Bictegravir

Gilead’s Innovative HIV Treatment Research Pipeline Aims to Address Unmet Needs and Advance Public Health

Retrieved on: 
Tuesday, March 5, 2024
Biotechnology, Pharmaceutical, AIDS, General Health, Health, Infectious Diseases, Hospitals, Clinical Trials, Bictegravir, ARV, CD4, Week, Doctor of Philosophy, Aes, Gilead Sciences, Fungal infection, Research, CROI, MDR, MD, Diarrhea, Science, Food, Female, Hook effect, ZAB, Conference, Constipation, European, Safety, Group 2, Black, Lancet, COVID-19, RNA, Public, Patient, Lenacapavir, Plasma, TAB, Observational study, HIV, Viral load

Gilead Sciences, Inc. (Nasdaq: GILD) today announced the presentation of key data highlighting the breadth of its innovative HIV treatment research pipeline.

Key Points: 
  • Gilead Sciences, Inc. (Nasdaq: GILD) today announced the presentation of key data highlighting the breadth of its innovative HIV treatment research pipeline.
  • “The latest findings across our HIV pipeline showcase the potential of multiple candidates to help transform HIV management,” said Jared Baeten, MD, PhD, Vice President, HIV Clinical Development, Gilead Sciences.
  • It is estimated that up to 10% of people with HIV take a complex treatment regimen, defined as 2 or more pills each day.
  • Results showed that all three treatment groups had robust virologic suppression at six months, with consistently low viral loads throughout the study.

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.

China National Medical Products Administration Approves Biktarvy® (Bictegravir, Emtricitabine and Tenofovir Alafenamide) for Treatment of HIV-1 Infection

Retrieved on: 
Friday, August 9, 2019
Biotechnology, Pharmaceutical, Health, Infectious diseases, Hospitals, Clinical trials, Drugs, Hepatotoxins, Organic compounds, Chemistry, Integrase inhibitors, Gilead Sciences, Fixed dose combination, RTT, Bictegravir, Tenofovir alafenamide, Emtricitabine, Tenofovir disoproxil

Gilead Sciences, Inc. (NASDAQ: GILD) announced today that the China National Medical Products Administration (NMPA) has approved Biktarvy (bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg, BIC/FTC/TAF), a once-daily single tablet regimen (STR) for the treatment of HIV-1 infection.

Key Points: 
  • Gilead Sciences, Inc. (NASDAQ: GILD) announced today that the China National Medical Products Administration (NMPA) has approved Biktarvy (bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg, BIC/FTC/TAF), a once-daily single tablet regimen (STR) for the treatment of HIV-1 infection.
  • In China, Biktarvy is indicated for the treatment of HIV-1 infection in adults without present or past evidence of viral resistance to the integrase inhibitor class, emtricitabine or tenofovir.
  • The government of China has provided free antiretroviral treatment to all persons living with HIV since 2003.
  • Biktarvy received marketing approval from the U.S. Food and Drug Administration (FDA) and the European Commission in 2018.

Gilead Presents New Data on Biktarvy® (Bictegravir, Emtricitabine and Tenofovir Alafenamide) and TAF-Based Regimens for the Treatment of HIV-1 in Children, Older Adults and Women

Retrieved on: 
Wednesday, March 6, 2019
Health, AIDS, Biotechnology, Clinical trials, Hospitals, Infectious diseases, Pharmaceutical, Research, Science, Fixed dose combination, Bictegravir/emtricitabine/tenofovir alafenamide, Hepatotoxins, Prevention of HIV/AIDS, Management of HIV/AIDS, Medicine, Integrase inhibitors, Clinical medicine, Health sciences, Bictegravir

Biktarvy is indicated in the U.S. as a complete regimen for the treatment of HIV-1 infection in adults who have no antiretroviral treatment history.

Key Points: 
  • Biktarvy is indicated in the U.S. as a complete regimen for the treatment of HIV-1 infection in adults who have no antiretroviral treatment history.
  • Virologically suppressed adults must have no history of treatment failure and no known substitutions associated with resistance to the individual components of Biktarvy.
  • All participants who initiated or switched to TAF-based regimens, including Biktarvy, were compared with those who initiated or continued TDF-based regimens.
  • Biktarvy, Gilead and the Gilead logo are trademarks of Gilead Sciences, Inc. or its related companies.