Browsing by Author "Krastev, Zahary"
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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.Item Seven-year efficacy and safety of treatment with tenofovir disoproxil fumarate for chronic hepatitis b virus ınfection(Springer, 2015-05) Tsai, Naoky; Petersen, Joerg; Flisiak, Robert; Krastev, Zahary; Schall, Raul Aguilar; Flaherty, John F.; Martins, Eduardo B.; Charuworn, Prista; Kitrinos, Kathryn M.; Subramanian, G. Mani; Gane, Edward; Marcellin, Patrick; Gürel, Selim; Uludağ Üniversitesi/Tıp Fakültesi/İç Hastalıkları Anabilim Dalı/Gastroenteroloji Bilim Dalı.; 7003706434Background Long-term tenofovir disoproxil fumarate (TDF) treatment for chronic hepatitis B (CHB) is associated with sustained viral suppression and regression of fibrosis and cirrhosis at year 5 (240 weeks) and no TDF resistance through 6 years (288 weeks). Aim We assessed the efficacy, safety, and resistance of TDF for up to 7 years (336 weeks) in HBeAg-positive and HBeAg-negative CHB patients. Methods Patients who completed 1 year (48 weeks) of randomized treatment with TDF or adefovir dipivoxil were eligible to receive open-label TDF for a total duration of 8 years (384 weeks). Results Of 641 patients initially randomized, 585 (91.3 %) entered the open-label phase; 437/585 (74.7 %) remained on study at year 7. For patients on treatment at year 7, 99.3 % maintained viral suppression (HBV DNA < 69 IU/mL), 80.0 % achieved serum alanine aminotransferase normalization, and in HBeAg-positive patients, 84/154 (54.5 %) and 25/154 (11.8 %) achieved HBeAg and HBsAg loss, respectively. One/375 (0.3 %) HBeAg-negative patients achieved HBsAg loss. No resistance to TDF was detected through 7 years. During the open-label phase, grade 3/4 drug-related adverse events were uncommon (1.0 %); ten (1.7 %) patients had elevation of serum creatinine >= 0.5 mg/dL above baseline. No significant change in bone mineral density was observed from year 4 to year 7 (week 192 to week 336). Conclusions Long-term TDF treatment was associated with sustained virologic, biochemical, and serologic responses, without resistance. TDF treatment was well tolerated, with a low incidence of renal and bone events. These data confirm the safety and efficacy of long-term TDF for CHB.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.