Efficacy and safety data of the use of tenofovir in patients with chronic hepatitis b

Postgraduate Thesis uoadl:2820533 74 Read counter

Κατεύθυνση Βιοστατιστική
Library of the School of Health Sciences
Deposit date:
Ionas Evangelos
Supervisors info:
Σπήλιος Μανωλακόπουλος, Αναπληρωτής Καθηγητής, Ιατρική, ΕΚΠΑ
Βασιλική-Αναστασία Σύψα, Επίκουρη Καθηγήτρια, Ιατρική, ΕΚΠΑ
Γεωργία Βουρλή, Διδάκτωρ, Ιατρική, ΕΚΠΑ
Original Title:
Αποτελεσματικότητα και δεδομένα ασφάλειας χρήσης τενοφοβίρης σε ασθενείς με χρόνια ηπατίτιδα β
Translated title:
Efficacy and safety data of the use of tenofovir in patients with chronic hepatitis b
Chronic HBV infection is estimated to affect worldwide approximately 240 million people and Greece is amongst the countries, that present median endemicity of the disease, with average presence of HBsAg that depends on the region, the population and the risk group of the patients. The main treatment options for the HBV infection are two, either the use of pegylated interferon or the use of nucleoside analogues. One of the broadly used nucleoside analogues with high resistance barrier is tenofovir.A database including 275 patients with chronic HBV infection, who were treated with tenofovir and were followed-up in 4 Greek Hepatology Departments, was analyzed. The analysis included both retrospective and prospective data. All the data was collected between December 2013 and December 2017. The outcomes that were studied were virologic response, biochemic response and the development of hepatocellular carcinoma. Kaplan-Meier survival curves as well as the semiparametric Cox Proportional Hazards model were used for the survival analysis. The mean age of the patients was 57 years (SD:15) and the median follow-up time was 60 months (IQR:35,80). As far as the outcome of the virological response was concerned in the analysis were included 89 patients of whom 97% achieved non-detectable HBV DNA values (<69 IU/mL) in a median time of 12 months (IQR:6,18). For the study of the biochemical response 108 patients were included in the analysis and the percentage of achievement ALT < 40 IU/L rose to 100% in a median response time of 6 months (IQR:6,12). In addition, overall 257 patients were included in the analysis of HCC development with 10 patients diagnosed with HCC in a median follow-up time of 61 months (IQR:12-161).Concerning the outcomes of virologic and biochemic responses were concerned, no factors were identified that could significantly be correlated with the specific outcomes in the course of time. However, the development of hepatocellular carcinoma, in the patients receiving tenofovir, was found by the multivariable analysis to be significantly correlated with the baseline logarithmized levels of platelets by 1 x log10 HR (95%CI):0.33(0.12,0.88), p-value=0.028 and HR (95%CI) by one year of age increase:1.06 (1.0,1.12), p-value=0.035 respectively. Undoubtedly some of the limitations of the analysis, as the number of the missing values and the sample size, could be held responsible for the lack of significant correlation between the variables that were included in the analysis and the outcomes of virologic and biochemic response, in contrast with the existing bibliography, where the baseline levels of HBV DNA and the presence or the absence of HBeAg consist prognostic factors of the achievent of the aforementioned outcomes. However, the participation in the study of patients, that were followed-up in four major Greek Hepatology Departments, reflects the results of treating HBV infected patients with tenofovir in everyday clinical practice.
Main subject category:
Health Sciences
Εfficacy, Safety, Tenofovir, Chronic hepatitis b
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