ViiV Healthcare to current 23 abstracts from modern HIV therapy and prevention portfolio at EACS 2023


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  • Key information to be offered embody long-term and real-world information from ViiV Healthcare’s portfolio of medicines, together with long-acting and 2-drug regimens.

LONDON — ViiV Healthcare, the worldwide specialist HIV firm majority owned by GSK, with Pfizer and Shionogi as shareholders, at this time introduced the presentation of key abstracts highlighting the breadth of its accredited and investigational medicines on the nineteenth Annual European AIDS Convention (EACS 2023) being held in Warsaw, Poland from 18-21 October 2023.

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Kimberly Smith, M.D., MPH, Head of Analysis & Growth at ViiV Healthcare, mentioned: “Residing effectively with HIV seems to be totally different for each particular person, and we consider our upcoming displays at EACS 2023 mirror our dedication and management to deal with the evolving wants of the HIV neighborhood. Our newest information from our various portfolio and modern pipeline discover real-world proof that additional consider the effectiveness, security, and tolerability of 2-drug and long-acting regimens; new findings for broadly neutralizing antibodies; and long-term follow-up in closely treatment-experienced people. We look ahead to sharing these new insights with the scientific and HIV communities at EACS 2023.”

Key information to be offered at EACS 2023 by ViiV Healthcare will embody:

Strengthening scientific and real-world proof (RWE) throughout our therapy portfolio: New real-world findings for the long-acting routine of Vocabria (cabotegravir injection) and Rekambys (rilpivirine long-acting injectable suspension) (CAB+RPV LA) in scientific settings throughout Europe shall be offered at EACS. ViiV Healthcare will share 12-month European findings from the SOLAR research, the primary head-to-head, section IIIb research of the whole long-acting injectable routine of CAB+RPV LA in contrast with every day oral Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide [BIC/FTC/TAF]).1

Findings for the 2-drug routine, Dovato (dolutegravir, lamivudine [DTG/3TC]), will embody three-year effectiveness, security, and tolerability outcomes amongst individuals dwelling with HIV in a real-world German cohort and information from a big observational cohort throughout Europe.2,3 Further information to be offered will embody a evaluate of real-world expertise of DTG+3TC in individuals dwelling with HIV over the age of fifty, in addition to in treatment-naïve individuals with a low CD4+ cell depend or excessive viral load at baseline.4

Lengthy-term information in closely treatment-experienced (HTE) populations: Lengthy-term, five-year information from the section III BRIGHTE scientific trial, which studied the usage of Rukobia (fostemsavir) in heavily-treatment skilled populations with multi-drug resistant HIV-1, shall be offered. New information will report on long-term security and the impression of immune restoration in adults receiving fostemsavir, together with fostemsavir’s impression on immune and inflammation-related biomarkers in these sufferers.5,6

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Advancing new mechanisms of motion in HIV analysis: New section IIa, proof of idea research findings shall be offered from the BANNER research of N6LS (VH3810109), a novel, investigational, broadly neutralizing antibody (bNAb). Security and tolerability findings following a single IV infusion or subcutaneous injection shall be shared.7 N6LS is a part of the corporate’s ultra-long-acting drugs growth technique, particularly being investigated for dosing intervals of at the least each 4 months.

Here’s a listing of ViiV Healthcare-sponsored or supported research being offered at EACS 2023:

Title

First Writer

Presentation Quantity

Presentation

Dolutegravir

3-year outcomes for dolutegravir (DTG) + lamivudine (3TC) in ART-naive and pre-treated individuals dwelling with HIV-1 (PLHIV) in Germany: real-world information from the German URBAN cohort

S. Noe

eP.A.072

ePoster

Systematic literature evaluate of real-world expertise with the 2-drug routine dolutegravir + lamivudine (DTG + 3TC) in individuals with HIV-1 (PWH) aged ≥50 years

E. Letang

eP.A.048

ePoster

Actual-world effectiveness of dolutegravir + lamivudine (DTG + 3TC) in treatment-naive individuals with HIV-1 (PWH) and low CD4+ cell depend or excessive viral load at baseline: a scientific literature evaluate

E. Letang

eP.A.050

ePoster

No related distinction in incident hypertension noticed by gender, race, baseline BMI, or different key subgroups by Week 96 amongst individuals dwelling with HIV-1 (PLWH) receiving dolutegravir (DTG)-based regimens or comparator antiretroviral remedy (cART) in pooled randomized scientific trials

P. Patel

eP.A.103

ePoster

CARAVEL: analysis of real-world antiviral effectiveness and sustainability of the 2-drug routine dolutegravir/lamivudine fastened dose mixture (FDC) in treatment-naive adults and pre-treated adults who’re virologically suppressed, in routine scientific care, in France: one-year interim evaluation outcomes

P. Philibert

eP.A.014

ePoster

Being pregnant and neonatal outcomes following prenatal publicity to dolutegravir: the DOLOMITE-EPPICC research

C. Thorne

PS5.O4

Oral in parallel session

Thursday, October 19 14:50 – 14:55 GMT

Dolutegravir + lamivudine 2-drug routine is very efficient and well-tolerated in a real-world scientific setting in Europe: information from the COMBINE-2 research

C. Mussini

eP.A.049

ePoster

Cabotegravir for Remedy

SOLAR 12-month European outcomes: randomized swap trial of CAB+RPV LA vs. oral BIC/FTC/TAF

I. De Los Santos Gil

eP.A.105

ePoster

Efficacy, security, and implementation outcomes of cabotegravir + rilpivirine long-acting by nation within the Cabotegravir And Rilpivirine Implementation Examine in European Areas (CARISEL)

C. J. Oldenbüttel

eP.A.101

ePoster

Cabotegravir + rilpivirine long-acting efficacy and security outcomes by intercourse at start, age, and race: a subgroup evaluation of the CARISEL research

J. Ghosn

eP.A.100

ePoster

Actual-world effectiveness of cabotegravir + rilpivirine in virologically suppressed therapy skilled people in Europe: information from COMBINE-2 research

A. Pozniak

eP.A.039

ePoster

Cabotegravir for PrEP

Drivers of discontinuation of oral PrEP inside Europe: findings from a real-world survey of PrEP use

M. Schroeder

eP.C2.021

ePoster

Fostemsavir

Early and sturdy reductions in soluble CD14 concentrations amongst treatment-experienced individuals with HIV-1 by 96 weeks of fostemsavir therapy in a section 2b scientific trial

E. R. Wonderlich

RA1.O4

Fast summary presentation

Friday, October 20

12:15 – 13:15 GMT

Lengthy-term security and impression of immune restoration in closely treatment-experienced adults receiving fostemsavir for as much as 5 years within the BRIGHTE research

J. M. Llibre

eP.A.093

ePoster

Sustained enhancements in biomarkers noticed with fostemsavir in closely treatment-experienced adults with multidrug-resistant HIV-1 from the section 3 BRIGHTE research by Week 240

A. Castagna

eP.A.092

ePoster

Fostemsavir use within the OPERA cohort: immunologic and virologic response

R. Okay. Hsu

eP.A.068

ePoster

Pipeline: Maturation Inhibitor GSK3640254

Efficacy and security of the HIV-1 maturation inhibitor GSK3640254 + 2 NRTIs in treatment-naive adults: 24-week outcomes from the section IIb, dose-range discovering DOMINO research

S. R. Joshi

RA2.O1

Fast summary presentation

Friday, October 20

12:15 – 13:15 GMT

Efficacy and security of the HIV-1 maturation inhibitor GSK3640254 + dolutegravir as a 2-drug routine in treatment-naive adults: 24-week outcomes from the section IIb DYNAMIC research

S. R. Joshi

RA2.O2

Rapis summary presentation

Friday, October 20

12:15 – 13:15 GMT

Pipeline: VH3810109 (N6LS)

Security and tolerability of VH3810109 (N6LS) amongst antiretroviral remedy–naive adults dwelling with HIV-1: outcomes from the monotherapy section of the section IIa BANNER research

P. Leone

PS8.O5

Oral parallel session

Friday, October 20

10:45 – 11:45 GMT

Pharmacokinetics/Pharmacodynamics and virological exercise of VH3810109 (N6LS) in antiretroviral-naive viremic adults from the section IIa BANNER research

A. Y. Edwards

eP.A.099

ePoster

Common HIV

Drivers of satisfaction and health-related high quality of life of individuals dwelling with HIV inside Europe: findings from a real-world survey of individuals dwelling with HIV

P. O’Brien

MtE3.O1

Oral meet-the-expert

Thursday, October 19

07:30 – 08:30 GMT

Sufferers’ fears and expectations associated to HIV an infection and its therapy in Poland: a Optimistic Perspective 2 (PP2) substudy

M. Moskwa

eP.C3.010

ePoster

Modifiable threat elements and their inhabitants attributable fractions for TB in individuals with HIV throughout Europe

C.Kraef

OS2.O5

Oral presentation

Friday, October 20

10:45 – 11:45 GMT

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About Dovato

Dovato is indicated as an entire routine to deal with HIV-1 an infection in adults with no antiretroviral (ARV) therapy historical past or to exchange the present ARV routine in those that are virologically suppressed (HIV-1 RNA &LT50 copies/mL) on a secure ARV routine with no historical past of therapy failure and no recognized resistance to any part of Dovato.

Please seek the advice of the total Abstract of Product Traits for all the protection data: Dovato 50 mg/300 mg film-coated tablets

About Vocabria

Vocabria (cabotegravir) injection is indicated, together with rilpivirine injection, for the therapy of Human Immunodeficiency Virus sort 1 (HIV-1) an infection in adults who’re virologically suppressed (HIV-1 RNA &LT50 copies/mL) on a secure antiretroviral routine with out current or previous proof of viral resistance to, and no prior virological failure with brokers of the non-nucleoside reverse transcriptase inhibitors (NNRTI) and integrase inhibitor (INI) class.

Vocabria tablets are indicated together with rilpivirine tablets for the short-term therapy of HIV-1 an infection in adults who’re virologically suppressed (HIV-1 RNA &LT50 copies/mL) on a secure antiretroviral routine with out current or previous proof of viral resistance to, and no prior virological failure with brokers of the NNRTI and INI class for:

  • oral lead in to evaluate tolerability of Vocabria and rilpivirine previous to administration of lengthy performing Vocabria injection plus lengthy performing rilpivirine injection.
  • oral remedy for adults who will miss deliberate dosing with Vocabria injection plus rilpivirine injection.

Vocabria tablets are solely indicated for therapy of HIV-1 together with rilpivirine tablets, subsequently, the prescribing data for Edurant tablets must also be consulted for really helpful dosing.

Please seek the advice of the total Abstract of Product Traits for all the protection data: Vocabria 400mg/600 mg prolonged-release suspension for injection and Vocabria 30 mg film-coated tablets

About Rekambys

Rekambys is indicated, together with cabotegravir injection, for the therapy of HIV‑1 an infection in adults who’re virologically suppressed (HIV-1 RNA < 50 copies/mL) on a secure antiretroviral routine with out current or previous proof of viral resistance to, and no prior virological failure with, brokers of the NNRTI and INI class.

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Rekambys ought to at all times be co-administered with a cabotegravir injection. The prescribing data for cabotegravir injection ought to be consulted for really helpful dosing.

Rekambys could also be initiated with oral lead-in or with out (direct to injection).

Please seek the advice of the total Abstract of Product Traits for all the protection data: Rekambys 600mg/900 mg prolonged-release suspension for injection

About Rukobia

Rukobia, together with different antiretrovirals, is indicated for the therapy of adults with multidrug resistant HIV-1 an infection for whom it’s in any other case not doable to assemble a suppressive anti-viral routine. Really useful dose is 600mg fostemsavir twice every day.

Please seek the advice of the total Abstract of Product Traits for all the protection data: Rukobia 600 mg prolonged-release tablets

About Apretude

Apretude is a drugs used for stopping sexually transmitted HIV-1 an infection (pre-exposure prophylaxis or PrEP) in adults and adolescents weighing at the least 35 kg who’re at excessive threat of being contaminated. It ought to be utilized in mixture with safer intercourse practices, similar to utilizing condoms. Apretude comprises the energetic substance cabotegravir.

Please seek the advice of the total Abstract of Product Traits for all the protection data: Apretude 600 mg prolonged-release suspension for injection

Emblems are owned by or licensed to the ViiV Healthcare group of firms.

About ViiV Healthcare

ViiV Healthcare is a world specialist HIV firm established in November 2009 by GSK (LSE: GSK) and Pfizer (NYSE: PFE) devoted to delivering advances in therapy and look after individuals dwelling with HIV and for people who find themselves prone to buying HIV. Shionogi grew to become a ViiV shareholder in October 2012. The corporate’s goals are to take a deeper and broader curiosity in HIV and AIDS than any firm has achieved earlier than and take a brand new method to ship efficient and modern medicines for HIV therapy and prevention, in addition to assist communities affected by HIV.

For extra data on the corporate, its administration, portfolio, pipeline, and dedication, please go to viivhealthcare.com.

About GSK

GSK is a world biopharma firm with a goal to unite science, expertise, and expertise to get forward of illness collectively. Discover out extra at gsk.com.

Cautionary assertion relating to forward-looking statements

GSK cautions traders that any forward-looking statements or projections made by GSK, together with these made on this announcement, are topic to dangers and uncertainties which will trigger precise outcomes to vary materially from these projected. Such elements embody, however should not restricted to, these described beneath Merchandise 3.D ‘Danger elements” within the firm’s Annual Report on Kind 20-F for 2022, GSK’s Q2 Outcomes for 2023 and any impacts of the COVID-19 pandemic.

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Registered in England & Wales:

GSK plc

No. 3888792

ViiV Healthcare Restricted
No. 06876960

Registered Workplace:

GSK plc

980 Nice West Street

Brentford, Middlesex

United Kingdom

TW8 9GS

ViiV Healthcare Restricted
GSK Medicines Analysis Centre
Gunnels Wooden Street, Stevenage
United Kingdom
SG1 2NY

References

_________________________________

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

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

3 Mussini C, et al. Dolutegravir + lamivudine 2-drug routine is very efficient and well-tolerated in a real-world scientific setting in Europe: information from the COMBINE-2 Examine. Introduced at European AIDS Society Convention (EACS). October 2023.

4 Letang E, et al. Systematic literature evaluate of real-world expertise with the 2-drug routine dolutegravir + lamivudine (DTG + 3TC) in individuals with HIV-1 (PWH) aged ≥50 years. Introduced at European AIDS Society Convention (EACS). October 2023.

5 Libre J, et al. Lengthy-term security and impression of immune restoration in closely treatment-experienced adults receiving fostemsavir for as much as 5 years within the BRIGHTE research. Introduced at European AIDS Society Convention (EACS). October 2023.

6 Castagna A, et al. Sustained enhancements in biomarkers noticed with fostemsavir in closely treatment-experienced adults with multidrug-resistant HIV-1 from the section 3 BRIGHTE research by Week 240. Introduced at European AIDS Society Convention (EACS). October 2023.

7 Leone P, et al. VH3810109 (N6LS) Was Protected and Properly Tolerated Amongst Antiretroviral Remedy-Naïve Adults Residing with HIV-1: Outcomes from the Section IIa BANNER Examine. Introduced at European AIDS Society Convention (EACS). October 2023.

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Contacts

ViiV Healthcare enquiries:
Media enquiries:
Nicola Andre +44 (0) 79 0187 7073 (London)
Rachel Jaikaran +44 (0) 78 2352 3755 (London)
Audrey Abernathy +1 919 605 4521 (North Carolina)

GSK enquiries:
Media enquiries:
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:
Nick Stone +44 (0) 7717 618834 (London)
James Dodwell +44 (0) 20 8047 2406 (London)
Mick Readey +44 (0) 7990 339653 (London)
Josh Williams +44 (0) 7385 415719 (London)
Camilla Campbell +44 (0) 7803 050238 (London)
Steph Mountifield +44 (0) 7796 707505 (London)
Jeff McLaughlin +1 215 751 7002 (Philadelphia)
Frannie DeFranco +1 215 751 4855 (Philadelphia)

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