Browsing by Author "Weilert, Frank"
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Item Three years of tenofovir disoproxil fumarate (tdf) treatment in hbeag-negative patients with chronic hepatitis b (study 102); preliminary analysis(Wiley, 2009-10) Marcellin, Patrick; Buti, Maria; Krastev, Zahary; Germanidis, George; Kaita, Kelly D.; Kotzev, Iskren; Buggisch, Peter; Weilert, Frank; Trinh, Huy N.; Heathcote, E. Jenny; Sorbel, Jeff; Anderson, Jane; Mondou, Elsa; Rousseau, Franck; Gürel, Selim; Uludağ Üniversitesi/Tıp Fakültesi/İç Hastalıkları Anabilim Dalı/Gastroenteroloji Bilim Dalı.Amer Assoc Study Liver DisItem Three-year efficacy and safety of tenofovir disoproxil fumarate treatment for chronic hepatitis B(Elsevier, 2011-01) Heathcote, E. Jenny; Marcellin, Patrick; Buti, Maria; Gane, Edward; De Man, Robert A.; Krastev, Zahary; Germanidis, George; Lee, Samuel S.; Flisiak, Robert; Kaita, Kelly; Manns, Michael; Kotzev, Iskren; Tchernev, Konstantin; Buggisch, Peter; Weilert, Frank; Kurdas, Oya Ovunc; Shiffman, Mitchell L.; Trinh, Huy; Snow-Lampart, Andrea; Borroto, Katyna Esoda; Mondou, Elsa; Anderson, Jane; Sorbel, Jeff; Rousseau, Franck; Gürel, Selim; Uludağ Üniversitesi/Tıp Fakültesi/ İç Hastalıkları Anabilim Dalı.; 7003706434BACKGROUND & AIMS: Tenofovir disoproxil fumarate (TDF), a nucleotide analogue and potent inhibitor of hepatitis B virus (HBV) polymerase, showed superior efficacy to adefovir dipivoxil in treatment of chronic hepatitis B through 48 weeks. We evaluated long-term efficacy and safety of TDF monotherapy in patients with chronic hepatitis B who were positive or negative for hepatitis B e antigen (HBeAg+ or HBeAg-). METHODS: After 48 weeks of double-blind comparison of TDF to adefovir dipivoxil, patients who underwent liver biopsy were eligible to continue the study on open-label TDF for 7 additional years; data presented were collected up to 3 years (week 144) from 85% of participants. Primary efficacy end points at week 144 included levels of HBV DNA and alanine aminotransferase, development of resistance mutations, and presence of HBeAg or hepatitis B surface antigen (HBsAg). RESULTS: At week 144, 87% of HBeAg- and 72% of HBeAg+ patients treated with TDF had levels of HBV DNA <400 copies/mL. Among patients who had previously received adefovir dipivoxil and then received TDF, 88% of the HBeAg- and 71% of the HBeAg+ patients had levels of HBV DNA <400 copies/mL; overall, 81% and 74%, respectively, maintained normalized levels of alanine aminotransferase and 34% had lost HBeAg. Amino acid substitutions in HBV DNA polymerase that are associated with resistance to tenofovir were not detected in any patient. Cumulatively, 8% of HBeAg+ patients lost HBsAg. TDF maintained a favorable safety profile for up to 3 years. CONCLUSIONS: TDF was safe and effective in the long-term management of HBeAg+ and HBeAg- patients with chronic hepatitis B.