Emtricitabine

Biktarvy® Demonstrates High Rates of Viral Suppression in People With HIV and Comorbidities

Retrieved on: 
Wednesday, March 6, 2024
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“People with HIV and comorbid conditions or pre-existing treatment resistance can often face complex and evolving treatment needs.

Key Points: 
  • “People with HIV and comorbid conditions or pre-existing treatment resistance can often face complex and evolving treatment needs.
  • The ALLIANCE trial is the first randomized clinical trial of TAF- vs TDF-based regimens in treatment naïve adults with HIV /HBV coinfection.
  • Additionally, ALLIANCE participants treated with Biktarvy exhibited numerically higher levels of HBV viral suppression and seroconversion.
  • The primary outcome measure is viral suppression rates at Week 24, defined as HIV-1 RNA ˂50 copies/mL.

Gilead to Present Late-Breaking Data and Real-World Evidence Highlighting Innovative Antiviral Portfolio and Research Pipeline at CROI 2024

Retrieved on: 
Monday, February 26, 2024
Biotechnology, FDA, AIDS, Health, Pharmaceutical, Research, Infectious Diseases, Hospitals, Science, COVID-19, Clinical Trials, Senior, Hepatitis B, CROI, Hook effect, RWE, STR, Viral, Virus, DTG, Mortality, Lenacapavir, Hepatitis, HBV, Vesatolimod, Fungal infection, HIV-1, MDR, PWH, HDV, Boxed warning, European, Islatravir, Tablet, European Commission, Liver disease, Omicron, Conference, Safety, ART, Civil service commission, Abstract, Bictegravir, Natural history, Virology, Emtricitabine, Gilead Sciences, MD, Food, Coinfection, Immunodeficiency, European Economic Area, Risk, Prevalence, Dexamethasone, Patient, Tuberculosis, INSIGHT, HIV, Pharmaceutical industry

Outcomes from pipeline research studies will also provide insights into investigational treatment candidates, including the novel combination regimen of lenacapavir plus bictegravir.

Key Points: 
  • Outcomes from pipeline research studies will also provide insights into investigational treatment candidates, including the novel combination regimen of lenacapavir plus bictegravir.
  • Additionally, a late-breaker oral presentation of Week 24 data from the INSIGHT trial evaluating Biktarvy in people with HIV and tuberculosis will be presented.
  • Gilead will present new data evaluating the safety and efficacy of Hepcludex® (bulevirtide) in people living with the coinfections of HIV, hepatitis B (HBV) and hepatitis delta (HDV).
  • Biktarvy combines the novel, unboosted INSTI bictegravir, with the Descovy® (emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, F/TAF) backbone.

Human medicines European public assessment report (EPAR): Emtricitabine/Tenofovir disoproxil Mylan, emtricitabine,tenofovir disoproxil, Date of authorisation: 16/12/2016, Revision: 15, Status: Authorised

Retrieved on: 
Tuesday, January 2, 2024
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Human medicines European public assessment report (EPAR): Emtricitabine/Tenofovir disoproxil Mylan, emtricitabine,tenofovir disoproxil, Date of authorisation: 16/12/2016, Revision: 15, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Emtricitabine/Tenofovir disoproxil Mylan, emtricitabine,tenofovir disoproxil, Date of authorisation: 16/12/2016, Revision: 15, Status: Authorised

Innovators Behind the Covid Vaccines & Antivirals, HIV Treatments, and More to Be Honored at the White House, Receive Bayh-Dole Coalition American Innovator Award

Retrieved on: 
Wednesday, September 13, 2023
Columbia University, Emory University, Emtricitabine, White House, Legislation, University, University of California, Berkeley, Worcester Polytechnic Institute, Bayh–Dole Act, Interview, HIV, COVID-19 vaccine, University of Pennsylvania, Emory, Messenger, White, American Innovations, COVID-19, UC, Nobel, Pfizer, Vaccine, Pharmaceutical industry

"By bringing groundbreaking discoveries from the lab into the real world, these visionaries improved millions of lives around the globe," said Brian O'Shaughnessy, the Bayh-Dole Coalition's board chair. "None of these stories would have been possible without the 1980 Bayh-Dole Act, one of our nation's most inspired -- and most successful -- pieces of legislation."

Key Points: 
  • They will be honored at the White House while in Washington.
  • "We're thrilled to welcome some of America's greatest scientists, researchers, and entrepreneurs to our nation's capital to recognize their brilliant achievements," said Joseph P. Allen, executive director of the Bayh-Dole Coalition.
  • To access the Faces of American Innovation report and learn more about the award recipients and their pioneering work, please visit www.bayhdolecoalition.org/FacesOfAmericanInnovation2023 .
  • If you'd like to schedule an interview with any of the awardees, please contact Jack Dunn at [email protected] .

"Faces of American Innovation" Report Celebrates People Behind Life-Changing Inventions Fostered by the Bayh-Dole Act

Retrieved on: 
Wednesday, August 16, 2023
Columbia University, Emory University, Emtricitabine, University, University of California, Berkeley, Bayh–Dole Act, Worcester Polytechnic Institute, HIV, COVID-19 vaccine, Politics, University of Pennsylvania, Research, Messenger, Congress, American Innovation dollars, COVID-19, UC, Nobel, Ecosystem, Pfizer, Lithium, Pharmaceutical industry

It passed with overwhelming support from both political parties and helped catalyze decades of American innovation," said Joseph P. Allen, executive director of the Bayh-Dole Coalition.

Key Points: 
  • It passed with overwhelming support from both political parties and helped catalyze decades of American innovation," said Joseph P. Allen, executive director of the Bayh-Dole Coalition.
  • "This report celebrates the often-overlooked sacrifice and perseverance that characterizes American innovation and is required to move breakthroughs out of the lab and into the real world."
  • Birch Bayh (D-IN) and Robert Dole (R-KS) – and all the other lawmakers who helped shepherd the Bayh-Dole Act through Congress.
  • To access this year's Faces of American Innovation report and learn more about the award recipients and their pioneering work, please visit www.bayhdolecoalition.org/FacesofAmericanInnovation2023 .

Gilead Showcases Latest HIV Pipeline Progress and the Impact of Global Collaboration on Health Equity Efforts at IAS 2023

Retrieved on: 
Wednesday, July 19, 2023
AIDS, Health, Infectious Diseases, Hospitals, Pharmaceutical, Biotechnology, Science, Emtricitabine, Maintenance, Gilead Sciences, Elton, Bictegravir/emtricitabine/tenofovir alafenamide, International, Public affairs, Senior, HIV, Health equity, AEST, Woman, Lenacapavir, Research, Doctor of Philosophy, Tablet, Elton John AIDS Foundation, DTG, HIV/AIDS denialism, MD, The Fire Within, IAS, Crisis communication, Conference, CAPELLA, Pharmaceutical industry

As the leader in HIV innovation, Gilead will provide updates on its signature initiatives and key collaborations while sharing new scientific data from its research and development programs.

Key Points: 
  • As the leader in HIV innovation, Gilead will provide updates on its signature initiatives and key collaborations while sharing new scientific data from its research and development programs.
  • Gilead is committed to continuous scientific discovery to meet the evolving needs of people affected by HIV.
  • At IAS 2023, Gilead will share new findings on HIV treatment and prevention strategies, as well as the latest updates from the company’s continued pursuit of an HIV cure.
  • Gilead scientists will also contribute to three IAS-hosted satellite sessions to further advance scientific dialogue on key issues including:

Gilead Partners with CHAI and Penta to Improve Treatment and Adherence Rates Among Children with HIV in Low and Middle Income Countries

Retrieved on: 
Thursday, July 13, 2023
Biotechnology, AIDS, Hospitals, Health, Pharmaceutical, Penta, Unitaid, Monell Chemical Senses Center, Emtricitabine, Gilead Sciences, CHAI, Partnership, Sofosbuvir, Prevalence, HIV, European and Developing Countries Clinical Trials Partnership, Bill & Melinda Gates Foundation, TAF, SOF, DBM, Global health, Research, Medicine, Doctor of Philosophy, Bangladesh Technical Education Board, UNIVERSAL, EDCTP, Foundation for the National Institutes of Health, MD, Patient, Child, Viral, Developing country, Science, Mortality, Pediatrics, Technology transfer, Caregiver, Pharmaceutical industry, Vaccine

For more than 30 years, Gilead has been a leading innovator in the field of HIV, driving advances in treatment, prevention and cure research.

Key Points: 
  • For more than 30 years, Gilead has been a leading innovator in the field of HIV, driving advances in treatment, prevention and cure research.
  • However, just over 50% of them are on antiretroviral treatment compared to 76% of adults living with HIV on treatment today.
  • Many LMICs have a high burden of mother-to-child transmission and the prevalence of HIV among children remains high.
  • “By developing medicine formulations that meet the needs of children, and by improving palatability, through these partnership, we have the ability to potentially increase adherence rates in children.

New Study Highlights the Complexity of Using Antiviral Drug Combinations for HIV Prevention

Retrieved on: 
Wednesday, April 5, 2023
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One promising approach involves delivering antiviral compounds vaginally, using inserts, gels, films, or intravaginal rings.

Key Points: 
  • One promising approach involves delivering antiviral compounds vaginally, using inserts, gels, films, or intravaginal rings.
  • They used a mathematical model to empirically study the effects of administering different doses of antiviral drugs.
  • This study provides a translational template for the preclinical evaluation of drug combinations for the prevention of HIV-1 and other viral diseases.
  • The interaction between drugs that are effective when used alone but may interfere with each other when combined highlights the complexity of predicting the effects of drug use in HIV prevention.

Gilead Demonstrates Transformative Potential Impact Of Antiviral Innovation at CROI 2023

Retrieved on: 
Tuesday, February 14, 2023
Biotechnology, AIDS, Health, General Health, Pharmaceutical, Oncology, Research, Infectious Diseases, Hospitals, Science, COVID-19, Lenacapavir, Viral, International AIDS Society, CROI, Woman, Fungal infection, Immunotherapy, Abstract, Pre-exposure prophylaxis, Safety, Incidence, Patient, Boxed warning, HBV, HIV, Food, Gilead Sciences, Senior, Virology, Coinfection, International, DTG, TLR9, Hook effect, Conference on Retroviruses and Opportunistic Infections, Vesatolimod, Emtricitabine, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Conference, Tablet, MD, Pharmaceutical industry, Vaccine, Remdesivir, Bictegravir/emtricitabine/tenofovir alafenamide

At CROI 2023, Gilead will share new findings on HIV treatment and prevention strategies, as well as the latest updates from the company’s continued pursuit of an HIV cure.

Key Points: 
  • At CROI 2023, Gilead will share new findings on HIV treatment and prevention strategies, as well as the latest updates from the company’s continued pursuit of an HIV cure.
  • Additionally, Gilead will present data from a pre-clinical in vivo assessment of a single subcutaneous administration of lenacapavir for pre-exposure prophylaxis (PrEP).
  • Gilead will present data that reinforce the critical role Veklury® (remdesivir) plays as the antiviral standard of care for the treatment of hospitalized patients with COVID-19.
  • Additionally, Gilead will present a new in vitro analysis that evaluates the antiviral activity of Veklury against common variants of concern, and data assessing the resistance profile of Veklury and other antiviral compounds.

European Commission Grants Expanded Marketing Authorization for Gilead’s Biktarvy® for the Treatment of HIV in Pediatric Populations

Retrieved on: 
Tuesday, November 29, 2022
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The European Marketing Authorization is the first pediatric approval for Biktarvy in the European Union (EU) and applies to all 27 member states of the EU, as well as Norway, Iceland and Liechtenstein.

Key Points: 
  • The European Marketing Authorization is the first pediatric approval for Biktarvy in the European Union (EU) and applies to all 27 member states of the EU, as well as Norway, Iceland and Liechtenstein.
  • Additional therapy choices help to ensure children can access care and expand their HIV treatment options, which helps advance the collective efforts to overcome the HIV epidemic.
  • Through the Gilead Global Pediatric Center of Excellence, we are committed to applying our decades of antiviral expertise to drive innovation in pediatric HIV research.
  • In 2021, an estimated 800,000 children under the age of 19 living with HIV were still not receiving HIV treatment.