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1027
REGRESSION OF LIVER FIBROSIS FOLLOWING 48 WEEKS OF
THERAPY WITH PEGINTERFERON LAMBDA IN PATIENTS WITH
CHRONIC HEPATITIS DELTA VIRUS (HDV) INFECTION
David Yardeni1,2,3, Ignacio Shtarker4, Anat Nevo-Shor1,
Daniela Munteanu1, Naim Abufreha3 and Ohad Etzion2,3,5,
(1)Gastroenterology and Liver Diseases, Soroka University
Medical Center, (2)Gastroenterology & Liver Diseases,
Soroka University Medical Center, (3)Faculty of Health
Sciences, Ben-Gurion University of the Negev, (4)Department
of Pathology, Soroka University Medical Center, (5)Liver
Diseases Branch, National Institute of Diabetes and Digestive
and Kidney Diseases
Background: Chronic hepatitis delta virus (HDV) infection
is the most severe form of hepatitis for which there is no
approved treatment HDV is associated with accelerated liver
fibrosis, liver cancer and liver failure. Recently, administration
of peginterferon lambda (Lambda) for 48 weeks was shown
to induce a durable virologic response (HDV RNA below
limit of quantification at 24 weeks post-treatment) in 36% of
patients with HDV and compensated liver disease (Phase 2
LIMT Study, NCT02765802) Impact of Lambda therapy on
liver histology was not assessed in the LIMT study Herein
we report two case reports of regression of liver fibrosis
following Lambda treatment in patients with HDV Methods:
Two patients from the LIMT study, who had liver biopsies prior
to study randomization, treated with subcutaneous injections
of Lambda 180 mcg once weekly for 48 weeks, followed by
a 24 week follow-up period, were evaluated with liver biopsy
18 months after last Lambda injection Liver biopsies, staged
according to the ISHAK scoring system, were compared with
results of historical biopsies of the patients HDV RNA viral
load and ALT levels were assessed at baseline (BL), end
of treatment (EOT) and end of study (EOS) Fibroscan was
performed at BL and EOS Results: In Patient 1, a 64-yearold
male, HDV RNA level was 3 7 log10 at BL, became
undetectable at EOT and rebounded to 2 6 log10 at EOS ALT
was 169 U/L at BL, declined to 55 U/L at EOT and remained
at 54 U/L at EOS Fibroscan scores declined from 20 kPa at
BL to 9 9 kPa at EOS Comparison of historical liver biopsy
to biopsy following Lambda treatment was significant for
reduction in fibrosis score from F5 (incomplete cirrhosis) to
F1 (mild portal fibrosis). In Patient 2, a 37-year-old female,
HDV RNA was 4 9 log10 at BL, became undetectable at EOT
and rebounded to 3 6 log10 at EOS ALT was 159 U/L at BL,
declined to 44 U/L at EOT and peaked to 162 U/L at EOS
Fibroscan score of 7 7 kPa at BL increased to 11 1 kPa at
EOS Comparison between the patient’s historical and posttreatment
biopsies showed reduction in fibrosis score from
F4 (marked bridging fibrosis) to F1. Conclusion: This is
the first report demonstrating fibrosis regression following
finite duration therapy with Lambda in patients with chronic
HDV, the most severe form of hepatitis for which there is
no approved treatment These case studies suggest clinical
benefit in the liver after 48 weeks of Lambda therapy in the
absence of HDV RNA clearance. |
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发表于 2020-11-3 21:01