ViiV Healthcare receives FDA approval for HIV treatment - Pharmaceutical Technology

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ViiV Healthcare receives FDA approval for HIV treatment


ViiV Healthcare received FDA approval for its Triumeq (abacavir 600 mg, dolutegravir 50 mg, and lamivudine 300 mg) tablets for the treatment of HIV-1 infection. ViiV Healthcare is an independent, global company that combines the expertise of GlaxoSmithKline, Pfizer, and Shionogi to deliver advances in treatment and care for people living with HIV. Triumeq is ViiV Healthcare’s first dolutegravir-based fixed-dose combination, offering many people living with HIV the option of a single-pill regimen that combines the integrase strand transfer inhibitor (INSTI) dolutegravir, with the nucleoside reverse transcriptase inhibitors (NRTIs) abacavir and lamivudine. The treatment is ViiV Healthcare's second to be approved in the US.

Approval is based primarily upon data from two clinical trials: a Phase III study of treatment-naïve adults, conducted with dolutegravir and abacavir/lamivudine as separate pills, and a bioequivalence study of the fixed-dose combination of abacavir, dolutegravir, and lamivudine when taken as a single pill compared to the administration of dolutegravir and abacavir/lamivudine as separate pills.

Source: GSK

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