New Combo Tablets Approved for HIV-1 Infection

TRIUMEQ (abacavir, dolutegravir, lamivudine) tablets by ViiV Healthcare
TRIUMEQ (abacavir, dolutegravir, lamivudine) tablets by ViiV Healthcare

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.

RELATED: Dolutegravir Plus Abacavir-Lamivudine Beats Combo Therapy

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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