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ViiV Healthcare announced the start of a phase III programme to support regulatory filings for a two-drug regimen of dolutegravir (Tivicay®) and lamivudine (Epivir®) as a treatment for HIV-1 infection in adults who have not received prior antiretroviral therapy.
The phase III programme comprises two identical studies (GEMINI 1 and 2) comparing a two-drug regimen of dolutegravir plus lamivudine with a three-drug regimen of dolutegravir plus the fixed-dose tablet tenofovir/emtricitabine (Truvada®). The studies together will include approximately 1,400 men and women living with HIV and are being conducted at research centres in Europe, Central and South America, North America, South Africa and Asia Pacific.
HIV care is a long-term prospect for those living with the disease, requiring life-long adherence to treatment. Since the introduction of highly active antiretroviral therapy 20 years ago, HIV treatment regimens have predominantly included three antiretroviral drugs.1,2ViiV Healthcare is looking to the future and exploring how HIV treatment could evolve to reduce drug exposure and improve treatment adherence, while maintaining the level of efficacy achieved with three-drug regimens.
John C Pottage, Jr, MD, Chief Scientific and Medical Officer, ViiV Healthcare, commented, “We believe the clinical profile for dolutegravir presents an important opportunity to investigate the possibility of first-line treatment of HIV with a two-drug regimen. With this ambitious phase III programme, we will explore whether this two-drug regimen can fundamentally change the existing HIV treatment strategy, reducing the number of medications and potentially streamlining treatment regimens for people living with HIV.”
The GEMINI trials are the third development programme undertaken by ViiV Healthcare to investigate a two-drug regimen for the treatment of HIV.
About Tivicay® (dolutegravir)
Dolutegravir (Tivicay) is an integrase strand transfer inhibitor (INSTI) for use in combination with other antiretroviral agents for the treatment of HIV. Integrase inhibitors block HIV replication by preventing the viral DNA from integrating into the genetic material of human immune cells (T-cells). This step is essential in the HIV replication cycle and is also responsible for establishing chronic infection. Tivicay is approved in over 100 countries across North America, Europe, Asia, Australia, Africa and Latin America.
About lamivudin
Lamivudine is a nucleoside analogue used in combination with other antiretroviral agents for the treatment of HIV infection. Lamivudine is available in branded (Epivir®) and generic forms.
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 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.
About GSK
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.
