ViiV Healthcare receives FDA approval for Triumeq® (abacavir, dolutegravir and lamivudine), a new single-pill regimen for the

ViiV Healthcare receives FDA approval for Triumeq® (abacavir, dolutegravir and
 lamivudine), a new single-pill regimen for the treatment of HIV-1 infection

  PR Newswire

  LONDON, Aug. 22, 2014

LONDON, Aug. 22, 2014 /PRNewswire/ -- ViiV Healthcare announced today that the
US Food and Drug Administration (FDA) has approved Triumeq ^® (abacavir 600mg,
dolutegravir 50mg and lamivudine 300mg) tablets for the treatment of HIV-1
infection. ^1 Triumeq is ViiV Healthcare's first dolutegravir-based fixed-dose
combination, offering many people living with HIV the option of a single-pill
regimen that combines the integrase strand transfer inhibitor (INSTI)
dolutegravir, with the nucleoside reverse transcriptase inhibitors (NRTIs)
abacavir and lamivudine.

Triumeq alone is not recommended for use in patients with current or past
history of resistance to any components of Triumeq. Triumeq alone is not
recommended in patients with resistance-associated integrase substitutions or
clinically suspected INSTI resistance because the dose of dolutegravir in
Triumeq is insufficient in these populations. 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. Products containing abacavir should not be used
in patients known to carry the HLA-B*5701 allele. ^1

Dr Dominique Limet, Chief Executive Officer, ViiV Healthcare, said: "Today's
approval of Triumeq offers many people living with HIV in the US the first
single-pill regimen containing dolutegravir. ViiV Healthcare is committed to
delivering advances in care and new treatment options to physicians and people
living with HIV. We are proud to announce this important milestone, marking
the second new treatment to be approved in the US from our pipeline of
medicines."

This FDA 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 abacavir,
    dolutegravir and lamivudine when taken as a single pill compared to the
    administration of dolutegravir and abacavir/lamivudine as separate pills.
    ^4

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 dolutegavir-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. ^5-7

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.
There is no cure for HIV, but with early diagnosis and effective treatment
most people with HIV will not go on to develop AIDS. ^5-7

An estimated 1.1 million people in the US are living with HIV. However, only
33 per cent are taking the medication they need. ^8

About Triumeq

Triumeq is a fixed-dose combination 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 INSTIs interfere with
the action of the two enzymes to prevent the virus from replicating and
further infecting cells.

Dolutegravir was approved in the US in August 2013 and in Europe in January
2014 under the brand name Tivicay ^® . The Committee for Medicinal Products
for Human Use (CHMP) of the European Medicines Agency (EMA) granted a positive
opinion on the Marketing Authorisation Application (MAA) for Triumeq on 26
June 2014. Regulatory applications are also being evaluated in other markets
worldwide, including Australia, Brazil and Canada.

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

Important Safety Information (ISI) for Triumeq (abacavir, dolutegravir and
lamivudine) tablets

The following ISI is based on the Highlights section of the Prescribing
Information for Triumeq. Please consult the full Prescribing Information for
all the labeled safety information for Triumeq.

BOXED WARNING: RISK OF HYPERSENSITIVITY REACTIONS, LACTIC ACIDOSIS AND SEVERE
HEPATOMEGALY, AND EXACERBATIONS OF HEPATITIS B

See full Prescribing Information for complete boxed warning.

  *Serious and sometimes fatal hypersensitivity reactions have been
    associated with abacavir-containing products.
  *Hypersensitivity to abacavir is a multi-organ clinical syndrome.
  *Patients who carry the HLA‑B*5701 allele are at high risk for experiencing
    a hypersensitivity reaction to abacavir.
  *Discontinue Triumeq as soon as a hypersensitivity reaction is suspected.
    Regardless of HLA-B*5701 status, permanently discontinue Triumeq if
    hypersensitivity cannot be ruled out, even when other diagnoses are
    possible.
  *Following a hypersensitivity reaction to abacavir, NEVER restart Triumeq
    or any other abacavir‑containing product.
  *Lactic acidosis and severe hepatomegaly with steatosis, including fatal
    cases, have been reported with the use of nucleoside analogues.
  *Severe acute exacerbations of hepatitis B have been reported in patients
    who are co‑infected with Hepatitis B Virus (HBV) and Human
    Immunodeficiency Virus (HIV-1) and have discontinued lamivudine, a
    component of Triumeq. Monitor hepatic function closely in these patients
    and, if appropriate, initiate anti-hepatitis B treatment.

CONTRAINDICATIONS

  *Presence of HLA-B*5701 allele.
  *Previous hypersensitivity reaction to abacavir, dolutegravir or
    lamivudine.
  *Co-administration with dofetilide.
  *Moderate or severe hepatic impairment.

WARNINGS AND PRECAUTIONS

  *Patients with underlying hepatitis B or C may be at increased risk for
    worsening or development of transaminase elevations with use of Triumeq.
    Appropriate laboratory testing prior to initiating therapy and monitoring
    for hepatotoxicity during therapy with Triumeq is recommended in patients
    with underlying hepatic disease such as hepatitis B or C.
  *Hepatic decompensation, some fatal, has occurred in HIV-1/Hepatitis C
    Virus (HCV) co‑infected patients receiving combination antiretroviral
    therapy and interferon alfa with or without ribavirin. Discontinue Triumeq
    as medically appropriate and consider dose reduction or discontinuation of
    interferon alfa, ribavirin, or both.
  *Immune reconstitution syndrome and redistribution/accumulation of body fat
    have been reported in patients treated with combination antiretroviral
    therapy.
  *Administration of Triumeq is not recommended in patients receiving other
    products containing abacavir or lamivudine.

ADVERSE REACTIONS

The most commonly reported (greater than or equal to 2%) adverse reactions of
at least moderate intensity in treatment-naive adult subjects receiving
Triumeq were insomnia (3%), headache (2%), and fatigue (2%).

DRUG INTERACTIONS

Co-administration of Triumeq with other drugs can alter the concentration of
other drugs and other drugs may alter the concentrations of Triumeq. The
potential drug-drug interactions must be considered prior to and during
therapy.

USE IN SPECIFIC POPULATIONS

  *Pregnancy: Triumeq should be used during pregnancy only if the potential
    benefit justifies the potential risk.
  *Nursing mothers: Breastfeeding is not recommended due to the potential for
    HIV transmission.
  *Triumeq is not recommended in patients with creatinine clearance less than
    50 mL per min.
  *If a dose reduction of abacavir, a component of Triumeq, is required for
    patients with mild hepatic impairment, then the individual components
    should be used.

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 a 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
www.viivhealthcare.com .

References:

1.Triumeq US label
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.
    http://journals.lww.com/jaids/Abstract/publishahead/Bioequivalence_of_a_Dolutegravir,_Abacavir_and.97920.aspx
    .
5.Centers for Disease Control and Prevention. HIV Basics.
    http://www.cdc.gov/hiv/basics/index.html . Accessed July 28, 2014.
6.NHS Choices, HIV & AIDS Overview.
    http://www.nhs.uk/conditions/HIV/Pages/Introduction.aspx . Accessed July
    28, 2014.
7.Centers for Disease Control and Prevention. CDC Fact Sheet. HIV in the
    United States: The Stages of Care.
    http://www.cdc.gov/hiv/pdf/research_mmp_StagesofCare.pdf . Accessed July
    28, 2014.
8.Centers for Disease Control and Prevention. Today's HIV/AIDS Epidemic.
    http://www.cdc.gov/nchhstp/newsroom/docs/HIVFactSheets/TodaysEpidemic-508.pdf
    . Accessed July 28, 2014.

^+ Atripla is a registered trademark of Bristol-Meyers Squibb and Gilead
Sciences, LLC.

                                Sebastien Desprez         +44 7920 567 707
ViiV UK/US Media enquiries:
                                Marc Meachem              +1 919 483 8756
                                David Daley               +44 20 8047 5502
GSK Global Media enquiries:
                                Melinda Stubbee           +1 919 483 2510
                                Ziba Shamsi               +44 20 8047 5543

                                Kirsty Collins (SRI & CG) +44 20 8047 5534

                                Tom Curry                 +1 215 751 5419

GSK Analyst/Investor enquiries: Gary Davies               +44 20 8047 5503

                                James Dodwell             +44 20 8047 2406

                                Jeff McLaughlin           +1 215 751 7002

                                Lucy Singah               +44 20 8047 2248

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.

Website: http://www.viivhealthcare.com
 
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