(Reuters Health) – Hyperimmune globulin therapy given to pregnant women with a cytomegalovirus (CMV) infection fails to protect their babies from congenital CMV infection or perinatal death, doctors behind a new study have concluded.
The test of the expensive, time-consuming monthly treatment was stopped early for futility after 22.7% of the children in the hyperimmune globulin group became infected or died – either in utero or shortly after birth — compared with 19.4% of the babies whose mothers received a monthly placebo infusion up to delivery (P=0.42).
By other measures used in the study, the therapy tended to produce worse outcomes, although none were statistically significant.
Neonatal or fetal death rates were 4.9% with hyperimmune globulin therapy versus 2.6% with placebo. Preterm birth rates were 12.2% and 8.3% respectively. The odds of the baby’s birth weight being below the 5th percentile were 10.3% and 5.45.
The age of the mother did not affect the results.
“The outcomes, unfortunately, were not even suggestive of benefit. Not even a single outcome was suggestive of improvement, which is quite disappointing,” chief author Dr. Brenna Hughes of Duke University in Durham, North Carolina, told Reuters Health in a telephone interview.
Nearly 400 women participated in the study, designed to prevent the risks of stillbirth, neonatal death, deafness, and both cognitive and motor delay often seen when there is a CMV infection. Up to 40,000 fetuses are infected by CMV in the U.S. each year.
A 2005 study, also published in the New England Journal of Medicine, “almost made it look like a miracle cure,” said Dr. Hughes.
Based on that result, and in spite of subsequent research suggesting that the treatment wasn’t a miracle at all, “in some areas, it is used routinely,” she said. “It isn’t currently recommended by any governing bodies, but it was fairly widespread in some regions of the country.”
In some areas, it is used very aggressively. Each infusion costs thousands of dollars.
The new findings may quell that enthusiasm.
Dr. Hughes, vice chair for obstetrics and quality at Duke, noted that the study only looked at hyperimmune globulin for prevention. “Someone may want to do a trial for treatment,” she said.
“There has been inadequate research and funding for research in this area, given how severe the outcomes can be,” she added. “I hope this trial will draw attention to the need for treatments and vaccines.”
SOURCE: https://bit.ly/3zpxgFY The New England Journal of Medicine, online July 28, 2021.
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