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  1. Guruprasad P Aithal, JournalScan Editor

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Birth without a burden

▶ Han GR, Cao MK, Zhao W, et al. 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. Published Online First: 15 April 2011. doi:10.1016/j.jhep.2011.02.032.

Vertical transmission of hepatitis B is a major worldwide health problem. Perinatal vaccination programmes can be highly effective at reducing transmission but fail in up to 10% of deliveries particularly with immunotolerant (HBeAg-positive, high-viral-load) mothers. Early studies with lamivudine in late pregnancy have reported reductions in transmission. The authors here conducted a large prospective single-centre non-randomised study of the use of the more potent agent, telbivudine, in the second and third trimesters to reduce transmission among (HIV-negative) women who were HBeAg positive with viral loads in excess of 2 000 000 IU. Two hundred and twenty-nine mothers received telbivudine 600 mg/day from week 20 to 32 of gestation (n=135) or served as untreated controls (n=94). There was a marked reduction in the proportion of infants who were HBsAg positive at birth (10% vs 20%) and at 7 months, the primary outcome measure (0% vs 8%). There were also, as expected, significant reductions in maternal viral loads and alanine transaminase levels. Development of resistance mutations are a major concern with short courses of antiviral therapy. No resistance was reported during pregnancy. However, 43 women continued antiviral treatment after delivery (predominantly due to high alanine transaminase (ALT) levels), and two of these developed resistance mutations.

This study suggests a highly significant benefit of antiviral treatment in high-risk pregnancies. Well-designed randomised controlled trials (including rigorous analysis of resistance) are required before perinatal care should be changed. Three such trials are listed on http://clinicialtrials.gov/, and the results of these are eagerly awaited.

Efficacy of Otilonium in IBS

▶ Clave P, …

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