Gilead Sciences Announces Chinese NMPA Approval of Biktarvy® (Bictegravir/Emtricitabine/Tenofovir Alafenamide) for the Treatment of HIV-1 Infection

Shanghai, August 9, 2019 /PRNewswire/ -- Gilead Sciences (NASDAQ: GILD) announced that the once-daily single-tablet regimen Biktarvy^®(Biktarvy tablets, bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg, BIC/FTC/TAF) have been approved by the China National Medical Products Administration for the treatment of HIV-1 infection. Biktarvy^®The drug structure combines the innovative, booster-free integrase strand transfer inhibitor (INSTI) bictegravir with the dual nucleoside reverse transcriptase inhibitor (NRTI) backbone Descovy, whose efficacy and safety have been validated.^®(Emtricitabine and Tenofovir Alafenamide Tablets, Emtricitabine 200 mg/Tenofovir Alafenamide 25 mg, FTC/TAF). Biktarvy^®Biktarvy is the smallest single-tablet, three-drug fixed-dose combination based on an integrase strand transfer inhibitor currently available.^®In China, it is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults, with no evidence of viral resistance to integrase inhibitors, emtricitabine, or tenofovir, either currently or historically.

Professor Li Taisheng, Director of the Department of Infectious Diseases at Peking Union Medical College Hospital, stated: “Biktarvy^®"with highly effective antiviral efficacy, a high barrier to resistance, and proven good tolerability, it will provide an important new option for the vast majority of patients in China in the treatment of HIV-1 infection."

In 2018, there were approximately 150,000 newly diagnosed HIV cases in China. In recent years, the number of new HIV infections has increased significantly, which is also attributable to the expansion of screening coverage. Meanwhile, the number of people living with HIV receiving antiretroviral therapy has been steadily increasing. Since 2003, the Chinese government has provided free antiretroviral therapy to all individuals infected with HIV.

Biktarvy^®The approval was based on data from four ongoing Phase 3 clinical studies conducted by Gilead: Studies 1489 and 1490 in treatment-naïve adults with HIV-1 infection, and Studies 1844 and 1878 in virologically suppressed, treatment-experienced adults with HIV-1 infection. A total of 2,414 participants were enrolled in the Biktarvy trials.^®or the control group in clinical trials, with a diverse participant population including adult patients of different ages and races. The 48-week results showed that Biktarvy^®The treatment group met the primary virologic endpoint for non-inferiority. No subjects experienced^®No treatment-emergent virologic resistance was observed in the treatment group, and no subjects discontinued Biktarvy due to renal, bone, or hepatic adverse events.^®. Take Biktarvy^®The common adverse reactions in subjects were diarrhea, nausea, and headache.

Diana Brainard, M.D., Senior Vice President of Research and Development for HIV and Emerging Viruses at Gilead Sciences, stated, “Gilead Sciences is delighted that people living with HIV in China will have access to our most innovative treatment regimens. Biktarvy^®Approved in China, it provides a completely new option for the treatment of HIV, and the rapid approval of this drug also confirms that China is making every effort to bring the most innovative drugs to patients with urgent medical needs.

Biktarvy^®Approved by the U.S. Food and Drug Administration and the European Commission in 2018.

Biktarvy^®HIV infection and AIDS are incurable.

About Gilead Sciences

Gilead Sciences is a research-based biopharmaceutical company dedicated to discovering, developing, and commercializing innovative therapies in areas of unmet medical need. The company’s mission is to transform and simplify care for people with life-threatening illnesses around the world. Gilead operates in more than 35 countries worldwide, with its headquarters located in Foster City, California.

Over the past 30 years, as an innovator in the field of HIV, Gilead Sciences has been leading the development of treatment, prevention, testing, care, and cure research for HIV. According to statistics, more than 12 million people living with HIV worldwide are currently receiving antiretroviral therapy provided by Gilead Sciences or our manufacturing partners.

For more information about Gilead Sciences, please visit the company’s website.www.gileadchina.cn

Biktarvy^®Daklinza^®, Gilead and the registered trademarks of Gilead Sciences, Inc. are owned by Gilead Sciences or its affiliates.