Browsing by Author "Buti, Maria"
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Publication Association between ALT flares and HBeAg loss and HBsAg decline in Patients with Chronic Hepatitis B during treatment with Tenofovir Disoproxil Fumarate or Adefovir Dipivoxil(Lippincott Williams & Wilkins, 2015-10-01) Marcellin, Patrick; Gane, Edward J.; Krastev, Zahary; Gürel, Selim; Dusheiko, Geoffrey M.; Gaggar, Anuj; Massetto, Benedetta; Kim, Kyungpil; Flaherty, John F.; Subramanian, Mani; Janssen, Harry L.; Buti, Maria; GÜREL, SELİM; Uludağ Üniversitesi/Tıp Fakültesi.; HLH-8209-2023Item 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 Efficacy and safety of tenofovir alafenamide (TAF) at 96 weeks in chronic HBV (CHB) patients with risk factors for use of tenofovir disoproxil fumarate (TDF)(Wiley, 2017-10) Buti, Maria; Stepanova, Tatjana; Celen, Mustafa K.; Flisiak, Robert; Ryder, Stephen D.; Streinu, Adrian Cercel; Flaherty, John F.; Gaggar, Anu; Suri, Vithika; Mo, Shuyuan; Subramanian, Mani; Nurmukhametova, Elena; Zoulim, Fabien; Andreone, Pietro; Marcellin, Patrick; Gürel, Selim; Uludağ Üniversitesi/Tıp Fakültesi/Dahiliye Anabilim Dalı/Gastroenteroloji Bilim Dalı.; HLH-8209-2023Publication Factors associated with a lack of viral suppression in chronic hbv (CHB) patients after 8 years of treatment with tenofovir alafenamide (TAF) or tenofovir disoproxil fumarate (TDF) followed by taf treatment(Lippincott Williams & Wilkins, 2023-10-01) Gane, Edward J.; Buti, Maria; Fung, Scott K.; Chan, Henry Lik Yuen; Izumi, Namiki; Chuang, Wan Long; Ahn, Sang Hoon; Mehta, Rajiv M.; Gürel, Selim; Abramov, Frida; Yee, Leland J.; Wang, Hongyuan; Mateo, Roberto; Flaherty, John F.; Ma, Xiaoli; Pan, Calvin Q.; Lim, Young-Suk; Marcellin, Patrick; GÜREL, SELİM; Bursa Uludağ Üniversitesi/Tıp Fakültesi/Gastroenteroloji Anabilim Dalı.; JKF-2069-2023Item Impact of long-term tenofovir disoproxil fumarate on incidence of hepatocellular carcinoma in patients with chronic hepatitis B(Wiley, 2015-10-15) Kim, W. Ray; Loomba, Rohit; Berg, Thomas; Schall, Raul E. Aguilar; Yee, Leland J.; Dinh, Phillip V.; Flaherty, John F.; Martins, Eduardo B.; Therneau, Terry M.; Jacobson, Ira; Fung, Scott; Buti, Maria; Marcellin, Patrick; Gürel, Selim; Uludağ Üniversitesi/Tıp Fakültesi/İç Hastalıkları Anabilim Dalı/Gastroenteroloji Bilim Dalı.; 7003706434BACKGROUND: Efficacy trials have shown that antiviral therapy improves the outcomes of patients with chronic hepatitis B virus (HBV) infection. However, prospective data regarding the effect of antiviral therapy on the incidence of hepatocellular carcinoma (HCC), especially among patients without cirrhosis, are limited. The authors examined the impact of tenofovir disoproxil fumarate (TDF) on the incidence of HCC using a validated prediction model. METHODS: The incidence of HCC in patients treated with TDF was obtained in the pivotal TDF registration studies after 384 weeks of follow-up. The predicted risk of HCC in individual patients was calculated using the Risk Estimation for Hepatocellular Carcinoma in Chronic Hepatitis B (REACH-B) model, which estimates HCC incidence for up to 10 years based on age, sex, alanine aminotransferase level, hepatitis B e antigen status, and HBV-DNA. Standardized incidence ratios (SIRs) were calculated comparing the observed and predicted numbers of HCC cases in the study cohort. RESULTS: Among 634 patients with evaluable baseline biopsies, 152 had cirrhosis (Ishak fibrosis score of 5 or 6) and 482 did not. During the 384 weeks of study, 14 cases of HCC were reported, with 4 occurring within the first year. The incidence of HCC was 0.37% per year in the study as a whole (0.28% among patients without cirrhosis and 0.65% among patients with cirrhosis). Among patients without cirrhosis, the observed incidence of HCC was significantly lower than predicted (SIR, 0.40; 95% confidence interval, 0.199-0.795). The last HCC case in a patient with cirrhosis occurred around week 192 with an SIR of 0.51 (95% confidence interval, 0.231-1.144) reported at week 384. CONCLUSIONS: Based on the REACH-B risk calculator, long-term therapy with TDF was associated with a reduced incidence of HCC among patients without cirrhosis who met treatment criteria.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 Long term tenofovir disoproxil fumarate (tdf) therapy and the risk of hepatocellular carcinoma(Elsevier, 2013-04) Kim, W. R.; Berg, Thomas; Loomba, Rohit; Schall, Raul Aguilar; Dinh, Phillip; Yee, Leland J.; Martins, Eduardo B.; Flaherty, John F.; Buti, Maria; Marcellin, P.; Gürel, Selim; Uludağ Üniversitesi/Tıp Fakültesi/İç Hastalıkları Anabilim Dalı.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-8209-2023Item Long-term clinical outcomes in cirrhotic chronic hepatitis B patients treated with tenofovir disoproxil fumarate for up to 5 years(Springer, 2015-04) Buti, Maria; Fung, Scott; Gane, Edward; Afdhal, Nezam H.; Flisiak, Robert; Flaherty, John F.; Martins, Eduardo B.; Yee, Leland J.; Dinh, Phillip; Bornstein, Jeffrey D.; Subramanian, G. Mani; Janssen, Harry L. A.; George, Jacob; Marcellin, Patrick; Gürel, Selim; Uludağ Üniversitesi/Tıp Fakültesi/Gastroenteroloji Anabilim Dalı.; 7003706434Phase 3 clinical studies have shown that long-term treatment with tenofovir disoproxil fumarate (TDF) can suppress hepatitis B viral load and promote significant fibrosis regression and cirrhosis reversal in a majority of treated chronic hepatitis B (CHB) patients. This retrospective analysis investigated the impact of baseline cirrhosis status on virologic, serologic, and histologic outcomes in patients treated with TDF. Patients enrolled in studies GS-US-174-0102 and GS-US-174-0103 who had baseline liver biopsy-diagnosed cirrhosis and entered the open-label phase of the studies were included in the virologic and serologic analyses. Patients (both HBeAg positive and negative) with paired liver biopsies at baseline and 5 years (N = 348) were included in a histologic analysis. After 5 years on study, comparing patients with and without baseline cirrhosis, respectively: 99.2 and 98.0 % achieved virologic response (hepatitis B viral load < 69 IU/ml) (p = 0.686); 79.7 and 81.9 % had normal serum levels of alanine aminotransferase (p = 0.586); 4.0 and 1.2 % developed hepatocellular carcinoma (p = 0.044). In HBeAg-positive patients with and without baseline cirrhosis, HBsAg loss occurred in 14.4 and 8.3 % of patients, respectively (p = 0.188). One HBeAg-negative patient had HBsAg loss. This represents the largest analyses to date of CHB patients with sequential liver biopsies demonstrating that treatment with TDF for up to 5 years is associated with favorable virologic, serologic, and histologic outcomes, regardless of baseline cirrhosis status. Notably, histologic improvement was observed in the majority of cirrhotic and noncirrhotic patients.Publication 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 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.