Liver International ISSN 1478-3223
VIRAL HEPATITIS
Tenofovir disoproxil fumarate in Asian or Pacific Islander chronic hepatitis B patients with high viral load (≥ 9 log10 copies/ml) € rg Petersen5, Jan Sperl6, Edward Gane7, Scott Fung1, Stuart C. Gordon2, Zahary Krastev3, Andrzej Horban4, Jo 8 9 9 9 Ira M. Jacobson , Leland J. Yee , Phillip Dinh , Eduardo B. Martins , John F. Flaherty9, Kathryn M. Kitrinos9, Geoffrey Dusheiko10, Huy Trinh11, Robert Flisiak12, Vinod K. Rustgi13, Maria Buti14 and Patrick Marcellin15 1 University of Toronto, Ontario, Canada 2 Henry Ford Health System, Detroit, MI, USA 3 University Hospital, St. Ivan Rilsky, Sofia Bulgaria 4 Warsaw Medical University, Warsaw, Poland 5 Liver Unit Asklepios Klinik St. Georg, Hamburg, Germany 6 Institute for Clinical and Experimental Medicine, Prague, Czech Republic 7 Auckland City Hospital, Aukland, New Zealand 8 Weill Cornell Medical College, New York, NY, USA 9 Gilead Sciences Inc., Foster City, CA, USA 10 Royal Free Hospital, London, UK 11 San Jose Gastroenterology, San Jose, CA, USA 12 Medical University of Bialystok, Bialystok, Poland 13 Metropolitan Liver Diseases, Fairfax, VA, USA 14 Hospital General Universitari Vall d’Hebron and Ciberehd del Instituto Carlos III, Barcelona, Catalonia, Spain ^pital Beaujon, University of Paris, Clichy, France 15 Ho
Keywords Asian – hepatitis B – tenofovir disoproxil fumarate – viremia Abbreviaitons ADV, adefovir dipivoxil; API, Asian or Pacific Islander; CHB, chronic hepatitis B; HBeAg, hepatitis B e antigen; HBsAg, hepatitis B surface antigen; HBV, hepatitis B virus; HVL, high viral load; TDF, tenofovir disoproxil fumarate. Correspondence Scott Fung, MD, FRCPC 200 Elizabeth St., 9N-981 Toronto General Hospital University Health Network Toronto, ON, M5G 2C4, Canada Tel: +416 340 3893 Fax: +416 340 3258 e-mail: [email protected] Received 26 June 2014 Accepted 17 September 2014 DOI:10.1111/liv.12694 Liver Int. 2015; 35: 422–428
Abstract Background & Aims: We evaluated the antiviral response of Asian or Pacific Islander (API) patients with chronic hepatitis B (CHB) who had baseline high viral load (HVL), defined as pre-treatment hepatitis B virus (HBV) DNA ≥9 log10 copies/ml, following up to 288 weeks of tenofovir disoproxil fumarate (TDF) treatment. Methods: A total of 205 HBeAg-negative and HBeAg-positive self-described API patients received 48 weeks of TDF 300 mg (HVL n = 18) or adefovir dipivoxil 10 mg (HVL n = 15) in a blinded fashion, followed by open-label TDF for an additional 240 weeks. The proportions of HVL vs. non-HVL patients with HBV DNA
VIRAL HEPATITIS
Tenofovir disoproxil fumarate in Asian or Pacific Islander chronic hepatitis B patients with high viral load (≥ 9 log10 copies/ml) € rg Petersen5, Jan Sperl6, Edward Gane7, Scott Fung1, Stuart C. Gordon2, Zahary Krastev3, Andrzej Horban4, Jo 8 9 9 9 Ira M. Jacobson , Leland J. Yee , Phillip Dinh , Eduardo B. Martins , John F. Flaherty9, Kathryn M. Kitrinos9, Geoffrey Dusheiko10, Huy Trinh11, Robert Flisiak12, Vinod K. Rustgi13, Maria Buti14 and Patrick Marcellin15 1 University of Toronto, Ontario, Canada 2 Henry Ford Health System, Detroit, MI, USA 3 University Hospital, St. Ivan Rilsky, Sofia Bulgaria 4 Warsaw Medical University, Warsaw, Poland 5 Liver Unit Asklepios Klinik St. Georg, Hamburg, Germany 6 Institute for Clinical and Experimental Medicine, Prague, Czech Republic 7 Auckland City Hospital, Aukland, New Zealand 8 Weill Cornell Medical College, New York, NY, USA 9 Gilead Sciences Inc., Foster City, CA, USA 10 Royal Free Hospital, London, UK 11 San Jose Gastroenterology, San Jose, CA, USA 12 Medical University of Bialystok, Bialystok, Poland 13 Metropolitan Liver Diseases, Fairfax, VA, USA 14 Hospital General Universitari Vall d’Hebron and Ciberehd del Instituto Carlos III, Barcelona, Catalonia, Spain ^pital Beaujon, University of Paris, Clichy, France 15 Ho
Keywords Asian – hepatitis B – tenofovir disoproxil fumarate – viremia Abbreviaitons ADV, adefovir dipivoxil; API, Asian or Pacific Islander; CHB, chronic hepatitis B; HBeAg, hepatitis B e antigen; HBsAg, hepatitis B surface antigen; HBV, hepatitis B virus; HVL, high viral load; TDF, tenofovir disoproxil fumarate. Correspondence Scott Fung, MD, FRCPC 200 Elizabeth St., 9N-981 Toronto General Hospital University Health Network Toronto, ON, M5G 2C4, Canada Tel: +416 340 3893 Fax: +416 340 3258 e-mail: [email protected] Received 26 June 2014 Accepted 17 September 2014 DOI:10.1111/liv.12694 Liver Int. 2015; 35: 422–428
Abstract Background & Aims: We evaluated the antiviral response of Asian or Pacific Islander (API) patients with chronic hepatitis B (CHB) who had baseline high viral load (HVL), defined as pre-treatment hepatitis B virus (HBV) DNA ≥9 log10 copies/ml, following up to 288 weeks of tenofovir disoproxil fumarate (TDF) treatment. Methods: A total of 205 HBeAg-negative and HBeAg-positive self-described API patients received 48 weeks of TDF 300 mg (HVL n = 18) or adefovir dipivoxil 10 mg (HVL n = 15) in a blinded fashion, followed by open-label TDF for an additional 240 weeks. The proportions of HVL vs. non-HVL patients with HBV DNA
