The Evaluation of efficacy and safety of Tenofovir in combination with peginterferon alpha-2a subcutaneous for 48 weeks in patients with chronic hepatitis B viral infections (HBV)

INTERVENTION: Arm 1 Oral antiviral Tenofovir 300mg (daily for 48weeks) plus Peginterferon 180micrograms (subcutaneous injection once weekly for 48 weeks) Arm 2 Peginterferon 180micrograms (subcutaneous injection once weekly for 24weeks) followed by combination Oral antiviral Tenofovir 300mg (daily for 24weeks) plus Peginterferon 180micrograms (subcutaneous injection once weekly for 24 weeks) Arm 3 Peginterferon monotherapy 180micrograms (subcutaneous injection once weekly for 48weeks) CONDITION: Chronic Hepatitis B viral infection PRIMARY OUTCOME: The primary objective of this study is to demonstrate the efficacy of the combination of peginterferon alpha‐2a with Tenofovir in achieving sustained HBV suppression as measured by HBsAg loss in adult patients with HBeAg positive CHB by serum assay (blood test) SECONDARY OUTCOME: Evaluating the effect of peginterferon and Tenofovir combination therapy on other parameters of viral suppression including; HBV DNA non‐detectability, reduction from baseline, and sustained reduction in HBV DNA over the course of the study. HBeAg loss, HBeAb seroconversion and reduction in HBeAg titres from baseline HBsAg loss, HBsAb seroconversion and reduction in HBsAg titres from baseline and ALT normalization by serum assay (blood test) Evaluating the effect of the combination of peginterferon alpha‐2a with Tenofovir on HBsAg clearance rates by a lead in phase of Peginterferon monotherapy for 24 weeks prior to combination therapy by serum assay (blood test) INCLUSION CRITERIA: Documented Chronic Hepatitis B defined by all of the following: 1.Clinical history compatible with CHB 2.Detectable serum HBsAg at the Screening visit and at least 6 months prior 3.HBeAg‐positive and HBeAb‐negative at the Screening visit 4.History of evidence of chronic liver inflammation, documented by previous history of elevated serum ALT (at least two documented elevated ALT values spanning six months or more)) 5.Elevated serum ALT level (1.1 – 10 x upper limit of normal (ULN)) at the Screening visit 6.Serum HBV DNA level = 3 log10 IU/mL at the screening visit 7.Chronic liver inflammation on a liver biopsy performed within the previous 5 years