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705
ONGOING ANALYSIS OF FUNCTIONAL CONTROL / CURE OF
HBV AND HDV INFECTION FOLLOWING REP 2139-CA AND
PEGYLATED INTERFERON ALPHA-2a THERAPY IN PATIENTS
WITH CHRONIC HBV / HDV CO-INFECTION: 3-YEAR FOLLOWUP
RESULTS FROM THE REP 301-LTF STUDY
Michel Bazinet1, Victor Pântea2, Valentin Cebotarescu2, Lilia
Cojuhari2, Pavlina Jimbei3, Adalbert Krawczyk4,5, Ulf Dittmer6
and Andrew Vaillant1, (1)Replicor Inc., (2)Department of
Infectious Diseases, Nicolae Testemiţanu State University of
Medicine and Pharmacy, (3)Toma Ciorbă Infectious Clinical
Hospital, (4)Institute for Virology, University Hospital Essen,
University of Duisburg-Essen, (5)Department of Infectious
Diseases, University Hospital Essen, University of Duisburg-
Essen, (6)Institute of Virology, University Hospital Essen,
University of Duisburg-Essen
Background: HBV / HDV co-infection represents a
significant unmet medical need, causes rapid progression
of liver disease and has no approved therapy REP 2139 is
a nucleic acid polymer which blocks the assembly of HDV
and HBV subviral particles, preventing release of HDV and
HBsAg while simultaneously lowering intracellular HBsAg
REP 2139 also directly targets HDAg to block HDV replication
upstream from its secretion REP 2139-Ca and pegylated
interferon clear both HBsAg and HDV RNA in the majority of
patients during therapy and initial follow-up demonstrated the
establishment of functional control of HBV (HBV DNA ≤ 2000
IU/mL, normal ALT) in 5/12 patients, functional control of HDV
(HBV RNA > 2 log10 reduction from baseline, normal ALT) in
8/12 patients. Functional cure of HDV (HDV RNA TND) was
further established in 7/12 patients and functional cure of HBV
(HBsAg < LLOQ, HBV TND) was further established in 4/12
patients A three-year supplemental follow-up study (REP
301-LTF, NCT02876419) is currently examining the longterm
stability of the functional control / cure of HBV and HDV
infection achieved in the REP 301 study (NCT02233075)
Methods: All REP 301 study participants completing therapy
were enrolled in the REP 301-LTF study Follow up safety
and efficacy evaluations are scheduled every 6 months
(for a period of three years) following the original 24-week
follow-up in the REP 301 study. Virologic status was verified
using Architect (HBV) and Robogene MKII (HDV RNA) test
platforms Hepatic stiffness was monitored by Fibroscan
Results: Currently, 5/11 participants have completed 3 years
of follow -up and 6/11 2 5 years of follow-up Functional
control of HBV, functional control/cure of HDV and ALT
normalization previously established is persisting in all
patients One participant transitioned from functional cure of
HBV at 2 years of follow-up to functional control at 2.5 years
follow-up (currently 0.15 IU/mL HBsAg, HBV DNA < LLOQ).
Two participants with functional cure of HDV have shown
improvement in their functional control of HBV with HBV DNA
declines transitioning from 183 IU/mL to TND and from 1904
to 105 IU/mL respectively Median hepatic stiffness continues
to decline or is stable in all participants Conclusion:
Functional control / cure of HDV and HBV infection achieved
with REP 2139 and pegIFN is stable at 3 years follow-up
and is associated with persistently normal liver function and
progressive reduction in median hepatic stiffness. |
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发表于 2019-10-25 17:50