Issued: Thursday 14 June 2018, London UK – LSE Announcement
ViiV Healthcare reports landmark phase III studies for dolutegravir and lamivudine, demonstrating the capability to control HIV with a two-drug regimen te treatment naive patients
– GEMINI 1&Two studies meet primary endpoint, demonstrating similar efficacy of two-drug regimen compared to standard three-drug regimen
– Total results from the studies will be introduced at an upcoming scientific meeting
London, 14 June 2018
ViiV Healthcare today announced positive headline results from its phase III GEMINI investigate programme. The studies (GEMINI-1 and GEMINI-2) are designed to evaluate the safety and efficacy of a two-drug regimen (2DR) of dolutegravir and lamivudine compared to a three-drug regimen of dolutegravir and two nucleoside switch sides transcriptase inhibitors, tenofovir disoproxil fumarate/emtricitabine (TDF/FTC), te treatment naive HIV-1 infected adults with baseline vírico fountains less than 500,000 copies vanaf ml.
The studies met their primary endpoint for non-inferiority based on plasma HIV-1 RNA <,50 copies vanaf millilitre (c/mL), a standard measure of HIV control, at Week 48. The safety results for the 2DR of dolutegravir and lamivudine were consistent with the product labelling for the medicines. No patient who experienced virologic failure ter either treatment arm developed treatment-emergent resistance.
Utter results from the studies will be introduced at an upcoming scientific meeting.
John C. Pottage, Jr., MD, Chief Scientific and Medical Officer of ViiV Healthcare, said : “People with HIV are living longer and more productive lives. However, under current standard of care, many patients still take three or more medicines every day. The GEMINI studies demonstrate the potency, safety and tolerability of the dolutegravir plus lamivudine combination. They affirm our two-drug regimen strategy, and reinforce our belief that many patients can control their disease with two drugs instead of three or more. Importantly, the studies showcase that this two-drug regimen could be an option for treatment naive patients and can support a broad range of patients living with HIV around the world.”
The GEMINI studies are part of ViiV Healthcare’s innovative clinical trial programme for two-drug regimens that seeks to address long-term toxicity concerns of people living with HIV by reducing the number of medicines used te their treatment. The studies together include approximately 1,400 dudes and women living with HIV and are being conducted at research centres ter Europe, Central and South America, North America, South Africa and Asia Pacific.
ViiV Healthcare will now project for regulatory submissions for the two-drug regimen of dolutegravir and lamivudine straks this year.
Notes to editors
GEMINI 1 & Two explore vormgeving
GEMINI 1 (204861) and GEMINI Two (205543) are duplicate, phase III, randomised, double-blind, multicentre, parallel group, non-inferiority studies. Thesis studies evaluate a two-drug regimen of dolutegravir and lamivudine compared with a standard three-drug, first-line regimen ter HIV-1 infected, antiretroviral therapy (Kunst)-naive adult participants with baseline virulento explosions less than 500,000 copies vanaf ml . The studies are designed to demonstrate the non-inferior efficacy, safety, and tolerability of once-daily dolutegravir and lamivudine compared to once-daily dolutegravir and the fixed-dose combination of TDF/FDC at 48 weeks ter HIV-1-infected, ART-naive participants.
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For more information please search for NCT02831673 (GEMINI 1) or NCT02831764 (GEMINI Two) on www.clinicaltrials.gov .
Dolutegravir (Tivicay) is an integrase zandstrand transfer inhibitor (INSTI) for use ter combination with other
antiretroviral agents for the treatment of HIV. Integrase inhibitors block HIV replication by preventing
the vírico DNA from integrating into the genetic material of human immune cells (t-cells). This step is essential ter the HIV replication cycle and is also responsible for establishing chronic infection. Tivicay is approved te overheen 100 countries across North America, Europe, Asia, Australia, Africa and Latin America.
Lamivudine is a nucleoside analogue used ter combination with other antiretroviral agents for the treatment of HIV infection. Lamivudine is available te branded (Epivir) and generic forms. Trademarks are possessed by or licensed to the ViiV Healthcare group of companies.
About ViiV Healthcare
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ViiV Healthcare is a completo specialist HIV company established te November 2009 by GlaxoSmithKline (LSE: GSK) and Pfizer (NYSE: PFE) dedicated to delivering advances te treatment and care for people living with HIV and for people who are at risk of becoming infected with HIV. Shionogi joined spil a shareholder te October 2012. The company’s aim is to take a deeper and broader rente ter HIV/AIDS than any company has done before and take a fresh treatment to supply effective and innovative medicines for HIV treatment and prevention, spil well spil support communities affected by HIV.
For more information on the company, its management, portfolio, pipeline, and commitment, please visit www.viivhealthcare.com .
Cautionary statement regarding forward-looking statements
ViiV Healthcare Limited, the integral specialist HIV company, is majority possessed by GlaxoSmithKline plc, with Pfizer Inc. and Shionogi Limited. GSK cautions investors that any forward-looking statements or projections made by GSK, including those made ter this announcement, are subject to risks and uncertainties that may cause flagrante results to differ materially from those projected. Such factors include, but are not limited to, those described under Voorwerp Three.D ‘Principal risks and uncertainties’ ter the company’s Annual Report on Form 20-F for 2018.
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GSK – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit www.gsk.com .
The information contained te this announcement is inwards information.