ViiV Healthcare announced that the Food and Drug Administration (FDA) has approved Triumeq (abacavir, dolutegravir, lamivudine) tablets for the treatment of HIV-1 infection.

Triumeq combines dolutegravir, an integrase strand transfer inhibitor (INSTI), with two nucleoside reverse transcriptase inhibitors (NRTIs), abacavir and lamivudine.

The FDA approval is based on data from 2 clinical trials: SINGLE, a Phase 3 study evaluating treatment-naive adults taking 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 vs. dolutegravir and abacavir/lamivudine as separate pills.

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In the SINGLE study, more patients were undetectable (HIV-1 RNA <50 copies/mL) in the dolutegravir and abacavir/lamviudine arm vs. the Atripla (efavirenz, emtricitabine, tenofovir; Bristol-Myers Squibb and Gilead) arm. The results were statistically significant and met the pre-specified endpoints for superiority. In the bioequivalence study, 80% of the participants on the dolutegravir-based regimen were virologically suppressed at Week 96 vs. 72% of participants on Atripla.

Triumeq will be available as fixed-dose 600mg/50mg/300mg tablets in 30-count bottles.

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