TDF reduces the transmission of HBV vertical -
By Shreeya Nanda
The transmission of hepatitis B (HBV) infection from mother to child is reduced with disoproxil fumarate tenofovir (TDF) treatment in the third quarter of patients in chronic HBV pregnant with a high viral load, show the results of a trial conducted in China.
The study included 0 B e antigen of hepatitis (HBeAg) -positive pregnant women with HBV DNA levels more than 0,000 IU / mL. They were randomly assigned to receive either TDF 300 mg / day, from 32 to 34 weeks of gestation and up to 4 weeks after delivery or usual care without antiviral treatment. The women were followed through week 28 post-partum; All pregnancies were single question and all infants received HBV immunoprophylaxis.
In the analysis by intention to treat, which included all women, except those who withdrew consent before treatment begins, the TDF treatment significantly reduced the vertical transmission rates 28 weeks, with the transmission to 5% of 97 children, against 18% of the 100 children born to mothers who received usual care ( p = 0.007).
The results were similar in the per protocol analysis that excluded participants who withdrew consent, discontinued treatment for any reason or have been lost sight of. The mother-child transmission rate was 0% for the 92 children born to women TDF-treated and 7% for the 88 children of women not given antiviral treatment, a significant difference ( p = 0, 01).
Furthermore, during childbirth, 68% of 97 women who received TDF had HBV DNA levels less than 0 000 IU / ml - it was significantly higher than the 2% 100 women in the control arm ( p <0.001). However, there was no difference between groups regarding the loss or seroconversion of HBeAg surface antigen or hepatitis B at week 28, which, the authors say, is "not unexpected because patients received only about 12 weeks of antiviral therapy. "
in the article published in The New England Journal of Medicine Calvin Pan (NYU Langone Medical Center, USA) and his fellow researchers also report safety instructions in infants who were comparable between infants whose mothers did and did not receive TDF, including the incidence of congenital malformations or defects (2 vs 1%).
the maternal side effect profiles were generally similar between TDF and arms control, except that a longer proportion of TDF-treated women had high levels of creatine kinase (7 vs 0%; p = 0.006) during treatment and elevation of alanine aminotransferase after stopping treatment (45 vs 30%; p = 0.03).
researchers believe that TDF "can be useful to prevent mother to child transmission, which is a crucial step towards the global eradication of HBV and a reduction in the incidence of liver cancer."
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