Blueprint
FORM 6-K
SECURITIES AND EXCHANGE COMMISSION
Washington D.C. 20549
Report of Foreign Issuer
Pursuant to Rule 13a-16 or 15d-16 of
the Securities Exchange Act of 1934
For
period ending 05 March 2018
GlaxoSmithKline plc
(Name
of registrant)
980 Great West Road, Brentford, Middlesex, TW8 9GS
(Address
of principal executive offices)
Indicate
by check mark whether the registrant files or
will
file annual reports under cover Form 20-F or Form 40-F
Form
20-F x Form 40-F
--
Indicate
by check mark whether the registrant by furnishing the
information
contained in this Form is also thereby furnishing the
information
to the Commission pursuant to Rule 12g3-2(b) under the
Securities
Exchange Act of 1934.
Yes
No x
Issued:
5 March 2018, London UK - LSE Announcement
ViiV Healthcare announces positive new dolutegravir data for the
treatment of people living with HIV co-infected with
tuberculosis
INSPIRING study results contribute to the extensive body of
evidence for dolutegravir, the leading integrase strand transfer
inhibitor, in diverse and hard to treat patient
populations
London, UK 5 March 2018 - ViiV
Healthcare, the global specialist HIV company, majority owned by
GlaxoSmithKline, with Pfizer Inc. and Shionogi Limited as
shareholders, today announced interim (Week 24) study results from
INSPIRING, a phase IIIb study evaluating the safety and efficacy of
dolutegravir in antiretroviral treatment-naive (ART-naïve)
adults with HIV, co-infected with tuberculosis (TB). Results
presented today at the annual Conference on Retroviruses and
Opportunistic Infections (CROI) in Boston, show that dolutegravir
when administered at 50mg twice-daily with dual nucleoside reverse
transcriptase inhibitors (NRTI), was effective and well-tolerated
in HIV/TB co-infected adults receiving rifampin-based TB
therapy.[1]
John C Pottage, Jr, MD, Chief Scientific and Medical Officer, ViiV
Healthcare, said, "Tuberculosis remains the leading cause of death
among people living with HIV, accounting for around one in three
AIDS-related deaths. Concurrent treatment of TB and HIV remains a
challenge as it is compounded by drug interactions, overlapping
toxicities and immune reconstitution inflammatory syndrome. This is
why the INSPIRING study is so important, as we look to provide this
underserved population with as many effective treatment options as
possible. The INSPIRING results add to the breadth and depth of
data available for dolutegravir and support its use in the
treatment of people living with HIV co-infected with
TB."
INSPIRING is a phase IIIb, non-comparative, active control,
randomised, open-label study in HIV-1 infected ART-naive adults
with drug-sensitive TB. Of the 113 enrolled participants on a
rifampin-based TB treatment for up to 8 weeks, 69 were randomised
to receive dolutegravir (50mg twice-daily during and for two weeks
after TB therapy followed by 50mg once-daily) with two NRTIs and 44
to receive efavirenz (600mg once-daily) with two NRTIs. The primary
endpoint of the study is the proportion of dolutegravir patients
with HIV-1 RNA <50 copies per mL at week 48.1
The study, being
conducted in Argentina, Brazil, Mexico, Peru, Russia, South Africa
and Thailand, was not powered to show a difference between study
arms and no formal statistical hypothesis was
tested.
An interim analysis conducted at 24 weeks showed that the
proportion of patients who maintained viral suppression (HIV-1 RNA
less than 50 copies per ml) in the dolutegravir arm was 56/69 (81%)
(95% confidence interval CI: 72%, 90%).1
In the efavirenz arm,
39/44 patients (89%) (95% CI: 79%, 98%) maintained viral
suppression. No patients in the dolutegravir arm and two patients
in the efavirenz arm discontinued due to adverse events, while five
participants (7%) in the dolutegravir arm and none in the efavirenz
arm discontinued due to non-treatment related reasons (loss to
follow-up/protocol deviations).1 There
were no reports of treatment emergent resistance in the
dolutegravir arm and there was one report in the efavirenz
arm.1 TB-associated
immune reconstitution inflammatory syndrome (IRIS) rates were low
in both arms (dolutegravir, n=4; efavirenz n=4) with no patients
discontinuing due to IRIS or liver events.1
The INSPIRING study is ongoing and 48-week data will be presented
at a future scientific meeting.
In 2016, there were an estimated 10.4 million cases of TB globally,
including 1.2 million (11%) among people living with HIV
(PLHIV).[2]
Although TB-related
deaths among PLHIV have been steadily declining (33% decrease
between 2005 and 2015), almost 60% of TB cases among PLHIV were not
diagnosed or treated, resulting in 390,000 tuberculosis-related
deaths among PLHIV in 2015.2
Notes to editors
About HIV
HIV stands for the Human Immunodeficiency Virus. Unlike some other
viruses, the human body cannot get rid of HIV, so once someone has
HIV they have it for life. There is no cure for HIV, but effective
treatment can control the virus so that people with HIV can enjoy
healthy and productive lives.
HIV has largely become a chronic treatable disease, with improved
access to antiretroviral treatment leading to a 22% drop in global
HIV mortality between 2009 and 2013, but more can be done for the
estimated 36.7 million people living with HIV and 1.8 million
individuals newly infected each year worldwide.[3]
About INSPIRING
INSPIRING is a phase IIIb, randomised, open-label, multicentre,
parallel-group study to assess the antiviral activity of
dolutegravir or efavirenz-containing regimens in HIV/TB co-infected
patients undergoing rifampin-based TB therapy. The study includes a
screening period, a randomised phase (Day 1 to 48 weeks plus a
4-week extension) and a dolutegravir open-label extension. During
the dolutegravir open-label extension, patients were provided with
dolutegravir until it is locally approved and commercially
available, the patient no longer derives clinical benefit, or the
patient meets a protocol-defined reason for discontinuation,
whichever comes first.
The primary endpoint is the proportion of dolutegravir patients
with plasma HIV-1 RNA <50 copies per millilitre (c/mL) at Week
48. Key secondary endpoints include the proportion of efavirenz
patients with plasma HIV-1 RNA <50 c/mL at Week 48 and
evaluation of both study arms at Week 24. Additional secondary
endpoints include evaluation of the development of viral
resistance, measurements of safety, tolerability and changes from
baseline CD4+ counts.
About Tivicay (dolutegravir)
Dolutegravir (Tivicay) is an integrase strand transfer inhibitor
(INSTI) for use in combination with other antiretroviral agents for
the treatment of HIV. Integrase inhibitors block 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
infection. Tivicay is approved in over 100 countries across North
America, Europe, Asia, Australia, Africa and Latin
America.
TIVICAY (dolutegravir) tablets
Professional Indication(s) and Important Safety
Information
Indications and Usage
TIVICAY is a human immunodeficiency virus type 1 (HIV-1) integrase
strand transfer inhibitor (INSTI) indicated in combination
with:
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other antiretroviral agents for the treatment of
HIV-1 infection in adults and pediatric patients weighing at least
30 kg
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rilpivirine 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 copies per mL) on a stable antiretroviral
regimen for ≥6 months with no history of treatment failure or
known substitutions associated with resistance to either
antiretroviral agent (US Only)
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Important Safety Information
CONTRAINDICATIONS:
TIVICAY is contraindicated in patients:
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with previous hypersensitivity reaction to
dolutegravir
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receiving dofetilide
(antiarrhythmic)
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WARNINGS AND PRECAUTIONS:
Hypersensitivity Reactions:
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Hypersensitivity reactions have been reported and
were characterized by rash, constitutional findings, and sometimes
organ dysfunction, including liver injury. The events were reported
in <1% of subjects receiving TIVICAY in Phase 3 clinical
trials
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Discontinue TIVICAY and other suspect agents
immediately if signs or symptoms of hypersensitivity reactions
develop, as a delay in stopping treatment may result in a
life-threatening reaction. Monitor clinical status, including liver
aminotransferases, and initiate appropriate therapy if
hypersensitivity reaction is
suspected
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Hepatotoxicity:
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Patients with underlying hepatitis B or C may be
at increased risk for worsening or development of transaminase
elevations with use of TIVICAY. In some cases the elevations in
transaminases were consistent with immune reconstitution syndrome
or hepatitis B reactivation, particularly in the setting where
anti-hepatitis therapy was
withdrawn
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Cases of hepatic toxicity, including elevated
serum liver biochemistries, hepatitis, and acute liver failure,
have also been reported in patients receiving a
dolutegravir-containing regimen who had no pre-existing hepatic
disease or other identifiable risk factors. Drug-induced liver
injury leading to liver transplant has been reported with TRIUMEQ
(abacavir, dolutegravir, and
lamivudine)
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Monitoring for hepatotoxicity is
recommended
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Risk of Adverse Reactions or Loss of Virologic Response Due to Drug
Interactions:
The concomitant use of TIVICAY and other drugs may result in known
or potentially significant drug interactions (see Contraindications
or Drug Interactions).
Immune Reconstitution Syndrome,
including the occurrence of autoimmune disorders with variable time
to onset, has been reported.
ADVERSE REACTIONS:
The most commonly reported (≥2%) adverse reactions of
moderate to severe intensity in treatment-naïve adult subjects
in any one trial receiving TIVICAY in a combination regimen were
insomnia (3%), fatigue (2%), and headache (2%).
DRUG INTERACTIONS:
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Coadministration of TIVICAY with certain inducers
of UGT1A and/or CYP3A may reduce plasma concentrations of
dolutegravir and require dose adjustments of
TIVICAY
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Administer TIVICAY 2 hours before or 6 hours after
taking polyvalent cation-containing antacids or laxatives,
sucralfate, oral supplements containing iron or calcium, or
buffered medications. Alternatively, TIVICAY and supplements
containing calcium or iron can be taken with
food
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Consult the full Prescribing Information for
TIVICAY for more information on potentially significant drug
interactions, including clinical comments
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USE IN SPECIFIC POPULATIONS:
Pregnancy:
There are insufficient human data on the use of TIVICAY during
pregnancy to inform a drug-associated risk of birth defects and
miscarriage. An Antiretroviral Pregnancy Registry has been
established.
Lactation:
Breastfeeding is not recommended due to the potential for HIV
transmission and developing viral resistance in HIV-positive
infants.
Paediatric Use:
Safety and efficacy of TIVICAY have not been established in
paediatric patients weighing less than 30 kg or in any paediatric
patients who are INSTI-experienced.
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.
GSK - 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
ViiV Healthcare Media enquiries:
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Patricia O'Connor
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+44 (0) 20 8047 5982
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Marc Meachem
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+1 919 483 8756
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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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David Daley
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+44 (0) 20 8047 5502
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Analyst/Investor enquiries:
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Sarah Elton-Farr
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+44
(0) 20 8047 5194
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Tom Curry
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+ 1 215 751 5419
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Gary Davies
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+44 (0) 20 8047 5503
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James Dodwell
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+44 (0) 20 8047 2406
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Jeff McLaughlin
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+1 215 751 7002
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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
'Principal risks and uncertainties' in the company's Annual Report
on Form 20-F for 2016.
References
[1] Dooley KE, et al. Safety
and efficacy of dolutegravir-based ART in TB/HIV co-infected adults
at week 24. Presented at the Conference on Retroviruses and
Opportunistic Infections, 2018. Boston, MA
[2] World Health Organization.
Global Tuberculosis Report. 2017
[3] World Health Organization.
HIV/AIDS Fact Sheet. Available at:
http://www.who.int/mediacentre/factsheets/fs360/en/. Last accessed
November 2017.
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: March
05, 2018
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By: 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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