Tenofovir fails to add extra hepatitis B protection for vaccinated newborns

Last Updated: 2018-03-07

By Reuters Staff

NEW YORK (Reuters Health) - Adding tenofovir disoproxil fumarate (TDF) to an aggressive treatment strategy fails to give extra protection to newborns at risk for contracting hepatitis B virus (HBV) from their infected mothers, according to a study at 17 public hospitals in Thailand.

The drug or placebo was given to 331 infected women from 28 weeks of gestation until two months postpartum. All newborns were also given both hepatitis B immune globulin and the first dose of hepatitis B vaccine at birth, with booster vaccine doses at 1, 2, 4 and 6 months.

None of the babies in the tenofovir group became infected. But the rate was so low in the control group - with three infections among 147 babies by the six-month mark - that the difference between the two groups was not statistically significant (P=0.29).

"No maternal or infant safety concerns that were considered by the investigators to be related to the maternal use of TDF or that occurred after the discontinuation of TDF were identified, but the sample size was small," writes the research team, led by Dr. Gonzague Jourdain of Chiang Mai University in northern Thailand. "No significant differences in infant growth were detected between the two groups."

In a linked editorial in the March 8 New England Journal of Medicine, where the study appears, Dr. Geoffrey Dusheiko of the University College London School of Medicine says rapid treatment of the newborns may be the secret behind the low infection rate in the placebo group. Only 4% if the newborns had to wait more than four hours to get their first vaccine treatment.

The trial, he writes, "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."

In countries where the vaccine is given - and many don't give it at birth - the first dose is usually administer at six weeks in combination with vaccines against diseases such as polio, tetanus, diphtheria and pertussis, Dr. Dusheiko notes.

SOURCE: http://bit.ly/2FbGKsN

N Engl J Med 2018