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Zika virus (ZIKV) infection in pregnancy is associated with adverse fetal outcomes, such as microcephaly and other congenital malformations. No therapeutic options are available to pregnant women with ZIKV infection to prevent these effects. Drug trials in pregnancy raise several scientific, ethical, and logistic challenges, which are compounded further in ZIKV because of limited knowledge of the disease pathophysiology and a product development pipeline in its infancy. We evaluate the major challenges in choosing therapeutics to prevent congenital ZIKV disease and conducting clinical trials of these treatments, with a focus on preventing congenital central nervous system malformations. These challenges must be characterized and planned for now so that clinical trials can progress expediently and effectively in the future.

Original publication




Journal article


Ann Intern Med

Publication Date





725 - 732


Antibodies, Antiviral Agents, Clinical Trials as Topic, Female, Humans, Immunity, Cellular, Microcephaly, Placenta, Pregnancy, Pregnancy Complications, Infectious, Proto-Oncogene Proteins, Receptor Protein-Tyrosine Kinases, Teratogens, Virus Replication, Zika Virus Infection