Published: Nov 4, 2013 | Updated: Nov 4, 2013
By Ed Susman , Contributing Writer, MedPage Today
Note that this study was published as an abstract and presented at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal.
WASHINGTON -- Pregnant women being treated for hepatitis B virus infections with the nucleotide inhibitor tenofovir (Viread) appeared to avoid transmission of the pathogen to their unborn children, researchers reported here.
Of the 14 pregnancies followed through to delivery, no cases of positive hepatitis B surface antigens were found among the infants, and no birth defects were observed even among the 12 women who took tenofovir throughout the pregnancy -- including the first trimester, said Christiane Stern, MD, senior medical scientist for Gilead Sciences, Boulogne, France, who presented the poster on behalf of a consortium of French doctors and hospitals who participated in the VIREAL study.
"In a hepatitis B virus real-life cohort, tenofovir treatment during pregnancy was well-tolerated, including in patients treated from the first trimester. No safety issues were reported for breastfeeding while on tenofovir up to 1 year," Stern told MedPage Today, at the American Association for the Study of Liver Diseases meeting.
She said five women reported breastfeeding, including three women taking tenofovir.
The researchers from three dozen hospitals in France recruited 441 chronic hepatitis B patients who were treated with tenofovir from June 2008 to April 2010. There were 16 pregnancies in the study cohort, and in 14 of them there was enough follow-up data for analysis.
In 11 of the 14 cases women were on tenofovir throughout the pregnancy; in one case treatment with tenofovir was commenced at 4 weeks of gestation. The other two cases involved women whose high level of hepatitis B status was discovered late in pregnancy who were given tenofovir after 20 weeks and 30 weeks to prevent mother-to-child transmission.
"As clinicians, this is information that we need to tell our patients," said Alexander Lalos, MD, a private practice gastroenterologist and a member of the adjunct faculty of Commonwealth Medical College in Scranton, Pa. "Many women want to know if it is safe to take certain medications while they are pregnant. Now we can say that there is a study which shows that it is safe."
Lalos told MedPage Today that preventing mother-to-child transmission of hepatitis B virus is crucial in breaking the cycle in which women pass on infection to their children, creating chronic infection which can then be passed on to others. "About 10% of mothers with hepatitis B virus infection transmit the virus to their newborns if they are not treated," he said.
Stern illustrated that all but two of the babies were full term (37 weeks or greater); one child was born at 34 weeks and one at 35 weeks. There were two Cesarean deliveries. In 11 cases where Apgar scores were recorded, all received scores of 10 at 10 minutes.
"Mother-to-child transmission is one of the main routes of hepatitis B virus transmission and the risk of transmission increases if the pregnant woman has virus DNA greater than 6-7 log IU/mL at delivery," Stern said. "Antiviral therapy given during the last trimester of pregnancy, in association with serovaccination of the newborn, can reduce the risk of mother-to-child transmission. However, tenofovir use from the first trimester has not been well-documented in patients with hepatitis B virus monoinfection."
The study was funded by Gilead Sciences.
Stern is an employee of Gilead.
Lalos had no disclosures.
Primary source: American Association for the Study of Liver Diseases
Source reference: Ganne-Carrie N, et al "Efficacy and safety results of tenofovir DF (TDF) treatment from the first trimester in HBV pregnant women in real-life clinical practice" AASLD 2013.