Gilead Sciences (GILD) Presents Long-Term Switch Data Reinforcing Biktarvy® as a Treatment Option for a Broad Range of People Living With HIV

Gilead Sciences, Inc. (Nasdaq: GILD) today announced the company’s upcoming contributions to the 18th European AIDS Conference (EACS 2021), taking place virtually and onsite in London from October 27-30. Forty-four studies from Gilead’s HIV research and development programs will be presented, including data from the global, observational, real-world BICSTaR study, which along with Gilead’s community-focused programs, reflect the company’s ongoing focus and commitment to advancing scientific discovery and supporting the development and delivery of practical solutions that can help improve care for all people affected by HIV.

“We look forward to presenting research at EACS 2021 that could help inform clinical outcomes and support clinicians in the collective endeavor to help end the HIV epidemic,” said Frank Duff, MD, Senior Vice President, Virology Therapeutic Area Head, Gilead Sciences. “In addition to helping create a world with no new HIV infections, we also strive to ensure the people living with HIV can realize long-term treatment success. This includes extending treatment success markers, which can lead to more holistic and patient-centered HIV care, in turn helping us better assess and address the evolving and unmet needs of people affected by the HIV epidemic.”

Gilead will present long-term safety and efficacy data evaluating outcomes in adults living with HIV who switched to Biktarvy® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) from boosted protease inhibitor-based regimens including in those with pre-existing resistance. The primary endpoint was at week 48; results of the open-label extension phase through a maximum of week 181 are slated for presentation at EACS 2021. The data further establish the robust and durable efficacy profile of Biktarvy as a treatment option for virologically suppressed people living with HIV with known resistance. The use of Biktarvy in individuals with known resistance to the components of Biktarvy is investigational.

Twelve-month data and a descriptive analysis of patient-reported outcomes from the ongoing BICSTaR Study, a global, observational, real-world study evaluating the effectiveness, safety, and tolerability of Biktarvy in treatment-naïve and treatment-experienced people living with HIV, will be presented at the conference. As the population of persons living with HIV increases, the evaluation and management of comorbid conditions that may occur in an individual’s life takes on a larger role in HIV clinical care. These findings may help inform a future paradigm of coordinated, patient-centered HIV care.

Additionally, at EACS 2021, Gilead will share new findings on long-acting HIV treatment strategies, as well as updates from the company’s continued pursuit of a cure for HIV. Data will include subgroup and resistance analyses from the ongoing Phase 3 CAPELLA trial evaluating the antiviral activity of investigational lenacapavir administered subcutaneously every six months in combination with an optimized antiretroviral background regimen in people living with HIV who are heavily treatment-experienced with multi-drug resistant HIV-1 infection.

To further aid the development of a functional HIV cure, Gilead conducted a study using mathematical modelling and machine learning in a Phase 1b study to identify predictive immune biomarkers of HIV post-treatment controllers. HIV post-treatment controllers, a rare group of people who manage to sustain their viral load suppression after stopping antiretroviral therapy, have the potential to help us further research and understand possible ways to induce a similar response to treatment in a broader group of people living with HIV.

Beyond presenting new scientific data from the company’s HIV research and development programs, Gilead will convene a symposium featuring community, clinical and health systems experts to discuss the ongoing impact of COVID-19 on the HIV cascade of care and lessons learned that can be applied in the future as we seek to accelerate the end of the HIV epidemic, work towards increased health equity, and prepare for future emerging viruses.

Select Gilead accepted abstracts are as follows:

For more information, including a complete list of abstracts, please visit: https://eacs-conference2021.com/programme/

Please see below for the U.S. Indication and Important Safety Information, including Boxed Warnings, for Biktarvy and Descovy for PrEP®.

Lenacapavir and vesatolimod are investigational compounds and are not approved anywhere globally. Their safety and efficacy have not been established.

The use of Biktarvy in individuals with a history of treatment failure or known resistance to the components of Biktarvy is investigational, and the safety and efficacy of Biktarvy for this use have not been established.

There is currently no cure for HIV or AIDS.

U.S. Indication for Biktarvy

Biktarvy is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and pediatric patients weighing at least 14 kg who have no antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically-suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no history of treatment failure and no known substitutions associated with resistance to the individual components of Biktarvy.

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