Leaders from ViiV Healthcare have launched a phase III program to find more supportive evidence for its dolutegravir (Tivicay) and lamivudine (Epivir) treatments, which are designed for adults with HIV-1 infections.
The company recently submitted regulatory filings for the regimen. Together, the studies will involve an estimated 1,400 women and men with HIV. Studies are currently beginning in Central and South America, South Africa, Europe, North America and Asia Pacific.
The program will include two separate but identical studies to compare the regimen. The first study will have a two-drug regimen comprising lamivudine and dolutegravir. The second study will feature a three-drug regimen comprising dolutegravir and fixed-dose tablet tenofovir/emtricitabine (Truvada).
“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,” Dr. John Pottage Jr., chief scientific and medical officer at ViiV Healthcare, said. “With this ambitious phase III program, 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.”
If successful, this new treatment could help countless people who live with HIV infections across the world.
