Title: An Open Label Prospective Study to Evaluate the Efficacy of Entecavir in HBeAg Positive Treatment Naive Chronic Hepatitis –B Patients in A Tertiary Care Centre in Eastern India

Authors: Manjushree Nayak, JayantaKumar Panda, Umesh Chandra Patra

 DOI:  https://dx.doi.org/10.18535/jmscr/v5i6.02

Abstract

 Background: Entecavir is a nucleoside analogue drug that has selective anti-hepatitis B virus (HBV) activity. It is indicated for the treatment of chronic hepatitis B virus infection in adults with evidence of active viral replication, persistent elevations in serum aminotransferase and histologically active disease. We conducted a study to evaluate the efficacy of entecavir (ETV) in hepatitis Beantigen (HBeAg) positive- chronic hepatitis B (CHB) treatment naive Indian patients in real life scenario.

Method: This is a single center open label prospective observational study to evaluate the efficacy of Entecavir in chronic hepatitis B patients. A total of 140 patients were enrolled in the study from January 2015 to December 2016. Parameters were evaluated at baseline and at 12, 24 and 40 weeks of the treatment, Efficacy of entecavir was assessed by evaluating hepatitis B virus DNA (HBV DNA), serum alanine aminotransferase (ALT) and sero-conversion.

 Result:  The mean HBV DNA at baseline was 5.99 log [on a base-10 scale] IU/mL which decreased to 2.12 log IU/mL at the end of 40 weeks. Thus there was a mean change of 3.87 log IU/ml which was statistically significant (P<0.0001). Out of 140 HBeAg positive subjects, 50 (35.71 %) had become negative at the end of 40 weeks. Only 10.71% of the patients had normal ALT (<40IU/l) values in the beginning which increased to 100% at the end of 40 weeks.

Conclusion: Entecavir significantly improves virological, biochemical and serological markers in HBeAg positive treatment naïve chronic hepatitis B patients.

Keywords: Chronic hepatitis B, Entecavir, (ETV) HBV DNA.

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