ALT evalation two months into therapy predicts outcome
ALT evaluation during the second month of interferon treatment
is a simple and inexpensive method of identifying chronic hepatitis
C patients who will fail therapy, according to a report from
Italy.
The report was one of several examining the predictive value of
ALT during therapy for chronic hepatitis presented at the VII
International Symposium on Viral Hepatitis, held January 25-27,
1996 in Madrid, Spain.
Researcher O. Fracassetti and colleagues conducted a
retrospective evaluation of patients with chronic hepatitis C and
no signs of cirrhosis treated with interferon-alpha (IFN-(alpha)),
with particular regard to the association between changes in serum
ALT levels during the first months of treatment and response to
therapy.
A total of 170 patients (105 males and 65 females, mean age 45
years), who were HBsAg and HIV negative and HCV antibody positive
by ELISA and RIBA methods, were included in the study. The subjects
were treated between 1988 and 1993 for histologically proven
chronic active hepatitis C with no histological signs of cirrhosis.
The disease course of patients was retrospectively evaluated in
order to assess early- and long-term response to IFN-(alpha)
treatment and the possible predictive value for outcome of serum
ALT level changes during the first months of treatment.
A total of 134 patients received conventional doses of
recombinant or lymphoblastoid IFN-(alpha) (CD: 3 MU t.i.w. for 12
months), whereas 36 patients were treated with higher doses (HD: 9
MU t.i.w.. for three months and then 3 MU t.i.w. for nine months).
Patients were defined as non-responders (NR), whose ALT did not
normalize within the fourth month of therapy; primary responders
(PR), who presented with normal ALT at the end of therapy;
relapsers (RR), whose ALT raised again during follow-up; long-term
responders (LTR), who presented with persistently normal ALT after
at least 12 months of follow-up.
Twenty-six patients with breakthrough after initial response to
the treatment were excluded from the analysis. Eighty-four out of
144 patients (58.3 percent) were primary responders (56 percent CD
and 68 percent HD), whereas 60 patients were non responders. Three
out of 84 primary responders versus all of the non responders (100
percent) had abnormal ATL at the second as well as the fourth month
of treatment.
Thirty-one out of 84 primary responders (37 percent) were
relapsers (38 percent CD and 31 percent HD); relapses occurred a
mean of 2.9 months (range 1-9) after treatment discontinuation.
Fifty-three out of 144 treated patients (36.8 percent) were LTR;
serum HCV RNA, detected by PCR method, was positive in nine out of
24 (37. 5 percent) tested LTR.
"We observed a higher rate of long-term responses after
IFN-(alpha) treatment of chronic hepatitis C than reported in
literature (36.8 percent versus 18-25 percent), probably because we
excluded patients with cirrhosis from the evaluation," Fracassetti
et al. wrote in an abstract presented at the Madrid conference. "We
observed that ALT normalization at the second month of treatment in
this population is a simple, efficient and inexpensive method for
identifying patients who will take advantage from IFN-(alpha)
treatment; furthermore, ALT are useful independently from the
knowledge of viral genotype or viremia levels at baseline. In
contrast, they do not seem to be useful in order to identify LTR,
whereas normal ALT associated with loss of viremia within the
second month of treatment are probably predictive of long-term
response."
The corresponding author for this study is O. Fracassetti,
Division of Infectious Diseases and Department of Pathology,
Ospedali Riuniti, Bergamo, Italy.
Hepatitis Weekly, 03-11-1996, pp 4.
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