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The FDA expanded approval of ViiV Healthcare's Dovato, making it available to HIV-positive people not new to treatment.
The HIV medication known as Dovato received an "expanded indication" from the Food and Drug Administration on Thursday, increasing the number of people who can utilize the two-drug, one pill medication.
ViiV Healthcare's Dovato was originally approved in April 2019 as a complete HIV regimen for those with no history of antiretroviral treatment and with no known resistance to the two components of the daily pill (dolutegravir and lamivudine).
This week's approval expands the reach of Dovato, making it available to virally suppressed HIV-positive people not new to treatment. Since the medication only features two antiretroviral drugs — rather than other pills that contain three or more — it's a new option for people living with HIV who, because of side effects or resistance, need fewer drugs in their system. Unlike many other HIV medications, Dovato does not contain tenofovir.
"As HIV treatment and care progress, people living with HIV will be on medication for decades and need solutions to challenges that may arise from prolonged use of ARV therapy," Lynn Baxter, Head of North America, ViiV Healthcare, said in a statement.
"At ViiV Healthcare, we’ve proven that with Dovato, adults living with HIV can reduce the number of ARVs they take every day without compromising efficacy or barrier to resistance. This remarkable, innovative approach challenges the notion that three or more drugs are needed to maintain virologic suppression, and today’s FDA approval brings this switch treatment option to virologically suppressed adults living with HIV."
