UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 6-K
REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR
15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the
month of March 2024
Commission
File Number 001-15170
GSK plc
(Translation
of registrant's name into English)
980 Great West Road, Brentford, Middlesex, TW8 9GS
(Address
of principal executive office)
Indicate
by check mark whether the registrant files or will file annual
reports under cover of Form 20-F or Form 40-F.
Form
20-F . . . .X. . . . Form 40-F . . . . . . . .
Issued:
6 March 2024, London UK
ViiV Healthcare announces interim data at CROI indicating superior
efficacy of long-acting injectable HIV treatment Cabenuva (cabotegravir +
rilpivirine) compared to daily oral therapy in individuals living
with HIV who have adherence challenges
London,
06 March 2024 - ViiV Healthcare, the global specialist HIV company
majority owned by GSK, with Pfizer Inc. and Shionogi Limited as
shareholders, today announced data from a planned interim analysis
of the LATITUDE phase III trial, indicating that their long-acting
injectable antiretroviral treatment (ART) for
HIV, Cabenuva (cabotegravir
+ rilpivirine), demonstrated superior efficacy in maintaining viral
load suppression compared to daily oral therapy in individuals with
a history of ART adherence challenges.
The
data were presented by the Advancing Clinical Therapeutics Globally
for HIV/AIDS and Other Infections (ACTG) network at the Conference
on Retroviruses and Opportunistic Infections (CROI), in Denver,
Colorado.
Kimberly Smith, MD, MPH, Head of Research & Development at ViiV
Healthcare said, "It's estimated that one-third of people living
with HIV in the United States struggle with maintaining viral
suppression. The findings of the LATITUDE study show that
long-acting injectable cabotegravir + rilpivirine could be
important for some people in this group, giving them another option
to help keep their virus under control and improve their health.
Further, since we know that individuals whose virus is undetectable
don't transmit to sexual partners, this could be an important
contribution to ending the HIV epidemic."
LATITUDE
is a phase III, randomised, open-label study. Participants received
comprehensive and incentivised adherence support while taking
guideline-recommended, three-drug regimen oral ART, including
dolutegravir and bictegravir-based regimens, to achieve viral
suppression. Those who achieved viral suppression were eligible to
randomise to staying on oral standard of care (SOC) regimens or
switch to long-acting injectable cabotegravir + rilpivirine
(LA-ART) dosed monthly.
During
the randomised phase of the study, 146 participants received
monthly LA-ART and 148 continued on SOC. The primary endpoint was a
comparison of regimen failure, defined as a combination of
virologic failures (VF) and regimen discontinuations, between arms.
24.1% of participants on LA-ART experienced regimen failure
compared to 38.5% on SOC {difference -14.4 (98.75% CI -29.8%,
-0.8%)}.
Although
the primary endpoint did not meet the strict predefined stopping
criterion for the interim analysis, key secondary endpoints of
virologic failure (7.2% LA-ART vs. 25.4% SOC {difference -18.2%
(98.75% CI-31.1%, -5.4%}) and treatment-related failure (9.6%
LA-ART vs 26.2% SOC {difference -16.6% (98.75% CI -29.9%, -3.3%)}
favoured the LA-ART regimen. The study's Data Safety Monitoring
Board (DSMB) considered the totality of all the study endpoints
together and concluded that the evidence indicated superior
efficacy of long-acting ART over daily oral standard of care. The
DSMB recommended that all eligible participants should be offered
long-acting injectable cabotegravir + rilpivirine.
The
rate of adverse events (AEs) was similar in both arms. Three
participants in the LA-ART arm had serious injection site reactions
(ISR) and one participant discontinued due to an ISR. Two confirmed
virologic failures in each arm had new resistance associated
mutations (RAMS), including at least two new integrase inhibitor
RAMs in both LA-ART participants.
The
LATITUDE (Long-Acting Therapy to Improve Treatment Success in Daily
Life) study is ongoing across 31 sites in the U.S. including Puerto
Rico, implemented through ACTG. The median age of study
participants was 40 years old; 40 percent of participants were
male, 64 percent were Black/African American, 17 percent were
Hispanic, 5 percent were transgender, and 14 percent currently or
previously used injection drugs. The study is sponsored and funded
by the National Institute of Allergy and Infectious Diseases
(NIAID), part of the National Institutes of Health, and is being
conducted by ACTG, with additional support from the National
Institute of Mental Health, the National Institute on Drug Abuse,
ViiV Healthcare and the Janssen Pharmaceutical Companies of Johnson
& Johnson.
About Cabenuva (cabotegravir +
rilpivirine)
Cabenuva is indicated as a complete regimen for the
treatment of HIV-1 infection in adults to replace the current
antiretroviral regimen in those who are virologically suppressed
(HIV-1 RNA <50 c/ml) on a stable antiretroviral regimen with no
history of treatment failure and with no known or suspected
resistance to either cabotegravir or
rilpivirine.
The
complete regimen combines the integrase strand transfer inhibitor
(INSTI) cabotegravir, developed by ViiV Healthcare, with
rilpivirine, a non-nucleoside reverse transcriptase inhibitor
(NNRTI) developed by Janssen Sciences Ireland Unlimited Company.
Rilpivirine tablets are approved in the US as a 25mg tablet taken
once a day to treat HIV-1 in combination with other antiretroviral
agents in antiretroviral treatment-naïve patients 12 years of
age and older and weighing at least 35kg with a viral load
≤100,000 HIV RNA c/ml.
INSTIs
inhibit HIV replication by preventing the viral DNA from
integrating into the genetic material of human immune cells
(T-cells). This step is essential in the HIV replication cycle and
is also responsible for establishing chronic disease. Rilpivirine
is an NNRTI that works by interfering with an enzyme called reverse
transcriptase, which stops the virus from multiplying.
Trademarks
are owned by or licensed to the ViiV Healthcare group of
companies.
Please
consult the full Prescribing
Information.[1]
About ACTG
ACTG is the world's
largest and longest running clinical trials network focused on HIV
and other infectious diseases and the people living with them. It
is funded by NIAID and collaborating NIH Institutes. Founded in
1987, ACTG conducts research to improve the management of HIV and
its comorbidities; develop a cure for HIV; and innovate treatments
for tuberculosis, hepatitis B, and emerging infectious diseases. It
comprises thousands of dedicated researchers, staff, and community
members who are pursuing research into novel treatments and cures
for infectious diseases at hundreds of locations across four
continents, with the ultimate goal of advancing science that
meaningfully impacts the lives of the people we serve.
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 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.
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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
2023.
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
[1] https://cabenuvahcp.com/
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf
by the undersigned, thereunto duly authorised.
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GSK plc
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(Registrant)
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Date: March
06, 2024
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By:/s/ VICTORIA
WHYTE
--------------------------
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Victoria Whyte
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Authorised
Signatory for and on
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behalf
of GSK plc
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