Sofosbuvir and ledipasvir (LDV/SOF) are new directly acting antiviral drugs for the treatment
of hepatitis C (HCV) that are highly effective, orally administered, well tolerated and
preclinical evaluations in animal models indicate safe administration during pregnancy. This
project will evaluate the safety and pharmacokinetics of antenatal LDV/SOF treatment for 12
weeks during the second and third trimester. If proven to be effective, antenatal treatment
of HCV with LDV/SOF will prevent maternal HCV-related liver disease, perinatal transmission
of HCV, and community transmission of HCV.
Phase:
Phase 1
Details
Lead Sponsor:
Catherine Chappell University of Pittsburgh
Collaborators:
Gilead Sciences University of Nebraska
Treatments:
Ledipasvir Ledipasvir, sofosbuvir drug combination Sofosbuvir