ViiV Healthcare launches Phase III trial for combo HIV treatment
pharmafile | August 16, 2016 | News story | Research and Development | Dolutegravir, HIV, Tivicay, ViiV Healthcare, epivir, lamivudine, phase III
The Pfizer/GSK spin off ViiV Healthcare has announced the beginning of a Phase III evaluating Tivicay (dolutegravir) and Epivir (lamivudine) as a combination treatment for HIV-1 infection in adults who have not received prior antiretroviral therapy.
The GEMINI 1 and 2 studies will directly compare the drug combination with Tivicay plus Gilead’s Truvada (tenofovir/emtricitabine). Truvada has been shown to be an effective form of PrEP and is well on its way to becoming a blockbuster for Gilead.
Each study will include around 700 subjects who will be randomised 1:1 to receive either treatment regimen. Both studies are designed to demonstrate the non-inferior antiviral activity of the Tivicay/Epivir regimen compared to Tivicay/Truvada.
ViiV will use the results of these trials to support regulatory filings for the combination treatment. Both are currently approved across numerous regions. Tivicay is an integrase strand transfer inhibitor which blocks HIV replication by preventing the viral DNA from integrating into T-cells. Epivir is a nucleoside analogue that has been widely genericised, and is commonly used alongside other antiretroviral agents.
John Pottage, chief scientific and medical officer at ViiV, says: “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 regime. 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 regiments for people living with HIV.”
Sean Murray
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