Efficacy and Safety of Entecavir 0. 5 mg in Treating Naive Chronic Hepatitis B Virus Patients in Egypt: Five Years of Real Life Experience

BACKGROUND: The aim of the study was to evaluate the efficacy and safety of entecavir (ETV) among chronic hepatitis B (CHB) nucleos(t)ide-naive Egyptian patients. METHODS: Forty-eight CHB patients on ETV were included. Males comprised 83.3% (40 cases), while females comprised 16.7% (eight cases). Minimum age was 19 years, while maximum age was 64 years. Hepatitis B envelope antigen (HBeAg)-negative cases were 60.4%. HBeAg-positive cases were 39.6%. Factors including sex, positive HBeAg, baseline hepatitis B virus (HBV) DNA level, baseline alanine aminotransferase (ALT) and aspartate aminotransferase (AST), were evaluated in terms of their predictive role in treatment response, which was defined as a serum HBV DNA decrease of < 10 IU/mL. RESULTS: Mean age of patients was 38.2 years; males were 83.3% and females were 16.7%. HBeAg-negative cases were 60.4%, while HBeAg-positive cases were 39.6%. Mean baseline DNA level was 44 × 10(6) IU/mL. Ultrasound results showed 14 cases had hepatomegaly, 10 cases had bright liver, seven cases had coarse liver, and eight cases had cirrhosis. Of the cases, 45.8% showed a negative PCR after the first 6 months of therapy to reach 64.6% by the end of the first year. HBV DNA undetectability reached 91.3% and 100% after 4 and 5 years, respectively for those who completed the study period. ALT reduction started after 6 months of treatment and reached 53.37% after 5 years. Similarly AST showed the same pattern of decline and reached 54.37% after 5 years. Only two cases achieved HBeAg seroconversion. Three patients experienced virological breakthrough and the three cases shared similar characteristics of being less than 40 years, with baseline HBV DNA of ≥ 10(5) IU/mL and positive HBeAg. None of the cases showed hepatitis B surface antigen (HBsAg) seroconversion. CONCLUSION: ETV proved to have a potent antiviral efficacy and safety in nucleoside/tide-naive Egyptian patients. Rate of HBV DNA undetectability was higher in patients above 40 years of age and in patients who initially had a low viral load. ETV was well tolerated during the treatment period with a good overall safety profile.