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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 14 February
2017
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
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file annual reports under cover Form 20-F or Form 40-F
Form
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--
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by check mark whether the registrant by furnishing the
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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.
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No x
PRESS RELEASE
ViiV Healthcare announces detailed positive phase III results for
investigational two-drug regimen of dolutegravir and rilpivirine
for HIV treatment
In the SWORD studies, the two-drug regimen showed comparable
efficacy to three- or four-drug regimens in virologically
suppressed patients
London, UK 13 February 2017 - ViiV Healthcare, the global
specialist HIV company majority-owned by GSK, with Pfizer Inc. and
Shionogi Limited as shareholders, today announced detailed study
results from its phase III programme evaluating the safety and
efficacy of switching virologically suppressed patients from a
three- or four-drug antiretroviral regimen to a two-drug regimen of
dolutegravir (ViiV Healthcare) and rilpivirine (Janssen Sciences
Ireland UC). Headline results were announced in December 2016 and
detailed study results are being presented at the annual Conference
on Retroviruses and Opportunistic Infections in
Seattle.
Use of
dolutegravir and rilpivirine as a two-drug regimen for HIV-1
maintenance therapy is investigational and not approved anywhere in
the world.
The
dolutegravir and rilpivirine regimen achieved non-inferior viral
suppression (HIV-1 RNA <50 copies/millilitre) at 48 weeks
compared with a three- or four-drug regimen in both pooled and
individual analyses of the SWORD 1 and SWORD 2 studies (current
antiretroviral therapy (CAR) 485/511 (95%), dolutegravir +
rilpivirine 486/513 (95%) [adjusted difference -0.2% (95% CI: 3.0%,
2.5%%], pooled analysis]). Virologic suppression rates were similar
between treatment arms. The median duration of antiretroviral
treatment was just over four years at the time of entry into the
studies. The most commonly reported (>5%) adverse events in the
dolutegravir and rilpivirine arm were nasopharyngitis, headache,
diarrhoea and upper respiratory tract infection. For the CAR arm,
the most commonly reported adverse events were nasopharyngitis,
upper respiratory tract infection, back pain, headache and
diarrhoea. The studies are ongoing for 148 weeks.
John C
Pottage, Jr, MD, Chief Scientific and Medical Officer, ViiV
Healthcare, commented, "The results from these studies may change
our understanding of how HIV can be managed. For more than 20 years
we thought that three or more drugs were required to maintain
virologic suppression, but the SWORD studies provide compelling
data that suppression may be maintained with a two drug regimen of
dolutegravir and rilpivirine. These data mark an exciting first
step towards making two drug regimens a reality in HIV treatment.
We are planning regulatory submissions for this two-drug regimen as
a single tablet in 2017."
The
programme comprises two studies with over 1000 patients who
previously achieved viral suppression on a three- or four-drug
(integrase strand transfer inhibitor [INSTI]-, non-nucleoside
reverse transcriptase inhibitor [NNRTI]-, or protease inhibitor
[PI]-based) antiretroviral regimen. These patients were randomised
to either stay on their three- or four-drug regimen or switch to a
dolutegravir and rilpivirine regimen.
Virologic
failure rates were <1% in the dolutegravir and rilpivirine arm
and 1% in the three- or four- antiretroviral-drug arm. No INSTI
resistance-associated mutations were reported.
The
overall rate of serious adverse events was comparable between
treatment groups (dolutegravir + rilpivirine: 27, CAR: 21). As
would be expected when switching from a stable regimen to a new
regimen, more adverse events were reported and led to withdrawal
from the study in the dolutegravir and rilpivirine arm compared to
the CAR arm (dolutegravir + rilpivirine: 21, CAR: 3).
The
safety profiles for dolutegravir and rilpivirine in these studies
were consistent with the product labelling for each
medicine.
Conference call for investors and analysts
ViiV
Healthcare will host a conference call for investors and analysts
at 15:00 GMT (10:00 EST) on the 15th February 2017.
UK
Freefone: 080 8234 7616
UK
direct: +44 207 365 4163
US Toll
free: 1 888 419 5570
International
direct: +1 617 896 9871
For a
complete list of dial-in numbers available by country, please
visit:
http://www.btconferencing.com/globalaccess/?bid=54_attended
Once
connected, follow the instructions provided over the phone. When
prompted, give the following information:
1.
Participant passcode: 188 060
38
2. Name,
Company Name
Notes to editors
In June 2014, ViiV Healthcare and Janssen Sciences Ireland UC, one
of the Janssen Pharmaceutical Companies of Johnson & Johnson
announced a partnership to investigate the potential of combining
dolutegravir and rilpivirine in a single tablet in order to expand
the treatment options available to people living with
HIV.
About the SWORD phase III programme for dolutegravir
(Tivicay®) and rilpivirine (Edurant®)
The phase III programme evaluates the efficacy, safety, and
tolerability of switching to dolutegravir and rilpivirine from
current integrase inhibitor-, non-nucleoside reverse transcriptase
inhibitor-, or boosted protease inhibitor-based antiretroviral
regimen in HIV-1-infected adults who are virologically suppressed
with a three or four-drug regimen. In the clinical trials,
dolutegravir and rilpivirine are provided as individual tablets.
SWORD-1 (NCT02429791) and SWORD-2 (NCT02422797) are replicate
148-week, randomised, open-label, non-inferiority studies to assess
the antiviral activity and safety of a two-drug, daily oral regimen
of dolutegravir plus rilpivirine compared with current
antiretroviral therapy.
The primary endpoint is the proportion of patients with plasma
HIV-1 RNA <50 copies per milliliter (c/mL) at Week 48. Key
secondary endpoints include evaluation of the development of viral
resistance, measurements of safety and tolerability, and changes in
renal, bone and cardiovascular biomarkers. The studies also include
exploratory measures to assess change in health-related quality of
life, willingness to switch and adherence to treatment
regimens.
Tivicay® is a registered trademark of the ViiV Healthcare
group of companies
Edurant® is a registered trademark of Janssen Sciences Ireland
UC
For more information on the trials please visit:
www.clinicaltrials.gov
TIVICAY® (dolutegravir) tablets
Professional Indication(s) and Important Safety
Information
U.S. Indications and Usage
TIVICAY is a human immunodeficiency virus type 1 (HIV-1) integrase
strand transfer inhibitor (INSTI) indicated in combination with
other antiretroviral agents for the treatment of HIV-1 infection in
adults
Limitations of use:
●
Use of TIVICAY in INSTI-experienced
patients should be guided by the number and type of baseline INSTI
substitutions. The efficacy of TIVICAY 50 mg twice daily is reduced
in patients with an INSTI-resistance Q148 substitution plus 2 or
more additional
INSTI-resistance substitutions
including T66A, L74I/M, E138A/K/T, G140S/A/C, Y143R/C/H, E157Q,
G163S/E/K/Q, or G193E/R
Important Safety Information
Contraindications:
TIVICAY
is contraindicated in patients:
●
With previous hypersensitivity reaction
to dolutegravir
●
Receiving dofetilide
(antiarrhythmic)
Hypersensitivity Reactions:
●
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
●
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
Effects on Serum Liver Biochemistries in Patients with Hepatitis B
or C Co-infection:
●
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
●
Appropriate laboratory testing prior to
initiating therapy and monitoring for hepatotoxicity during therapy
with TIVICAY are recommended in patients with underlying hepatic
disease such as hepatitis B or C
Fat Redistribution or accumulation has been observed in
patients receiving antiretroviral therapy.
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:
●
Coadministration of TIVICAY with
certain inducers of UGT1A and/or CYP3A may reduce plasma
concentrations of dolutegravir and require dose adjustments of
TIVICAY
●
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
●
Consult the full Prescribing
Information for TIVICAY for more information on potentially
significant drug interactions, including clinical
comments
Pregnancy: TIVICAY should be used during pregnancy only if
the potential benefit justifies the potential risk. An
Antiretroviral Pregnancy Registry has been
established.
Nursing Mothers: Breastfeeding is not recommended due to the
potential for HIV transmission and the potential for adverse
reactions in nursing infants.
About rilpivirine
Edurant®
(rilpivirine) is a once daily non-nucleoside reverse transcriptase
inhibitor (NNRTI) used for the treatment of human immunodeficiency
virus (HIV-1) infection in combination with other antiretroviral
agents in antiretroviral treatment-naïve adult patients with a
viral load ≤ 100,000 HIV RNA copies/mL.
Rilpivirine
was developed by Janssen Sciences Ireland UC, one of the Janssen
Pharmaceutical Companies of Johnson & Johnson. Rilpivirine is
approved in the U.S. and E.U. as Edurant® as a 25mg tablet
taken once-a-day and is always taken with a meal. The overall
safety and efficacy profile of rilpivirine is based on phase III
clinical studies. The most common side effects of Edurant include:
depression, headache, trouble sleeping (insomnia) and
rash.
EDURANT® Consumer Indication and Important Safety Information
(ISI)
About EDURANT®
● EDURANT® (rilpivirine) is a prescription HIV medicine
that is used with other antiretroviral medicines to treat Human
Immunodeficiency Virus-1 (HIV-1)
in adults:
- Who have never taken HIV medicines before, and
- Who have an amount of HIV in their blood (called "viral load")
that is no more than 100,000 copies/mL. Your healthcare
professional will measure your viral load
● EDURANT® should be taken in combination with other HIV
medicines. Your healthcare professional will work with you to find
the right combination of HIV medicines
● It is important that you remain under the care of your
healthcare professional during treatment with
EDURANT®
● EDURANT® is not recommended for patients less
than 18 years of age
EDURANT® does not cure HIV infection or AIDS. You should
remain on your HIV medications without stopping to ensure that you
control your HIV infection and decrease the risk of HIV-related
illnesses.
Ask your healthcare professional about how to prevent passing HIV
to other people.
Please read Important Safety Information below, and talk to your
healthcare professional to learn if EDURANT® is right for
you.
Important Safety Information
Can EDURANT® be taken with other medicines?
EDURANT® may affect the way other medicines work and other
medicines may affect how EDURANT® works and may cause serious
side effects. If you take certain medicines with EDURANT®, the
amount of EDURANT® in your body may be too low and it may not
work to help control your HIV infection, and the HIV virus in your
body may become resistant to EDURANT® or other HIV medicines
that are like it. To help get the right amount of medicine in your
body, you should always take EDURANT® with a meal. A protein
drink alone does not replace a meal.
Do not take EDURANT® if:
●
Your HIV infection has been previously
treated with HIV medicines
●
You are taking any of the following
medicines:
- Anti-seizure medicines: carbamazepine (Carbatrol®,
Equetro®, Tegretol®, Tegretol-XR®, Teril®,
Epitol®), oxcarbazepine (Trileptal®), phenobarbital
(Luminal®), phenytoin (Dilantin®, Dilantin-125®,
Phenytek®)
- Anti-tuberculosis (anti-TB) medicines: rifampin (Rifater®,
Rifamate®, Rimactane®, Rifadin®), rifapentine
(Priftin®)
- Proton pump inhibitor (PPI) medicine for certain stomach or
intestinal problems: esomeprazole (Nexium®, Vimovo®),
lansoprazole (Prevacid®), omeprazole (Prilosec®,
Zegerid®), pantoprazole sodium (Protonix®), rabeprazole
(Aciphex®)
- More than 1 dose of the steroid medicine dexamethasone or
dexamethasone sodium phosphate
- St. John's wort (Hypericum perforatum)
Especially tell your doctor if you take:
●
Rifabutin (Mycobutin®), a medicine to treat some bacterial
infections). Talk to your doctor or pharmacist about the right
amount of EDURANT® you should take if you also take
rifabutin
● Medicines used to treat HIV
● An antacid medicine that contains aluminum, magnesium
hydroxide, or calcium carbonate. Take antacids at least 2 hours before or at
least 4 hours after you take EDURANT®
● Medicines to block acid in your stomach, including
cimetidine (Tagamet®), famotidine (Pepcid®), nizatidine
(Axid®), or ranitidine hydrochloride (Zantac®). Take
these medicines at least 12 hours before or at
least 4 hours after you take EDURANT®
● Any of these medicines (if taken by mouth or injection):
clarithromycin (Biaxin®), erythromycin (E-Mycin®,
Eryc®, Ery-Tab®, PCE®, Pediazole®,
Ilosone®), fluconazole (Diflucan®), itraconazole
(Sporanox®), ketoconazole (Nizoral®), methadone
(Dolophine®), posaconazole (Noxafil®), telithromycin
(Ketek®), voriconazole (Vfend®)
This is not a complete list of medicines. Before starting
EDURANT®, be sure to tell your healthcare professional about
all the medicines you are taking or plan to take, including
prescription and nonprescription medicines, vitamins, and herbal
supplements.
Before taking EDURANT®, also tell your healthcare professional
if you have had or currently have liver problems (including
hepatitis B or C), have ever had a mental health problem, are
pregnant or planning to become pregnant, or breastfeeding. It is
not known if EDURANT® will harm your unborn baby.
You and your healthcare professional will need to decide if taking
EDURANT®
is right for you.
Do not breastfeed if you are taking EDURANT®.
You should not breastfeed if you have
HIV because of the chance of passing HIV to your
baby
What are the possible side effects of EDURANT®?
EDURANT® can cause serious side effects
including:
● Severe skin rash and allergic reactions.
Call your doctor right away if you get
a rash. Stop taking EDURANT® and seek medical help right away
if you get a rash with any of the following symptoms: severe
allergic reaction causing swelling of the face, eyes, lips, mouth,
tongue, or throat (which may lead to difficulty swallowing or
breathing); mouth sores or blisters on your body; inflamed eye
(conjunctivitis); fever; dark urine; or pain on the right side of
the stomach area (abdominal pain)
● Depression or mood changes. Tell your doctor right away if you have any of the
following symptoms: feeling sad or hopeless, feeling anxious or
restless, have thoughts of hurting yourself (suicide), or have
tried to hurt yourself
● Liver problems.
People with a history of hepatitis B
or C virus infection or who have certain liver function test
changes may have an increased risk of developing new or worsening
liver problems during treatment. Liver problems were also reported
during treatment in some people without a history of liver disease.
Your healthcare professional may need to do tests to check liver
function before and during treatment
● Changes in body shape or body
fat have been seen in some
patients taking HIV medicines. The exact cause and long-term health
effects of these conditions are not known
● Changes in your immune system
(immune reconstitution syndrome).
Your immune system may get stronger and begin to fight infections.
Tell your healthcare professional right away if you start having
any new symptoms of infection
Other common side effects of EDURANT® include depression,
headache, trouble sleeping (insomnia), and rash.
This is not a complete list of all side effects. If you experience
these or other symptoms, contact your healthcare professional right
away. Do not stop taking EDURANT® or any other medications
without first talking to your healthcare professional.
You are encouraged to report negative side effects of prescription
drugs to the FDA. Visit www.fda.gov/medwatch,
or
call 1-800-FDA-1088.
Please see full Product Information for more details.
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 -
one of the world's leading research-based pharmaceutical and
healthcare companies - is committed to improving the quality of
human life by enabling people to do more, feel better and live
longer. For further information please visit
www.gsk.com.
ViiV
Healthcare Media enquiries:
|
Sébastien
Desprez
|
+44 (0)
20 8380
6275
|
|
Patricia
O'Connor
|
+44 (0)
208 047 5982
|
|
Marc
Meachem
|
+1 919
483 8756
|
|
|
|
GSK
Global Media enquiries:
|
David
Daley
|
+44 (0)
20 8047 2615
|
|
Kathleen
Cuca
|
+1 215
859 1922
|
|
|
|
GSK US
Media enquiries:
|
Mary
Anne Rhyne
|
+1 919
483 0492
|
|
Sarah
Spencer
|
+1 215
751 3335
|
|
|
|
Analyst/Investor
enquiries:
|
Sarah
Elton-Farr
|
+44 (0)
20 8047 5194
|
|
Gary
Davies
|
+44 (0)
20 8047 5503
|
|
James
Dodwell
|
+44 (0)
20 8047 2406
|
|
|
|
|
Tom
Curry
|
+1 215
751 5419
|
|
Jeff
McLaughlin
|
+1 215
751 7002
|
|
|
|
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.
|
GlaxoSmithKline plc
|
|
(Registrant)
|
|
|
Date: February
14, 2017
|
|
|
|
|
By: VICTORIA
WHYTE
|
|
|
|
Victoria Whyte
|
|
Authorised
Signatory for and on
|
|
behalf
of GlaxoSmithKline plc
|