Due to the possibility of immunoprophylaxis failure, if maternal serum hepatitis B virus (HBV) DNA levels are more than 200,000 IU/ml, tenofovir disoproxil fumarate (TDF) treatment was studied for preventing mother-to-child transmission (PMTCT). PUBMED, EMBASE, Cochrane, CNKI, and Wanfang databases were searched for maternal TDF treatment for PMTCT between January 1, 2015, and July 1, 2015. Data from randomized controlled trials conducted in English or Chinese were retrieved and analyzed. TDF’s effectiveness and safety against placebo for PMTCT were among the outcomes of interest. The risk of bias was minimal among the 11 RCTs included in the databases. Except for one RCT conducted, which showed no therapeutic advantage on TDF treatment versus placebo for PMTCT of HBV, all studies demonstrated that maternal TDF therapy initiated in the second or third trimester for highly viremic chronic hepatitis B mothers is highly effective and safe in the PMTCT of HBV (0% vs 3% transmission). Recent evidence suggested that maternal TDF treatment began in the second or early third trimester in women with HBV DNA levels of more than 200,000 IU/ml and achieved viremic control prior to delivery. There were no effects on newborns’ physical growth, psychosocial or mental development, or bone mineral density following prenatal exposure to TDF in a 4-year follow-up study for maternal TDF treatment. An algorithm was presented in light of current effectiveness and safety data from RCTs. Approaches in resource-constrained settings were considered.

As the primary therapy for PMTCT in highly viremic women, TDF is safe for both mothers and newborns. TDF should be started in the second or early third trimester, in conjunction with immunoprophylaxis for the relevant neonates.