Efficacy and Safety of PegIFN +/- FTC / TDF to Treat Chronic Hepatitis B in HIV-Coinfected Patients

Inclusion Criteria: * Documented chronic hepatitis B infection (\> 6 months) with detectable HBV DNA \> 5x100000 copies/ml (PCR-Assay) on two separate occasions * HBe-Ag positive, anti-HBe negative * HBs-Ag positive, anti-HBs negative * a liver biopsy within the last 12 months prior to screening consistent with chronic hepatitis B * Documented HIV-infection * CD4-cell count \> 200 cells/µl * Elevated serum ALT \> ULN but £ 10X ULN as determined by two abnormal values taken \>14 days apart during the six months before the first dose of study drug with at least one of the determinations obtained during the screening period * Serum-creatinine clearance \> 70 ml/min, according to Cockcroft-Gault * Anorganic phosphate \> 0,65 mmol/l (2,0 mg/dl) * Neutrophils above 1.5 G/l, Hb above 11.5 g/dl (females) or 12.5 g/dl(males), thrombocytes above 90 G/l * Ability to understand and sign a written consent form Exclusion Criteria: * Older than 65 years of age, younger than 18 years of age * Pregnancy, lactating women * Concomitant / prior medication / hypersensitivity to study medication * Prior use of antiretroviral therapy in particular adefovir dipivoxil, tenofovir DF, lamivudine, emtricitabine, or interferon * Treatment with interleukin 2 or corticosteroids less than 6 months prior to the first dose of study drug or the expectation that such treatment will be needed at any time during the study. * Currently receiving investigational agents unless approved by the study coordinator * …