Preventing Vertical Transmission of Hepatitis B with Telbivudine

Briefly noted:

Wu Q et al. Clin Gastroenterol Hepatol 2015; 13: 1170-76.  This was a prospective study of 450 Hepatitis B e antigen-positive pregnant women with HBV DNA levels greater than 10 to the 6th IU/mL.  279 women received telbivudine 600 mg daily starting between 24 to 32 weeks of gestation until delivery or up to a month thereafter; this treatment group was compared to 171 controls women unwilling to take the medication. All infants received vaccinations after birth along with hepatitis B immune globulin. None of the infants in the treatment arm acquired hepatitis B (negative HBsAg at 6 months) compared with 14.7% of infants in the control arm who were positive for infection.  no serious adverse effects were noted in the women receiving telbivudine or their infants.

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Hepatology Update -Summer 2014

Preventing Perinatal Transmission of Hepatitis B Virus (HBV): Hepatology 2014; 60: 468-76.  This nonrandomized study, conducted between 2009-2011 with approximately 700 patients, showed that the rate of perinatal transmission of can be brought down almost to zero by instituting therapy with either telbivudine or lamivudine in the third trimester of pregnancy.  The accompanying editorial (pgs 448-51) indicates that either telbivudine or tenofovir (both pregnancy class B agents with regard to teratogenicity) are preferred agents due to higher barrier to resistance. And, the article suggests starting as early as week 28 (especially if high viral HBV DNA load) and no later than 32 weeks gestation. Other recommendations from editorial include stopping antiviral after delivery in women who intend to breastfeed.

More on coffee: Hepatology 2014; 60: 661-69.  Coffee but not tea conferred protection from cirrhosis mortality.  “Compared to non-daily coffee drinkers, those who drank two or more cups per day had a 66% reduction in mortality risk.”  This study also had an accompanying editorial (pg 464-67) which reviews the biologic plausibility and potential mechanisms.

NASH pathology: Hepatology 2014; 60: 565-75.  The study describes a more precise way to categorize the diagnosis of nonalcoholic steatohepatitis (NASH) using the European Fatty Liver Inhibition of Progression (FLIP) pathology consortium proposal.  The diagnosis of NASH requires the presence of ballooning and lobular inflammation in addition to steatosis.  Using the FLIP approach, diagnosis concordance increased significantly.

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How to stop HBV vertical transmission

A review and a study this month help delineate a strategy to lower the rate of HBV transmission (Clin Gastro Hepatol 2012; 10: 452-59 & 520-526).  Overall, using HBIG and HBV vaccine within 12 hours of birth (followed by two additional doses of vaccines within 6-12 months) prevents about 95% of HBV transmission from HBsAg-positive mothers to their infants.  This has made a huge difference.  Yet, among mothers with high levels of viremia, HBV is still transmitted in 8-30%.  As such, this review proposes an algorithm to reduce mother to child transmission (MTCT).

The key risk factor is HBV DNA levels >200,000 IU/mL; the most effective way to reduce transmission from highly-viremic mother to infancts is the use of antiviral therapy.  The authors recommend that in addition to the usual preventive measures (HBIG/HBV vaccine within 12 hours of birth), that efforts to lower MTCT include use of either lamivudine (pregnancy category C), telbivudine (pregnancy category B), or tenofovir (pregnancy category B) at the 3rd trimester in the following:

  • Infected women with high HBV DNA levels
  • Infected women who have had children who have failed previous prophylaxis
  • Infected women with threatened pre-term labor

In addition, elective C-section should be considered if HBV DNA >20 million IU/mL at full term.

The second citation refers to an open-label prospective study of 88 HBe-Ag positive women.  All women had HBV DNA >6 log10 copies/mL and increased ALT.  Telbivudine (600 mg/day) was administered to 53 women starting between 12 and 30 weeks gestation; there were 35 control patients who all received HBIG/HBV vaccine.  In the treatment group, none of the infants developed HBV infection.  In the control group, the transmission rate was 8.6%.  No significant adverse effects were noted; specifically, no congenital malformations were noted.

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