Lactoferrin
in Combination with Interferon Alfa-2b (Intron A) Does Not Increase
Virological and Biochemical Response Rate in Patients with High
HCV RNA Levels or in Nonresponders and Relapsers to Interferon
Monotherapy
Lactoferrin
(LF), an iron-binding glycoprotein, exhibits several biological
activities, including anti-viral activity and immunomodulatory
functions. LF has been reported to inhibit hepatitis C virus
(HCV) infection in cultured human hepatocytes and HCV viremia
in low pretreatment HCV RNA titers of patients with chronic
hepatitis C (CHC). However, the combination
of interferon (IFN) alfa-2b plus ribavirin with LF
for CHC has not been previously investigated.
Thirty-six
CHC patients, who were positive for HCV RNA with high serum
levels of HCV RNA or who did not respond to or relapsed after
interferon monotherapy, were randomly assigned to two groups:
IFN alfa-2b (Intron A) and ribavirin plus LF for 24 weeks
(18 patients), and IFN alfa-2b and ribavirin plus placebo
(18 patients).
Results
· Treatment
was discontinued in three patients (17%) in the LF
group and eight patients (44%) in the placebo group.
· For
the 25 patients who finished the 24 weeks of treatment, sustained virological
response (SVR) was seen in 6 (40%) patients in the LF group
and in 5 (50%) patients in the placebo group and there was
no statistically significant difference between the two groups
(p=0.7).
· Serum
alanine aminotransferase (ALT) concentrations remained normal throughout
the follow-up period in nine patients (60%) in the LF group
as compared with five patients (50%) in the placebo group
(p=0.7).
· The
proportion of patients with a virological or biochemical response
at the end of the treatment period did not differ between
the two groups.
· There
were no statistically significant differences between the
two groups in hemoglobin
concentration, serum iron, ferritin, Th1/Th2 ratio
or ribavirin concentration throughout the treatment and follow-up
periods.
The
authors conclude, “We could not demonstrate that LF in combination
with IFN alpha-2b and ribavirin increases the virological
and biochemical response rate for CHC patients with high serum
levels of HCV RNA or for CHC patients who do not response
to or relapse after IFN monotherapy.”
Department of Medical Oncology, Hokkaido
University Graduate School of Medicine, N15W7, Kita-ku, Sapporo,
Hokkaido 060-8638, Japan.
06/10/05
Reference
Y
Ishibashi and others. Randomized placebo-controlled
trial of interferon alpha-2b plus ribavirin with and without
lactoferrin for chronic hepatitis C.
Hepatology Research.
June 1, 2005 [Epub ahead of print].
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