ViiV Healthcare has reported that the Phase III TANGO clinical trial of dolutegravir plus lamivudine met the primary endpoint of controlling HIV-1 infection in virally suppressed patients.
Dolutegravir belongs to the integrase inhibitor (INI) class, which block HIV replication, while lamivudine is a nucleoside analogue. The combination of these drugs is indicated to treat HIV-1 in adults with no antiretroviral treatment (ARV) history.
The randomised, open-label, active-controlled, multi-centre TANGO trial evaluated the antiviral efficacy and safety of switching to dolutegravir plus lamivudine regimen in patients who are virally suppressed and stable on a regimen of at least three drugs containing tenofovir alafenamide fumarate (TAF).
Patients were either switched to the two-drug regimen or continued on the TAF regimen until week 148.
According to the week 48 data, patients who maintained viral suppression rates for at least six months on a TAF-containing regimen demonstrated similar rates even after switching to the two-drug regimen.
None of the participants met confirmed virologic withdrawal criteria or acquired treatment resistance with dolutegravir plus lamivudine.
In addition, the safety profile of ViiV Healthcare’s two-drug regimen was observed to be consistent with the drugs’ product labelling.
ViiV Healthcare Global Research and Medical Strategy head 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. Individuals who are already on treatment can maintain viral suppression if they switch from a three-drug, TAF-containing regimen to a two-drug regimen of dolutegravir plus lamivudine.”
Trial data will be presented at the 10th International AIDS Society Conference on HIV Science (IAS 2019) that will be held from 21-24 July in Mexico City.