NAPSR News: Viiv Healthcare receives FDA approval for Triumeq® to treat HIV-1

WASHINGTON - Aug. 25, 2014 - PRLog -- The US Food and Drug Administration (FDA) has approved Triumeq® tablets to treat HIV-1 infection. Triumeq® is a combination of the integrase strand transfer inhibitor (INSTI) dolutegravir, with the nucleoside reverse transcriptase inhibitors (NRTIs) abacavir and lamivudine in a single tablet. This represents the company’s first dolutegravir-based fixed-dose combination. The single pill regimen will certainly be a convenient method of administration for HIV patients.

Dr Dominique Limet, Chief Executive Officer, ViiV Healthcare, said: “Today’s approval of Triumeq offers many people living with HIV in the US the first single-pill regimen containing dolutegravir. ViiV Healthcare is committed to delivering advances in care and new treatment options to physicians and people living with HIV. We are proud to announce this important milestone, marking the second new treatment to be approved in the US from our pipeline of medicines.”

The FDA approval stems from the results of two studies:
**Phase III study (SINGLE) of treatment-naïve adults, conducted with dolutegravir and abacavir/lamivudine as separate pills2,3
**Bioequivalence study of the fixed-dose combination of abacavir, dolutegravir and lamivudine when taken as a single pill compared to the administration of dolutegravir and abacavir/lamivudine as separate pill

Based on the results, at 96 weeks, 80% of the patients on the dolutegravir-based regimen were virologically suppressed compared to 72% of participants on Gilead’s Atripla (efavirenz, emtricitabine and tenofovir).

An estimated 1.1 million people in the US are currently living with the Human Immunodeficiency Virus (HIV). HIV infects and destroys  CD4 cells or T-cells over time, ultimately leading to a weakened immune system and the body’s inability to fight infections and diseases.

Triumeq is a registered trademark of the ViiV Healthcare group of companies.

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