ViiV Healthcare has started a Phase III study to examine a two-drug regimen (2DR) of dolutegravir (TIVICAY) and lamivudine (EPIVIR) for treating patients with HIV-1 who have achieved viral suppression on a tenofovir alafenamide fumarate (TAF) based regimen.
The TANGO trial aims to enrol around 550 adults with HIV-1 from clinical trial sites in North America, Europe, Australia, and Japan.
Under the trial, the subjects will be randomised 1:1 to switch to dolutegravir and lamivudine once-daily for up to 96 weeks, or to continue their TAF-based regimen for 48 weeks.
The patients in the TAF-based arm who achieve <50c/ml of HIV-1 RNA at week 48 of the trial will be switched to dolutegravir and lamivudine for the study’s remaining period.
Primary endpoint of the trial is the proportion of participants who meet the Snapshot virologic failure criteria at week 48 using the intent-to-treat exposed (ITT-E) population.
ViiV Healthcare chief scientific and medical officer John Pottage Jr said: “We are asking a simple question in the TANGO study: can virally suppressed people with HIV reduce the number of medicines in their HIV treatment regimen while maintaining viral suppression?
“If the data show the answer to be yes, this may allow healthcare providers to address issues of long-term toxicity by reducing exposure to antiviral agents over a lifetime of treatment.
“We believe that with its high-barrier to resistance, dolutegravir has the right clinical profile to be a core part of 2DRs for the treatment of HIV-1 and look forward to seeing the results of TANGO in 2019.”
The TANGO study is based on ViiV’s GEMINI studies’ investigation of the 2DR of dolutegravir and lamivudine in treatment-naïve patients with HIV-1.
Trial results are expected later this year.