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EASL 2018 FRI-326
Establishment of persistent functional remission of HBVand HDV
infection following REP 2139 and pegylated interferon alpha 2a
therapy in patients with chronic HBV/HDV co-infection: 18 month
follow-up results from the REP 301-LTF study
M. Bazinet1, V. Pantea2, V. Cebotarescu2, L. Cojuhari2, P. Jimbei3,
A. Vaillant1. 1Replicor Inc., Montreal, Canada; 2Nicolae Testemitanu State
University of Medicine and Pharmacy, Chisinau, Moldova; 3Toma Ciorba
Infectious Clinical Hospital, Chisinau, Moldova
Email: [email protected]
Background and Aims: HBV/HDV co-infection represents a significant
unmet medical need, causes rapid progression of liver disease
and has no approved therapy. The previous REP 301 study
(NCT02233075) demonstrated the safety and tolerability of REP
2139 in combination with pegylated interferon alpha 2a (pegIFN) and
the establishment of functional control of HBV (in 5/12 patients) and
HDV (in 9/12 patients) which persisted after the removal of all
antiviral therapy (functional remission) in 7 patients (HDV RNA
target not detected), 5 of whom also maintained functional remission
of HBV (HBsAg < LLOQ, HBV DNA < LLOQ). A three-year supplemental
follow-up study (REP 301-LTF, NCT02876419) is currently examining
the long-term stability of the functional remissions of HBV and HDV
infection achieved in the REP 301 protocol.
Method: All patients completing the proscribed therapy in the REP
301 study were eligible to participate in this study. Supplemental
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) test platforms. Hepatic
stiffness was monitored by Fibroscan.
Results: Of the seven patients which achieved functional remission of
their HDV infection at the end of the 24-week follow-up in REP 301
study, all are still maintaining HDV RNA target not detected at 1.5
years of follow-up. Five of these patients also had functional
remission of their HBV infection, which is still persisting in 4
patients. In the fifth of these patients, HBV infection is still well
controlled (HBV DNA < LLOQ). In all seven patients with functional
remission of HDV at 1.5 years of follow-up, liver function is normal
and is accompanied by continual reductions in median hepatic
stiffness, now below pre-treatment levels in 6 of 7 patients.
Of the remaining five patients who did not achieve functional
remission of HBV or HDV infection, new HDV RNA setpoints >1log
below baseline are persistent in 2 patients and are accompanied by
normal liver function or reduced/stable median hepatitis stiffness.
Conclusion: Functional remission of HDV and HBV infection achieved
with REP 2139 and pegIFN is stable at 1.5 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 2018-4-5 05:59
