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  LONDON, Aug. 22, 2014 /CNW/ -- 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 <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)     --  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,_Abaca vir_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.     ViiV UK/US Media enquiries:     Sébastien Desprez         +44 7920 567 707                                     Marc Meachem               +1 919 483 8756     GSK Global Media enquiries:     David Daley               +44 20 8047 5502                                     Melinda Stubbee            +1 919 483 2510     GSK Analyst/Investor enquiries: 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                                     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  CO: FDA ST: England NI: MTC HEA  
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