Tag Archives: vertical transmission

Preventing Neonatal Hepatitis B Transmission with Tenofovir

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A recent study (CQ Pan et al. NEJM 2016; 374: 2324-34) showed that tenofovir administered to mothers starting at 30-32 weeks of gestation lowered the rate of perinatal hepatitis B virus (HBV) acquisition.This was a multi center, open-label, randomized parallel-group design trial.  The maternal tenofovir dose was 300 mg.

Key points:

  • 200 mothers with HBeAg and HBV DNA >200,000 IU/mL in this study
  • 68% achieved an HBV DNA level <200,000 IU/mL (compared with 2% of controls).  Above this threshold has been shown to be associated with increased HBV transmission.
  • 5 of 97 (5%) in the treatment group acquired HBV compared to 18 of 100 in the control group.  However, in the per-protocol analysis which excluded infants born to women who withdrew consent, were lost to follow-up, or discontinued therapy there were 0 cases of transmission (0 of 88).
  • There were no specific safety signals identified in this study.  In the discussion, the authors note that the Antiretroviral Pregnancy Registry which includes data from 4013 women who received tenofovir, the rate of birth defects with TDF was 2.4% compared to the general population rate of 2.7%.

My take: This study provides more evidence that antivirals can prevent perinatal HBV infection.

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Preventing Vertical Transmission of Hepatitis B with Telbivudine

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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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Liver Update: Headlines and Links Only

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  1. From AGA: Hepatic failure flagged as unexpected boceprevir safety signal in adverse event review. GI & Hep News: http://ow.ly/rSCEF 
  2. From NY Times: Spike in Harm to Liver Is Tied to Dietary Aids nyti.ms/JPN9fK 
  3. From Jeff Schwimmer (The Liver Post): First case report of Liver Cancer in a child with Nonalcoholic Fatty Liver Disease. He is only 7 years-old. http://goo.gl/6dJbzs 
  4. “Recurrence of Hepatopulmonary Syndrome Post-Orthotopic Liver Transplantation in a Patient with Noncirrhotic Portal Hypertension” Hepatology 2013; 58: 2205-06.
  5. “Management of Hepatitis B: Our Practice and How It Relates to the Guidelines” Clin Gastroenterol Hepatol 2014; 12: 16-26.  Terrific review and insights.
  6. “Acute Liver Failure” NEJM 2013; 369: 2525-34.
  7. “Cesarean Section Reduces Perinatal Transmission of Hepatitis B Virus Infection from Hepatitis B Surface Antigen-Positive Women to Their Infants” Clin Gastroenterol Hepatol 2013; 11: 1349-55. Retrospective, nonrandomized study -“performing elective cesarean section only in highly viremic mothers with pre-delivery HBV DNA levels ≥1,000,000 copies/mL may be advisable.”

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How to stop HBV vertical transmission

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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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