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Dolutegravir+3TC 2-Drug ART Awaiting FDA Approval
 
 
  HIV DART-11/2018: Initial Viral Load Decline and Response Rates by Baseline Viral Load Strata With Dolutegravir Plus Lamivudine Versus Dolutegravir Plus Tenofovir Disoproxil Fumarate/Emtricitabine: Pooled Results From the GEMINI Studies - (12/05/18)
 
ViiV Healthcare submits New Drug Application to US FDA for single-tablet, two-drug regimen of dolutegravir and lamivudine for treatment of HIV - (10/19/18)
 
A priority review voucher was submitted to the FDA along with the NDA. Under the Prescription Drug User Fee Act, the anticipated target action date for this NDA with a priority review voucher is six months after receipt of the application by the FDA. A marketing authorisation application (MAA) to the European Medicines Agency (EMA) was submitted in September and other global regulatory submissions for DTG and 3TC as a single-tablet, two-drug regimen for HIV-1 therapy are anticipated in the coming months.
 
ViiV Healthcare receives CHMP Positive Opinion for Tivicay EU label update with GEMINI study data for the 2-drug regimen of Tivicay + lamivudine
 
Published Lancet - Dolutegravir plus lamivudine versus dolutegravir plus tenofovir disoproxil fumarate and emtricitabine in antiretroviral-naive adults with HIV-1 infection (GEMINI-1 and GEMINI-2): week 48 results from two multicentre, double-blind, randomised, non-inferiority, phase 3 trials - (11/20/18)

 
 
 
 
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