Efficacy of Generic Entecavir 0.5 mg Capsule Form “Cludine Tech 0.5” Among Nucleoside Naive Chronic HBV Egyptian Patients; A Single Center Experience

Objective: The aim is to detect early virological response evidenced by undetectable HBV DNA after 6 months up to 1 year of treatment by Entecavir 0.5mg capsule form (Cludine Tech 0.5mg, Pharma Tech) among naive chronic Hepatitis B Egyptian patients. Patients and Methods: This is a cohort pilot study in which 30 chronic HBV naive patients were enrolled. Those chronic HBV patients received Entecavir 0.5mg capsule form (Cludine Tech 0.5mg, Pharma Tech) for 6 months to 1 year as part of their medical care that they receive at chronic HBV outpatient clinic on twice weekly basis at National Hepatology and Tropical Medicine Research Institute NHTMRI. All patients were subjected to full history taking, including exposure history, clinical examination, abdominal ultrasound, liver function tests, HBsAg, HBeAg and HBeAb testing, quantifiable HBV DNA testing, alpha feto protein, and serum creatinine. Patients were assessed after the first 3 months of treatment by liver function tests, CBC, prothrombin conc., and serum creatinine. The same assessment was done after 6 months and 1 year of treatment according to the treatment duration of each patient by the same parameters in addition to HBsAg, HBeAg and HBeAb testing (in case of HBeAg positive), quantifiable HBV DNA testing and alpha Feto protein. Results: Only 27 cases were included for analysis with 3 dropouts. The mean age of our patients was 26.8±7.2 (min 21-max 58), The patients included showed male predominance; 24 males and 3 females. Twenty patients were HBeAg positive (74.1%) and seven patients were HBeAg negative (25.9%). Abdominal ultrasound results showed that 11 cases (40.7%) had bright hepatomegaly, 10 cases (37%) had coarse liver, and 6 cases (22.2%) had normal ultrasound (Table 1). After the first six months of treatment there was a statistically significant reduction of ALT, AST levels and HBV DNA levels with a p-value of 0.001. The response pattern of our patients after the first 6 months of treatment was as follows: Primary non responders were 3 cases (11%), Partial virological responders were 19 cases (70.4%), Virological responders after the first 6 months of treatment were 5 cases (18.5%). There were no breakthrough cases. After one year of treatment results showed that 6 cases (37.5%) were responders, 8 cases (50%) were still partial responders and 2 cases (12.5%) experienced breakthrough. Only 2 cases (18.2%) out of 11 cases with positive baseline HBeAg managed to achieve HBeAg seroconversion. In our study the baseline HBV DNA was not found to be directly correlated with the virological response at 6 or 12 months of treatment course. In Conclusion: Generic entecavir 0.5mg capsule form (Cludine Tech 0.5mg) shows favorable therapeutic efficacy and safety profile in our preliminary pilot study. Further studies are required on a large scale of patients and for extended treatment durations to assess the efficacy and safety on long term treatment.