GSK’s majority owned global specialist HIV company ViiV Healthcare announced positive headline results from its phase III GEMINI study programme. 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 in their treatment.
The studies together 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. The studies 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 reverse transcriptase inhibitors, tenofovir disoproxil fumarate/emtricitabine (TDF/FTC), in treatment naïve HIV-1 infected adults with baseline viral loads less than 500,000 copies per ml.
The studies met their primary endpoint for non-inferiority based on plasma HIV-1 RNA <50 copies per 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 in either treatment arm developed treatment-emergent resistance.
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.
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.
ViiV Healthcare was established in November 2009 by GlaxoSmithKline and Pfizer. The company is dedicated to delivering advances in treatment and care for people living with HIV and for people who are at risk of becoming infected with HIV. ViiV Healthcare Limited is majority owned by GlaxoSmithKline, with Pfizer and Shionogi Limited.