TIDMGSK
RNS Number : 9761P
GlaxoSmithKline PLC
22 August 2014
GlaxoSmithKline plc (LSE:GSK) today announced that ViiV
Healthcare Ltd (a global specialist HIV
company with GlaxoSmithKline, Pfizer, Inc. and Shionogi Limited
as shareholders) is issuing the
following statement today:
ViiV Healthcare receives FDA approval for Triumeq(R) (abacavir,
dolutegravir and lamivudine), a new single-pill regimen for the
treatment of HIV-1 infection
London, UK, 22 August, 2014 - ViiV Healthcare announced today
that the US Food and Drug Administration (FDA) has approved
Triumeq(R) (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-naïve 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 <50 copies/mL) in the dolutegravir and
abacavir/lamivudine arm (the separate components of Triumeq) than
in the Atripla(R) (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 percent 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 integrase inhibitors 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(R) . 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 (>=2%) adverse reactions of at
least moderate intensity in treatment-naïve 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.
Sébastien 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
Kirsty Collins (SRI +44 20 8047 5543
& CG) +44 20 8047 5534
Tom Curry +1 215 751 5419
Gary Davies +44 20 8047 5503
James Dodwell +44 20 8047 2406
GSK Analyst/Investor Jeff McLaughlin +1 215 751 7002
enquiries: 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.
This information is provided by RNS
The company news service from the London Stock Exchange
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