{"id":787748,"date":"2023-10-03T11:41:05","date_gmt":"2023-10-03T15:41:05","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/gilead-to-present-latest-innovative-virology-data-on-current-and-potentially-transformative-therapies-across-hiv-and-covid-19-at-idweek-2023\/"},"modified":"2023-10-03T11:41:05","modified_gmt":"2023-10-03T15:41:05","slug":"gilead-to-present-latest-innovative-virology-data-on-current-and-potentially-transformative-therapies-across-hiv-and-covid-19-at-idweek-2023","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/gilead-to-present-latest-innovative-virology-data-on-current-and-potentially-transformative-therapies-across-hiv-and-covid-19-at-idweek-2023\/","title":{"rendered":"Gilead to Present Latest Innovative Virology Data on Current and Potentially Transformative Therapies Across HIV and COVID-19 at IDWeek 2023"},"content":{"rendered":"

<\/p>\n

Gilead to Present Latest Innovative Virology Data on Current and Potentially Transformative Therapies Across HIV and COVID-19 at IDWeek 2023<\/b><\/p>\n

\u2013 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 \u2013<\/i><\/b><\/p>\n

\u2013 Data Reinforces Veklury\u2019s Strong Safety Profile and Continued In Vitro Activity Against New Variants \u2013<\/i><\/b><\/p>\n

\u2013 Studies Evaluate Utility of Obeldesivir as a Potential Treatment for COVID-19 \u2013<\/i><\/b><\/p>\n

FOSTER CITY, Calif.–(BUSINESS WIRE<\/a>)–
\nGilead 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\u2019s 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.<\/p>\n

\n\u201cGilead is committed to advancing transformational innovation in virology research and development that aims to help address unmet needs,\u201d said Frank Duff, MD, Senior Vice President, Therapeutic Area Head Virology Clinical Development, Gilead Sciences. \u201cAt 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.\u201d<\/p>\n

HIV Research<\/span><\/b><\/p>\n

\nAt IDWeek 2023, the latest outcomes from Gilead\u2019s 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.<\/p>\n

\nResearch studies evaluating Biktarvy\u00ae<\/sup> (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, which involves a diverse range of people with HIV. Additional results include two retrospective observational studies that investigate the efficacy and safety of Biktarvy in adults with HIV who have suboptimal adherence to daily oral antiretroviral therapy and in people living with the virus who have pre-existing drug resistance.<\/p>\n

\nGilead will also present outcomes from multiple studies evaluating lenacapavir, Gilead\u2019s 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.<\/p>\n

\nHIV 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.<\/p>\n

COVID-19 Research<\/span><\/b><\/p>\n

\nAt IDWeek 2023, Gilead will present data that reinforces the ongoing role Veklury\u00ae<\/sup> (remdesivir) plays as the antiviral standard of care for the treatment of hospitalized patients with COVID-19. One in vitro<\/i> 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.<\/p>\n

\nAs part of the company\u2019s 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 <\/i>analysis examining obeldesivir\u2019s antiviral activity against recent Omicron subvariants, including BF.7, BQ.1, XBB.1.5, CH.1.1, and XBF.<\/p>\n

Summary of Presentations<\/span><\/b><\/p>\n

\nKey abstracts will include:<\/p>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
\n

HIV Treatment Research<\/b><\/p>\n<\/td>\n<\/tr>\n

\n

Poster 1611<\/b><\/p>\n<\/td>\n

\n

\nReal-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<\/p>\n<\/td>\n<\/tr>\n

\n

Poster 1561<\/b><\/p>\n<\/td>\n

\n

\nEfficacy of Bictegravir\/Emtricitabine\/Tenofovir Alafenamide (B\/F\/TAF) Versus Dolutegravir (DTG)\u2011Based 3-Drug Regimens in Adults with HIV Who Have Suboptimal Antiretroviral Adherence<\/p>\n<\/td>\n<\/tr>\n

\n

Poster 1569<\/b><\/p>\n<\/td>\n

\n

\nAntiretroviral Treatment (ART) Packaging Preferences and Their Impact on Adherence Among People with HIV (PWH): Findings from a Best-Worst Scaling Survey<\/p>\n<\/td>\n<\/tr>\n

\n

Poster 1596<\/b><\/p>\n<\/td>\n

\n

\nEfficacy and Safety of Long-Acting Subcutaneous Lenacapavir in Heavily Treatment-Experienced People with Multi-Drug Resistant HIV: Week 104 Results<\/p>\n<\/td>\n<\/tr>\n

\n

Poster 1542<\/b><\/p>\n<\/td>\n

\n

\nImpact of Subcutaneous Administration Sites on the Clinical Pharmacokinetics of Lenacapavir, a Long-Acting HIV Capsid Inhibitor: Does Body Site Matter?<\/p>\n<\/td>\n<\/tr>\n

\n

Poster 1581<\/b><\/p>\n<\/td>\n

\n

\nWeight and Metabolic Changes with Long-Acting Lenacapavir in a Combination Regimen in Treatment-Na\u00efve People with HIV-1 at Week 80<\/p>\n<\/td>\n<\/tr>\n

\n

HIV Prevention Research<\/b><\/p>\n<\/td>\n<\/tr>\n

\n

Poster 1557<\/b><\/p>\n<\/td>\n

\n

\nThe Real-World Impact of Pre-exposure Prophylaxis (PrEP) Prescription Uptake and Dispensing Status on HIV Infection Risk in the US<\/p>\n<\/td>\n<\/tr>\n

\n

Poster 1556<\/b><\/p>\n<\/td>\n

\n

\nIncrease in New HIV Diagnoses Following Decrease in Use of Pre-exposure Prophylaxis (PrEP) during the COVID-19 Pandemic<\/p>\n<\/td>\n<\/tr>\n

\n

COVID-19 Research<\/b><\/p>\n<\/td>\n<\/tr>\n

\n

Poster Presentation 120<\/b><\/p>\n<\/td>\n

\n

\nResistance Analyses from the Remdesivir Phase 3 REDPINE Study in Participants with Severely Reduced Kidney Function Who Were Hospitalized for COVID-19\u200b<\/p>\n<\/td>\n<\/tr>\n

\n

Poster 545<\/b><\/p>\n<\/td>\n

\n

\nRemdesivir and Obeldesivir Retain Potent Activity Against SARS-COV-2 Omicron Variants<\/p>\n<\/td>\n<\/tr>\n

\n

Poster 524<\/b><\/p>\n<\/td>\n

\n

\nHepatic Safety of Remdesivir Across Phase 3 Placebo-controlled COVID-19 Studies\u200b<\/p>\n<\/td>\n<\/tr>\n

\n

Poster 538<\/b><\/p>\n<\/td>\n

\n

\nClinical Evaluation of Drug-Drug Interactions with Remdesivir\u200b<\/p>\n<\/td>\n<\/tr>\n

\n

Poster 403<\/b><\/p>\n<\/td>\n

\n

\nDemographics, Characteristics and Health Outcomes of US Individuals Diagnosed With COVID-19 in the Outpatient Setting\u200b<\/p>\n<\/td>\n<\/tr>\n

\n

Poster 539<\/b><\/p>\n<\/td>\n

\n

\nEfficacy in Multiple SARS-CoV-2 Animal Models Supports Phase 3 Dose Selection for Obeldesivir<\/p>\n<\/td>\n<\/tr>\n

\n

Poster 1343<\/b><\/p>\n<\/td>\n

\n

\nDrug 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)\u200b<\/p>\n<\/td>\n<\/tr>\n

\n

Poster 505<\/b><\/p>\n<\/td>\n

\n

\nDrug-Drug Interaction Profiling of Obeldesivir, A Promising Oral Treatment for COVID-19<\/p>\n<\/td>\n<\/tr>\n<\/table>\n

\nFor 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\/<\/a>.<\/p>\n

\nThe 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.<\/p>\n

\nPlease see below for the U.S. Indication and Important Safety Information for Sunlenca\u00ae<\/sup> 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.<\/p>\n

About Biktarvy<\/span><\/b><\/p>\n

\nBiktarvy 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\u00ae<\/sup><\/i> (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.<\/p>\n

About Sunlenca<\/span><\/b><\/p>\n

\nSunlenca (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 \u201cBest Pharmaceutical Product\u201d 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.<\/p>\n

\nThe multi-stage mechanism of action of Sunlenca\u2019s 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 <\/i>to other existing drug classes.<\/p>\n

\nLenacapavir 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.<\/p>\n

About Gilead\u2019s COVID-19 Development Program<\/span><\/b><\/p>\n

\nVeklury (remdesivir) is a nucleotide analog prodrug invented and developed by Gilead, building on more than a decade of the company\u2019s 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.<\/p>\n

\nVeklury directly inhibits viral replication inside of the cell by targeting the SARS-CoV-2 viral RNA polymerase. Based on in vitro<\/i> 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.<\/p>\n

\nVeklury 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\u2019s voluntary licensing program.<\/p>\n

\nWith 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.<\/p>\n

\nObeldesivir 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.<\/p>\n

U.S. Indication for Biktarvy<\/span><\/b><\/p>\n

\nBiktarvy 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.<\/p>\n

U.S. Important Safety Information for Biktarvy<\/span><\/b><\/p>\n

BOXED WARNING: POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B<\/b><\/p>\n