GSK

GSK and ViiV Healthcare to present scientific advancements in their industry-leading infectious diseases portfolio at IDWeek 2023

Published By GSK [English], Tue, Oct 10, 2023 4:43 AM


For media and investors only

- First scientific presentation of RSV vaccine efficacy and safety data over two seasons

- New public health impact modelling study data on meningococcal B immunisation with gonorrhea protection

- Evidence on advancing and improving how care is delivered for specific HIV patient populations

- Breadth of data presented demonstrates GSK’s commitment to preventing and treating infectious diseases

GSK plc (LSE/NYSE: GSK) and ViiV Healthcare will share new data on its industry-leading infectious diseases pipeline and portfolio at the Infectious Disease Society of America’s IDWeek 2023 annual meeting in Boston, US from 11-15 October 2023. Data from 47 abstracts will be presented in total, which will focus on scientific developments in a range of infectious diseases, including seasonal respiratory viruses, HIV, and chronic viral infections, affecting large patient populations.

Eleven abstracts have been accepted across GSK’s world-leading vaccines portfolio, including the first scientific presentation of Respiratory Syncytial Virus (RSV) vaccine efficacy and safety data over two full RSV seasons, which has been accepted for oral presentation on 13 October 2023 at 1:45 ET, as well as data on the role of meningococcal B vaccine recommendation on gonorrhea public health impact in older adolescents.

An additional 23 abstracts will be presented by ViiV Healthcare, the global specialist HIV company majority-owned by GSK, with Pfizer, Inc. and Shionogi & Co., Ltd. as shareholders, and its research partners, advancing knowledge in the areas of treatment, prevention, and improving the care of specific patient populations. Of note, the ABOVE clinical trial, which highlights real-world adherence and persistence data of ViiV Healthcare’s long-acting, two drug regimen against other therapies, will be presented on 12 October 2023 at 3:00 ET.

Tony Wood, Chief Scientific Officer, GSK, said:

We are proud to share new data from across our infectious diseases portfolio at this year’s IDWeek. Of the more than 2.5 billion people we will reach this decade, a significant majority will be through this portfolio. Our abstracts demonstrate our focus on the prevention and treatment of infections, and on the care pathway to ensure our vaccines and medicines reach those who need them. We look forward to connecting with the scientific community to determine how we can continue to develop innovative solutions to prevent and treat bacterial, viral and other infections in areas of unmet need.

In infectious diseases, GSK has pioneered innovation for more than 70 years. Infectious diseases are a significant global burden, responsible for one in six deaths worldwide 1. They affect everyone, everywhere, and this is a major concern for patients and society. Around one billion people are infected annually by seasonal respiratory viruses such as RSV 2, influenza 3 and COVID-19 4, and many require hospitalisation, with those who live with underlying health conditions at increased risk. About 38 million people live with HIV worldwide, many of whom still face stigma and do not have adequate access to care. Millions of individuals are also struggling with bacterial and fungal infections, while hundreds of millions live with chronic viral conditions like hepatitis B. The breadth of data presented at IDWeek across these disease areas reinforces GSK and ViiV Healthcare’s goal to revolutionise the prevention and treatment of infection, enhancing the quality of life for billions of people around the world.

GSK and ViiV Healthcare sponsored and supported studies to be presented at IDWeek 2023 include:

| Abstract title | First author | Presentation |

| A Systematic Literature Review of Disparities That May Influence Health Equity in Invasive Meningococcal Disease Prevention in the US| Shahina Begum | Poster |

| The Value of Invasive Meningococcal Disease Combination Vaccine – A Qualitative Study of Adolescents and Parents/Caregivers’ Preferences in the US| Shahina Begum | Poster |

| Meningococcal Vaccination Coverage Disparities in the United States: An Analysis with 2016-2021 National Immunization Survey-Teen Data| Oscar Herrera-Restrepo | Poster |

| Meningococcal B Immunization for Adolescents in the Presence of Added Gonorrhea Protection: A Public Health Impact Modelling Study in the United States| Zeki Kocaata | Poster |

| Invasive Meningococcal Disease Vaccination – A Targeted Literature Review of Adolescents and Parents/Caregivers’ Preferences| Shahina Begum | Poster |

| Follow-Up of Vaccine Preventable Disease Hospitalisations in the Ageing Population: Loss of Independence| Ahmed Salem | Poster |

| Follow-Up of Vaccine Preventable Disease Hospitalisations in the Ageing Population: Onset of Chronic Comorbidities| Ahmed Salem | Poster |

| Quantifying the Health Equity Related Public Health Impact of National Immunisation Programmes | Eliana Biundo | Poster |

| Efficacy of One Dose of the Respiratory Syncytial Virus (RSV) Prefusion F Protein Vaccine (RSVPreF3 OA) Persists for 2 Seasons in Adults ≥ 60 Years of Age| Michael G. Ison | Oral presentation |

| Burden of Herpes Zoster Among Employed Adults in the Department of Veterans Affairs Health System | Shaloo Gupta | Poster |

| Real-World Effectiveness of Recombinant Zoster Vaccine in Chinese Adults Aged ≥50 Years in the US | Ana Florea | Poster |

| Efficacy and Safety of Gepotidacin for Uncomplicated Urinary Tract Infection: Pooled Subgroup Analyses of the EAGLE-2 and EAGLE-3 Randomized Phase 3 Trials| Thomas M. Hooton | Rapid Fire poster |

| Impact of Regulatory Guidelines on Therapeutic, Clinical, and Microbiological Success Rates in Uncomplicated Urinary Tract Infection: Results from Two Phase 3 Randomized Controlled Trials of Oral Gepotidacin (EAGLE-2 and EAGLE-3)| Florian Wagenlehner | Poster |

| Gepotidacin Efficacy In E. coli Drug-Resistant Phenotypes: A Pooled Analysis of the EAGLE-2 and EAGLE-3 Randomized Controlled Trials in Uncomplicated Urinary Tract Infection| Thomas M. Hooton | Poster |

| Incidence of Treatment Failure When Treated with Empiric Oral Antibiotics Among US Female Outpatients with Uncomplicated Urinary Tract Infection| Debra L. Fromer | Poster |

| Clinician Treatment Considerations and Decisions in Hypothetical Uncomplicated Urinary Tract Infection Patient Vignettes| Jeffrey J. Ellis | Poster |

| Cost Burden of Patients with Oral Antibiotic Treatment Failure for Uncomplicated Urinary Tract Infection in the United States| Meg Franklin | Poster |

| Clinical Application and Validation of a Predictive Antimicrobial Resistance Risk Categorization Framework for Patients with Uncomplicated Urinary Tract Infection| Ryan K. Shields | Poster |

| Prevalence of Acute Uncomplicated Cystitis in Japan | Meg Franklin | Poster |

| Analysis of Resistance to Oral Standard-of-Care Antibiotics for Urinary Tract Infections Caused By Escherichia coli and Staphylococcus saprophyticus Collected in the United States in 2022| S. J. Ryan Arends | Poster |

| Interim Results of a Prospective Cohort Study to Monitor the Emergence of Resistance in Immunocompromised Non-Hospitalized Patients with COVID-19 Who Were Treated with Sotrovimab in Great Britain: LUNAR Study| Judith Breuer | Poster |

| Safety and Tolerability of Intramuscular (IM) Sotrovimab 500 mg Administered at Different Injection Sites: Results from the Phase I COSMIC Study| Jennifer Moore | Poster |

| Real-World Effectiveness of Sotrovimab for COVID-19: Evidence from United States (US) Administrative Claims Data| Christopher Bell | Poster |

| SCS: Safety and Tolerability of 2000mg Intravenous Sotrovimab Dose in Immunocompromised Participants Uninfected with SARS-CoV-2 in the PROTECT-V Trial| Davinder Dosanjh | Poster |

| Virological suppression in people with HIV-1 (PWH) receiving dolutegravir/lamivudine was high and similar across age groups despite older PWH having increased rates of comorbidities and polypharmacy (TANDEM subgroup analysis) (encore)| Andrew P. Brogan | Poster |

| Real-world adherence and persistence with long-acting cabotegravir plus rilpivirine (CAB+RPV LA) compared to oral antiretroviral therapy (ART) among people with HIV (PWH) in the US: the ABOVE study| Cindy Garris | Oral presentation |

| Clinical outcomes at Month 6 after initiation of cabotegravir and rilpivirine long-acting (CAB+RPV LA) in an observational real-world study (BEYOND)| Gary Sinclair | Poster |

| Perspectives of people with HIV (PWH) 6 months following a switch to cabotegravir and rilpivirine long-acting (CAB+RPV LA) in an observational real-world US study (BEYOND)| Dima Dandachi | Poster |

| SOLAR 12-month North American results: randomized switch trial of CAB+RPV LA vs. oral BIC/FTC/TAF | Mehri S. McKellar | Poster |

| Real-world effectiveness of long-acting cabotegravir + rilpivirine in virologically suppressed treatment-experienced individuals: two years of data from the OPERA cohort| Michael G. Sension | Poster |

| Real-world use of long-acting cabotegravir + rilpivirine in people with HIV with detectable viral loads at initiation: findings from the OPERA cohort| Ricky K. Hsu | Oral presentation |

| Real-world utilization and effectiveness of long-acting cabotegravir + rilpivirine among people with HIV with detectable viral loads at initiation: Trio cohort study| Richard A. Elion | Poster |

| Healthcare staff perceptions of feasibility and acceptability on implementing injectable HIV pre-exposure prophylaxis into standard of care: baseline results from the PrEP Implementation Study for Cabotegravir Long Acting for Men in the Real World (PILLAR)| Julian A. Torres | Poster |

| Engaging Black women on cabotegravir LA for PrEP by optimizing novel implementation strategies (EBONI) study: provider perceptions of appropriateness of cabotegravir LA for PrEP for cis- and-trans Black women| Teriya Richmond | Poster |

| Integrating long-acting injectable cabotegravir for PrEP into standard of care for cisgender women, transgender women, transgender men, and men who have sex with men: results from the PILLAR & EBONI studies| William Valenti | Poster |

| HIV acquisition following oral pre-exposure prophylaxis (PrEP) initiation | Aimee A. Metzner | Poster |

| Acceptability of an HIV pre-exposure prophylaxis (PrEP) shared decision-making tool for diverse populations and healthcare providers| Wendy Davis | Poster |

| Exploring cisgender women’s HIV pre-exposure prophylaxis (PrEP) needs and preferences across settings: the role of social-structural factors| Deanna Kerrigan | Poster |

| Risk factors, risk perception, and long-acting PrEP awareness and interest among US women: a national survey| Tonia Poteat | Poster |

| Durable efficacy and robust CD4+ T-cell count improvement observed among age, race, sex, and geographic subgroups of heavily treatment-experienced people with multidrug-resistant HIV-1 after 240 weeks of fostemsavir treatment| Alftan Dyson | Poster |

| DTG/RPV Switch Study in Persons with HIV-1 and Chronic Kidney Disease: 48-week Assessment of Viral Suppression, Treatment Adherence and Quality of Life| Helena Kwakwa | Poster |

| Switch to DOVATO in Patients Suppressed on Biktarvy (The SOUND Study), week 48 interim analysis | Jihad Slim | Poster |

| Efficacy, safety and tolerability of switching to dolutegravir/lamivudine in virologically suppressed adults living with HIV on bictegravir/emtricitabine/tenofovir alafenamide -the DYAD study| Charlotte-Paige M. Rolle | Poster |

| Steady-state PK of Fixed Dose Dolutegravir+Rilpivirine in Hemodialysis | Samir Gupta | Poster |

| At-Home vs. In-Clinic Receipt of Cabotegravir and Rilpivirine Long-Acting: An Implementation Science Trial| Jamila K. Williams | Oral presentation |

| Sociodemographic and epidemiological factors related to the acceptability of telemedicine among patients for HIV care in four hospitals in Buenos Aires| Maria Acosta | Poster |

| Patients' perceptions on barriers that prevent and promote the use of telemedicine for HIV care in the public health system of Buenos Aires| Tomas Kierszenowicz | Poster |

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.

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 options. 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.

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 Q1 Results for 2023 and any impacts of the COVID-19 pandemic.

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-..., accessed 1 May 2021).

PubMed. Global Disease Burden Estimates of Respiratory Syncytial Virus-Associated Acute Respiratory Infection in Older Adults in 2015: A Systematic Review and Meta-Analysis. Accessed June 2023. Available at: https://pubmed.ncbi.nlm.nih.gov/30880339/

World Health Organization. WHO launches new global influenza strategy. Accessed June 2023. Available at: https://www.who.int/news/item/11-03-2019-who-launches-new-glob...

World Health Organization. WHO Coronavirus (COVID-19) Dashboard. Accessed June 2023. Available at: https://covid19.who.int/

Press release distributed by Wire Association on behalf of GSK, on Oct 10, 2023. For more information subscribe and follow GSK