Clinical Trials of Therapeutics for the Prevention of Congenital Zika Virus Disease: Challenges and Potential Solutions
Alex P Salam, Amanda Rojek, Jake Dunning, Peter W Horby
ANNALS OF INTERNAL MEDICINE | AMER COLL PHYSICIANS | Published : 2017
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. Thes..View full abstract
Awarded by Wellcome Trust of Great Britain
Awarded by European Union FP7 project PREPARE (Platform for European Preparedness Against [Re-]emerging Epidemics)
Awarded by Medical Research Council UK
Peter Horby is supported by the Wellcome Trust of Great Britain (grants 107834/Z/15/Z and 106491/Z/14/Z), European Union FP7 project PREPARE (Platform for European Preparedness Against [Re-]emerging Epidemics; grant 602525), and Medical Research Council UK (MC_PC_15001). Dr. Rojek is funded by a Rhodes Scholarship.