Does CMV-HIG Have an Effect on Congenital Infections?

Brenna Hughes, MD, MSc, Division Director of Maternal Fetal Medicine at Duke University, discusses the hypothesis that CMVHIG could have an effect on stopping congenital infections, as well as results of the trial.

Interview Transcript (modified slightly for readability):

Contagion®: Why did you hypothesize that CMVHIG could have an effect on stopping congenital infections or fetal deaths?

Hughes: The reasons we thought that CMV hyperimmune globulin might prevent congenital infection of CMV are a couple. First, there's a long history of hyperimmune globulins potentially stopping infections during pregnancy. The second is there were prior data done in Europe that suggested that there might be some benefit of administration of hyperimmune globulin to prevent congenital CMV.

Contagion®: Can you summarize the data from the 399 patients who completed the trial?

Hughes: Yes, the trial was stopped early at enrollment of 399 patients, because the data safety monitoring board felt that the likelihood of showing benefit was so low that there was not any potential benefit of continuing the trial at that point. What we found, unfortunately, is that CMV hyperimmune globulin did not decrease the rates of congenital infection or fetal death among women with primary CMV infection during pregnancy. We also found that it did not decrease the risk of symptomatic congenital infection among those that were infected. And there was an increase in some of the side effects that we were looking for among women who actually received hyperimmune globulin. So unfortunately, we found that it did not benefit women or their fetuses or infants and potentially had increased side effects.