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Objective: To determine the effectiveness of Entecavir or Tenofovir in eradication of chronic Hepatitis B infection in
patients with superimposed acute hepatitis A or E infection.
Material and Methods: This simple, non-blinded randomized controlled trial was conducted in Department of Medicine,
Khyber Teaching Hospital, Peshawar and the private practice of primary author from February, 2011 to April, 2017.702
chronic Hepatitis B patients of either gender, aged between 14 and 55 were recruited in the study after fulfilling the
inclusion criteria. These patients were initially chronic Hepatitis B positive, but were not started on antiviral therapy
owing to low viral counts. They subsequently developed acute hepatitis (either Hepatitis A or E).60% of the patients
had positive hepatitis E serology, while 40% had positive serology for hepatitis A.These patients were divided into 3
wings: 1. 281 patients were started on Entecavir 0.5mg OD; 2. 281 patients were started on Tenofovir 300mg OD; 3.
140 patients who were willing to wait for spontaneous clearance of the virus were started on liver supplements used
as placebo. These patients were followed at every 4 weeks for first 3 months and then every 6 months for the next 3
years. HBsAg clearance by 3rd generation ELISA, and negative HBV PCR at 12 months was taken as End Point of the
study. Results were analyzed using SPSS 23 and expressed in percentages.
Results: At the end of 6 months, 39.1% of patients started on either of Entecavir or Tenofovir achieved HBsAg clearance
with negative PCR for Hepatitis B virus DNA, while only 3.3% of the placebo group achieved HBsAg negativity
with negative PCR. At 12 months of initiation of treatment, 55% of patients started on either of Entecavir or Tenofovir
achieved HBsAg clearance with negative PCR, while only 3.3% of the placebo group did.
Conclusion: No statistical difference was found between Entecavir and Tenofovir in the management of Acute Hepatitis
in Chronic Hepatitis B patients with superimposed acute Hepatitis A / E.Both entecavir and tenofovir were statistically
significant as compared to placebo in the management of Acute Hepatitis in Chronic Hepatitis B patients with superimposed
acute Hepatitis A / E
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