Virological and clinical anti-HBV efficacy of tenofovir in antiretroviral naive patients with HIV/HBV co-infection

INTERVENTION: Tenofovir, Lamivudine over 48 weeks CONDITION: HIV Hepatitis B Coinfection PRIMARY OUTCOME: To compare HBV DNA suppression to levels below the limit of detection (<400 copies/ml) by week 48 in each group SECONDARY OUTCOME: To compare the effect of therapy on histological changes in the liver and on the presence of ccc‐DNA. To compare changes in ALT from baseline and the rate of hepatic cytolysis (ALT > 5x ULN). To compare suppression of HIV‐1 RNA and changes in CD4/CD8 counts. To compare the proportion of patients who achieve HBeAg and HBsAg seroconversion. To compare the proportion of patients with undetectable HBV DNA To evaluate the emergence of HBV resistance INCLUSION CRITERIA: Written informed consent; Documented HIV infection (positive serology for HIV‐1 and detectable HIV‐1 RNA); HBV DNA > 105 copies/ml; HBsAg positive >6 months or HBsAg positive and anti HB core IgM negative; Creatinine <= 2.0mg/dl (<= 0.2 mmol/L); Platelet count >= 50,000/mm; HIV‐1 antiretroviral therapy naive; No prior exposure to anti‐HBV agents (LAM, adefovir, TDF) although prior IFN treatment allowed.