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FDA Approves Triumeq (Abacavir/Dolutegravir/Lamivudine) as Single-Pill Regimen for HIV-1 Infection

Therapy is non-inferior to Atripla

The FDA has given the nod to Triumeq tablets (abacavir 600 mg, dolutegravir 50 mg, and lamivudine 300 mg, ViiV Healthcare) for the treatment of human immunodeficiency virus-1 (HIV-1) infection.

Triumeq is a dolutegravir-based, fixed-dose combination offering people with HIV infection 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.

Triumeq alone is not recommended for use in patients with a history of or current resistance to any components of Triumeq. Triumeq alone is not recommended in patients with resistance-associated integrase substitutions or clinically suspected INSTI resistance because the dose of dolutegravir in Triumeq is insufficient in these populations.

Before initiating treatment with abacavir-containing products, clinicians should screen for the presence of a genetic marker — the HLA-B*5701 allele — in any HIV-infected patient, irrespective of racial origin. Products containing abacavir should not be used in patients known to carry the HLA-B*5701 allele.

The FDA’s approval was based primarily on data from two clinical studies: the phase III SINGLE trial in 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 with the administration of dolutegravir and abacavir/lamivudine as separate pills.

In the SINGLE study, more patients in the dolutegravir and abacavir/lamivudine arm (the separate components of Triumeq) had undetectable HIV-1 (RNA < 50 copies/mL) compared with patients treated with Atripla (efavirenz, emtricitabine, and tenofovir, Bristol Myers-Squibb/Gilead Sciences) — the most commonly used single-pill regimen. The difference was statistically significant and met the pre-specified test for superiority. The difference was driven by a higher rate of discontinuation due to adverse events in the Atripla arm.

At 96 weeks, 80% of patients treated with the dolutegravir-based regimen were virologically suppressed compared with 72% of patients treated with Atripla.

Grade-2 to -4 treatment-emergent adverse reactions occurring in 2% or more of patients treated with the dolutegavir-based regimen included insomnia (3%), headache (2%), and fatigue (2%).

Triumeq is a fixed-dose combination containing the INSTI dolutegravir and the NRTIs abacavir and lamivudine. Two essential steps in the HIV life cycle are replication (when the virus turns its RNA copy into DNA) and integration (the moment when viral DNA becomes part of the host cell’s DNA). These processes require two enzymes: reverse transcriptase and integrase. NRTIs and integrase inhibitors interfere with the action of the two enzymes to prevent the virus from replicating and further infecting cells.

The labeling for Triumeq includes a boxed warning regarding the potential for hypersensitivity reactions, lactic acidosis, severe hepatomegaly, and exacerbations of hepatitis B.

Dolutegravir was approved in the U.S. in August 2013.

Source: ViiV Healthcare; August 22, 2014.

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