October 03, 2023
– Latest HIV Treatment Research Reinforces Biktarvy Efficacy Data in a Broad Range of People with HIV and Highlights the Potential Impact of Twice-Yearly Lenacapavir on the Future of HIV Clinical Care –
– Data Reinforces Veklury’s Strong Safety Profile and Continued In Vitro Activity Against New Variants –
– Studies Evaluate Utility of Obeldesivir as a Potential Treatment for COVID-19 –
FOSTER CITY, Calif.–(BUSINESS WIRE)– Gilead Sciences, Inc. (Nasdaq: GILD) today announced new data from its virology research and development programs that will be presented at IDWeek 2023, October 11-15 in Boston. These latest data demonstrate the company’s ongoing efforts to address the unmet medical needs of people and communities affected by HIV and COVID-19. Gilead will be presenting 16 abstracts, including real-world evidence, as the company continues to pursue the next wave of scientific discovery in virology.
“Gilead is committed to advancing transformational innovation in virology research and development that aims to help address unmet needs,” said Frank Duff, MD, Senior Vice President, Therapeutic Area Head Virology Clinical Development, Gilead Sciences. “At IDWeek 2023, we look forward to sharing our latest data with the broader community and discussing potential implications for the treatment of COVID-19 among some of the most vulnerable populations. In HIV we are pleased to share the latest data from long-term treatment studies, and new data that can help inform strategies to meet the needs of a range of people affected by HIV.”
At IDWeek 2023, the latest outcomes from Gilead’s HIV treatment and prevention programs will demonstrate how the company is working to advance transformational innovation in HIV research to meet the changing needs of people affected by HIV worldwide.
Research studies evaluating Biktarvy® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) for HIV treatment include long-term real-world efficacy and safety data from the ongoing observational BICSTaR study in people living with the virus who have pre-existing drug resistance. Additional results include a retrospective observational study investigating the efficacy and safety of Biktarvy in adults with HIV who have suboptimal adherence to daily oral antiretroviral therapy.
Gilead will also present outcomes from multiple studies evaluating lenacapavir, Gilead’s first-in-class, long-acting HIV-1 capsid inhibitor. This includes two-year results from CAPELLA, an ongoing Phase 2/3 registrational study designed to evaluate the antiviral activity and safety of twice-yearly lenacapavir administered as a subcutaneous injection in adults with multi-drug resistant HIV who are heavily treatment-experienced. Additionally, research will be presented on the evaluation of alternative subcutaneous administration sites for lenacapavir.
HIV prevention data include results from a study investigating the real-world impacts of pre-exposure prophylaxis (PrEP) access and dispensing status on likelihood of acquiring HIV, as well as a study on the increase in new HIV cases among people who could benefit from PrEP during the COVID-19 pandemic.
At IDWeek 2023, Gilead will present data that reinforces the ongoing role Veklury® (remdesivir) plays as the antiviral standard of care for the treatment of hospitalized patients with COVID-19. One in vitro analysis will demonstrate the continued antiviral activity of Veklury against recent SARS-CoV-2 Omicron subvariants. Separate studies will examine the safety of Veklury across vulnerable populations including a study on the safety profile of Veklury and its impact on the liver across phase 3 placebo-controlled COVID-19 studies, as well as a study that included resistance analyses in patients with severely reduced kidney function who were hospitalized for COVID-19.
As part of the company’s ongoing commitment to COVID-19 and the unmet needs of patients, Gilead will present a study analyzing the potential for drug-drug interactions (DDIs) with the investigational oral antiviral obeldesivir, as well as an in vitro analysis examining obeldesivir’s antiviral activity against recent Omicron subvariants, including BF.7, BQ.1, XBB.1.5, CH.1.1, and XBF.
Summary of Presentations
Key abstracts will include:
HIV Treatment Research
Real-World Effectiveness and Tolerability of Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) in Treatment-Experienced People with HIV and a History of Antiretroviral Drug Resistance Mutations
Efficacy of Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) Versus Dolutegravir (DTG)‑Based 3-Drug Regimens in Adults with HIV Who Have Suboptimal Antiretroviral Adherence
Antiretroviral Treatment (ART) Packaging Preferences and Their Impact on Adherence Among People with HIV (PWH): Findings from a Best-Worst Scaling Survey
Efficacy and Safety of Long-Acting Subcutaneous Lenacapavir in Heavily Treatment-Experienced People with Multi-Drug Resistant HIV: Week 104 Results
Impact of Subcutaneous Administration Sites on the Clinical Pharmacokinetics of Lenacapavir, a Long-Acting HIV Capsid Inhibitor: Does Body Site Matter?
Weight and Metabolic Changes with Long-Acting Lenacapavir in a Combination Regimen in Treatment-Naïve People with HIV-1 at Week 80
HIV Prevention Research
The Real-World Impact of Pre-exposure Prophylaxis (PrEP) Prescription Uptake and Dispensing Status on HIV Infection Risk in the US
Increase in New HIV Diagnoses Following Decrease in Use of Pre-exposure Prophylaxis (PrEP) during the COVID-19 Pandemic
Poster Presentation 120
Resistance Analyses from the Remdesivir Phase 3 REDPINE Study in Participants with Severely Reduced Kidney Function Who Were Hospitalized for COVID-19
Remdesivir and Obeldesivir Retain Potent Activity Against SARS-COV-2 Omicron Variants
Hepatic Safety of Remdesivir Across Phase 3 Placebo-controlled COVID-19 Studies
Clinical Evaluation of Drug-Drug Interactions with Remdesivir
Demographics, Characteristics and Health Outcomes of US Individuals Diagnosed With COVID-19 in the Outpatient Setting
Efficacy in Multiple SARS-CoV-2 Animal Models Supports Phase 3 Dose Selection for Obeldesivir
Drug Education Needs of HCPs and Patients During the COVID-19 Pandemic Based on Over 60,000 Unsolicited Medical Information Requests Globally Over 3 Years (2020-2022)
Drug-Drug Interaction Profiling of Obeldesivir, A Promising Oral Treatment for COVID-19
For more information about Gilead at IDWeek 2023, including a complete list of abstracts and their corresponding oral and poster sessions, please visit https://idweek.org/program/.
The use of Biktarvy in patients with known drug resistance and obeldesivir for any use are investigational and have not been determined to be safe or efficacious and is not approved by the FDA.
Please see below for the U.S. Indication and Important Safety Information for Sunlenca® and Veklury. Please also see below for U.S. Indication and Important Safety Information, including Boxed Warning, for Biktarvy. There is currently no cure for HIV or AIDS.
Biktarvy is a complete HIV treatment that combines three powerful medicines to form the smallest 3-drug, integrase strand transfer inhibitor (INSTI)-based single-tablet regimen (STR) available, offering simple once-daily dosing with or without food, with a limited drug interaction potential and a high barrier to resistance. Biktarvy combines the novel, unboosted INSTI bictegravir, with the Descovy® (emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, F/TAF) backbone. Biktarvy is a complete STR and should not be taken with other HIV medicines.
Sunlenca (300 mg tablet and 463.5 mg/1.5 mL injection) [(lenacapavir)] is a first-in-class, long-acting HIV capsid inhibitor approved in Australia, Canada, the European Union, Israel, Japan, Switzerland, the United Arab Emirates, the United Kingdom, and the United States for the treatment of HIV-1 infection, in combination with other antiretroviral(s), in adults with multi-drug resistant HIV who are heavily treatment-experienced. Sunlenca is the only HIV treatment option administered twice-yearly. Sunlenca tablets are approved for oral loading during initiation of Sunlenca treatment, prior to or at the time of the first long-acting lenacapavir injection depending on initiation option. Sunlenca is a nominee from the USA for the Prix Galien Award in the “Best Pharmaceutical Product” category. The Galien Foundation is widely recognized as the leading global institution dedicated to honoring innovators in life sciences, and the Prix Galien Award is highly prestigious. The award will be selected by a distinguished panel of judges and announced during the Prix Galien USA Awards Ceremony on October 26, 2023.
The multi-stage mechanism of action of Sunlenca’s active pharmaceutical agent, lenacapavir, is distinguishable from other currently approved classes of antiviral agents. While most antivirals act on just one stage of viral replication, Sunlenca is designed to inhibit HIV at multiple stages of its lifecycle and has no known cross resistance exhibited in vitro to other existing drug classes.
Lenacapavir is being evaluated as a long-acting option in multiple ongoing and planned early and late-stage clinical studies in Gilead’s HIV prevention and treatment research program. Lenacapavir for HIV prevention is investigational, and its safety and efficacy for this use have not been established. Lenacapavir is being developed as a foundation for potential future HIV therapies with the goal of offering both long-acting oral and injectable options with several dosing frequencies, in combination or as a mono agent, that help address individual needs and preferences of people and communities affected by HIV.
About Gilead’s COVID-19 Development Program
Veklury (remdesivir) is a nucleotide analog prodrug invented and developed by Gilead, building on more than a decade of the company’s research on broad-spectrum antivirals for emerging viruses. Veklury is the antiviral standard of care for the treatment of hospitalized patients with COVID-19 and is also recommended for the treatment of non-hospitalized patients at high risk of disease progression. Veklury has an established safety profile and minimal known drug interactions in diverse populations. It plays an important role in enabling faster recovery and reducing disease progression across a spectrum of disease severity.
Veklury directly inhibits viral replication inside of the cell by targeting the SARS-CoV-2 viral RNA polymerase. Based on in vitro analyses, Veklury retains antiviral activity against recent Omicron subvariants of concern, including XBB, XBB.1.5 and CH.1.1. Veklury continues to be evaluated against emerging variants of interest and concern, including EG.5, EG.5.1 and BA.2.86.
Veklury is approved in more than 50 countries worldwide. To date, Veklury and generic remdesivir have been made available to more than 13 million patients around the world, including more than 8 million people in middle- and low-income countries through Gilead’s voluntary licensing program.
With most people being treated for COVID-19 outside the hospital, Gilead is working to address the need for additional effective oral antiviral treatments that can be easily taken by the broadest range of patients. Obeldesivir is an investigational oral pill that is designed to stop the replication of the SARS-CoV-2 virus by inhibiting the SARS-CoV-2 RNA-dependent RNA polymerase (RdRp), a critical component that the virus uses to replicate.
Obeldesivir is a GS-441524 prodrug, which is currently being evaluated in Phase 3 trials as a single tablet, with twice daily dosing for 5 days.
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.
U.S. Important Safety Information for Biktarvy
BOXED WARNING: POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B
Warnings and precautions
Dosage and administration
Pregnancy and lactation
U.S. Indication for Sunlenca
Sunlenca, a human immunodeficiency virus type 1 (HIV-1) capsid inhibitor, in combination with other antiretroviral(s), is indicated for the treatment of HIV-1 infection in heavily treatment-experienced adults with multidrug resistant HIV-1 infection failing their current antiretroviral regimen due to resistance, intolerance, or safety considerations.
U.S. Important Safety Information for Sunlenca
Warnings and precautions
Dosage and administration
Pregnancy and lactation
U.S. Indication for Veklury
Veklury (remdesivir 100 mg for injection) is indicated for the treatment of COVID-19 in adults and pediatric patients (≥28 days old and weighing ≥3 kg) who are:
U.S. Important Safety Information for Veklury
Veklury is contraindicated in patients with a history of clinically significant hypersensitivity reactions to Veklury or any of its components.
Warnings and precautions
Dosage and administration
Pregnancy and lactation
About Gilead Sciences
Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, COVID-19, and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.
Gilead has a long history in virology and has pioneered inventions once thought impossible, including antiviral treatments for people and communities affected by some of the most challenging public health concerns including HIV, viral hepatitis and COVID-19.
Gilead helps people and communities across the full continuum of care in virology by developing bold advances that treat, prevent, cure and eradicate viral diseases and collaborating with community and research partners around the world. Gilead is deploying decades of antiviral expertise to provide solutions that help address the unmet and evolving needs of those impacted by viral diseases.
Our work in virology has helped to transform the global health landscape and we are committed to advancing person-centered science and actionable education programs that make a difference for people and communities affected by viral diseases.
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 Gilead’s ability to effectively manage the supply and distribution of Veklury; Gilead’s ability to initiate, progress or complete clinical trials within currently anticipated timelines or at all, and the possibility of unfavorable results from ongoing or additional clinical trials, including those involving Biktarvy, Veklury, lenacapavir and obeldesivir; the possibility that Gilead may make a strategic decision to discontinue development of investigational treatments, including lenacapavir and those in its COVID-19 development program; uncertainties relating to regulatory applications and related filing and approval timelines; the risk that any regulatory approvals, if granted, may be subject to significant limitations on use; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and factors are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2023, as filed with the U.S. Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The reader is cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation and disclaims any intent to update any such forward-looking statements.
U.S. Prescribing Information for Veklury, U.S. Prescribing Information for Sunlenca, and U.S. Prescribing Information for Biktarvy, including BOXED WARNING, are available at www.gilead.com .
Veklury, Sunlenca, Biktarvy, Gilead and the Gilead logo are registered trademarks of Gilead Sciences, Inc., or its related companies. All other trademarks are the property of their respective owner(s).
For more information about Gilead, please visit the company’s 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.
Jacquie Ross, Investors
Meaghan Smith, Media
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