Ayse Batirel1, Ertugrul Guclu2, Ferhat Arslan3, Funda Kocak4, Oguz Karabay2, Serdar Ozer5, Munevver Turanli6, Ali Mert3. 1. Infectious Diseases and Clinical Microbiology, Kartal Dr. Lutfi Kirdar Education and Research Hospital, Semsi Denizer Cd. E-5 Karayolu Cevizli Mevkii, 34890 Kartal, Istanbul, Turkey. Electronic address: aysebatirel@yahoo.com. 2. Infectious Diseases and Clinical Microbiology, Medical Faculty, Sakarya University, Sakarya, Turkey. 3. Infectious Diseases, Medical Faculty, Istanbul Medipol University, Istanbul, Turkey. 4. Infectious Diseases and Clinical Microbiology, Basaksehir State Hospital, Istanbul, Turkey. 5. Infectious Diseases and Clinical Microbiology, Kartal Dr. Lutfi Kirdar Education and Research Hospital, Semsi Denizer Cd. E-5 Karayolu Cevizli Mevkii, 34890 Kartal, Istanbul, Turkey. 6. Biostatistics, Istanbul Commerce University, Istanbul, Turkey.
Abstract
OBJECTIVE: To compare responses to tenofovir (TDF) and entecavir (ETV) therapy. METHODS: This was a multicenter retrospective study including treatment-naïve patients with chronic hepatitis B (CHB) who received TDF or ETV. The primary end-points were undetectable HBV-DNA at 48 weeks and serological and biochemical responses. RESULTS: Out of 195 CHB patients, 90 (46%) received TDF and 105 (54%) received ETV; 72% were male, their mean age was 43±12 years, and the mean duration of treatment was 30.2±15.7 months. Hepatitis B e antigen (HBeAg) seropositivity was 32% in the TDF group and 34% in the ETV group. HBeAg seroconversion rates in HBeAg-positive patients were 24% in the TDF group and 39% in the ETV group; the difference was not significant (p=0.2). The mean time to alanine aminotransferase (ALT) normalization and rates of ALT normalization at 3, 6, 12, 18, and 24 months were similar in the two groups (p > 0.05). The mean time to undetectable HBV-DNA levels in the TDF and ETV groups was 11.5±8.9 and 12.9±10.8 months, respectively (p=0.32). A significantly greater decline in HBV-DNA levels at 12 and 18 months was observed in the TDF group (p=0.02 and p=0.03, respectively). Seven (7%) patients on ETV therapy had virological breakthrough (p=0.01). Only one patient in each group had hepatitis B surface antigen (HBsAg) clearance. None of the patients developed decompensation or hepatocellular carcinoma during treatment. CONCLUSIONS: The two drugs appear to have similar efficacy in CHB patients. However, 7% of patients on ETV therapy had virological breakthrough, while none of the patients on TDF therapy did.
OBJECTIVE: To compare responses to tenofovir (TDF) and entecavir (ETV) therapy. METHODS: This was a multicenter retrospective study including treatment-naïve patients with chronic hepatitis B (CHB) who received TDF or ETV. The primary end-points were undetectable HBV-DNA at 48 weeks and serological and biochemical responses. RESULTS: Out of 195 CHB patients, 90 (46%) received TDF and 105 (54%) received ETV; 72% were male, their mean age was 43±12 years, and the mean duration of treatment was 30.2±15.7 months. Hepatitis B e antigen (HBeAg) seropositivity was 32% in the TDF group and 34% in the ETV group. HBeAg seroconversion rates in HBeAg-positive patients were 24% in the TDF group and 39% in the ETV group; the difference was not significant (p=0.2). The mean time to alanine aminotransferase (ALT) normalization and rates of ALT normalization at 3, 6, 12, 18, and 24 months were similar in the two groups (p > 0.05). The mean time to undetectable HBV-DNA levels in the TDF and ETV groups was 11.5±8.9 and 12.9±10.8 months, respectively (p=0.32). A significantly greater decline in HBV-DNA levels at 12 and 18 months was observed in the TDF group (p=0.02 and p=0.03, respectively). Seven (7%) patients on ETV therapy had virological breakthrough (p=0.01). Only one patient in each group had hepatitis B surface antigen (HBsAg) clearance. None of the patients developed decompensation or hepatocellular carcinoma during treatment. CONCLUSIONS: The two drugs appear to have similar efficacy in CHB patients. However, 7% of patients on ETV therapy had virological breakthrough, while none of the patients on TDF therapy did.
Authors: Norah A Terrault; Natalie H Bzowej; Kyong-Mi Chang; Jessica P Hwang; Maureen M Jonas; M Hassan Murad Journal: Hepatology Date: 2015-11-13 Impact factor: 17.425