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FOSTER CITY, Calif.--(BUSINESS WIRE)--Gilead Sciences, Inc. (Nasdaq: GILD) today announced its upcoming contributions to the HIV Glasgow 2020 conference, taking place virtually from October 5-8. Gilead will present 13 studies from the companys HIV research and development programs in addition to supporting several other independent studies at the conference, which, along with its community-focused programs, reflect Gileads 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. As the needs of the HIV community evolve, we must also evolve our efforts to end the HIV epidemic through our scientific innovation and community support, said Diana Brainard, MD, Senior Vice President and Virology Therapeutic Area Head, Gilead Sciences. We constantly seek to understand the evolving unmet needs among persons living with HIV, and we are pleased to present new switch data for Biktarvy, as well as real-world findings and patient-reported outcomes from a treatment perspective, and new data on our first-in-class investigational long-acting injectable lenacapavir, which may represent a novel approach to HIV treatment. Key Gilead data to be presented: Gilead will present new studies evaluating the safety, efficacy and resistance profile of the once-daily single tablet regimen, Biktarvy (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) in people living with HIV, including older adults and those with a history of resistance, who have switched from other regimens. Twelve-month data and a preliminary, descriptive analysis of patient-reported outcomes will also be presented from the global BICSTaR study, a real-world, observational study evaluating the effectiveness, safety, and tolerability of Biktarvy in treatment-nave and treatment-experienced people living with HIV. The results of this large-scale study are expected to underline the importance of real-world evidence and patient-reported outcomes in understanding the impact on mental health component scores, health-related quality of life (HRQoL) and treatment satisfaction of people living with HIV, which could inform treatment strategies for these groups. Additional treatment research presented at the meeting includes findings from a Phase 1b proof-of-concept study evaluating Gileads investigational, novel inhibitor of HIV-1 capsid function, lenacapavir, which is being developed as a component of a long-acting regimen in combination with other antiretroviral agents. Data on the impact of the COVID-19 pandemic on HIV clinics and services in Greece will also be presented. Key Gilead activities during the conference: Beyond presenting scientific data from the companys HIV research and development program, Gilead will address the impact of COVID-19 on the HIV community in a satellite symposium that will explore the shifting management strategies and treatment approaches to deliver patient-centered care during and after the COVID-19 pandemic. In an effort to better understand the barriers that can influence engagement in HIV care at individual, systemic and community levels, Gilead will also convene discussions with the HIV community. These Gilead-supported sessions are part of the companys ongoing efforts to help change the future of the epidemic through partnerships that help to support community goals of getting to zero new infections and AIDS-related deaths. Select Gilead HIV clinical development program data to be presented at Glasgow 2020: HIV treatment research Investigational long-acting HIV therapy For more information, including a complete list of abstract titles at the meeting, please visit: http://www.hivglasgow.org/wp-content/uploads/2020/09/Poster-Listing_16-September.pdf Please see below for U.S. Indication and Important Safety Information, including Boxed Warning, for Biktarvy. In the U.S., 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. Lenacapavir is an investigational compound and is not approved by the U.S. Food and Drug Administration (FDA) or any other regulatory authority and its safety and efficacy are not yet known. In May 2019, the FDA granted Breakthrough Therapy Designation for the development of lenacapavir (GS-6207) for the treatment of HIV-1 infection in heavily treatment-experienced patients with multi-drug resistance. There is no cure for HIV or AIDS. U.S. Indication for Biktarvy Biktarvy is indicated as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 25 kg who have no antiretroviral (ARV) treatment history or to replace the current ARV regimen in those who are virologically suppressed (HIV-1 RNA <50 copies per mL) on a stable ARV regimen with no history of treatment failure and no known resistance to any component of Biktarvy. U.S. Important Safety Information for Biktarvy BOXED WARNING: POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B Contraindications Warnings and precautions Adverse reactions Drug interactions Dosage and administration Pregnancy and lactation About Gilead Sciences Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. The company strives to transform and simplify care for people with life-threatening illnesses around the world. Gilead has operations in more than 35 countries worldwide, with headquarters in Foster City, California. For more than 30 years, Gilead has been a leading innovator in the field of HIV, driving advances in treatment, prevention, testing and linkage to care, and cure research. Today, its estimated that more than 12 million people living with HIV globally receive antiretroviral therapy provided by Gilead or one of the companys manufacturing partners. Gilead is committed to supporting the global health community to quickly and effectively respond to serious and life-threatening viral outbreaks worldwide. To that end, we are contributing our antiviral expertise and resources to help investigate potential treatments for patients with COVID-19. Forward-Looking Statement This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including the possibility of unfavorable results from ongoing and additional clinical trials involving Biktarvy and lenacapavir, and the possibility that we are unable to complete one or more of such trials in the currently anticipated timelines or at all. In addition, it is possible that Gilead may make a strategic decision to discontinue development of lenacapavir and as a result, lenacapavir may never be successfully commercialized. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gileads Quarterly Report on Form 10-Q for the quarter ended June 30, 2020, as filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements. U.S. full Prescribing Information for Biktarvy, including BOXED WARNING, is available at www.gilead.com Biktarvy, Gilead and the Gilead logo are trademarks of Gilead Sciences, Inc., or its related companies. For more information about Gilead, please visit the companys website at www.gilead.com, follow Gilead on Twitter (@Gilead Sciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.

Answer: Gilead Sciences Presents Data From HIV Research and Development Programs at HIV Glasgow 2020 -- New Findings on Biktarvy to Include Long-term Switch Studies as well as Real-World Data and Patient Reported Outcomes from the BICSTaR Study -- -- Data Evaluating Drug Resistance in People Receiving Lenacapavir, Gileads Investigational HIV-1 Capsid Inhibitor, as Part of a Long-acting HIV Treatment Regimen to be Presented --