Telbivudine during pregnancy safely reduces vertical transmission of hepatitis B?

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Telbivudine during pregnancy safely reduces vertical transmission of hepatitis B?

Summary

by: Nicola Pocock

According to the results of an open-label study conducted in China, perinatal transmission of hepatitis B virus (HBV) from highly viraemic mothers to their offspring is reduced when telbivudine is administered during the second and third trimesters of pregnancy.

The authors note that perinatal HBV infection is the main cause of chronic hepatitis B in the Asia-Pacific region. Although passive and active immunisation given within 12 hours of birth can usually prevent transmission, this strategy fails in up to 15% of cases, more commonly when maternal viraemia is high. Treatment of highly viraemic mothers with lamivudine during the last month of pregnancy in has been shown to reduce mother-to-infant transmission and the risk of vaccination breakthrough in infants who received passive-active immunoprophylaxis. The purpose of the current study was to evaluate telbivudine in this setting.

The study included 229 mothers with HBV DNA levels greater than 10 million copies/mL, who were either treated with open-label telbivudine 600 mg/day from week 20-32 of gestation (n=135) or served as untreated controls (n=94). All of the infants received 200IU of hepatitis B immunoglobulin within 12 hours postpartum and HBV vaccination at 0, 1 and 6 months. Infants were assessed within 24 hours of delivery and followed up at 1 and 7 months after delivery. The primary endpoint was the rate of perinatal transmission, established by detectable HBV DNA and hepatitis B surface antigen (HBsAg) levels in the peripheral blood of infants at 7 months. All of the women treated with telbivudine were registered in the Antiretroviral Pregnancy Registry.

The main findings were as follows:

• Serum HBV DNA began to decline at week 2, dropping to 3.99±1.37 log10 copies/mL after 4 weeks of treatment in the telbivudine group. Prior to delivery, every patient treated had a >3log10 reduction in serum HBV DNA. In contrast the serum HBV DNA levels remained relatively unchanged in the placebo group (7.82±0.66 log10 copies/mL; P<0.001).

• Undetectable viraemia (DNA<500 copies/mL) was seen at delivery in 44 (33%) of the telbivudine-treated mothers and none (0%) of the untreated controls.

• 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).

No serious adverse events were noted in the telbivudine-treated mothers or their infants after shirt-term follow-up. Based on their 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 note that "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."

http://www.nelm.nhs.uk/en/NeLM-Area/News/2011---April/28/Telbivudine-during-pregnancy-safely-reduces-vertical-transmission-of-hepatitis-B-/