NEW YORK (Reuters Health) – Perinatal transmission of hepatitis B virus from highly viremic mothers to their offspring is substantially reduced with telbivudine therapy during pregnancy, without any apparent adverse effects, a team in China has shown.
Dr. Guo-Rong Han and colleagues at the Second Affiliated Hospital of the Southeast University in Nanjing, explain in the Journal of Hepatology online April 18 that perinatal hepatitis B virus (HBV) infection is the main cause of chronic hepatitis B in the Asia-Pacific region. While passive and active immunization given within 12 hours of birth can usually prevent transmission, the strategy fails in up to 15% of cases when maternal HBV DNA levels are high.
To assess the utility and safety of telbivudine in this setting, the researchers enrolled 229 mothers with HBV DNA levels greater than 10 million copies per mL in an open-label trial. From gestational week 20 to week 32, 135 of the women received telbivudine 600 mg/day while 94 served as controls.
All the infants were given HBIg within 12 hours postpartum, and received HBV vaccine at 0, 1 and 3 months.
“Seven months after delivery, the incidence of perinatal transmission was lower in the infants that completed follow-up born to the telbivudine-treated mothers than to the controls (0% vs 8%; p=0.002),” Dr. Han and colleagues report.
Furthermore, the incidence and nature of adverse events were similar in the two groups, and none were considered to be drug related.
Based on the results, the authors conclude that telbivudine “should be recommended in pregnant women who are at high risk of transmitting HBV infection to their newborns.”
However, they add, “Additional randomized, multi-center, long-term follow-up studies are needed to better define the utility of telbivudine in preventing transmission. The best timing for intervention with telbivudine should be further studied.”
A prospective and open-label study for the efficacy and safety of telbivudine in pregnancy for the prevention of perinatal transmission of hepatitis B virus infection
J Hepatol 2011.