Research & Development
ViiV Healthcare Wins FDA Nod of Expanded Dovato Indication
7 August 2020 - - The US Food and Drug Administration approved Dovato (dolutegravir/lamivudine) as a complete regimen for the treatment of HIV-1 infection to replace the current antiretroviral regimen in adults who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable ARV regimen with no history of treatment failure and no known resistance to the individual components of Dovato, UK-based specialist HIV company ViiV Healthcare said.

Dovato, a complete, once-daily, single-tablet, two-drug regimen of dolutegravir 50 mg and lamivudine 300 mg, allows adults living with HIV the option to manage their virus without a third ARV.

It is free of tenofovir alafenamide fumarate, tenofovir disoproxil fumarate and abacavir.

Dovato was first approved by the FDA in April 2019 as a complete regimen for the treatment of HIV-1 infection in adults with no ARV treatment history and with no known resistance to the individual components of Dovato.

The approval of Dovato in adults who are virologically suppressed is based on the Week 48 results from the phase III TANGO study.

This study demonstrated adults living with HIV-1, who had maintained virologic suppression for at least six months on a TAF-containing regimen of at least three drugs, were able to maintain similar rates of virologic suppression after switching to Dovato, compared with those who continued the original regimen.

No participants on Dovato and one participant on the TAF-containing regimen met confirmed virologic failure criteria, with no resistance mutations observed at failure.

The safety results for those who switched to Dovato were consistent with the product labeling for dolutegravir and lamivudine.

Dovato is approved for the treatment of HIV-1 in treatment-naïve and virologically suppressed adults by the European Medicines Agency and additional regulatory authorities around the world.

In 2019, the Adult and Adolescent Antiretroviral Treatment Guidelines from the Department of Health and Human Services included Dovato in the list of Recommend Initial Regimens for Most People with HIV, the first time a complete two-drug regimen has been recommended by the DHHS in the first-line setting (except in individuals with HIV RNA >500,000 copies/ml, HBV co-infection, or in whom ART is to be started before the results of the HIV genotypic resistance testing for RT or HBV testing are available).

Dolutegravir is an integrase strand transfer inhibitor (INSTI) for use in combination with other antiretroviral agents for the treatment of HIV-1. INSTIs 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.

Dolutegravir is authorized in more than 100 countries across North America, Europe, Asia, Africa and Latin America.

Lamivudine, commonly known as 3TC, is a nucleoside analogue used in combination with other antiretroviral agents for the treatment of HIV-1 infection. Lamivudine is available in branded and generic forms.

Dolutegravir plus lamivudine (Dovato) is a complete, once-daily, single-tablet regimen to treat HIV-1 infection in adults with no antiretroviral treatment history or to replace the current ARV regimen in those who are virologically suppressed (HIV-1 RN
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