1.History of antiviral therapy for chronic hepatitis B in the 6 months prior inclusion 2.Positivity for serologic markers of hepatitis C virus or Human immunodeficiency virus (HIV-1,2) infection. 3.Hepatocarcinoma, suspected hepatocarcinoma or hepatic cirrhosis by clinic/sonography 4.Clinical, sonographic or serologic evidences of decompensate liver disease (gastrointestinal bleeding, hepatic encephalopathy, ascites, spontaneous peritonitis, hepato-renal syndrome, ALAT greater than 10 folds the ULN). 5.Clinical history of concomitant hepatopathy of any aetiology: Alcoholism, Autoimmune hepatitis, Toxic Hepatitis, Wilson’s Disease, Haemochromatosis. 6.Acute or chronic disease of the respiratory airways and perinasal sinuses (eg. nasal cavity, nostril and nasal septum malformations, recurrent epistaxis, severe allergic rhinitis, rhinopharingitis, sinusitis, nasal polyps, bronchial asthma, etcetera) 7.Has any of the following acute or chronic clinically significant (decompensate) disease inappropriate for participation in the study based on the investigator's judgment. [Eg, Cardiovascular system: cardiopathy, myocardial infarction, congestive heart failure, angina pectoris, severe hypertension, significant arrhythmia); Endocrine: (uncontrolled metabolism diseases such as Diabetes mellitus, uncontrolled thyroid diseases, etc); Renal: (Kidney failure); Others: autoimmune disorders (lupus, colagenosis, Rheumatoid arthritis, Multiple Sclerosis), uncontrolled epilepsy, active tuberculosis, malignancies (e.g.tumor), psychiatric disease or severe mental depression]. 8.Immunosuppressive treatment within 6 months of Screening Visit [eg: chemotherapy, radiotherapy, steroids at high doses (=20 mg per day of prednisone or its equivalent longer than 2 weeks)]. The use of topical or intra-(articular/bursal/tendon) corticosteroids will not be considered a contraindication. 9.Malignancy other than curatively treated, superficial skin cancer or carcinoma in situ of the cervix. 10.Participation in any experimental protocol or antihepatitis B vaccination or therapy within 6 months prior to the Screening Visit. 11.History of severe allergy (Grade III or IV Asthma, urticaria, severe dermatitis or bronchitis) or suspected allergy to the ingredients of the study drug 12.Female who is in pregnancy, puerperium, in lactation or women of childbearing potential that do not use methods of contraception or are planning to become pregnant during the course of the study. 13.Has a history of alcohol abuse (Alcohol consumption for more than 5 years, with daily consumption over 40g for males and over 20g for females) and known drug dependence. 14.Has a history of organ transplant (except external corneal transplantation and hair transplantation) 15.Hemoglobin levels = 9 g/dL (females) or = 10 g/dL(males), or Platelets = 80 x 109/L, Global leukocyte count = 12x109/L or =3.0 x109/L. 16.History of mental or psychiatric disorders in a way that the patients is not able to give written informed consent or cannot comply with the requirements of the study 17.Any other factor inappropriate for enrollment in the study or study completion in the view of the investigator.