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Pharmaceuticals / Submissions and Approvals

FDA Approves ViiV Healthcare’s Combination HIV Drug Triumeq

Sept. 2, 2014

Triumeq (abacavir/lamivudine/dolutegravir) is the first fixed-dose combination HIV therapy approved in the U.S. that contains dolutegravir, which the FDA approved last August as a single drug under the name Tivicay.

"Although single-pill regimens have been available to people living with HIV for some time, Triumeq offers many people living with HIV the option of a single-pill regimen that combines dolutegravir with abacavir and lamivudine," ViiV spokesman Marc Meacham said.

The agency’s approval was based on data from two clinical trials in which 8 percent more patients given Triumeq’s three components showed undetectable viral loads than patients given Bristol-Myers Squibb and Gilead Sciences’ Atripla (efavirenz, emtricitabine and tenofovir).

Dolutegravir is an integrase inhibitor that blocks viral DNA from entering human CD4 immune cells. Lamivudine and abacavir have been available since 1995 and 2004, respectively, and both are reverse transcriptase inhibitors that block transcription of viral RNA into DNA.

The European Medicines Agency approved dolutegravir in January, but a decision on authorization for the combination drug Triumeq is still pending there, as it is in Australia, Brazil and Canada.

ViiV, which was created by GlaxoSmithKline, Pfizer and Shionogi to develop HIV therapies, generated roughly $2.3 billion in sales last year, GSK said.

Triumeq joins a handful of other once-daily HIV therapies, including Gilead Sciences’ Complera (rilpivirine/tenofovir/emtricitabine), Stribild (elvitegravir, cobicistat, emtricitabine, tenofovir) and Truvada (emtricitabine/tenofovir disoproxil fumarate). — Lena Freund

Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.