Success of Clinical Research under the Collaboration of Thai & French Governments has been published in the New England Journal of Medicine
Hepatitis B: A new strategy to eliminate mother-to-child transmission
Results of the clinical study entitled “Maternal Antiviral Prophylaxis to Prevent Perinatal Transmission” conducted by experts from the French National Institute for Research for Sustainable Development (IRD) and Dr. Wasna Sirirungsi, Dr. Wootichai Khamduang from Chiang Mai University under support of French Government & Thailand International Cooperation Agency with their Thai public health teams from 17 hospitals and American, European partners, increases the interest for a new strategy to prevent the transmission of hepatitis B virus from mother to child. The results of this clinical trial, conducted in Thailand, was published on March 8, 2018 in the New England Journal of Medicine.
According to the World Health Organization (WHO), hepatitis B virus affects 257 million people worldwide. It causes an acute illness when it is contracted in adulthood. In Asia, the infection is most often contracted in infancy and becomes a chronic infection. The most common mode of transmission is contact with infected blood or body fluids, especially during delivery. Treatments can reduce the risk of progression to cirrhosis and liver cancer. In 2015, 887,000 people died of this infection worldwide.
In Asia, chronic hepatitis B infection affects more than 100 million people and is a major public health problem. Hepatitis B virus is most commonly acquired at birth or early in infancy, and frequently becomes a chronic disease, leading to cirrhosis and liver cancer in adulthood.
In Thailand, more than 2 million adults are currently infected with this virus, about 5 times more than people living with HIV. The World Health Organization has recognized that Thailand has eliminated mother-to-child transmission of HIV and syphilis. The elimination of perinatal transmission of hepatitis B virus is also possible.
A safe strategy
In this study, the international team led by Dr. Gonzague Jourdain, a medical epidemiologist at the IRD, mobilizing Thai, American and European partners, sought to evaluate the efficacy and safety of a new approach to prevent the transmission of the hepatitis virus B in mothers at high risk of transmission. Because of their very high viral load, these mothers may transmit the virus to their child, despite the injection of vaccine and immunoglobulin to the newborn.
The scientific team added to the current strategy (vaccine and immunoglobulin) an antiviral prescribed to the mother (tenofovir disoproxil fumarate or TDF), once a day from the beginning of the third trimester of pregnancy and until 2 months after the birth. There were two objectives for the research: to limit as much as possible the number of children infected at birth and to check that mother could tolerate the treatment.
331 women participated in this trial, randomly divided into two groups: one group received TDF and the other a placebo of identical appearance. No children born in the group of women who received TDF were infected with the virus and the treatment was very well tolerated by the mothers. In the placebo group, only 2% of children were infected, while previous studies reported more transmissions.
Towards the elimination of perinatal transmission of hepatitis B virus in Thailand
Dr. Sombut Thanprasertsuk, Senior Expert from the Department of Diseases Control, Ministry of Public Health, stated that “these results demonstrate that important health issues for South East Asia can be addressed through high quality research in Thailand. These results bring hope of eliminating the risk of mothers transmitting this virus to their infants.”
Jourdain G, Ngo-Giang-Huong N, Harrison L, Decker L, Khamduang W, Tierney C, Salvadori N, Cressey TR, Sirirungsi W, Achalapong J, Yuthavisuthi P, Kanjanavikai P, Na Ayudhaya OP, Siriwachirachai T, Prommas S, Sabsanong P, Limtrakul A, Varadisai S, Putiyanun C, Suriyachai P, Liampongsabuddhi P, Sangsawang S, Matanasarawut W, Buranabanjasatean S, Puernngooluerm P, Bowonwatanuwong C, Puthanakit T, Klinbuayaem V, Thongsawat S, Thanprasertsuk S, Siberry GK, Watts DH, Chakhtoura N, Murphy TV, Nelson NP, Chung RT, Pol S, Chotivanich N. Tenofovir versus placebo to prevent perinatal transmission of hepatitis B. N Engl J Med. 2018 Mar 8;378(10):911-923. doi: 10.1056/NEJMoa1708131. PubMed PMID: 29514030.