Bircan Kayaaslan1, Esragul Akinci2, Alpay Ari3, Zeliha Kocak Tufan4, Saygın Nayman Alpat5, Ozgur Gunal6, Selma Tosun7, Rahmet Guner8, Fehmi Tabak9. 1. Yildirim Beyazit University, Faculty of Medicine, Ankara Ataturk Education and Research Hospital, Department of Infectious Disease and Clinical Microbiology, Ankara, Turkey. Electronic address: drbican@gmail.com. 2. Ankara Numune Education and Research Hospital, Department of Infectious Disease and Clinical Microbiology, Ankara, Turkey. Electronic address: esragulakinci@gmail.com. 3. Izmir Bozyaka Education and Research Hospital, Department of Infectious Disease and Clinical Microbiology, Izmir, Turkey. Electronic address: alpayari@gmail.com. 4. Yildirim Beyazit University, Faculty of Medicine, Ankara Ataturk Education and Research Hospital, Department of Infectious Disease and Clinical Microbiology, Ankara, Turkey. Electronic address: drztufan@yahoo.com. 5. Eskisehir Osmangazi University, Faculty of Medicine, Department of Infectious Disease and Clinical Microbiology, Eskisehir, Turkey. Electronic address: snalpat@mynet.com. 6. Samsun Education and Research Hospital, Department of Infectious Disease and Clinical Microbiology, Samsun, Turkey. Electronic address: ozgurgop@yahoo.com. 7. Izmir Bozyaka Education and Research Hospital, Department of Infectious Disease and Clinical Microbiology, Izmir, Turkey. Electronic address: selma.tosun@yahoo.com. 8. Yildirim Beyazit University, Faculty of Medicine, Ankara Ataturk Education and Research Hospital, Department of Infectious Disease and Clinical Microbiology, Ankara, Turkey. Electronic address: rahmetguner@yahoo.com. 9. Istanbul University Cerrahpasa Faculty of Medicine, Department of Infectious Disease and Clinical Microbiology, Istanbul, Turkey. Electronic address: fehmitabak@hotmail.com.
Abstract
BACKGROUND: Entecavir (ETV) and tenofovir disoproxil fumarat (TDF) are the two first-line therapies recommended in the treatment of chronic hepatitis B because of having potent antiviral effect and high genetic barriers against resistance. We aimed to compare efficacy of these drugs and to evaluate predictors of viral suppression. METHODS: This multicenter retrospective study was conducted in nucleos(t)ide analogue-naive chronic hepatitis B (CHB) patients from different 6 centers. RESULTS: Of the 252 patients, 166 received ETV and 86 TDF. The two groups were similar in terms of age, gender, baseline ALT levels and fibrosis scores. ETV had significantly higher baseline HBV DNA, histological activity index and lower hepatitis B early antigen (HBeAg) seropositivity. Treatment duration was longer in ETV group (P<0.001). In univariate analysis, undetectable HBV DNA and ALT normalization rates were detected significantly higher in ETV groups (P<0.001 and 0.049, respectively). There was no significant difference between groups in terms of HBeAg seroconversion, virological breakthrough, time to virological breakthrough and time to ALT normalization. Entecavir was more effective in reducing HBV DNA levels at the 3rd, 6th and 12th months of the treatment (P=0.06, 0.021 and 0.012, respectively). However, multivariate Cox regression analysis indicated that TDF therapy compared to ETV had an increased probability of achieving complete viral suppression (HR=1, 66; 95% CI 1.21-2.33; P=0.010). Hepatitis B surface antigen (HBsAg) seroconversion was occurred in only one patient in ETV group. CONCLUSION: ETV leads to an early response on HBV DNA decline in the first year of the treatment. However, TDF is more successful than entecavir in achieving virological suppression.
BACKGROUND:Entecavir (ETV) and tenofovir disoproxil fumarat (TDF) are the two first-line therapies recommended in the treatment of chronic hepatitis B because of having potent antiviral effect and high genetic barriers against resistance. We aimed to compare efficacy of these drugs and to evaluate predictors of viral suppression. METHODS: This multicenter retrospective study was conducted in nucleos(t)ide analogue-naive chronic hepatitis B (CHB) patients from different 6 centers. RESULTS: Of the 252 patients, 166 received ETV and 86 TDF. The two groups were similar in terms of age, gender, baseline ALT levels and fibrosis scores. ETV had significantly higher baseline HBV DNA, histological activity index and lower hepatitis B early antigen (HBeAg) seropositivity. Treatment duration was longer in ETV group (P<0.001). In univariate analysis, undetectable HBV DNA and ALT normalization rates were detected significantly higher in ETV groups (P<0.001 and 0.049, respectively). There was no significant difference between groups in terms of HBeAg seroconversion, virological breakthrough, time to virological breakthrough and time to ALT normalization. Entecavir was more effective in reducing HBV DNA levels at the 3rd, 6th and 12th months of the treatment (P=0.06, 0.021 and 0.012, respectively). However, multivariate Cox regression analysis indicated that TDF therapy compared to ETV had an increased probability of achieving complete viral suppression (HR=1, 66; 95% CI 1.21-2.33; P=0.010). Hepatitis B surface antigen (HBsAg) seroconversion was occurred in only one patient in ETV group. CONCLUSION:ETV leads to an early response on HBV DNA decline in the first year of the treatment. However, TDF is more successful than entecavir in achieving virological suppression.