Preliminary study on the efficacy and safety of lamivudine and interferon alpha therapy in decreasing serum HBV DNA level in HBV positive transgenic mice during pregnancy.

Previous studies reported that the HBV DNA level in maternal serum is an important risk factor for intrauterine infection. Two antiviral drugs, lamivudine (3TC) and interferon alpha (IFNalpha), are used extensively clinically to reduce maternal HBV DNA level, However, because of a lack of evidence on the efficacy and safety of these drugs during pregnancy, they are categorized as grade C which prevents their use during pregnancy. This study provides new data on the efficacy and safety of lamivudine and IFNalpha in HBV positive transgenic pregnant mice. In this study, transgenic mice with high titers of hepatitis B virus (HBV) were employed to study the antiviral effects of 3TC and IFNalpha during different gestation periods. The study also examined changes in several serological HBV markers, the effects of perinatal exposure to antiviral drugs on the mother and offspring, drug efficacy in reducing the level of HBV DNA in maternal blood, and the safety to both the mother and offspring. The main conclusion of the study is that a significant decrease in HBV DNA level can be obtained after treatment with lamivudine but not with IFNalpha. No adverse effects were observed in the maternal mice and the offsprings. This finding may provide a rationale for the potential use of lamivudine for the treatment of pregnant women as a safe and effective measure to reduce the level of maternal viremia.