To date, no antiviral drugs active against HBV have been approved for the prevention of perinatal transmission of HBV. The use of antivirals to prevent perinatal transmission of HBV has been proposed by some international medical associations but there are currently no firm recommendations to use a short antiviral(s) course during pregnancy. Pregnant Women with high levels of HBV in the blood are at the highest risk to transmit the virus to their baby during pregnancy and the efficacy and safety of a short antiviral treatment course during pregnancy and in the early postpartum period to prevent HBV perinatal transmission in these women are not well known:
Efficacy: The only clinical, randomized, double-blind, placebo controlled efficacy trial, conducted in China and the Philippines, failed to demonstrate the efficacy of lamivudine (3TC) to prevent perinatal transmission of HBV (Xu et al, J Viral Hepat, 2009). However, a non-randomized study conducted in China showed the efficacy of telbivudine, suggesting that a potent antiviral may prevent HBV perinatal transmission (Han GR et al, J Hepatol, 2011).
Safety: Maternal tolerance following antiviral treatment discontinuation in the early postpartum period has not been adequately evaluated. It is well known that immunologic changes during pregnancy and the postpartum period may result in elevations in liver enzymes (ALT). A rebound of viral replication usually follows antiviral treatment interruption, which may trigger additional ALT elevations in this context. There are almost no reliable data on the safety of antiviral discontinuation in this context.
The iTAP study will provide both efficacy and safety data on the use of tenofovir disoproxil fumarate (TDF) to prevent HBV transmission in women with high risk of transmission.
For further information please refer to: ClinicalTrials.gov NCT01745822
Or refer to the Protocol: BMC Infectious Diseases