Browsing by Author "Heathcote, E. Jenny"
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Item Continued efficacy and safety through 4 years of tenofovir disoproxil fumarate (tdf) treatment in hbeag-negative patients with chronic hepatitis b (study 102): Preliminary analysis(Wiley, 2010-10) Marcellin, Patric; Buti, Maria; Krastev, Zahary; Di Bisceglie, Adrian M.; Odin, Joseph A.; Dusheiko, Geoffrey; Heathcote, E. Jenny; E. Jenny, Katyna; Coombs, Derek; Mondou, Elsa; Anderson, Jane; Gürel, Selim; Uludağ Üniversitesi/Tıp Fakültesi/İç Hastalıkları Anabilim Dalı.Publication Kinetics of hepatitis B surface antigen loss in patients with HBeAg-positive chronic hepatitis B treated with tenofovir disoproxil fumarate(Elsevier, 2014-07-11) Marcellin, Patrick; Buti, Maria; Krastev, Zahari; de Man, Robert A.; Zeuzem, Stefan; Lou, Lillian; Gaggar, Anuj; Flaherty, John F.; Massetto, Benedetta; Lin, Lanjia; Dinh, Phillip; Subramanian, G. Mani; McHutchison, John G.; Flisiak, Robert; Gürel, Selim; Dusheiko, Geoffrey M.; Heathcote, E. Jenny; GÜREL, SELİM; Uludag Üniversitesi/Tıp Fakültesi.; HLH-8209-2023Background & Aims: In a study of 266 chronic hepatitis B e antigen (HBeAg)-positive patients, 23 experienced hepatitis B surface antigen (HBsAg) loss with up to 5 years of tenofovir disoproxil fumarate (TDF) treatment. HBsAg kinetics in patients with and without HBsAg loss and predictors of HBsAg loss were evaluated.Methods: HBsAg levels were quantified every 12 weeks. A multivariable regression analysis, involving prespecified baseline characteristics and on-treatment response parameters, was performed; a stepwise procedure identified independent predictors of HBsAg loss.Results: Among patients with HBsAg loss, 14 (61%), 1 (4%), 0 and 7 (30%) were genotypes A through D, respectively; 1 (4%) was genotype F. HBsAg loss was preceded by viral suppression (HBV DNA < 29 IU/ml; n = 23) and HBeAg loss (n = 19). Among treated patients the strongest independent predictors of HBsAg loss were Caucasian race with genotype A/D and 64 years of infection (HR = 14.3, 95% confidence interval [CI] 4.7-43.4; p < 0.0001) and an HBsAg decline of >= 1 log(10) IU/ml at week 24 (HR = 13.7, 95% CI 5.6-33.7; p < 0.0001). Among TDF-treated patients, a reduction in HBsAg level of >= 1-log(10) by week 12 or 24 had a positive predictive value of 35%-45%, respectively, and a negative predictive value of 94%-97%, respectively.Conclusions: HBsAg loss in HBeAg-positive patients receiving TDF involves a chronology of virologic and serologic responses; patients with HBV genotypes A or D and a rapid early decline in HBsAg are more likely to lose HBsAg.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.