Browsing by Author "Tsai, Naoky"
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Item Long term tenofovir disoproxil fumarate for chronic hepatitis B infection is associated with sustained virological, biochemical and serological responses with no detectable resistance(Wiley, 2014-11) Chan, Alain; Marcellin, Patrick; Tsai, Naoky; Flisiak, Robert; Petersen, Jorg; Kotzev, Iskren; Flaherty, John; Gaggar, Anuj; Kitrinos, Kathryn; Mchutchison, John; George, Jacob; Buti, Maria; Gane, Edward; Gürel, Selim; Uludağ Üniversitesi/Tıp Fakültesi.; HLH-8209-2023Publication Long term treatment with tenofovir disoproxil fumarate for chronic hepatitis b infection is safe and well tolerated and associated with durable virologic response with no detectable resistance: 8 year results from two phase 3 trials(Wiley, 2014-01-01) Marcellin, Patrick; Gane, Edward J.; Flisiak, Robert; Trinh, Huy N.; Petersen, Joerg; Gürel, Selim; Kaita, Kelly D.; Kotzev, Iskren A.; Tsai, Naoky; Flaherty, John F.; Schall, Raul E. Aguilar; Kitrinos, Kathryn M.; Subramanian, Mani; McHutchison, John G.; George, Jacob; Janssen, Harry L.; Buti, Maria; GÜREL, SELİM; Uludağ Üniversitesi/Tıp Fakültesi; HLH-8209-2023Publication Seven years of treatment with tenofovir df for chronic hepatitis b virus infection is safe and well tolerated and associated with sustained virological, biochemical and serological responses with no detectable resistance(Wiley-blackwell, 2013-10-01) Marcellin, Patrick; Gane, Edward J.; Tsai, Naoky; Flisiak, Robert; Petersen, Joerg; Kotzev, Iskren A.; Flaherty, John F.; Dinh, Phillip; Gaggar, Anuj; Kitrinos, Kathryn M.; Subramanian, Mani; McHutchison, John G.; George, Jacob; Buti, Maria; Gurel, Selim; GÜREL, SELİM; Bursa Uludağ Üniversitesi/Tıp Fakültesi; HLH-8209-2023Item 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.