Human and nonclinical disposition of [14C]bictegravir, a potent integrase strand-transfer inhibitor for the treatment of HIV-1 infection

Author:

Subramanian Raju1ORCID,Ling John1,Wang Jianhong1,Wang Kelly1,Hao Jia1,Jin Haolun1,Lai Yurong1ORCID,Murray Bernard1,Wijaya Samantha1,Zhang Heather1,Smith Bill J.1

Affiliation:

1. Gilead Sciences, Inc., Foster City, CA, USA

Funder

Gilead Sciences, Inc

Publisher

Informa UK Limited

Subject

Health, Toxicology and Mutagenesis,Pharmacology,Toxicology,Biochemistry,General Medicine

Reference12 articles.

1. Intracellular Activation of Tenofovir Alafenamide and the Effect of Viral and Host Protease Inhibitors

2. CDER (Center for Drug Evaluation and Research). 2016. Guidance for industry: safety testing of drug metabolites. Silver Spring, MD: U.S. Department of Health and Human Services, Food and Drug Administration. [accessed 2022 Dec 7]. https://www.fda.gov/media/72279/download.

3. Prediction of Creatinine Clearance from Serum Creatinine

4. EMA (European Medicines Agency). 2018. Public assessment report Biktarvy®. [accessed 2022 Dec 7]. https://www.ema.europa.eu/documents/assessment-report/biktarvy-epar-public-assessment-report_en.pdf. Last.

5. FDA (Food and Drug Administration). 2018. Biktarvy® (bictegravir, emtricitabine, and tenofovir alafenamide) tablets, for oral use. [accessed 2022 Dec 10]. https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210251s000lbl.pdf.

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