title: Efficacy of tenofovir disoproxil fumarate therapy in nucleoside-analogue naive Iranian patients treated for chronic hepatitis B.
abstract: BACKGROUND
  Tenofovir disoproxil fumarate (TDF) is a new effective treatment option for patients with chronic hepatitis B (CHB).
  
  
  OBJECTIVE
  To evaluate TDF efficacy in nucleos(t)ide analogues (NAs)-naive Iranian patients with CHB.
  
  
  METHODS
  The NA-naive patients received TDF for at least six months. The primary endpoint was the proportion of patients achieving a complete virological response (CVR) during the treatment. Multivariate Cox regression analysis determined predictive factors independently associated with the time to CVR. The secondary endpoints were biochemical and serological responses, frequency of virological breakthrough, genotypic resistance development, safety and tolerability.
  
  
  RESULTS
  In all, 93 patients (64.5% hepatitis B e antigen [HBeAg]-negative) were eligible. Of these, 70 patients completed 24 months of treatment. The cumulative CVR rates in HBeAg-negative and HBeAg-positive patients were 87% versus 53% at 24 months, respectively. The multivariate Cox regression model showed only HBeAg positivity at baseline and a high baseline HBV DNA level were independent factors predicting a CVR. No patient achieved hepatitis B surface antigen (HBsAg) and HBeAg loss or seroconversion and no virologic breakthrough occurred. A new amino acid substitution (rtD263E) was observed to develop in 60% of patients with viremia.
  
  
  CONCLUSIONS
  The cumulative CVR rates showed that patients with HBeAg-negative have better virologic respond than those with HBeAg-positive during the same period. The rtD263E mutation might be associated with partial resistance to TDF.
authors.affiliation: Hepatitis and AIDS Department, Pasteur Institute of Iran, Tehran, IR Iran.
authors.forename: Fatemeh
authors.initials: F
authors.lastname: Bakhshizadeh
authors.affiliation: Hepatitis and AIDS Department, Pasteur Institute of Iran, Tehran, IR Iran.
authors.forename: Soheila
authors.initials: S
authors.lastname: Hekmat
authors.affiliation: Blood Transfusion Research Center, High Institute for Research and Education in Transfusion Medicine, Tehran, IR Iran.
authors.forename: Maryam
authors.initials: M
authors.lastname: Keshvari
authors.affiliation: Middle East Liver Diseases Center (MELD), Tehran, IR Iran.
authors.forename: Seyed Moayed
authors.initials: SM
authors.lastname: Alavian
authors.affiliation: Epidemiology Department, Pasteur Institute of Iran, Tehran, IR Iran.
authors.forename: Ehsan
authors.initials: E
authors.lastname: Mostafavi
authors.affiliation: Virology Department, School of Medicine, Iran University of Medical Sciences, Tehran, IR Iran.
authors.forename: Hossein
authors.initials: H
authors.lastname: Keivani
authors.affiliation: Department of Epidemiology and Biostatistics, School of Public Health, Tehran University of Medical Sciences, Tehran, IR Iran.
authors.forename: Amin
authors.initials: A
authors.lastname: Doosti-Irani
authors.affiliation: Hepatitis and AIDS Department, Pasteur Institute of Iran, Tehran, IR Iran.
authors.forename: Fatemeh
authors.initials: F
authors.lastname: Motevalli
authors.affiliation: Middle East Liver Diseases Center (MELD), Tehran, IR Iran.
authors.forename: Bita
authors.initials: B
authors.lastname: Behnava
keywords: Chronic Hepatitis B; Tenofovir; nucleoside analogue