Entecavir 1mg versus combined lamivudine/adefovir dipivoxil in chronic HBV Egyptian patients resistant to LAM monotherapy, non-randomised controlled study.

BACKGROUND AND STUDY AIMS: 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. PATIENTS AND 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. CONCLUSION: 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.

Response and seroconversion rates among HBeAg-positive chronic HBV Egyptian patients treated with peginterferon alpha 2a (Pegasys), a single-centre experience.

BACKGROUND AND STUDY AIMS: We aimed to evaluate the therapeutic efficacy of pegylated interferon alpha-2a 180µg as a treatment for hepatitis B 'e' antigen (HBeAg)-positive genotype D chronic hepatitis B patients. PATIENTS AND METHODS: Thirty patients attending the outpatient clinic at the National Hepatology and Tropical Medicine Research Institute were treated with peg.interferon alpha-2a (180µg) weekly for a period of 48 weeks. Pre-enrolment assessment was performed through biochemical, serological and quantitative HBV DNA testing. Liver biopsy was performed in all patients. Evaluation was done at weeks 12, 24 and 48 of treatment by liver enzymes, complete blood count (CBC), HBeAg/HBeAb and quantitative HBV DNA testing. RESULTS: At the end of 48 weeks of treatment only three cases (10%) of the study population showed HBeAg seroconversion and an undetectable HBV DNA level. None of responders exhibited hepatitis B surface antigen (HbsAg) loss. There were five (16.7%) primary non-responders, four (13.3%) relapsers, four (13.3%) cases flared at week 12, and 14 (46.6%) cases who were non-responders. No specific predictors of response could be identified among patients. CONCLUSION: One year of peg. interferon alpha-2a 180µg weekly led to HBeAg seroconversion and an undetectable HBV DNA level in 10% of cases. Considering the privilege of a finite duration of treatment, tailoring of treatment and proper patient selection is of great importance in considering this therapy as a first line of treatment among HBeAg-positive chronic HBV Egyptian patients.