title: Comparable efficacy of tenofovir versus entecavir and predictors of response in treatment-naïve patients with chronic hepatitis B: a multicenter real-life study.
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.
authors.affiliation: 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.
authors.forename: Ayse
authors.initials: A
authors.lastname: Batirel
authors.affiliation: Infectious Diseases and Clinical Microbiology, Medical Faculty, Sakarya University, Sakarya, Turkey.
authors.forename: Ertugrul
authors.initials: E
authors.lastname: Guclu
authors.affiliation: Infectious Diseases, Medical Faculty, Istanbul Medipol University, Istanbul, Turkey.
authors.forename: Ferhat
authors.initials: F
authors.lastname: Arslan
authors.affiliation: Infectious Diseases and Clinical Microbiology, Basaksehir State Hospital, Istanbul, Turkey.
authors.forename: Funda
authors.initials: F
authors.lastname: Kocak
authors.affiliation: Infectious Diseases and Clinical Microbiology, Medical Faculty, Sakarya University, Sakarya, Turkey.
authors.forename: Oguz
authors.initials: O
authors.lastname: Karabay
authors.affiliation: 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.
authors.forename: Serdar
authors.initials: S
authors.lastname: Ozer
authors.affiliation: Biostatistics, Istanbul Commerce University, Istanbul, Turkey.
authors.forename: Munevver
authors.initials: M
authors.lastname: Turanli
authors.affiliation: Infectious Diseases, Medical Faculty, Istanbul Medipol University, Istanbul, Turkey.
authors.forename: Ali
authors.initials: A
authors.lastname: Mert
mesh_terms: D000328:Adult; D000410:Alanine Transaminase / Q000032:analysis; D000998:Antiviral Agents / Q000627:therapeutic use*; D004279:DNA, Viral / Q000097:blood; D005260:Female; D006147:Guanine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D006513:Hepatitis B e Antigens / Q000276:immunology; D006515:Hepatitis B virus / Q000235:genetics / Q000302:isolation & purification; D019694:Hepatitis B, Chronic / Q000175:diagnosis / Q000188:drug therapy* / Q000821:virology; D006801:Humans; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies; D000068698:Tenofovir / Q000627:therapeutic use*
chemical_list: D000998:Antiviral Agents; D004279:DNA, Viral; D006513:Hepatitis B e Antigens; C413685:entecavir; D006147:Guanine; D000068698:Tenofovir; D000410:Alanine Transaminase
keywords: Chronic hepatitis B; Entecavir; HBV; Tenofovir; Treatment