Therapy Areas: AIDS & HIV
Gilead Show 96-Week Results From Phase 3 Study of Biktarvy(Bictegravir, Emtricitabine, Tenofovir Alafenamide) for the Treatment of HIV-1 in Adults New to HIV Therapy
1 November 2018 - - US-based biopharmaceutical company Gilead Sciences, Inc. (NASDAQ: GILD) has released 96-week results from a Phase 3, randomized, double-blinded study (Study 1490) evaluating the safety and efficacy of Biktarvy (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, BIC/FTC/TAF) for the treatment of HIV-1 infection in treatment-naïve adults, the company said.

In the ongoing study, Biktarvy was found to be statistically non-inferior to a regimen of dolutegravir and emtricitabine/tenofovir alafenamide (50 mg) (DTG+FTC/TAF) through 96 weeks of therapy.

The data were presented during a late-breaking abstract session at the 2018 HIV Glasgow conference in Glasgow, Scotland, UK.

Biktarvy is indicated in the US as a complete regimen for the treatment of HIV-1 infection in adults who have no antiretroviral treatment history or to replace the current antiretroviral regimen in those adults who are virologically suppressed (HIV-1 RNA 100,000 c/mL) or low CD4 counts (CD4 < 200 cells/µL) are also being presented in a poster session at HIV Glasgow. Biktarvy is only approved for use in adults.

Study 1490 is ongoing and will remain randomized and blinded through 144 weeks.
Biktarvy is approved in Australia, Canada, the European Union, Hong Kong and the United States.
Biktarvy does not cure HIV infection or AIDS.
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