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Gilead’s Biktarvy Maintained High Efficacy With No Cases of Treatment-Emergent Resistance Through Three Years in Phase 3 HIV Clinical Trials

Published: 2019-11-06 11:45:00 ET

– Data from the Two 144-week Studies in Treatment-naïve Adults Living with HIV Presented at European AIDS Conference (EACS)–

FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (NASDAQ: GILD) today announced findings from two randomized, double-blind, active-controlled Phase 3 studies (Study 1489 and Study 1490) evaluating the safety and efficacy of Biktarvy® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets) compared with dolutegravir (DTG)-containing regimens for the treatment of HIV-1 infection in adults new to HIV therapy. In both studies, Biktarvy was well-tolerated and demonstrated high rates of virologic suppression through Week 144. These data are being presented at the 17th European AIDS Conference (EACS) in Basel, Switzerland.

“The findings presented today support the value of Biktarvy as an effective treatment that offers durable viral suppression and maintains a high barrier to resistance,” said Diana Brainard, MD, Senior Vice President, HIV and Emerging Viruses, Gilead Sciences. “These longer-term data reaffirm Biktarvy’s role as a first-line treatment option for appropriate adults who are living with HIV and are starting therapy.”

Biktarvy is indicated in the United States as a complete regimen for the treatment of HIV-1 infection in patients who have no antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically suppressed on a stable antiretroviral regimen for at least three months with no history of treatment failure and no known substitutions associated with resistance to the individual components of Biktarvy. Biktarvy carries a Boxed Warning in its U.S. product label regarding the risk of post-treatment acute exacerbation of hepatitis B. See below for Important Safety Information.

Studies 1489 and 1490 randomized 1,274 treatment-naïve adults to receive Biktarvy or either dolutegravir/ abacavir/lamivudine (50/600/300 mg, DTG/ABC/3TC) (Study 1489) or DTG + emtricitabine/tenofovir alafenamide (50/200/25 mg, F/TAF) (Study 1490). The primary endpoint of both studies was virologic suppression, defined as the proportion of participants who were virologically suppressed (HIV-1 RNA levels

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All statements made via social media sites sponsored or maintained by Enhanced Investments and its affiliates are for informational purposes only and do not constitute a comprehensive description of Enhanced Investments' investment advisory services.
Certain investments are not suitable for all investors. Before investing, consider your investment objectives and applicable fees. The rate of return on investments can vary widely over time, especially for long term investments. Investment losses are possible, including the potential loss of all amounts invested. Information provided by Enhanced Investments is for informational and general educational purposes only and is not investment or financial advice.