Ledipasvir/Sofosbuvir for Hepatitis B Virus Infection
Status:
Completed
Trial end date:
2021-06-30
Target enrollment:
Participant gender:
Summary
The goals of therapy against chronic hepatitis B are to decrease the morbidity and mortality
related to chronic HBV infection. Currently available antiviral therapy can suppress viral
replication but only a small proportion attain functional cure, which is defined as HBV
surface antigen-to-antibody seroconversion. Hepatitis B surface antigen (HBsAg) is a marker
of persistent hepatitis B infection.
It has been observed that patients who had both hepatitis B and hepatitis C, and who were
treated for their hepatitis C with 12 weeks of ledipasvir/sofosbuvir for had a decline in
HBsAg levels. This study hypothesizes that a similar decrease would be seen in mono-infected
hepatitis B subjects over the course of 12 weeks treatment with ledipasvir/sofosbuvir.
Phase:
Phase 2
Details
Lead Sponsor:
University of Maryland University of Maryland, Baltimore
Collaborators:
Gilead Sciences KlinEra Global Services
Treatments:
Ledipasvir Ledipasvir, sofosbuvir drug combination Sofosbuvir