ViiV Healthcare, the global specialist HIV company majority-owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, today announced positive Week 48 results from its phase III TANGO study.
The TANGO study was conducted to assess whether adults living with HIV-1 who had maintained viral suppression for at least six months on a tenofovir alafenamide fumarate (TAF)-containing regimen of at least three drugs, were able to maintain similar rates of viral suppression after switching to the 2-drug regimen (2DR) of dolutegravir plus lamivudine in a fixed dose combination, compared to continuing the TAF-containing regimen.
The study met its primary endpoint for non-inferiority, based on the proportion of participants with plasma HIV-1 RNA ≥50 copies per millilitre (c/mL) using the FDA Snapshot algorithm at Week 48. No patients met confirmed virologic withdrawal criteria or developed treatment resistance in the dolutegravir plus lamivudine arm of the study. The safety results for the 2DR of dolutegravir plus lamivudine were consistent with the product labelling for the medicines.
Full results from the study will be presented at the 10th International AIDS Society Conference on HIV Science (IAS 2019), to be held from 21-24 July in Mexico City.
Kimberly Smith, M.D., 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 single-pill, 2DR of dolutegravir plus lamivudine, was authorised in the United States earlier this year for the treatment of HIV-1 infection in adults with no antiretroviral treatment (ARV) 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 above 12 years of age weighing at least 40 kg, with no known or suspected resistance to the integrase inhibitor (INI) class, or lamivudine.
Source: Company Press Release