Twenty-eight day safety, antiviral activity, and pharmacokinetics of tenofovir alafenamide for treatment of chronic hepatitis B infection - Agarwal, Kosh; Fung, Scott K.; Nguyen, Tuan T.; Cheng, Wendy; Sicard, Eric; Ryder, Stephen D.; Flaherty, John F.; Lawson, Eileen; Zhao, Sally; Subramanian, G. Mani; McHutchison, John G.; Gane, Edward J.; et al. (Journal of hepatology, 2015)
Keywords: Adenine - adverse effects; Adenine - analogs & derivatives; Adenine - pharmacokinetics; Adenine - therapeutic use; Adult; Antiviral; Antiviral Agents - adverse effects; Antiviral Agents - pharmacokinetics; Antiviral Agents - therapeutic use; Clinical Trial; DNA, Viral - blood; Female; Gastroenterology and Hepatology; Hepatitis B, Chronic - drug therapy; Hepatitis B, Chronic - metabolism; Hepatitis B, Chronic - virology; Humans; Male; Middle Aged; Tenofovir - adverse effects; Tenofovir - pharmacokinetics; Tenofovir - therapeutic use; Time Factors; Treatment; Treatment Outcome; Viral hepatitis; Young Adult; CLcr; ALT; AUCinf; TFV-DP; Viral hepatitis; TDF; DAVGx; BMD; Antiviral; HDV; CKD-EPI; eGFR; Cmax; AST; Clinical Trial; TFV; HBeAg; HBsAg; PBMC; bsAP; Treatment; HIV; AUC0–last; t; Tmax; TAF; HCV; CHB; AUC 0–last; area under the concentration-time curve from time of dosing (0 h) to the last time point with measurable plasma concentration prior to next dose; tenofovir; maximum observed plasma concentration; alanine aminotransferase; bone mineral density; AUC inf; chronic hepatitis B; time to maximum observed plasma concentration; creatinine clearance; T max; human immunodeficiency virus; tenofovir diphosphate; estimated glomerular filtration rate; C max; disease epidemiology collaboration; hepatitis B e antigen; bone-specific alkaline phosphatase; CL cr; hepatitis C virus; tenofovir alafenamide; time-weighted average change in HBV DNA from baseline through Week X; peripheral blood mononuclear cells; hepatitis B surface antigen; tenofovir disoproxil fumarate; AUC from time of dosing (0 h) extrapolated to infinity; aspartate aminotransferase; hepatitis D virus; terminal elimination half-life of the drug in plasma