Multimedia assets now available: ViiV Healthcare receives FDA approval for Triumeq® (abacavir, dolutegravir and lamivudine), a

  Multimedia assets now available: ViiV Healthcare receives FDA approval for  Triumeq® (abacavir, dolutegravir and lamivudine), a new single-pill regimen                      for the treatment of HIV-1 infection  Multimedia assets associated with the below announcement are now available. Assets include: b-roll footage, corporate sound bites, product images and additional information. Please click: http://www.multivu.com/players/English/7197331-viiv-healthcare-vhc-triumeq-fda-approval  PR Newswire  LONDON, Aug. 25, 2014  LONDON, Aug. 25, 2014 /PRNewswire/ --On August 22, ViiV Healthcare announced that the US Food and Drug Administration (FDA) 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 regimenthat 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 Triumeqoffers 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:    othe Phase III study (SINGLE) of treatment-naïve adults, conducted with     dolutegravir and abacavir/lamivudine as separate pills^2,3   oa 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^®+ (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    oAt 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 requiretwo enzymes called reverse transcriptase and integrase. NRTIs andINSTIs 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.    oSerious and sometimes fatal hypersensitivity reactions have been     associated with abacavir-containing products.   oHypersensitivity to abacavir is a multi-organ clinical syndrome.   oPatients who carry the HLA‑B*5701 allele are at high risk for experiencing     a hypersensitivity reaction to abacavir.   oDiscontinue 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.   oFollowing a hypersensitivity reaction to abacavir, NEVER restart Triumeq     or any other abacavir‑containing product.   oLactic acidosis and severe hepatomegaly with steatosis, including fatal     cases, have been reported with the use of nucleoside analogues.   oSevere 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    oPresence of HLA-B*5701 allele.   oPrevious hypersensitivity reaction to abacavir, dolutegravir or     lamivudine.   oCo-administration with dofetilide.   oModerate or severe hepatic impairment.  WARNINGS AND PRECAUTIONS    oPatients 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.   oHepatic 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.   oImmune reconstitution syndrome and redistribution/accumulation of body fat     have been reported in patients treated with combination antiretroviral     therapy.   oAdministration 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    oPregnancy: Triumeq should be used during pregnancy only if the potential     benefit justifies the potential risk.   oNursing mothers: Breastfeeding is not recommended due to the potential for     HIV transmission.   oTriumeq is not recommended in patients with creatinine clearance less than     50 mL per min.   oIf 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 visitwww.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               +44 20 8047 5543                                  Kirsty Collins (SRI & CG) +44 20 8047 5534                                  Tom Curry                 +1 215 751 5419                                  Gary Davies               +44 20 8047 5503 GSK Analyst/Investor enquiries:                                 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.  SOURCE ViiV Healthcare  
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