ViiV Healthcare Launches Phase III Programme Evaluating a Two-drug Regimen Combining Dolutegravir and Lamivudine for HIV

LONDON, August 16, 2016 /PRNewswire/ --

ViiV Healthcare today announced the start of a phase III programme to support regulatory filings for a two-drug regimen of dolutegravir (Tivicay(R)) and lamivudine (Epivir(R)) as a treatment for HIV-1 infection in adults who have not received prior antiretroviral therapy.

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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(R)). 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],[2] ViiV 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.

Notes to editors 

GEMINI 1 & 2: Study design 

Each study is a randomised, double-blind study and will compare the safety, efficacy, and tolerability of a two-drug regimen of dolutegravir plus lamivudine administered once daily, against dolutegravir plus two nucleoside reverse transcriptase inhibitors (tenofovir/emtricitabine fixed-dose combination) administered once daily in HIV-1 infected adult subjects that have not previously received antiretroviral therapy.

Each study will include approximately 700 subjects who will be randomised 1:1 to receive dolutegravir plus lamivudine or dolutegravir plus tenofovir/emtricitabine fixed-dose combination. Both studies are designed to demonstrate the non-inferior antiviral activity of a dolutegravir plus lamivudine regimen to that of dolutegravir plus tenofovir/emtricitabine fixed-dose combination. The primary efficacy endpoint will be measured at Week 48 and the study will continue to evaluate the long term antiviral activity, tolerability and safety of dolutegravir plus lamivudine through Week 148.

For more information please search for NCT02831673 (GEMINI 1) or NCT02831764 (GEMINI 2) on http://www.clinicaltrials.gov.

Epivir(R) is a registered trademark of the ViiV Healthcare group of companies.

Tivicay(R) is a registered trademark of the ViiV Healthcare group of companies.

Truvada(R) is a registered trademark of Gilead Sciences, Inc.

About Tivicay(R) (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 lamivudine 

Lamivudine is a nucleoside analogue used in combination with other antiretroviral agents for the treatment of HIV infection. Lamivudine is available in branded (Epivir(R)) and generic forms.

About ViiV Healthcare 

ViiV Healthcare is a global specialist HIV company established in November 2009 by GlaxoSmithKline and Pfizer 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 http://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 http://www.gsk.com.

TIVICAY(R) (dolutegravir) tablets 

Professional Indication(s) and Important Safety Information 

Note: this is taken from the US label and local variations apply. Please refer to applicable local labelling 

FDA Indications and Usage 

TIVICAY(R) is a human immunodeficiency virus type 1 (HIV-1) integrase strand transfer inhibitor (INSTI) indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 30 kg.

Limitations of Use: 

- Use of TIVICAY in INSTI-experienced patients should be guided by the number and
type of baseline INSTI substitutions. The efficacy of TIVICAY 50 mg twice daily is
reduced in patients with an INSTI-resistance Q148 substitution plus 2 or more
additional INSTI-resistance substitutions including T66A, L74I/M, E138A/K/T, G140S/A/C,
Y143R/C/H, E157Q, G163S/E/K/Q, or G193E/R

Important Safety Information 

Contraindications: 

TIVICAY is contraindicated in patients:

- with previous hypersensitivity reaction to dolutegravir
- receiving dofetilide (antiarrhythmic)

Hypersensitivity Reactions: 

- Hypersensitivity reactions have been reported and were characterised by rash,
constitutional findings, and sometimes organ dysfunction, including liver injury. The
events were reported in <1% of subjects receiving TIVICAY in Phase 3 clinical trials
- Discontinue TIVICAY and other suspect agents immediately if signs or symptoms of
hypersensitivity reactions develop, as a delay in stopping treatment may result in a
life-threatening reaction. Monitor clinical status, including liver aminotransferases,
and initiate appropriate therapy if hypersensitivity reaction is suspected

Effects on Serum Liver Biochemistries in Patients with Hepatitis B or C Co-infection: 

- Patients with underlying hepatitis B or C may be at increased risk for worsening
or development of transaminase elevations with use of TIVICAY. In some cases the
elevations in transaminases were consistent with immune reconstitution syndrome or
hepatitis B reactivation, particularly in the setting where anti-hepatitis therapy was
withdrawn
- Appropriate laboratory testing prior to initiating therapy and monitoring for
hepatotoxicity during therapy with TIVICAY are recommended in patients with underlying
hepatic disease such as hepatitis B or C  

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