for People Living with HIV (PLWH) Enrolled in Medicaid Had Minimal Impact on Pharmacy Costs |
A. P. Brogan |
Poster |
|
Clinical and Sociodemographic Characteristics Associated with Poor Self-rated Health Across Multiple Domains Among Older North American Adults Living with HIV |
M. Dominguez |
Poster |
|
Single-Tablet Regimens (STR) Offer Better Persistence and Adherence, with Lower Costs by Adherence Status, Than Multiple-Tablet Regimens (MTR) for People Living with HIV (PLWH) Enrolled in Medicaid |
A. P. Brogan |
Poster |
About infectious diseases
Infectious diseases are a significant global health and economic burden and are responsible for more than one in six deaths, worldwide.[5] GSK’s commitment to preventing and treating infectious diseases is reflected by the broad portfolio of marketed products. Our global specialist company, ViiV Healthcare, is driven to deliver effective and innovative medicines for HIV treatment and prevention, and our rich pipeline aims to address currently unmet medical needs with high impact.
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 in the Company's Annual Report on Form 20-F for 2021, GSK’s Q2 Results for 2022 and any impacts of the COVID-19 pandemic.
References
[1] Lal H et al. Efficacy of an Adjuvanted Herpes Zoster Subunit Vaccine in Older Adults. N Engl J Med. 2015;372:2087-96.
[2] Cunningham et al. Efficacy of the herpes zoster subunit vaccine in adults 70 years of age or older. N Engl J Med. 2016;375:1019-32.
[3] ZOE-50 and ZOE-70 are placebo-controlled trials with two doses of recombinant zoster vaccine (RZV) two months apart. Vaccine efficacy (VE) was assessed in the modified Total Vaccinated Cohort (mTVC) of 7277 participants, i.e. excluding adults who did not receive second dose of vaccine or who had confirmed diagnosis of herpes zoster (HZ) ≤1 month after second dose. Data in subjects ≥70 years old were from pre-specified pooled analyses of ZOE-50/70, as these provide robust estimates for VE. HZ cases in RZV vs. placebo: ≥50 years (ZOE-50; median follow-up of 3.1 years): 6/7344 vs. 210/7415 and ≥70 years (pooled analysis ZOE-50 & ZOE-70; median follow-up of 4 years): 25/8250 vs. 284/8346 cases
[4] G. Pierone et. al. Suppressed Switch to DTG/3TC 2-Drug Regimen vs BIC- or DTG-Based 3-Drug Regimens. Presented at IDWeek 2022.
[5] Global Health Estimates 2019: Global Health Estimates: Life expectancy and leading causes of death and disability. Geneva, World Health Organization; 2020. (https://www.who.int/data/gho/data/themes/mortality-and-global-health-estimates, accessed September 2022).
