Browsing by Author "Massetto, Benedetta"
Now showing 1 - 3 of 3
- Results Per Page
- Sort Options
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-8209-2023Publication 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.Publication Randomized comparison of tenofovir disoproxil fumarate vs emtricitabine and tenofovir disoproxil fumarate in patients with lamivudine-resistant chronic hepatitis b(W B Saunders Co-Elsevier Inc, 2014-04-01) Fung, Scott; Kwan, Peter; Fabri, Milotka; Horban, Andrzej; Pelemis, Mijomir; Hann, Hie-Won; Gürel, Selim; Caruntu, Florin A.; Flaherty, John F.; Massetto, Benedetta; Dinh, Phillip; Corsa, Amoreena; Subramanian, G. Mani; McHutchison, John G.; Husa, Petr; Gane, Edward; GÜREL, SELİM; Uludag Üniversitesi/Tıp Fakültesi.; HLH-8209-2023BACKGROUND & AIMS: Tenofovir disoproxil fumarate (TDF) is active against lamivudine-resistant hepatitis B virus (HBV) infection, but data to support its clinical efficacy in this setting are limited.METHODS: In a prospective, double-blind, 96-week trial, patients were randomly assigned (1:1) to groups given TDF (300 mg, n = 141) or a combination of emtricitabine (FTC, 200 mg; n 139) and TDF (300 mg, FTC/TDF). Patients were hepatitis B e antigen (HBeAg) - positive or HBeAg-negative, with levels of HBV DNA >= 3 log10 IU/mL and lamivudine resistance mutations (HBV polymerase or reverse transcriptase amino acid substitutions rtM204I/V +/- rtL180M by INNO-LiPA Multi-DR v3; Innogenetics, Inc, Alpharetta, GA). The primary end point was proportion with HBV DNA <69 IU/mL (Roche COBAS Taqman assay; Roche Molecular Systems, Inc, Pleasanton, CA).RESULTS: Patient groups were well matched for demographic and disease characteristics, including region (60% from Europe), HBV genotype (45% genotype D), HBeAg status (47% HBeAg-positive), and duration of lamivudine treatment (mean, 3.8 years). At week 96 of treatment, 89.4% of patients in the TDF group and 86.3% in the FTC/TDF group had levels of HBV DNA <69 IU/mL (P = .43). HBeAg loss and seroconversion did not differ between groups; only 1 patient (0.7%) in the FTC/TDF group lost hepatitis B surface antigen. Treatment was well tolerated; confirmed renal events (creatinine increase of >= 0.5 mg/dL [>44 umol/L], creatinine clearance <50 mL/min, or level of PO4 <2 mg/dL [<0.65 mmol/L]) were generally mild and infrequent (<1%). Small reductions (<2%) in mean bone mineral density of hip and spine were detected by dual-energy x-ray absorptiometry in both groups. No TDF resistance developed through 96 weeks of treatment.CONCLUSIONS: TDF alone is safe and effective for treatment of patients with lamivudine-resistant, chronic HBV infection. Clinical Trials.gov No, NCT00737568.