Fernandez JL, Rendo P, del Pino N, Viola L, Cusumano A, HCV
Study Group
A controlled trial of interferon alfa 2b in hemodialysis
patients with chronic hepatitis C
Am Soc Nephrol
J Am Soc Nephrol (abstract)
(Sep) 7:1446 1996
Hepatitis C virus (HCV) infection is an important cause of liver
disease in patients on dialysis [1]. Interferon therapy (IFN-alfa 2b)
has been used with some degree of success in non-renal patients with
chronic liver disease due to hepatitis B, C and D [2-10]. Recent
studies have reported the use of IFN-alfa 2b therapy in hemodialysis
patients with chronic viral hepatitis [11-15]. However, as was found in
the studies of non-renal patients, relapses are common after stopping
therapy. The purpose of this study is to further assess the safety
and efficacy of IFN-alfa 2b in hemodialysis patients with chronic hepatitis
C.
The authors conducted a double-blind prospective controlled trial of
the use of IFN-alfa 2b in 23 hemodialysis patients with chronic hepatitis C
(as defined by positive antibodies to hepatitis C), and chronic
alanine aminotransferase (ALT) elevation (more than 1.5 fold normal
values during at least six months). Group I consisted of 14 patients
who received IFN-alfa 2b therapy at an initial dose of 1.5 MU (increasing to
3 MU if no response was observed for three months) during six months,
and Group II consisted of 9 patients who received placebo (albumin)
during the same period. Twelve patients in Group I received 1.5 MU
and two patients received 3 MU over a six month period. There was a
normalization of ALT at six months in 10/14 (71.4%) of patients from
Group I and in 1/9 (11.1%) from Group II (p <0.01), and at one year in
4/14 (28.6%) from Group I and in none from Group II (NS). Serum HCV
RNA was not detected in 4/14 (28.6%) of patients from Group I at six
months and in none from Group II (NS). At twelve months serum HCV RNA
was undetectable in 2/14 (14.2%) from Group I and none from Group II
(NS). Side effects resulting in an interruption of therapy occurred
in 3/14 (21.4%) of patients from Group I (depressive syndrome 2,
leukopenia 1) and in 2/9 (22.2%) from Group II (fever and ascites 1,
asthenia 1). Hence, the authors concluded that approximately 15% in
the study group achieved a sustained virological response (absence of
HCV RNA at one year), and that IFN-alfa 2b therapy at this dose appears to
be appropriate therapy for hemodialysis patients with chronic
hepatitis C.
Comment: The study is prospective,
randomized and double-blind which certainly helps to eliminate bias.
The number of patients is small and the duration of follow-up is short
(one year). Their dose of IFN-alfa 2b is less than that used in other
studies which was typically 3MU starting dose [11-13]. Their sustained
normalization of ALT and virologic responses at one year are better
than those reported in non-renal and renal patients [2-10, 12, 13].
While this study is no doubt encouraging, the long-term efficacy of
IFN-alfa 2b remains incompletely defined. Further, whether IFN-alfa 2b
induced
remission achieved before transplantation is sustained after
transplantation needs to be ascertained.
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(Reviewed by : Beth A. Bouthot, M.D. and Brian J. G.
Pereira, M.D., Division of Nephrology, New England Medical Center,
Boston, MA)
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Am Soc Nephrol
CRF by organ system :
GI/Liver, Hepatitis