ViiV Healthcare announced the phase 3 TANGO study, conducted in patients with HIV-1 who switched to Dovato (dolutegravir plus lamivudine) had similar success in maintaining viral suppression at 48 weeks compared to patients on a tenofovir alafenamide fumarate (TAF)-containing regimen of at least three drugs.
TANGO was a randomized, open-label, active-controlled, multicenter study to assess the antiviral efficacy and safety of switching to a two drug regimen consisting of Dovato in HIV-infected adults who are virally suppressed and stable on a TAF-containing regimen. Subjects were HIV-1 infected adults on a TAF-containing regimen with HIV-1 RNA<50c/mL for at least six months, without prior virologic failure, no historical nucleoside reverse transcriptase inhibitors (NRTI) or INI major resistance mutation, and no evidence of hepatitis B infection. The subjects were randomized to switch to Dovato or continue the TAF-containing regimen through Week 148. The study met its primary endpoint for non-inferiority, based on the proportion of subjects 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 Dovato were consistent with the product labeling for the medicines.
Full results from the TANGO study will be presented later this month at the 10th International AIDS Society Conference on HIV Science in Mexico City.
Dovato was approved by the FDA in the United States in April of 2019 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 approved 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.
About Dovato (dolutegravir plus lamivudine)
Dolutegravir is an integrase inhibitor (INI) for use in combination with other antiretroviral agents for the treatment of HIV. INIs block HIV replication by preventing the viral DNA from integrating into the genetic material of human immune cells (T-cells). This step is essential in the HIV replication cycle and is also responsible for establishing chronic infection.
Lamivudine, commonly known as 3TC, is a nucleoside analogue used in combination with other antiretroviral agents for the treatment of HIV infection.