ViiV Healthcare receives EU marketing authorisation for Triumeq® (dolutegravir/abacavir/lamivudine), a new once-daily single

       ViiV Healthcare receives EU marketing authorisation for Triumeq®
 (dolutegravir/abacavir/lamivudine), a new once-daily single-pill regimen for
                             the treatment of HIV

  PR Newswire

  LONDON, Sept. 3, 2014

LONDON, Sept. 3, 2014 /PRNewswire/ -- ViiV Healthcare announced today that the
European Commission (EC) has granted marketing authorisation for Triumeq ^®
(dolutegravir 50mg / abacavir 600mg / lamivudine 300mg) tablets for the
treatment of HIV in adults and adolescents aged 12 years and older and
weighing at least 40kg. Before initiating treatment with abacavir-containing
products, screening for the presence of a genetic marker, the HLA-B*5701
allele, should be performed in any HIV-infected patient, irrespective of
racial origin. Abacavir should not be used in patients known to carry the
HLA-B*5701 allele. ^1 Patients who carry this genetic marker are at high risk
of experiencing a hypersensitivity reaction to abacavir.

Triumeq is ViiV Healthcare's first once-daily single-pill dolutegravir-based
regimen that combines the integrase strand transfer inhibitor (INSTI)
dolutegravir, with the nucleoside reverse transcriptase inhibitors (NRTIs)
abacavir and lamivudine.

Dr Dominique Limet, Chief Executive Officer, ViiV Healthcare, said: "We are
delighted with today's approval that offers people living with HIV in Europe
the first single-pill regimen containing dolutegravir. Triumeq is a direct
result of ViiV Healthcare's patient-centred approach to innovation. As a
company that focuses 100% on HIV, our commitment is to continue to deliver new
options for care and treatment for people living with HIV."

This EC approval is based primarily upon data from two clinical trials:

  *the Phase III study (SINGLE) of treatment-naive adults, conducted with
    dolutegravir and abacavir/lamivudine as separate pills ^2,3
  *a bioequivalence study of the fixed-dose combination of dolutegravir,
    abacavir and lamivudine when taken as a single pill compared to the
    administration of dolutegravir and abacavir/lamivudine as separate pills.

In the SINGLE study, a non-inferiority trial with a pre-specified superiority
analysis, more patients were undetectable (HIV-1 RNA ^®† (efavirenz,
emtricitabine and tenofovir) arm, the most commonly used single-pill regimen.
The difference was statistically significant and met the pre-specified test
for superiority. The difference was driven by a higher rate of discontinuation
due to adverse events in the Atripla arm. ^2,3

  *At 96 weeks, 80% of participants on the dolutegravir-based regimen were
    virologically suppressed compared to 72% of participants on Atripla. Grade
    2-4 treatment emergent adverse reactions occurring in 2% or more
    participants taking the dolutegravir-based regimen were insomnia (3%),
    headache (2%) and fatigue (2%). ^3

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. ^5

HIV infects specific cells of the immune system, called CD4 cells, or T-cells.
Over time, HIV can destroy so many of these cells that the body cannot fight
off infections and disease. When this happens, HIV infection leads to Acquired
Immunodeficiency Syndrome (AIDS) which is the final stage of HIV infection. ^5
There is no cure for HIV, but with early diagnosis and effective treatment
most people with HIV will not go on to develop AIDS. ^6

By the end of 2012, an estimated 35.3 million people were living with HIV
worldwide, up 18% from 2001. 2.3 million people had new HIV infections
contracted that year. ^7 An estimated 2.2 million people are living with HIV
in the World Health Organisation (WHO) European Region in 2012 and around half
are unaware of their diagnosis. In 2012, over 131,000 people were newly
diagnosed with HIV in the region and over 29,000 of these were in the European
Union or European Economic Area (EU/EEA). ^8

About Triumeq Triumeq is a once-daily single-pill dolutegravir-based regimen,
containing the INSTI dolutegravir and the NRTIs abacavir and lamivudine.

Two essential steps in the HIV life cycle are replication – when the virus
turns its RNA copy into DNA – and integration – the moment when viral DNA
becomes part of the host cell's DNA. These processes require two enzymes
called reverse transcriptase and integrase. NRTIs and integrase inhibitors
interfere with the action of the two enzymes to prevent the virus from
replicating. This decrease in replication will lead to less virus being
available to cause subsequent infection of uninfected cells.

Please refer to the full European Summary of Product Characteristics for full
prescribing information, including contraindications, special warnings and
precautions for use.

Today's approval of Triumeq is the European regulatory authorisation to market
the medicine in each member state of the European Union. Triumeq will become
available in each country as pricing and reimbursement processes are
completed, with availability in some of the first countries anticipated in the
immediate future.

The US Food and Drug Administration (FDA) approved Triumeq on 22 August 2014.
Regulatory applications are also being evaluated in other markets worldwide,
including Australia, Brazil and Canada.

Dolutegravir was approved in the US in August 2013 and in Europe in January
2014 under the brand name Tivicay ^® .

Tivicay and Triumeq are registered trademarks of the ViiV Healthcare group of

Safety Information for Triumeq in the European Union: ^1 The risk for abacavir
hypersensitivity reactions (HSR) to occur is high in patients who test
positive for a genetic marker, the HLA-B*5701 allele. Because Triumeq contains
abacavir, before initiating treatment with Triumeq, screening for the presence
of the HLA-B*5701 allele should be performed.

Dolutegravir has also been associated with a risk for HSR. Clinically it is
not possible to determine whether an HSR with Triumeq is caused by abacavir or
dolutegravir. However, HSR have been observed more commonly with abacavir.

If an HSR is suspected, Triumeq must be stopped immediately. Any delay in
stopping treatment with Triumeq after the onset of hypersensitivity may result
in an immediate and life-threatening reaction.

After stopping treatment with Triumeq for reasons of a suspected HSR, Triumeq
or any other medicinal product containing abacavir or dolutegravir must never
be re-initiated.

Triumeq is contraindicated in any patient with hypersensitivity to
dolutegravir, abacavir or lamivudine or to any of the excipients.

Co-administration with dofetilide is also contraindicated.

Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases,
have been reported with the use of nucleoside analogues.

Triumeq is not recommended for use in patients with a creatinine clearance <
50 mL/min.

A dose reduction of abacavir may be required for patients with mild hepatic
impairment (Child-Pugh grade A). As dose reduction is not possible with
Triumeq, the separate preparations of dolutegravir, abacavir or lamivudine
should be used when this is judged necessary.

Triumeq is not recommended in patients with moderate and severe hepatic

Triumeq includes lamivudine, which is active against hepatitis B. Abacavir and
dolutegravir lacks such activity. Lamivudine monotherapy is generally not
considered an adequate treatment for hepatitis B, since the risk for hepatitis
B resistance development is high. If Triumeq is used in patients co-infected
with hepatitis B an additional antiviral is therefore generally needed.

The safety and efficacy of Triumeq in children less than 12 years of age has
not yet been established. No data are available.

Observational studies have shown an association between myocardial infarction
and the use of abacavir. Data from clinical trials showed limited numbers of
myocardial infarction and could not exclude a small increase in risk. Overall
the available data from observational cohorts and from randomised trials show
some inconsistency so can neither confirm nor refute a causal relationship
between abacavir treatment and the risk of myocardial infarction. To date,
there is no established biological mechanism to explain a potential increase
in risk.

Cases of osteonecrosis have been reported in patients with advanced
HIV-disease and/or long-term exposure to CART. Patients should be advised to
seek medical advice if they experience joint aches and pain, joint stiffness
or difficulty in movement.

Factors that decrease the exposure of the components of Triumeq (dolutegravir,
abacavir and lamivudine) should be avoided. Triumeq should not be taken with
any other medicinal products containing dolutegravir, abacavir, lamivudine or

In HIV-infected patients with severe immune deficiency at the time of
institution of combination antiretroviral therapy (CART), an inflammatory
reaction to asymptomatic or residual opportunistic pathogens may arise and
cause serious clinical conditions, or aggravation of symptoms. Typically, such
reactions have been observed within the first few weeks or months of
initiation of CART.

Patients should be advised that Triumeq or any other antiretroviral therapy
does not cure HIV infection and that they may still develop opportunistic
infections and other complications of HIV infection.

Please refer to the full European Summary of Product Characteristics for full
prescribing information, including contraindications, special warnings and
precautions for use.

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. Shionogi joined as shareholder 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 new HIV medicines, as
well as support communities affected by HIV. For more information on the
company, its management, portfolio, pipeline, and commitment, please visit

^† Atripla ^® is a registered trademark of Bristol-Myers Squibb and Gilead
Sciences, LLC

GlaxoSmithKline 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. Factors that may affect GSK's operations are described under Item
3.D "Risk factors" in the company's Annual Report on Form 20-F for 2013.


1.Triumeq Summary of Product Characteristics
2.Walmsley SL, Antela A, Clumeck N et al ; for the SINGLE Investigators.
    Dolutegravir plus abacavir–lamivudine for the treatment of HIV-1
    infection. N Engl J Med. 2013;369(19):1807-1818
3.Walmsley S, Berenguer J, Khuong-Josses M, et al . Dolutegravir regimen
    statistically superior to efavirenz/tenofovir/emtricitabine: 96-week
    results from the SINGLE study (ING114467). Poster presented at: 21st
    Conference on Retroviruses and Opportunistic Infections; March 3-6, 2014;
    Boston, MA. Poster 543
4.Weller S, Chen S, Borland J et al . Bioequivalence of a Dolutegravir,
    Abacavir and Lamivudine Fixed-Dose Combination Tablet and the Effect of
    Food. JAIDS. 2014 May doi: 10.1097/QAI.0000000000000193.,_Abacavir_and.97920.aspx
5.Centers for Disease Control and Prevention. HIV Basics. (Accessed August 2014)
6.NHS Choices, HIV & AIDS Overview . (Accessed 18
    August 2014)
7.Terrence Higgins Trust. Facts and statistics about HIV.
    . (Accessed August 2014)
8.Terrence Higgins Trust. Facts and statistics about HIV. .
    (Accessed August 2014)

Contact: ViiV UK/US Media enquiries: Manuel Goncalves, +35 191 980 5423, Marc
Meachem, +1 919 483 8756, GSK Global Media enquiries: David Daley, +44 (0) 20
8047 5502, Melinda Stubbee, +1 919 483 2510, GSK Analyst/Investor enquiries:
Ziba Shamsi, +44 (0) 20 8047 5543, Kirsty Collins (SRI & CG), +44 (0) 20 8047
5534, Tom Curry, + 1 215 751 5419, Gary Davies, +44 (0) 20 8047 5503, James
Dodwell, +44 (0) 20 8047 2406, Jeff McLaughlin, +1 215 751 7002, Lucy Singah,
44 (0) 20 8047 2248
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