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ViiV Healthcare Receives FDA Approval for Dovato for Adolescents

Expanded indication marks the first time an oral, two-drug, single-tablet regimen is available for adolescents between 12 & 18 living with HIV.

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By: Charlie Sternberg

Associate Editor

ViiV Healthcare, a specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders, has received approval from the U.S. Food and Drug Administration (FDA) for Dovato (dolutegravir/lamivudine) for the treatment of HIV-1 infection in adolescents 12 years of age and older and weighing at least 25 kg with no antiretroviral (ARV) treatment history or to replace the current ARV regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies/mL) on a stable ARV r...

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