Comparison of tenofovir disoproxil fumarate and telbivudine in preventing hepatitis B transmission in mothers with high viral load.

ABSTRACT

OBJECTIVE: To add to the limited data that exist on the selection of drugs to prevent mother-to-child transmission (MTCT) of hepatitis B virus (HBV). METHODS: This is a prospective cohort study that enrolled mothers with HBV-DNA ≥2 × 105  IU/ml. All enrolled mothers received either tenofovir disoproxil fumarate (TDF) or telbivudine (LdT) to prevent HBV transmission. RESULTS: A total of 270 mothers received TDF treatment and 275 mothers received LdT treatment. The predelivery decline in HBV-DNA in the TDF group was higher than the LdT group (3.92 ± 0.93 log IU/ml vs. 3.76 ± 0.94 log IU/ml, P = 0.043). In the primary analysis, the MTCT rate of the TDF group was comparable to that of the LdT group, both in the intention-to-treat analysis (1.5% [4/275] vs. 1.8% [5/273], P > 0.99) and the per-protocol analysis (0% in both groups, P > 0.99). The alanine aminotransferase elevation rates in the TDF group were lower than in the LdT group (17.3% vs. 27.4%, P = 0.005). Less anorexia and more arthralgia were observed in the LdT group than the TDF group. CONCLUSIONS: TDF and LdT are both effective in preventing MTCT of HBV, but they may cause different adverse events. TDF is more effective in reducing HBV viral load and had fewer alanine aminotransferase abnormalities than LdT.