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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 July 2023
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: 24 July 2023, London UK
ViiV Healthcare's cabotegravir for HIV prevention receives positive
CHMP opinion from European Medicines Agency
● Cabotegravir is the first and
only long-acting injectable option for pre-exposure prophylaxis
(PrEP) to reduce the risk of sexually acquired
HIV-1
●
Positive opinion is
based on results from the HPTN 083 and 084 phase IIb/III studies in
which the medicine, given as few as six times per year,
demonstrated superior efficacy to a daily oral PrEP option (FTC/TDF
tablets) in reducing the risk of HIV acquisition1,2,3,4
●
With approximately
100,000 people in Europe newly diagnosed with HIV each
year5,
this is an important step towards expanding HIV prevention options
in the region
GSK plc (LSE/NYSE: GSK) announced that ViiV
Healthcare, the global specialist HIV company majority owned by
GSK, with Pfizer and Shionogi as shareholders, welcomed a positive
opinion by the European Medicines Agency's (EMA) Committee for
Medicinal Products for Human Use (CHMP) recommending marketing
authorisation for cabotegravir long-acting (LA) injectable and
tablets for HIV prevention. Cabotegravir is recommended in
combination with safer sex practices for pre-exposure prophylaxis
(PrEP) to reduce the risk of sexually acquired HIV-1 infection in
high-risk adults and adolescents weighing at least 35
kg.
In Europe, strong progress has been made in the delivery of HIV
treatment and prevention services, seeing a continuous decline in
the incidence of new HIV cases. However, with approximately 100,000
new diagnoses each year, if approved, cabotegravir LA will be the
only prevention option for people at risk of HIV acquisition that
is administered as few as six times per year.5
Kimberly Smith, M.D., MPH, Head of Research & Development at
ViiV Healthcare, said: "The
expansion of prevention options is critical if we are to end the
HIV epidemic. Long-acting options have the potential to play an
important role in reducing challenges such as inconsistent
adherence to taking daily pills, and stigma associated with oral
PrEP use that can be faced by people who could benefit from PrEP.
At ViiV Healthcare we are at the forefront of cutting-edge science,
developing innovative solutions to address the biggest unmet needs
in HIV prevention. With the CHMP positive opinion, we are hopeful
that people in Europe will soon be able to benefit from greater
choice".
The positive opinion is supported by data from two international
phase IIb/III multicentre, randomised, double-blind, active
controlled studies, HPTN 083 and HPTN 084, which evaluated the
safety and efficacy of cabotegravir LA for PrEP in HIV-negative men
who have sex with men, transgender women, and cisgender women who
were at increased risk of acquiring HIV. The studies demonstrated
that cabotegravir LA for PrEP was superior to daily oral
emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), with
clinical trial participants given cabotegravir LA experiencing a
69% lower rate of HIV acquisition compared to FTC/TDF tablets in
HPTN 083 (12 vs 39; annual incidence: 0.37% vs 1.22%; HR 0.31 [CI:
0.16, 0.58]) , and a 90% lower rate of HIV acquisition
compared to FTC/TDF tablets in HPTN 084 (3 vs 36; annual incidence:
0.15% vs 1.85%; HR 0.10 [CI: 0.04, 0.27]).1,2,3,4
Cabotegravir LA for PrEP is
currently approved for use in the US, Australia, Zimbabwe, South
Africa, Malawi, Botswana, and Brazil as Apretude. Submission
to other regulatory agencies is on-going.
About cabotegravir extended-release injectable
suspension
Cabotegravir long-acting for HIV prevention is the first and only
long-acting injectable PrEP option proven superior to daily oral
FTC/TDF in reducing HIV acquisition.
Cabotegravir long-acting for PrEP is an integrase strand transfer
inhibitor (INSTI). INSTIs, like cabotegravir extended-release
injectable suspension, 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.
Cabotegravir long-acting for PrEP is provided as an injection
administered six times per year by a healthcare professional and is
initiated with a single 600 mg (3-ml) injection given one month
apart for two consecutive months. After the second initiation
injection, the recommended continuation injection dose is a single
600 mg (3-ml) injection given every two months. Cabotegravir oral
tablets may be administered for approximately one month before
initiating the first injection to assess the tolerability of the
medicine.
About HPTN 083
(NCT02720094)1,3
The HPTN 083 trial is a phase IIb/III double blind non-inferiority
trial designed to evaluate the safety and efficacy of long-acting
injectable cabotegravir for HIV prevention administered every eight
weeks compared to daily oral FTC/TDF tablets (200 mg/300 mg). The
trial included the prespecified ability to test for superiority of
long-acting cabotegravir over FTC/TDF.
The trial design included an oral lead-in phase to assess
tolerability to cabotegravir before administering the intramuscular
(IM) injection. Each participant was to receive a maximum of three
years of blinded trial medication. The trial opened to enrolment in
November 2016. HPTN 083 was conducted in 4,566 HIV-negative men who
have sex with men and transgender women who have sex with
men, who
are at increased risk of HIV acquisition. The trial is being
conducted at research centres in Argentina, Brazil, Peru, the
United States, South Africa, Thailand, and
Vietnam.
Long-acting cabotegravir was found to be superior to daily oral
FTC/TDF in preventing HIV acquisition in the trial population. The
most common adverse reactions (all grades) observed in at least 1%
of subjects receiving long-acting cabotegravir were injection site
reactions, diarrhoea, headache, pyrexia, fatigue, sleep disorders,
nausea, dizziness, flatulence, and abdominal pain.
For further information on HPTN 083 please
see https://clinicaltrials.gov/ct2/show/NCT02720094.
About HPTN 084
(NCT03164564)2,4
The HPTN 084 trial is a phase III double blind superiority trial
designed to evaluate the safety and efficacy of the long-acting
injectable cabotegravir for HIV prevention administered every eight
weeks compared to daily oral FTC/TDF tablets (200 mg/300 mg) in
3,224 cisgender women who are at increased risk of HIV acquisition.
The trial design included an oral lead-in phase to assess
tolerability to cabotegravir before administering the IM injection.
HPTN 084 opened to enrolment in November 2017 and is being
conducted at research centres in Botswana, Kenya, Malawi, South
Africa, Eswatini, Uganda, and Zimbabwe.
Long-acting cabotegravir was found to be superior to daily oral
FTC/TDF in preventing HIV acquisition in the trial population. The
most common adverse reactions (all grades) observed in at least 1%
of subjects receiving long-acting cabotegravir were injection site
reactions, diarrhoea, headache, fatigue, sleep disorders, nausea,
dizziness, abdominal pain, vomiting, myalgia, and
rash.
For further information please see
https://clinicaltrials.gov/ct2/show/NCT03164564.
Trademarks are owned by or licensed to the ViiV Healthcare group of
companies
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
https://www.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
2022, and Q1 Results for 2023 and any impacts of the COVID-19
pandemic.
Registered in England & Wales:
No.
3888792
Registered Office:
980
Great West Road
Brentford,
Middlesex
TW8
9GS
References
[1] Landovitz RJ, Donnell D, Clement
ME, et al. Cabotegravir for HIV Prevention
in Cisgender Men and Transgender Women. The New
England Journal of Medicine 2021;385:595-608.
DOI: 10.1056/NEJMoa2101016
2 Delaney-Moretlwe S, Hughes J,
Bock P, et al. Cabotegravir for the prevention of HIV-1 in women:
results from HPTN 084, a phase 3, randomised clinical trial. The
Lancet 2022;399:1779-89.
3 Clinical Trials.gov - Safety and
Efficacy Study of Injectable Cabotegravir Compared to Daily Oral
Tenofovir Disoproxil Fumarate/Emtricitabine (TDF/FTC), For
Pre-Exposure Prophylaxis in HIV-Uninfected Cisgender Men and
Transgender Women Who Have Sex With Men. Available at
https://clinicaltrials.gov/ct2/show/NCT02720094.Last accessed July
2023.
4 Clinical Trials.gov - Evaluating
the Safety and Efficacy of Long-Acting Injectable Cabotegravir
Compared to Daily Oral TDF/FTC for Pre-Exposure Prophylaxis in
HIV-Uninfected Women. Available at
https://clinicaltrials.gov/ct2/show/NCT03164564. Last accessed July
2023.
5 ECDC/World Health Organisation
(2021) HIV/AIDS surveillance in Europe. Available at
http://www.ecdc.europa.eu/en/publications-data/hive-aids-surveillance-europe-2021-2020-data.
Last accessed July 2023.
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: July
24, 2023
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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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