From the Journals

Tenofovir didn’t prevent hepatitis B transmission to newborns


Key clinical point: Tenofovir was no different than placebo in preventing HBV transmission to newborns.

Major finding: The transmission rate was 0% in the tenofovir group and 2% in the placebo group (P = .12).

Study details: The study randomized 331 pregnant women to tenofovir or placebo from gestational week 28 to 2 months postpartum.

Disclosures: Dr. Jourdain had no financial disclosures; the National Institute of Child Health and Development sponsored the study.

Source: Jourdain G et al. N Engl J Med. 2018;378:911-23.

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A negative trial with a positive spin

The trial by Jourdain et al. – although described by the authors as negative – “puts down an intriguing marker attesting to the possibility that rapidly phasing in the timely administration of a safe monovalent HBV vaccine within a few hours after birth could contribute to the interruption of mother-to-child transmission and avert preventable HBV infections in childhood,” Geoffrey Dusheiko, MD, wrote in an accompanying editorial (N Engl J Med. 2018;378:952-3).

The World Health Organization supports HBV vaccine schedules of three or four doses, which are usually given as part of a combination immunization protocol beginning at 6 weeks of age. “Currently, HBV vaccination is most frequently administered as a pentavalent or hexavalent vaccine as part of the Expanded Program on Immunization, typically in combination with vaccines against diphtheria, tetanus, pertussis, polio, and Haemophilus influenzae type B,” wrote Dr. Dusheiko. “Paradoxically, support for combination vaccines within an integrated EPI schedule has unwittingly but undesirably shifted thinking and policy away from HBV vaccination at birth. This gap in vaccine strategy is disadvantageous.”

While the study doesn’t support tenofovir for maternal prophylaxis, it does imply value for treating the infant with immune globulin and HBV vaccination soon after birth. Delivering this kind of care globally will be challenging, but it’s entirely feasible, Dr. Dusheiko said.

“It is necessary to analyze regional data to assess the requirements for implementing vaccination at birth, including ... the training of otherwise unskilled birth attendants to deliver monovalent HBV vaccine at the same time as the vaccines against polio and bacille Calmette–Guérin. Importantly, the use of monovalent HBV vaccine would also require governmental or nongovernmental support. HBV vaccination at birth, despite the challenges for poverty-affected countries to deliver vaccination in rural and isolated locales, is feasible.”

Dr. Dusheiko is a hepatologist at the University College London School of Medicine and King’s College Hospital, London.



Prenatal tenofovir didn’t reduce the rate of hepatitis B among infants born to women infected with the virus.

Among 322 6-month-olds, the rate of HBV transmission was 0 in those whose mothers received the antiviral during pregnancy and 2% among those whose mothers received placebo – not a statistically significant difference, Gonzague Jourdain, MD, and his colleagues reported in the New England Journal of Medicine.

Hepatitis B virus ©sarathsasidharan/Thinkstock
All of the infants in the study, who were born in Thailand, got hepatitis B immune globulin and began a 5-dose HBV vaccination schedule within the first few hours after birth, something that “may have contributed to the low rate of HBV transmission that was observed” in the study, said Dr. Jourdain, a visiting scientist at the Harvard School of Public Health, Boston.

The study randomized 331 pregnant women with proven HBV infections to either tenofovir or placebo from 28 weeks’ gestation to 2 months post partum. All infants received HBV immune globulin at birth, and HBV vaccine at birth and at 1, 2, 4, and 6 months. The primary endpoint was confirmed HBV infection in the infant at 6 months.

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