Dovato filed with FDA in sNDA for adults with HIV-1 infection.- ViiV Healthcare

ViiV Healthcare announced the submission of a supplemental New Drug Application to the FDA for Dovato (dolutegravir and lamivudine) as a switch treatment for HIV-1 infection in virologically suppressed adults on a stable antiretroviral regimen with no treatment failure. In the US, Dovato is currently approved as a complete, once-daily, single-tablet regimen of dolutegravir (DTG) 50 mg and lamivudine (3TC) 300 mg for the treatment of HIV-1 infection in adults with no antiretroviral treatment history and with no known resistance to either DTG or 3TC.

The filing is based on the results from the phase III TANGO study, which demonstrated adults living with HIV-1, who had maintained virologic 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 virologic suppression after switching to the two-drug regimen (2DR) Dovato, compared to those who continued the TAF-containing regimen. The safety results for those who switched to Dovato were consistent with the product labeling for DTG and 3TC.

Comment: TANGO (NCT03446573) is a phase III, randomized, open-label, active-controlled, multicenter study to assess the antiviral efficacy and safety of switching to a 2DR consisting of DTG/3TC in HIV-infected adults who are virologically suppressed and on a stable antiretroviral regimen with no treatment failure. Study participants 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 integrase inhibitor ini major resistance mutation and no evidence of hepatitis b infection. participants were randomized to switch to dtg 3tc or continue on the taf-containing regimen through week 148. the primary endpoint was the proportion of participants with a viral load of>50 c/mL at Week 48 (FDA Snapshot algorithm) for the Intention To Treat-Exposed (ITT-E) population.