- Findings from the SEIMC-GeSIDA Foundation (FSG) PASO-DOBLE
study will include treatment efficacy, safety, and weight gain
experienced by participants taking Dovato (dolutegravir/lamivudine)
or Biktarvy (bictegravir/emtricitabine/tenofovir
alafenamide)
- Additional key abstracts from ViiV Healthcare’s
industry-leading, long-acting pipeline and portfolio include data
introducing a third-generation integrase strand transfer inhibitor
(INSTI) with potential for ultra long-acting applications;
pregnancy data for Apretude (cabotegravir long-acting injectable)
for PrEP; and real-world evidence for long-acting treatment regimen
Cabenuva (cabotegravir + rilpivirine long-acting)
ViiV Healthcare, the global specialist HIV company majority
owned by GSK, with Pfizer and Shionogi as shareholders, today
announced it will be presenting the largest head-to-head,
randomised clinical trial (RCT) of the 2-drug regimen Dovato
(dolutegravir/lamivudine [DTG/3TC]) compared against the 3-drug
regimen, Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide
[BIC/FTC/TAF]) at the 25th International AIDS Conference in Munich,
Germany (22 – 26 July). The presentation is one of 25 abstracts
evaluating the company’s portfolio of marketed HIV treatment and
prevention options alongside its next-generation pipeline
assets.
Harmony P. Garges, M.D., Chief Medical Officer at ViiV
Healthcare, said: “The exciting findings we’ll be presenting at
AIDS 2024 continue to underscore our position as industry leaders
in the development of long-acting and 2-drug regimens and our
pioneering approaches to both HIV treatment and prevention. People
living with HIV continue to tell us they want more treatment
options to allow for more personal choice to address needs beyond
viral suppression. The breadth of the data we’re announcing,
including the head-to-head study between Dovato and Biktarvy, helps
individuals better understand those options. We’re proud to be at
the forefront of innovative science, driving advancements that have
and will continue to transform the future of HIV care and
contribute to ending the epidemic.”
Key abstracts to be presented at AIDS 2024 by ViiV Healthcare
and its study partners will include:
Head-to-head study comparing ViiV Healthcare’s oral 2-drug
regimen against a commonly prescribed oral 3-drug regimen: The
FSG-sponsored PASO-DOBLE head-to-head RCT of the 2-drug regimen
Dovato (DTG/3TC) compared with the 3-drug regimen Biktarvy
(BIC/FTC/TAF) will be presented as a late breaker abstract. The
non-inferiority study assessed virologically suppressed adults on
an established treatment regimen and who could benefit from
treatment optimisation, who were randomised to switch to treatment
with DTG/3TC or BIC/FTC/TAF. Researchers will share 48-week
findings on treatment efficacy and safety, as well as changes in
weight experienced by participants while taking either
regimen.1
Additional findings for DTG/3TC will include the DYAD study,
presenting 48-week findings among virologically suppressed
participants with no prior virologic failure who either switched to
DTG/3TC or remained on BIC/FTC/TAF;2 and 96-week findings from the
SOUND study, which followed virologically suppressed participants
with unknown resistance history who switched from BIC/FTC/TAF to
DTG/3TC.3
Pregnancy data from the HPTN 084 open label extension study
for Apretude: New findings will be presented from the HPTN 084
trial that assess the impact of cabotegravir long-acting (LA) for
PrEP exposure during pregnancy.4,5 The study focuses on maternal,
pregnancy, and infant safety outcomes among participants who became
pregnant during the open label extension of HPTN 084 and continued
with injections of cabotegravir LA for PrEP.
New pipeline data from ViiV Healthcare’s third generation
INSTI: Researchers will share phase I findings from the
first-time-in-human study of VH184, a third-generation integrase
inhibitor (INSTI), along with analysis showing potent activity in
vitro against multiple INSTI resistant mutations.6 This is the
first data presentation of the company’s next INSTI as a part of
its ultra long-acting development strategy.
Real-world evidence from long-acting treatment regimen:
Findings from several real-world studies of the complete
long-acting HIV treatment regimen cabotegravir + rilpivirine
long-acting (CAB+RPV LA) will be presented, including the
perspectives of people living with HIV 12 months after switching
their treatment regimen to CAB+RPV LA from the BEYOND study;7,8
effectiveness, participant adherence to injections, and patient
reported outcomes from the German cohort of the CARLOS study;9 and
utilisation and effectiveness of CAB+RPV LA among virologically
suppressed, treatment-experienced individuals from the COMBINE-2
study.10
Here is a list of ViiV Healthcare-sponsored or supported studies
to be presented at AIDS 2024:
Title
First author
Presentation number
Presentation
Dolutegravir/3TC
Non-inferior efficacy and less weight gain
when switching to DTG/3TC than when switching to BIC/FTC/TAF in
virologically suppressed people with HIV (PWH): the PASODOBLE
(GeSIDA 11720) randomized clinical trial
P. Ryan
OAB3606LB
Oral
Date of presentation: Friday, 26 July
Session time: 12:00-13:00 CEST
PAIRED - Patient reported experiences and
perceived benefit of treatment with dolutegravir/lamivudine -
qualitative interviews: diverse group of people with HIV-1 (PWH)
reflect on life and health
J. Slim
THPEB094
Poster
Date of presentation: Thursday, 25
July
Time of presentation:
12:00-13:00 CEST
Real-world effectiveness and tolerability
of the 2-drug regimen dolutegravir and lamivudine (DTG/3TC) in
people living with HIV: a systematic literature review and
meta-analysis from clinical practice
J. Fraysse
TUPEB101
Poster
Date of presentation: Tuesday, 23 July
Time of presentation: 12:00-13:00 CEST
Effectiveness and durability of
dolutegravir/lamivudine in older people with HIV from the Veterans
Aging Cohort Study (VACS)
L. Yan
WEPEB111
Poster
Date of presentation: Wednesday, 24
July
Time of presentation: 12:00-13:00 CEST
Switch to dolutegravir/lamivudine
(DTG/3TC) in people living with HIV-1 suppressed on
bictegravir/emtricitabine/ tenofovir alafenamide (B/F/TAF): 96-week
final analysis from the SOUND study
J. Slim
THPEB092
Poster
Date of presentation: Thursday, 25
July
Time of presentation:
12:00-13:00 CEST
Efficacy, safety and tolerability of
switching to dolutegravir/lamivudine in virologically suppressed
adults living with HIV on bictegravir/emtricitabine/tenofovir
alafenamide - 48-week results from the DYAD study
C. Rolle
THPEB089
Poster
Date of presentation: Thursday, 25
July
Time of presentation:
12:00-13:00 CEST
Dolutegravir
Viral suppression, viral failure and
safety outcomes in children and adolescents on dolutegravir (DTG)
in Europe and Thailand
K. Scott
OAB3803
Oral
Session date:
Friday, 26 July
Session time:
13:30-14:30 CEST
Changes in body mass index in children and
adolescents in Europe and Thailand before and after starting
dolutegravir and compared to protease inhibitors using propensity
scoring analysis
S. Crichton
TUPEB086
Poster
Date of presentation: Tuesday, 23 July
Time of presentation: 12:00-13:00 CEST
Prenatal dolutegravir-based regimen use,
and pregnancy and birth outcomes: data from the Antiretroviral
Pregnancy Registry
V. Vannappagari
TUPEB128
Poster
Date of presentation: Tuesday, 23 July
Time of presentation: 12:00-13:00 CEST
Effectiveness and durability of
dolutegravir/ rilpivirine in older people with HIV from the
Veterans Aging Cohort Study (VACS)
L. Yan
THPEB090
Poster
Date of presentation: Thursday, 25
July
Time of presentation: 12:00-13:00 CEST
Cabotegravir for treatment
Subcutaneous injections of cabotegravir +
rilpivirine in virally suppressed adults with HIV-1: a substudy of
the phase 3 FLAIR study
R. D’Amico
OAB2604
Oral
Session date: Thursday, 25 July 2024
Session time:
15:00-16:00 CEST
Clinical outcomes at month 12 after
initiation of cabotegravir and rilpivirine long acting (CAB+RPV LA)
in an observational real-world study (BEYOND)
S. Schneider
THPEB099
Poster
Date of presentation: Thursday, 25
July
Time of presentation: 12:00-13:00 CEST
Perspectives of people with HIV (PWH) 12
months following a switch to cabotegravir and rilpivirine
long-acting (CAB+RPV LA) in an observational real-world US study
(BEYOND)
W. Valenti
TUPEB116
Poster
Date of presentation: Tuesday, 23 July
Time of presentation: 12:00-13:00 CEST
12-Month outcomes of cabotegravir plus
rilpivirine long-acting every 2 months in a real-world setting:
effectiveness, adherence to injections, and patient-reported
outcomes from people with HIV-1 in the German CARLOS cohort
C. Jonsson-Oldenbüttel
TBUPEB095
Poster
Date of presentation: Tuesday, 23 July
Time of presentation: 12:00-13:00 CEST
Increased screening for sexually
transmitted infections and HIV surrogate marker testing among
long-acting injectable versus daily oral antiretroviral therapy
users in the OPERA® cohort
P. C. Lackey
WEPEC319
Poster
Date of presentation: Wednesday, 24
July
Time of presentation: 12:00-13:00 CEST
Real-world utilization and effectiveness
of long-acting cabotegravir + rilpivirine in virologically
suppressed treatment experienced individuals in Europe: data from
COMBINE-2 cohort study
A. Pozniak
TUPEC278
Poster
Date of presentation: Tuesday, 23 July
Time of presentation: 12:00-13:00 CEST
Re-thinking ‘community’ in the
implementation of long-acting injectable cabotegravir and
rilpivirine: qualitative findings from the ILANA study
R. Hayes
TUPEE529
Poster
Date of presentation: Tuesday, 23 July
Time of presentation: 12:00-13:00 CEST
Adherence through the prism of long-acting
injectable therapy: qualitative findings from the ILANA
implementation study
S. Paparini
TUPED306
Poster
Date of presentation: Tuesday, 23 July
Time of presentation: 12:00-13:00 CEST
“Closer to a cure:” mixed-methods analysis
of reasons for switching to cabotegravir + rilpivirine
S. Paparini
WEPEE551
Poster
Date of presentation: Wednesday, 24
July
Time of presentation: 12:00-13:00 CEST
Cabotegravir for PrEP
“The simplest way to go:” A mixed methods
analysis of why women who inject drugs selected long-acting
injectable cabotegravir instead of daily oral PrEP
A. M. Roth
OAD07
Oral
Session date:
Tuesday, 23 July
Session time:
17:05-17:13 CEST
Knowledge, awareness, feasibility, and
acceptability of long-acting cabotegravir for HIV prevention:
results from the SEARCH Dynamic Choice HIV prevention trial
E. Kakande
OAE12
Oral
Session date: Wednesday, 24 July
Session time:
10:41-10:49 CEST
Location preferences for accessing
long-acting injectable pre-exposure prophylaxis (LA-PrEP) among men
who have sex with men (MSM) in the US currently using daily-oral
PrEP
J. L. Glick
WEPEC269
Poster
Date of presentation: Wednesday, 24
July
Time of presentation: 12:00-13:00 CEST
HIV pre-exposure prophylaxis awareness,
willingness, and use among transfeminine persons with high
likelihood of HIV in the United States: recent results from the
Transgender Women’s Internet Survey and Testing (TWIST)
D. I. Yaras
THPEC186
Poster
Date of presentation: Thursday, 25
July
Time of presentation: 12:00-13:00 CEST
Preference for long-acting HIV prevention
methods among transgender women at greatest risk for HIV
acquisition in eastern and southern United States: findings from
the LITE cohort
E. E. Cooney
THPED410
Poster
Date of presentation: Thursday, 25
July
Time of presentation: 12:00-13:00 CEST
Influencers and decision-making factors
for choosing injectable PrEP among men who have sex with men and
transgender men in the United States
D. Dandachi
THPEE504
Poster
Date of presentation: Thursday, 25
July
Time of presentation: 12:00-13:00 CEST
Need for increased HIV testing prior to
and during pre-exposure prophylaxis with cabotegravir long-acting
injections in routine clinical care in the United States
R. K. Hsu
WEPEB046
Poster
Date of presentation: Wednesday, 24
July
Time of presentation: 12:00-13:00 CEST
Pre-exposure prophylaxis (PrEP) product
choice of participants in HPTN 083
M. E. Clement
TUPEC184
Poster
Date of presentation: Tuesday, 23 July
Time of presentation: 12:00-13:00 CEST
“Everyone should have access to it”:
Perspectives on PrEP product choice and implementation from MSM and
TGW in an injectable PrEP trial
C. Psaros
WEPEC206
Poster
Date of presentation: Wednesday, 24
July
Time of presentation: 12:00-13:00 CEST
Pipeline
Phase 1 study of VH4524184 (VH-184), a new
third-generation integrase strand transfer inhibitor (INSTI) with a
unique resistance profile
L. Rogg
OAB26
Oral
Session date: Thursday, 25 July
Session time:
15:00-16:00 CEST
Preclinical assessments of a cabotegravir
prodrug predicting human dosing durations of >6 months
M. Baker
WEPEA028
Poster
Date of presentation: Wednesday, 24
July
Time of presentation: 12:00-13:00 CEST
Pre-clinical profiles of HIV-1 capsid
inhibitors VH4004280 (VH-280) and VH4011499 (VH-499)
C. Wang
WEPEA027
Poster
Date of presentation: Wednesday, 24
July
Time of presentation: 12:00-13:00 CEST
Clinical pharmacokinetics and safety of
orally administered VH4004280 (VH-280), a novel HIV-1 capsid
inhibitor, in healthy volunteers
R. Griesel
THPEB093
Poster
Date of presentation: Thursday, 25
July
Time of presentation: 12:00-13:00 CEST
Clinical pharmacokinetics and safety of
orally administered VH4011499 (VH-499), a novel HIV-1 capsid
inhibitor, in healthy volunteers
N. Thakkar
WEPEB105
Poster
Date of presentation: Wednesday, 24
July
Time of presentation: 12:00-13:00 CEST
Above Brand
Detailed modelling of viremia exposure
does not independently predict cardiovascular disease in people
with HIV
O. Elvstam
OAB34
Oral
Session date: Friday, 26 July 2024
Session time:
10:30-11:30 CEST
About Dovato
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 <50 copies/mL) on a stable
ARV regimen with no history of treatment failure and no known
resistance to any component of Dovato.
Please consult the full Summary of Product Characteristics for
all the safety information: Dovato 50 mg/300 mg film-coated
tablets.
About Vocabria
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 <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
non-nucleoside reverse transcriptase inhibitors (NNRTI) and
integrase inhibitor (INI) class.
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 <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 for:
- 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: Vocabria 400mg/600 mg prolonged-release
suspension for injection and Vocabria 30 mg film-coated
tablets.
About Rekambys
Rekambys is indicated - in combination with cabotegravir
injection - for the treatment of 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.
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: Rekambys 600mg/900 mg prolonged-release
suspension for injection.
About Apretude
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: Apretude 600 mg prolonged-release
suspension for injection.
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 SEIMC-GeSIDA Foundation (FSG)
The SEIMC-GeSIDA Foundation (FSG) was founded by the Spanish
Society of Clinical Microbiology and Infectious Diseases as a tool
to promote high-quality investigation in the field of HIV infection
and other infectious diseases. The Foundation is composed of
qualified professionals with experience in the field of clinical
trials and multicentre studies. Its streamlined infrastructure
facilitates performance of clinical studies and responds to the
needs of investigators in terms of methodology/statistical analysis
and of logistics and management of trials and other multicentre
studies. For more information on the SEIMC-GeSIDA Foundation (FSG),
please visit
https://fundacionseimcgesida.org/en/quienes-somos/.
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.
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 GSK’s Annual Report on Form 20-F for 2023, and
GSK’s Q1 Results for 2024.
Registered in England &
Wales:
GSK plc
ViiV Healthcare Limited
No. 3888792
No. 06876960
Registered Office:
GSK plc
ViiV Healthcare Limited
980 Great West Road
GSK Medicines Research Centre
Brentford, Middlesex
Gunnels Wood Road, Stevenage
United Kingdom
United Kingdom
TW8 9GS
SG1 2NY
References
___________________________________________
1 P. Ryan, et al. Non-inferior efficacy and less weight gain
when switching to DTG/3TC than when switching to BIC/FTC/TAF in
virologically suppressed people with HIV (PWH): the PASODOBLE
(GeSIDA 11720) randomized clinical trial. Presented at the 25
International AIDS Conference. July 2024. 2 C.P. Rolle, et al.
Efficacy, safety and tolerability of switching to
dolutegravir/lamivudine in virologically suppressed adults living
with HIV on bictegravir/emtricitabine/tenofovir alafenamide -
48-week results from the DYAD study. Presented at the 25
International AIDS Conference. July 2024. 3 J. Slim, et al. Switch
to dolutegravir/lamivudine (DTG/3TC) in people living with HIV-1
suppressed on bictegravir/emtricitabine/tenofovir alafenamide
(B/F/TAF): 96-week final analysis from the SOUND study. Presented
at the 25 International AIDS Conference. July 2024. 4 S.
Delany-Moretlwe, et al. Initial evaluation of CAB-LA Safety during
pregnancy in the HPTN 084 open-label extension. Presented at the
25th International AIDS Conference. July 2024. 5 M. Marzinke, et
al. Evaluation of Long-Acting Cabotegravir (CAB-LA)
Pharmacokinetics During Pregnancy: A Sub-Study Analysis of the HPTN
084 Open Label Extension. Presented at the 25th International AIDS
Conference. July 2024. 6 L. Rogg, et al. Phase 1 study of VH4524184
(VH-184), a new third-generation integrase strand transfer
inhibitor (INSTI) with a unique resistance profile. Presented at
the 25th International AIDS Conference. July 2024. 7 S. Schneider,
et al. Clinical outcomes at Month 12 after initiation of
cabotegravir and rilpivirine long acting (CAB+RPV LA) in an
observational real-world study (BEYOND). Presented at the 25th
International AIDS Conference. July 2024. 8 W. Valenti, et al.
Perspectives of people with HIV (PWH) 12 months following a switch
to cabotegravir and rilpivirine long-acting (CAB+RPV LA) in an
observational real-world US study (BEYOND). Presented at the 25th
International AIDS Conference. July 2024. 9 CJ. Oldenbüttel, et al.
12-Month outcomes of cabotegravir plus rilpivirine long-acting
every 2 months in a real-world setting: effectiveness, adherence to
injections, and patient-reported outcomes from people with HIV-1 in
the German CARLOS cohort. Presented at the 25th International AIDS
Conference. July 2024. 10 A. Pozniak, et al. Real-world utilization
and effectiveness of long-acting cabotegravir + rilpivirine in
virologically suppressed treatment experienced individuals in
Europe: data from COMBINE-2 cohort study. Presented at the 25th
International AIDS Conference. July 2024.
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