ViiV Healthcare, an HIV specialist firm majority owned by GlaxoSmithKline, has announced the launch of a late-stage study investigating the effectiveness of a two-drug regimen programme in patients with HIV.
The Phase III TANGO study will look at whether HIV positive adults with virologic suppression on a tenofovir alafenamide fumarate (TAF)-based regimen of at least three drugs are able to maintain viral suppression when switched to a two-drug regimen of Tivicay (dolutegravir) and Epivir (lamivudine).
TANGO aims to enrol around 550 adults with HIV-1, from clinical trial sites in North America, Europe, Australia, and Japan, and will characterise patient satisfaction as well as the long-term antiviral activity, tolerability and safety of a two-dose regimen of dolutegravir and lamivudine through to 96 weeks.
“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,” said John Pottage, chief scientific and medical officer at ViiV.
“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 firm notes that TANGO is the eighth Phase III study in its two-drug regimen programme for HIV-1 treatment.