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 May 2020
Commission
File Number 001-15170
GlaxoSmithKline 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 . . . . . . . .
Indicate
by check mark if the registrant is submitting the Form 6-K in paper
as permitted by Regulation S-T Rule 101(b)(1): ____
Indicate
by check mark if the registrant is submitting the Form 6-K in paper
as permitted by Regulation S-T Rule 101(b)(7): ____
Issued: 18 May 2020, London UK - LSE announcement
Global HIV prevention study to stop early after ViiV Healthcare's
long-acting injectable formulation of cabotegravir dosed every two
months shows higher efficacy than daily oral PrEP
●
Interim analysis from HPTN 083 study shows investigational,
long-acting injectable cabotegravir (CAB LA) administered every two
months is 69% more effective than daily pills in preventing HIV
acquisition
●
Participants who were in the daily oral emtricitabine/tenofovir
disoproxil fumarate 200 mg and 300 mg (FTC/TDF) tablet arm of the
study will be offered CAB LA
London, 18 May 2020 - ViiV
Healthcare, the global specialist HIV company majority owned by
GSK, with Pfizer Inc. and Shionogi Limited as shareholders, today
announced the interim analysis of the HIV Prevention Trials Network
(HPTN) 083 study evaluating the safety and efficacy of
investigational, long-acting, injectable cabotegravir for HIV
prevention. In the study cabotegravir was found to be 69% more
effective (95% CI 41%-84%) in preventing HIV acquisition in men who
have sex with men (MSM) and transgender women who have sex with men
when compared to the current standard of care, daily oral
emtricitabine/tenofovir disoproxil fumarate 200 mg and 300 mg
(FTC/TDF) tablets. The study achieved its primary objective of
non-inferiority with the difference approaching superiority in
favour of cabotegravir, pending final analysis.
The HPTN 083 study, with approximately 4,600 participants
across more than 40 sites in North and South America, Asia, and
Africa, is one of the first-ever clinical trials to directly
compare two active prevention agents. In a planned interim
review, the independent Data and Safety Monitoring Board (DSMB)
found the study data clearly indicated that long-acting injectable
cabotegravir was highly effective at preventing HIV in the study
population. Among the 50 people in the trial who acquired HIV, 12
were randomised to the long-acting cabotegravir arm and 38 were
randomised to the daily, oral FTC/TDF arm. This translated to an
HIV incidence rate of 0.38% (95% confidence interval [CI]
0.20%-0.66%) in the cabotegravir group and 1.21% (95% CI
0.86%-1.66%) in the FTC/TDF group. Adherence to oral FTC/TDF was
high, based on a random subset sampling that detected tenofovir
(> 0.31
ng/ml) in 87% of all samples tested. Despite this high level of
adherence to oral therapy, long-acting cabotegravir was 69% (95% CI
41%-84%) more effective than FTC/TDF in preventing HIV acquisition
in the study population.
Myron S. Cohen, M.D., Co-Principal Investigator of the HPTN and the
Yeargan-Bate Distinguished Professor of Medicine, Microbiology and
Immunology and Epidemiology at the University of North Carolina
(UNC) at Chapel Hill, said:
"Each year, an estimated 1.7 million people are newly diagnosed
with HIV. To lower that number, we believe more prevention options
are needed in addition to currently available oral tablets for
daily use. If approved, a new injectable agent, such as long-acting
cabotegravir administered every two months, could play an important
role in reducing HIV transmission and helping to end the HIV
epidemic."
Safety was similar in the two groups. Most participants in the
cabotegravir group (80%) reported pain or tenderness at the
injection site, compared to only 31% of those in the FTC/TDF arm,
who received placebo injections. Discontinuation due to
injection site reactions or injection intolerance in the
cabotegravir arm of the study was 2% and there were no
discontinuations due to ISRs in the FTC/TDF arm.
Following review of these findings, the DSMB recommended the
blinded, randomised portion of the study be stopped early and
results released. Participants who were in the FTC/TDF arm will be
offered CAB LA and participants in the CAB LA arm will continue to
receive it. Participants who do not want to receive CAB LA will be
offered FTC/TDF until the end of the originally planned blinded
component of the study. The DSMB decision was approved by the U.S.
National Institute of Allergy and Infectious Diseases (NIAID), part
of the National Institutes of Health (NIH), the study
sponsor.
The HPTN 083 study enrolled HIV-negative men who have sex with men
and transgender women who have sex with men, participants
considered at risk for HIV acquisition. Two-thirds of study
participants were under 30 years of age, and 12% were transgender
women. Half of the participants in the United States identified as
black or African American.
"These study results demonstrate that long-acting injectable
cabotegravir dosed every two months can successfully reduce HIV
acquisition in at-risk MSM and transgender women,"
said Kimberly Smith, M.D., Head of
Research & Development at ViiV Healthcare. "We are thrilled with the results not only
because of the high efficacy of cabotegravir but also because we
have demonstrated high efficacy in a study that adequately
represents some of the populations most disproportionately impacted
by HIV -- black MSM in the US, young MSM globally and transgender
women," she said.
"We continue to be focused on the completion of the companion HPTN
084 study, which will give us important information about the
effectiveness of cabotegravir in women. New options are needed for
HIV prevention that offer an effective alternative to daily oral
PrEP. If approved, this long-acting injectable has the potential to
be a game-changer for HIV prevention by reducing the frequency of
dosing from 365 days to six times per year."
HTPN 083 was jointly funded by the U.S. NIAID, part of the NIH, and
ViiV Healthcare, and was conducted by the HPTN. Study product was
provided by ViiV Healthcare and Gilead Sciences.
The DSMB also reviewed data from HPTN 084, which began a year later
than HPTN 083, and recommended that it continue as planned. To
date, more than 3,000 sexually active women in seven African
countries have enrolled in HPTN 084, which is co-funded by NIAID,
ViiV Healthcare and the Bill & Melinda Gates
Foundation.
Detailed results from HPTN 083 will be presented at an upcoming
scientific meeting. ViiV Healthcare plans to use the data from HPTN
083 for future regulatory submissions. Cabotegravir has not yet
been approved for the treatment or prevention of HIV as a single
agent by regulatory authorities anywhere in the world.
About HPTN 083 (NCT02720094)
The HPTN 083 study is a phase IIb/III double blind study 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). Each
participant was to receive a maximum of three years of blinded
study medication. The study opened to enrolment in November 2016.
HPTN 083 was conducted in approximately 4,600 men who have sex with
men and transgender women who have sex with men at research centres
in Argentina, Brazil, Peru, United States, South Africa, Thailand
and Vietnam.
For further information on HPTN 083 please
visit https://clinicaltrials.gov/ct2/show/NCT02720094.
About HPTN 084 (NCT03164564)
The HPTN 084 study is a phase III double blind safety and efficacy
study 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 3,200 women who are at increased risk of HIV
acquisition. 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.
For further information please see https://clinicaltrials.gov/ct2/show/NCT03164564
About HIV Prevention Trials Network (HPTN)
The HIV Prevention Trials Network (HPTN) is a worldwide
collaborative clinical trials network that brings together
investigators, ethicists, community members and other partners to
develop and test the safety and efficacy of interventions designed
to prevent the acquisition and transmission of HIV. The National
Institutes of Health (NIH), the National Institute of Mental Health
(NIMH) and the National Institute on Drug Abuse (NIDA) co-fund the
HPTN. The HPTN has collaborated with more than 85 clinical research
sites in 19 countries to evaluate new HIV prevention interventions
and strategies in populations that bear a disproportionate burden
of infection. The HPTN research agenda - more than 50 trials
ongoing or completed with over 161,000 participants enrolled and
evaluated - is focused primarily on the use of antiretroviral drugs
(antiretroviral therapy and pre-exposure prophylaxis); and
integrated strategies including interventions for substance abuse,
particularly injection drug use; behavioural risk reduction
interventions and structural interventions. For more information,
visit hptn.org.
About ViiV Healthcare
ViiV Healthcare is a global specialist HIV company established in
November 2009 by GlaxoSmithKline (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 becoming infected
with HIV. Shionogi joined in October 2012. The company's aim is to
take a deeper and broader interest in HIV/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 www.viivhealthcare.com.
About GSK
GSK is a science-led global healthcare company with a special
purpose: to help people do more, feel better, live longer. For
further information please visit www.gsk.com.
Inside information
The information contained in this announcement is inside
information. If you have any queries on this, then please contact
Victoria Whyte GSK Company Secretary (responsible for arranging the
release of this announcement) at GSK House Brentford, Middlesex,
TW8 9GS on +44 208 047 5000.
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 2019
and any impacts of the COVID-19 pandemic.
ViiV Healthcare Media enquiries:
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Melinda Stubbee
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+1 919 491 0831
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Audrey Abernathy
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+1 919 605 4521
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GSK Global Media enquiries:
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Simon Steel
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+44 (0) 20 8047 5502
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Analyst/Investor enquiries:
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Kristen Neese
Sarah Elton-Farr
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+1 804 217 8147
+44 (0) 20 8047 5194
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Danielle Smith
James Dodwell
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+44 (0) 20 8047 0932
+44 (0) 20 8047 2406
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Jeff McLaughlin
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+1 215 751 7002
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Frannie DeFranco
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+1 215 751 4855
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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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GlaxoSmithKline plc
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(Registrant)
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Date: May
18, 2020
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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 GlaxoSmithKline plc
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