title: Entecavir 1mg versus combined lamivudine/adefovir dipivoxil in chronic HBV Egyptian patients resistant to LAM monotherapy, non-randomised controlled study.
abstract: OBJECTIVE
  The development of antiviral-resistant mutations with long-term treatment remains a major concern in the treatment of chronic hepatitis B virus (HBV) infection. The study aimed to compare the therapeutic efficacy of entecavir 1mg versus combined lamivudine/adefovir dipivoxil (Lam/Adv) in chronic HBV patients resistant to lamivudine monotherapy.
  
  
  METHODS
  This study included two groups of lamivudine-resistant patients who received lamivudine 100mg for 1-3 years. Group 1 was composed of 25 cases (52% HBeAg+ve) who received combined Lam/Adv, and group 2 was composed of 13 patients (30.8% HBeAg+ve) who received entecavir 1mg. Pre-enrolment assessment included biochemical, serological and quantitative HBV-DNA testing as well as HBeAg and hepatitis B envelope antibody (HBeAb) assessment. Evaluation was done at 3, 6, 12, 24 and 36 months of treatment by the same parameters. Hepatitis B surface antigen and antibody (HbsAg and HBsAb) were assessed after each year of treatment.
  
  
  RESULTS
  At the end of 36 months of treatment, 16 cases (69%) in group 1 completed the study period, versus 13 (100%) in group 2. Two cases in group 1 underwent HBeAg seroconversion, accompanied by HBV-DNA undetectability, at 6 and 12months, respectively; no cases were seroconverted in group 2. Both treatments achieved improvement in alanine aminotransferase (ALT), bilirubin and alpha-foetoprotein equally at the end of the study. HBV-DNA undetectability was better achieved in group 2 when compared to group 1. HBeAg seroconversion was only achieved in two cases in group 1, whereas no cases lost HBeAg in group 2. None of our cases achieved HbsAg seroconversion or loss at the end of the study period.
  
  
  CONCLUSIONS
  The entecavir 1-mg monotherapy group achieved better HBV-DNA undetectability starting at 3 months of treatment when compared to the Lam/Adv group; however, both lines of treatment showed almost similar results over the rest of the study period. HBeAg seroconversion was only achieved in two cases in the combined Lam/Adv group, whereas no cases lost HBeAg in the other group.
authors.affiliation: National Hepatology and Tropical Medicine Research Institute, NHTMRI, Cairo, Egypt. Electronic address: szmaklad@yahoo.com.
authors.forename: Sahar
authors.initials: S
authors.lastname: Maklad
authors.affiliation: Faculty of Medicine, Cairo University, Cairo, Egypt.
authors.forename: Wahid
authors.initials: W
authors.lastname: Doss
authors.affiliation: National Hepatology and Tropical Medicine Research Institute, NHTMRI, Cairo, Egypt.
authors.forename: Sameh Seif
authors.initials: SS
authors.lastname: El Din
authors.affiliation: National Hepatology and Tropical Medicine Research Institute, NHTMRI, Cairo, Egypt.
authors.forename: Kamal
authors.initials: K
authors.lastname: Hassan
authors.affiliation: Faculty of Medicine, Cairo University, Cairo, Egypt.
authors.forename: Alaa Abou
authors.initials: AA
authors.lastname: Zeid
mesh_terms: D000225:Adenine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000328:Adult; D000998:Antiviral Agents / Q000627:therapeutic use*; D004279:DNA, Viral / Q000097:blood; D024882:Drug Resistance, Viral; D004359:Drug Therapy, Combination; D004534:Egypt; D005260:Female; D006147:Guanine / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use; D006510:Hepatitis B Antibodies / Q000097:blood; D006514:Hepatitis B Surface Antigens / Q000097:blood; D006513:Hepatitis B e Antigens / Q000097:blood; D006515:Hepatitis B virus / Q000276:immunology*; D019694:Hepatitis B, Chronic / Q000097:blood / Q000188:drug therapy*; D006801:Humans; D019259:Lamivudine / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D063065:Organophosphonates / Q000627:therapeutic use*; D055815:Young Adult
chemical_list: D000998:Antiviral Agents; D004279:DNA, Viral; D006510:Hepatitis B Antibodies; D006514:Hepatitis B Surface Antigens; D006513:Hepatitis B e Antigens; D063065:Organophosphonates; D019259:Lamivudine; C413685:entecavir; D006147:Guanine; D000225:Adenine; C106812:adefovir dipivoxil
keywords: Adefovir; Egypt; Entecavir; HBV; Lamivudine resistance