GlaxoSmithKline has announced that in the Phase III TANGO study, its two-drug combination Dovato (dolutegravir/lamivudine) was as effective in controlling HIV-1 as a tenofovir alafenamide fumarate-containing regimen of at least three drugs.
The study met its primary endpoint for non-inferiority, suppressing the AIDS-causing virus for 48 weeks at similar levels to the tenofovir alafenamide fumarate combination.
No patients met confirmed virologic withdrawal criteria or developed treatment resistance in the dolutegravir plus lamivudine arm of the study.
Kimberly Smith, head of global research & medical strategy at ViiV Healthcare, 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 – individuals who are already on treatment can maintain viral suppression if they switch from a 3-drug, TAF-containing regimen to a 2-drug regimen of dolutegravir plus lamivudine.”
The Dovato single-pill was authorised in the United States earlier this year for the treatment of HIV-1 infection in adults with no antiretroviral treatment history and with no known resistance to either dolutegravir or lamivudine.
It was also authorised in Europe in July 2019 for the treatment of HIV-1 infection in adults and adolescents older than 12 who weigh at least 40 kg.
Full results from the study will be presented at the 10th International AIDS Society Conference on HIV Science