Antiviral drug not beneficial for reducing mother-to-child transmission of hep B when added to existing preventatives

March 7, 2018, NIH/Eunice Kennedy Shriver National Institute of Child Health and Human Development
A microscopic image of the Hepatitis B virus, taken by the Centers for Disease Control and Prevention

Tenofovir disoproxil fumarate (TDF), an antiviral drug commonly prescribed to treat hepatitis B infection, does not significantly reduce mother-to-child transmission of hepatitis B virus when taken during pregnancy and after delivery, according to a phase III clinical trial in Thailand funded by the National Institutes of Health. The study tested TDF therapy in addition to the standard preventative regimen—administration of hepatitis B vaccine and protective antibodies at birth—to explore the drug's potential effects on mother-to-child transmission rates. The results appear in the New England Journal of Medicine.

"Limited evidence of the benefit of using antiviral drugs to prevent mother-to-child transmission of B has led to conflicting practice recommendations around the world," said Nahida Chakhtoura, M.D., a study team member and medical officer at NIH's Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). "Our study suggests that adding TDF to the current regimen seems to have little effect on infant infection rates when transmission rates are already low."

Hepatitis B virus can cause serious, long-term health problems, such as liver disease and cancer, and can spread from mother-to-child during delivery. According to the latest estimates from the World Health Organization (WHO), approximately 257 million people in 2015 were living with the virus. Countries in Asia have a high burden of hepatitis B. There is no cure, and antiviral drugs used to treat the infection usually need to be taken for life.

To prevent infection, WHO recommends that all newborns receive their first dose of hepatitis B vaccine within 24 hours of delivery. Infants born to hepatitis B-infected mothers are also given protective antibodies called hepatitis B immune globulin (HBIG). However, mother-to-child transmission can still occur in women with high levels of virus in their blood, as well as those with mutated versions of the virus.

The current study was conducted at 17 hospitals of the Ministry of Public Health in Thailand. It screened more than 2,500 women for eligibility and enrolled 331 pregnant women with hepatitis B. The women received placebo (163) or TDF (168) at intervals from 28 weeks of pregnancy to two months after delivery. All received standard hepatitis B preventatives given in Thailand, which include HBIG at birth and five doses of the hepatitis B vaccine by age 6 months (which differs from the three doses given in the United States). A total of 294 infants (147 in each group) were followed through age 6 months.

Three infants in the had hepatitis B infection at age 6 months, compared to zero infants in the TDF treatment group. Given the unexpectedly low transmission rate in the placebo group, the researchers concluded that the addition of TDF to current recommendations did not significantly reduce mother-to-child transmission of the virus.

"We observed no treatment-related safety concerns for the mothers or infants and no significant differences in infant growth," said the study's lead author Gonzague Jourdain, M.D., Ph.D., of Thailand's Chiang Mai University, the Harvard T.H. Chan School of Public Health and France's IRD (Institut de recherche pour le développement). "These safety data also are relevant for pregnant women receiving TDF as part of HIV treatment or HIV pre-exposure prophylaxis."

According to the study authors, the clinical trial had enough participants to detect statistical differences if the transmission rate in the placebo group reached at least 12 percent, a rate observed in previous studies. Though the reasons are unknown, the researchers speculate that the lower rate seen in the study may relate to the number of doses of hepatitis B vaccine given to infants in Thailand, lower rates of amniocentesis and Cesarean section deliveries in this study, or the lower prevalence of mutated viruses that result in higher vaccine efficacy in Thailand compared to other countries.

Explore further: AAP: hep B vaccine to be given within first 24 hours of life

More information: Jourdain G et al., Tenofovir versus placebo to prevent hepatitis B perinatal transmission. New England Journal of Medicine (2018). DOI: 10.1056/NEJMoa170813

Related Stories

AAP: hep B vaccine to be given within first 24 hours of life

August 29, 2017
(HealthDay)—The first dose of the hepatitis B vaccine should be given within the first 24 hours of life, according to an American Academy of Pediatrics (AAP) policy statement published online Aug. 28 in Pediatrics.

Worldwide 52 million children living with viral hepatitis

November 3, 2017
New data presented at this year's World Hepatitis Summit in Sao Paulo, Brazil (1-3 November) show that 52 million children are living with viral hepatitis worldwide, compared to 2.1 million children living with HIV/AIDS.

Tenofovir disoproxil fumarate can cut HBV transmission

June 16, 2016
(HealthDay)—Use of tenofovir disoproxil fumarate (TDF) during pregnancy can reduce the rate of mother-to-child transmission of hepatitis B virus (HBV), according to a study published in the June 16 issue of the New England ...

Anti-viral treatment during pregnancy reduces HBV transmission from mother to child

April 24, 2017
An analysis of published studies indicates that the antiviral drug tenofovir given to pregnant women in the second or third trimester can help prevent mother to child transmission of the hepatitis B virus (HBV).

Drug prevents passage of HBV during pregnancy

June 1, 2015
The antiviral drug telbivudine prevents perinatal transmission of hepatitis B virus (HBV), according to a study in the June issue of Clinical Gastroenterology and Hepatology, the official clinical practice journal of the ...

ACP and CDC issue recommendations for hepatitis B screening, vaccination, and care

November 20, 2017
Reducing chronic hepatitis B infections by screening at-risk adults, increasing hepatitis B vaccination rates, and linking infected persons to care is a public health priority, the American College of Physicians (ACP) and ...

Recommended for you

Discovery of novel mechanisms that cause migraines

December 17, 2018
Researchers at CNRS, Université Côte d'Azur and Inserm have demonstrated a new mechanism related to the onset of migraine. They found how a mutation that causes dysfunction in a protein which inhibits neuronal electrical ...

Small-scale poultry farming could mean big problem in developing countries

December 16, 2018
Small-scale farming in developing countries provides those in rural communities with income and access to protein, but it may have a large impact on antibiotic resistance, according to a new University of Michigan study.

RNA processing and antiviral immunity

December 14, 2018
The RIG-I like receptors (RLRs) are intracellular enzyme sentries that detect viral infection and initiate a first line of antiviral defense. The cellular molecules that activate RLRs in vivo are not clear.

Faster test for Ebola shows promising results in field trials

December 13, 2018
A team of researchers with members from the U.S., Senegal and Guinea, in cooperation with Becton, Dickinson and Company (BD), has developed a faster test for the Ebola virus than those currently in use. In their paper published ...

Urbanisation and air travel leading to growing risk of pandemic

December 13, 2018
Increased arrivals by air and urbanisation are the two main factors leading to a growing vulnerability to pandemics in our cities, a University of Sydney research team has found.

Drug targets for Ebola, Dengue, and Zika viruses found in lab study

December 13, 2018
No drugs are currently available to treat Ebola, Dengue, or Zika viruses, which infect millions of people every year and result in severe illness, birth defects, and even death. New research from the Gladstone Institutes ...

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.