Induction of Fibrosis Regression on Patients With Chronic Hepatitis B Infection

Inclusion Criteria: * chronic hepatitis B infection with detectable HBV (hepatitis B virus)-DNA at baseline * results of a current liver biopsy (date of liver biopsy must not be longer than 3 months as date of screening visit) * detection of relevant liver fibrosis in liver histology after percutaneous or laparoscopic biopsy (histologically ≥ F2) after estimation by an experienced pathologist in the liver pathology and sufficient evaluability of the biopsy (usually evaluation of portal at least 8 fields) * Therapy indication according to current guidelines cHBV infection ( any virus replication in the presence of liver cirrhosis, or detection of HBV-DNA ≥ 2000 IU / ml and/or liver histology with inflammatory Grade ≥2 / fibrosis stage 2 and presence of ALT \<5 x ULN) * non-pregnant and non-breastfeeding women, who fitful one of following criteria: \* post-menopausal (12 months natural amenorrhea or 6 months amenorrhea with serum FSH (follicle stimulating hormone)\> 40mlU/ml) * 6 weeks after surgical sterilization by bilateral tubal transection or after bilateral oophorectomy with or without hysterectomy * Correct application of two methods of sure contraception (any combination of a hormonal contraceptive (the pill, hormone IUD (intrauterine device), Depo-Provera, Implanon, contraceptive patch or vaginal ring) or IUD with a barrier contraceptive with spermicide (diaphragm, cervical cap, LEA contraceptive, female condoms or condom)or a spermicide. * Sexual abstinence for 2 weeks before the first administration of the study medication, during the study period and after the study during 30 days (time of elimination of study medication) * Patients, who have only female sexual partners * Male partner of a female patient, who before study inclusion, sterile and only one sexual partner of this female patient is * Patients willing and able to complete the requirements of this study Exclusion Criteria: * anamnestic known hypersensitivity to Baraclude® or its ingredients or to drugs with similar chemical structure * Participation of patients in another clinical study within last 4 weeks prior to the inclusion or simultaneous participation in another clinical study * anamnestic known substance dependance or another diseases, which not allowed persons to understand essence and importance and possible consequences of the trial * lack of cooperation and informed consent * co-infection with hepatitis C, hepatitis D or HIV * detection of hepatocellular carcinoma * serious, chronic disease with an estimated prognosis for survival shorter than the study period of 5 years * every previous therapy with lamivudine or telbivudine or previous therapy with other antiviral substance within last 6 months before study inclusion * contraindications to the use of entecavir * creatinine clearance \<50 ml / min and / or need for hemodialysis * MELD score \>15 points and / or detection of ascites