ViiV Healthcare files EU marketing application for two-drug HIV regimen combining Tivicay, lamivudine

ViiV Healthcare on Friday announced that it has applied to the European Medicines Agency for approval of a two-drug regimen combining its integrase inhibitor Tivicay (dolutegravir) plus lamivudine, which ViiV markets under the brand Epivir, for the treatment of HIV-1 infection. Deborah Waterhouse, chief executive at ViiV, said "this regulatory submission, if approved, will make available a two-drug regimen option with [Tivicay] and lamivudine instead of the traditional three-drug regimen and is an important step in the evolution of HIV treatment." 

The company noted that its submission was backed by data from the GEMINI 1 and GEMINI 2 trials involving more than 1400 adults infected with HIV-1. In the late-stage studies, whose results were released in July, the combination regimen exhibited similar efficacy as Tivicay plus Gilead Sciences' Truvada (tenofovir disoproxil fumarate/emtricitabine) in treatment-naïve HIV-1 infected adults. 

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ViiV, which is majority-owned by GlaxoSmithKline, with Pfizer and Shionogi as shareholders, noted that an FDA submission of the combination of Tivicay and lamivudine is expected next month, using a priority review voucher. The company said it also plans to file the therapy for regulatory clearance in other markets "in the coming months." 

Tivicay was previously authorised in both the US and EU as part of a two-drug regimen with Johnson & Johnson's non-nucleoside reverse transcriptase inhibitor Edurant (rilpivirine) under the name Juluca. 

For related analysis, see Physician Views Results: HIV specialists impressed by ViiV's GEMINI data but not yet sold on two-drug regimen.

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