Back to Search Start Over

A Phase 2 open label study of ledipasvir/sofosbuvir for 12 weeks in subjects with hepatitis B virus infection

A Phase 2 open label study of ledipasvir/sofosbuvir for 12 weeks in subjects with hepatitis B virus infection

Authors :
Angie S. Price
Amy K. Nelson
Alip Ghosh
Shyamasundaran Kottilil
Joel V. Chua
Source :
Journal of medical virologyREFERENCES.
Publication Year :
2022

Abstract

Retrospective data showed that when we administered ledipasvir/sofosbuvir (LDV/SOF) to patients with hepatitis B and C coinfection, there was a modest reduction in hepatitis B surface antigen (HBsAg). Therefore, we hypothesize that similar HBsAg reduction can be seen in hepatitis B virus (HBV) monoinfected subjects. Primary and secondary efficacy endpoints are the decline in HBsAg and HBV DNA at Week 12 from baseline, respectively. We conducted an open-label Phase 2 pilot study to evaluate the safety, tolerability, and antiviral activity of LDV and/or SOF for HBV. Eligible subjects were either suppressed on antivirals (Group B) or inactive chronic HBV (Group A, C, D). Group A and B received LDV/SOF. Group C and D received SOF 400 mg and LDV 90 mg, respectively. All subjects completed the study, and all related adverse events (AEs) were mild. No discontinuations due to AEs or hepatitis flare occurred. At Week 12, HBsAg decline (log

Subjects

Subjects :
Infectious Diseases
Virology

Details

ISSN :
10969071
Database :
OpenAIRE
Journal :
Journal of medical virologyREFERENCES
Accession number :
edsair.doi.dedup.....4abe21cc191cd1493d1f335af21a1dd4