ViiV Healthcare to present 23 abstracts from innovative HIV treatment and prevention portfolio at EACS 2023

Published By GSK [English], Wed, Oct 18, 2023 3:58 AM

For media and investors only

- Key data to be presented include long-term and real-world data from ViiV Healthcare’s portfolio of medicines, including long-acting and 2-drug regimens.

GSK plc (LSE/NYSE: GSK) announced that ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders, today announced the presentation of key abstracts highlighting the breadth of its approved and investigational medicines at the 19th Annual European AIDS Conference (EACS 2023) being held in Warsaw, Poland from 18-21 October 2023.

Kimberly Smith, M.D., MPH, Head of Research & Development at ViiV Healthcare said:

Living well with HIV looks different for every individual, and we believe our upcoming presentations at EACS 2023 reflect our commitment and leadership to address the evolving needs of the HIV community. Our latest data from our diverse portfolio and innovative pipeline explore real-world evidence that further evaluate the effectiveness, safety, and tolerability of 2-drug and long-acting regimens; new findings for broadly neutralizing antibodies; and long-term follow-up in heavily treatment-experienced individuals. We look forward to sharing these new insights with the scientific and HIV communities at EACS 2023.

Key data to be presented at EACS 2023 by ViiV Healthcare will include:

Strengthening clinical and real-world evidence (RWE) across our treatment portfolio: New real-world findings for the long-acting regimen of Vocabria (cabotegravir injection) and Rekambys (rilpivirine long-acting injectable suspension) (CAB+RPV LA) in clinical settings across Europe will be presented at EACS. ViiV Healthcare will share 12-month European findings from the SOLAR study, the first head-to-head, phase IIIb study of the complete long-acting injectable regimen of CAB+RPV LA compared with daily oral Biktarvy (bictegravir/emtricitabine/ tenofovir alafenamide [BIC/FTC/TAF]). 1

Findings for the 2-drug regimen, Dovato (dolutegravir, lamivudine [DTG/3TC]), will include three-year effectiveness, safety, and tolerability outcomes among people living with HIV in a real-world German cohort and data from a large observational cohort across Europe. 2, 3 Additional data to be presented will include a review of real-world experience of DTG/3TC in people living with HIV over the age of 50, as well as in treatment-naïve people with a low CD4+ cell count or high viral load at baseline. 4

Long-term data in heavily treatment-experienced (HTE) populations: Long-term, five-year data from the phase III BRIGHTE clinical trial, which studied the use of Rukobia (fostemsavir) in heavily-treatment experienced populations with multi-drug resistant HIV-1, will be presented. New data will report on long-term safety and the impact of immune recovery in adults receiving fostemsavir, along with fostemsavir’s impact on immune and inflammation-related biomarkers in these patients. 5, 6

Advancing new mechanisms of action in HIV research: New phase IIa, proof of concept study findings will be presented from the BANNER study of N6LS (VH3810109), a novel, investigational, broadly neutralizing antibody (bNAb). Safety and tolerability findings following a single IV infusion of subcutaneous injection will be shared. 7 N6LS is a component of the company’s ultra-long-acting medicine development strategy, specifically being investigated for dosing intervals of at least every four months.

Here is a list of ViiV Healthcare-sponsored or supported studies being presented at EACS 2023:

| 3-year outcomes for dolutegravir (DTG) + lamivudine (3TC) in ART-naive and pre-treated people living with HIV-1 (PLHIV) in Germany: real-world data from the German URBAN cohort| S. Noe | eP.A.072 | ePoster |

| Systematic literature review of real-world experience with the 2-drug regimen dolutegravir + lamivudine (DTG + 3TC) in people with HIV-1 (PWH) aged ≥50 years| E. Letang | eP.A.048 | ePoster |

| Real-world effectiveness of dolutegravir + lamivudine (DTG + 3TC) in treatment-naive people with HIV-1 (PWH) and low CD4+ cell count or high viral load at baseline: a systematic literature review| E. Letang | eP.A.050 | ePoster |

| No relevant difference in incident hypertension observed by gender, race, baseline BMI, or other key subgroups through Week 96 among people living with HIV-1 (PLWH) receiving dolutegravir (DTG)-based regimens or comparator antiretroviral therapy (cART) in pooled randomized clinical trials| P. Patel | eP.A.103 | ePoster |

| CARAVEL: evaluation of real-world antiviral effectiveness and sustainability of the 2-drug regimen dolutegravir/lamivudine fixed dose combination (FDC) in treatment-naive adults and pre-treated adults who are virologically suppressed, in routine clinical care, in France: one-year interim analysis results| P. Philibert | eP.A.014 | ePoster |

| Pregnancy and neonatal outcomes following prenatal exposure to dolutegravir: the DOLOMITE-EPPICC study| C. Thorne | PS5.O4 | Oral in parallel session

| Efficacy, safety, and implementation outcomes of cabotegravir + rilpivirine long-acting by country in the Cabotegravir And Rilpivirine Implementation Study in

European Locations (CARISEL) | C. J. Oldenbüttel | eP.A.101 | ePoster |

| Real-world effectiveness of cabotegravir + rilpivirine in virologically suppressed

treatment experienced individuals in Europe: data from COMBINE-2 study | A. Pozniak | eP.A.039 | ePoster |

| Early and durable reductions in soluble CD14 concentrations among treatment-experienced persons with HIV-1 through 96 weeks of fostemsavir treatment in a phase 2b clinical trial| E. R. Wonderlich | RA1.O4 | Rapid abstract presentation

| Long-term safety and impact of immune recovery in heavily treatment-experienced adults receiving fostemsavir for up to| J. M. | eP.A.093 | ePoster |

| Sustained improvements in biomarkers observed with fostemsavir in heavily treatment-experienced adults with multidrug-resistant HIV-1 from the phase 3 BRIGHTE study through Week 240| A. Castagna | eP.A.092 | ePoster |

| Fostemsavir use in the | R. K. | eP.A.068 | ePoster |

| Pipeline: Maturation Inhibitor GSK3640254 | | | |

| Efficacy and safety of the HIV-1 maturation inhibitor GSK3640254 + 2 NRTIs in treatment-naive adults: 24-week results from the phase IIb, dose-range finding DOMINO study| S. R. Joshi | RA2.O1 | Rapid abstract presentation

| Efficacy and safety of the HIV-1 maturation inhibitor GSK3640254 + dolutegravir as a 2-drug regimen in treatment-naive adults: 24-week results from the phase IIb DYNAMIC study| S. R. Joshi | RA2.O2 | Rapis abstract presentation

| Safety and tolerability of VH3810109 (N6LS) among antiretroviral therapy–naive adults living with HIV-1: results from the monotherapy phase of the phase IIa BANNER study| P. Leone | PS8.O5 | Oral parallel session

| Pharmacokinetics/ | A. Y. | eP.A.099 | ePoster |

| Drivers of satisfaction and health-related quality of life of people living with HIV within Europe: findings from a real-world survey of people living with HIV| P. O’Brien | MtE3.O1 | Oral meet-the-expert

| Modifiable risk factors and their population attributable fractions for TB in people with HIV across Europe| C. Kraef | OS2.O5 | Oral presentation

Dovato is indicated as a complete regimen to treat HIV-1 infection in adults with no antiretroviral (ARV) treatment history or to replace the current ARV regimen in those who are virologically suppressed (HIV-1 RNA

Please consult the full Summary of Product Characteristics for all the safety information: ema.europa.eu/en/medicines/human/EPAR/dovato

Vocabria (cabotegravir) injection is indicated, in combination with rilpivirine injection, for the treatment of Human Immunodeficiency Virus type 1 (HIV-1) infection in adults who are virologically suppressed (HIV-1 RNA

Vocabria tablets are indicated in combination with rilpivirine tablets for the short-term treatment of HIV-1 infection in adults who are virologically suppressed (HIV-1 RNA

- 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 tablets should also be consulted for recommended dosing.

Please consult the full Summary of Product Characteristics for all the safety information: https://www.ema.europa.eu/en/medicines/human/EPAR/vocabria

Rekambys is indicated, in combination with cabotegravir injection, for the treatment of HIV‑1 infection in adults who are virologically suppressed (HIV-1 RNA

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: https://www.ema.europa.eu/en/medicines/human/EPAR/rekambys

Rukobia, in combination with other antiretrovirals, is indicated for the treatment of adults with multidrug resistant HIV-1 infection for whom it is otherwise not possible to construct a suppressive anti-viral regimen. Recommended dose is 600mg fostemsavir twice daily.

Please consult the full Summary of Product Characteristics for all the safety information: https://www.ema.europa.eu/en/medicines/human/EPAR/rukobia

Apretude is a medicine used for preventing sexually transmitted HIV-1 infection (pre-exposure prophylaxis or PrEP) in adults and adolescents weighing at least 35 kg who are at high risk of being infected. It should be used in combination with safer sex practices, such as using condoms. Apretude contains the active substance cabotegravir.

Please consult the full Summary of Product Characteristics for all the safety information: https://www.ema.europa.eu/en/medicines/human/EPAR/apretude

Trademarks are owned by or licensed to the ViiV Healthcare group of companies.

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.

GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at gsk.com.

Cautionary statement regarding forward-looking statements

GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D 'Risk factors” in the company's Annual Report on Form 20-F for 2022, and Q2 Results for 2023 and any impacts of the COVID-19 pandemic.

De Los Santos Gil I, et al. SOLAR 12-month European results: randomized switch trial of CAB+RPV LA vs. oral BIC/FTC/TAF. Presented at European AIDS Society Conference (EACS). October 2023.

Noe S, et al. 3-year outcomes for dolutegravir (DTG) + lamivudine (3TC) in ART-naive and pre-treated people living with HIV-1 (PLHIV) in Germany: real-world data from the German URBAN cohort. Presented at European AIDS Society Conference (EACS). October 2023.

Mussini C, et al. Dolutegravir + lamivudine 2-drug regimen is highly effective and well-tolerated in a real-world clinical setting in Europe: data from the COMBINE-2 Study. Presented at European AIDS Society Conference (EACS). October 2023.

Letang E, et al. Systematic literature review of real-world experience with the 2-drug regimen dolutegravir + lamivudine (DTG + 3TC) in people with HIV-1 (PWH) aged ≥50 years. Presented at European AIDS Society Conference (EACS). October 2023.

Libre J, et al. Long-term safety and impact of immune recovery in heavily treatment-experienced adults receiving fostemsavir for up to 5 years in the BRIGHTE study. Presented at European AIDS Society Conference (EACS). October 2023.

Castagna A, et al. Sustained improvements in biomarkers observed with fostemsavir in heavily treatment-experienced adults with multidrug-resistant HIV-1 from the phase 3 BRIGHTE study through Week 240. Presented at European AIDS Society Conference (EACS). October 2023.

Leone P, et al. VH3810109 (N6LS) Was Safe and Well Tolerated Among Antiretroviral Therapy-Naïve Adults Living with HIV-1: Results from the Phase IIa BANNER Study. Presented at European AIDS Society Conference (EACS). October 2023.

Press release distributed by Wire Association on behalf of GSK, on Oct 18, 2023. For more information subscribe and follow GSK

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