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.

July 3, 2011

J Hepatol. 2011 Apr 15. [Epub ahead of print]

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.

Han GR, Cao MK, Zhao W, Jiang HX, Wang CM, Bai SF, Yue X, Wang GJ, Tang X,

Zhi-Xun F.

Source

Department of Gynecology and Obstetrics, The Second Affiliated Hospital of the

Southeast University, Nanjing, China.

Abstract

In the Asia-Pacific region, perinatal transmission of the hepatitis B virus

(HBV) is the primary cause of chronic hepatitis B infection. Two hundred and

twenty nine HBeAg+ HBV DNA levels>1.0 ×10(7) copies/mL mothers received

telbivudine 600 mg/day from week 20-32 of gestation (n = 135) or served as

untreated controls (n = 94). All infants in both arms received 200 IU of HBIg

within 12 hours postpartum and recombinant HBV vaccine of 20 ug at 0, 1 and

6month. HBsAg and HBV DNA results of infants at week 28 were used to determine

perinatal transmission rate. All telbivudine treated subjects were registered in

the Antiretroviral Pregnancy Registry. Telbivudine treatment was associated with

a marked reduction in serum HBV DNA and hepatitis B e antigen (HBeAg) levels and

normalization of elevated ALT levels before delivery. A striking decline of HBV

DNA levels started from treatment onset to week 4, and sustained in a low level

since week 12. Forty four (33%) of the 135 telbivudine-treated mothers and none

(0%) of the untreated controls had polymerase chain reaction-undetectable

viremia (DNA<500 copies/mL) at delivery. 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%vs8%;

P=0.002). HBV DNA levels were only detectable in HBsAg+ infants. No significant

differences were observed in anti-HBs levels during postnatal follow-up. No

serious adverse events were noted in the telbivudine-treated mothers or their

infants. Telbivudine used during pregnancy in CHB HBeAg+ highly viremic mothers

can safely reduce perinatal HBV transmission. Telbivudine was well-tolerated

with no safety concerns in the telbivudine-treated mothers or their infants on

short term follow up. These data support the use of telbivudine in this special

population.

PMID: 21703206 [PubMed - as supplied by publisher]

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