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Gilead at CROI 2023 – The Next Wave of Innovation in Virology Research
February 14, 2023 - Gilead has announced new clinical and real-world data from the company’s HIV, COVID-19 and viral hepatitis research and development programs that will be presented at the 30th Conference on Retroviruses and Opportunistic Infections (CROI) from February 19-22.
Key upcoming presentations include:
HIV
- To be included in the CROI press conference, proof-of-concept Phase 1b data on the safety and efficacy profile of lenacapavir in combination with investigational broadly neutralizing antibodies (bNAbs) – teropavimab and zinlirvimab – dosed twice-yearly in virologically suppressed adults for the treatment of HIV.
- Clinical data from Gilead’s cure research program and collaborations evaluating the potential impact of bNAbs and lefitolimod on HIV-1 persistence; results from a pre-clinical study conducted in collaboration with Gritstone exploring the potential of vaccines as part of a combination therapeutic approach for HIV cure; the safety, immunogenicity, and efficacy profile of a therapeutic vaccine and vesatolimod regimen conducted in collaboration with AELIX Therapeutics; and the potential impact of HIV vaccine, lefitolimod, and bNAbs (GS-2872 and VRC07-523LS) combination strategies on virologic control in people living with HIV after ART discontinuation conducted in collaboration with amfAR, The Foundation for AIDS Research.
- Pre-clinical in vivo assessment of a single subcutaneous administration of lenacapavir for pre-exposure prophylaxis (PrEP).
COVID-19
- Real-world evidence studies evaluating the use of Veklury®(remdesivir) in the routine clinical practices of hospitals throughout the US to gain insights on patient outcomes as COVID-19 continues to evolve over time. These studies also evaluate the role of Veklury in patients with immunocompromised conditions, as well as all-cause readmissions for COVID-19 patients.
- New in vitro data that evaluates the antiviral activity of Veklury against common variants of concern, as well as data assessing resistance of Veklury and other antiviral compounds.
- Pharmacokinetics (PK) data for Veklury in COVID-19 patients with severe renal impairment.
Viral Hepatitis
- New data from the ALLIANCE trial, which is an ongoing Phase 3 trial evaluating Biktarvy® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) versus dolutegravir (50mg, DTG) + emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg,F/TDF, DTG+F/TDF, in adults with HIV-1/HBV co-infection who are initiating treatment.
U.S. Prescribing Information for Biktarvy, including BOXED WARNING, U.S. full Prescribing Information for Sunlenca, and U.S. full Prescribing Information for Veklury are available at www.gilead.com.
Teropavimab, zinlirvimab lefitolimod, vesatolimod, GS-5423, GS-2872, VRC07-523LS are investigational compounds and are not approved by the U.S. Food and Drug Administration or any other regulatory authority for any use. Their safety and efficacy are unknown.
The use of lenacapavir for HIV prevention is investigational and the safety and efficacy of lenacapavir for this use have not been established. Gilead is studying the safety and efficacy of lenacapavir for HIV prevention in multiple ongoing clinical studies.
The use of Biktarvy in individuals with HIV-1/HBV coinfection is investigational, and the safety and efficacy of Biktarvy for this use have not been established.
Contact:
Brian Plummer, Media
brian.plummer@gilead.com
Source: Gilead Sciences, Inc.
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