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SOURCE ViiV Healthcare
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:
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®+ (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
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
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.
WARNINGS AND PRECAUTIONS
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%).
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
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.
+Atripla is a registered trademark of Bristol-Meyers Squibb and Gilead Sciences, LLC.
ViiV UK/US Media enquiries:
+44 7920 567 707
+1 919 483 8756
GSK Global Media enquiries:
+44 20 8047 5502
+1 919 483 2510
GSK Analyst/Investor enquiries:
Kirsty Collins (SRI & CG)
+44 20 8047 5543
+44 20 8047 5534
+1 215 751 5419
+44 20 8047 5503
+44 20 8047 2406
+1 215 751 7002
+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.
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