(Alliance News) - GlaxoSmithKline PLC on Wednesday noted that the Tango study of a dolutegravir plus lamivudine two-drug regimen in HIV-1 met its primary endpoint.
The phase 3 Tango study involved virally suppressed patients with HIV-1 who switched from a three-drug regimen to a regimen of dolutegravir plus lamivudine.
At 48 weeks, patients taking the new two-drug regimen maintained "similar rates of viral suppression" to what they had before the switch.
The study therefore met its primary endpoint of non-inferiority and no patients developed any resistance to the new treatment. Moreover, the two-drug regimen's safety results were consistent with product labelling for both medicines.
The results were announced by HIV specialist ViiV Healthcare. Glaxo has a majority stake in ViiV Healthcare, while Pfizer Inc and Shionogi Ltd are also shareholders.
ViiV Healthcare Head of Global Research & Medical Strategy Kimberly Smith said: "When we developed the Tango study, we asked if virally suppressed people living with HIV could reduce the number of medicines in their HIV treatment regimen while maintaining viral suppression. These Week 48 data clearly indicate that they can."
A single pill combination of dolutegravir and lamivudine taken once per day has already been authorised in the US and in Europe for adults and adolescents with HIV who are over the age of 12.
Glaxosmithkline (GSK)