ViiV Healthcare has kicked off a Phase III programme that it hopes will lead to regulatory filings for a two-drug regimen of Tivicay and Epivir as a treatment for HIV in adults who have not received prior antiretroviral therapy.
The programme comprises two identical studies - GEMINI 1 and 2 - comparing the two-drug regimen with a three-drug regimen of Tivicay (dolutegravir) plus the fixed-dose tablet Truvada (tenofovir/emtricitabine).
The studies will include around 1,400 men and women with HIV and are to be carried out at research centres in Europe, Central and South America, North America, South Africa and Asia Pacific.
HIV therapy regimens predominantly include three antiretroviral drugs - ViiV is exploring how HIV treatment could evolve to reduce drug exposure and improve treatment adherence, while maintaining the same level of efficacy.
"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," noted John C Pottage, ViiV's chief scientific and medical officer.
"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."