Efficacy of tenofovir disoproxil fumarate to prevent vertical transmission in mothers with lamivudine-resistant HBV.

Background: In China, women with chronic HBV infection and who are of childbearing age receive lamivudine at an early age. Thus, viral resistance becomes a challenge for intervention to prevent mother-to-infant transmission. We prospectively assessed the efficacy of tenofovir in pregnant women with lamivudine-resistant HBV.

Methods: Chronic HBV-infected mothers resistant to lamivudine were enrolled. Tenofovir was administrated at gestation weeks 24 or 28. Virological and biochemical parameters were assessed. All infants received combined immunoprophylaxis and were followed for 1 year.

Results: Of the 48 mothers enrolled, 21 started tenofovir therapy at gestation week 24 and 27 started at week 28. Tenofovir resulted in an HBV DNA decline of 5.23 ± 1.68 log10 IU/ml at delivery. The group starting therapy at week 24 exhibited a more rapid viral inhibition (P<0.001) and more significant HBV DNA load decline (5.89 ± 1.66 versus 4.72 ± 1.55; P=0.019) than the group starting at week 28. At delivery, all mothers had a viral titre <10(6) IU/ml, 76.2% from the week 24 starting group displayed virus <10(4) IU/ml, and 52.4% showed undetectable virus at delivery, much higher than the week 28 starting group (29.6%), although there was no statistically significant difference in viral levels at delivery between the two groups. Congenital abnormalities and neonatal growth were comparable to the normal population. No case of perinatal transmission was diagnosed.

Conclusions: This investigation clarifies the efficacy of tenofovir for reducing vertical transmission of HBV in mothers with lamivudine-resistant HBV and demonstrates that tenofovir is well-tolerated in the second and third trimesters.