Hepatitis C Clinical Trial
Official title:
The Impact of Peginterferon Alpha-2a Maintenance Therapy on Portal Hypertension in Patients With Chronic Hepatitis C Virus Infection and Advanced Fibrosis and Cirrhosis Enrolled in the HALT-C Trial
The primary purpose of this study is to determine if peginterferon alpha-2a maintenance therapy (90 mcg/week) will lower portal pressure in patients with hepatitis C virus infections and advanced fibrosis or cirrhosis.
Portal hypertension develops in patients with advanced fibrosis and cirrhosis and is the
primary driving force leading to complications of cirrhosis, hepatic decompensation and
mortality in patients with chronic liver disease. None of the three major complications of
advanced liver disease variceal hemorrhage, ascites and hepatic encephalopathy occur in the
absence of portal hypertension. As a result, measuring portal pressure and treating portal
hypertension is an important part in the management of patients with advanced liver disease.
A sub-study to measure portal pressure was initially proposed as part of the HALT-C clinical
trial. Unfortunately, only 2/10 centers elected to participate in this sub-study and as a
result, this was eventually dropped as a sub-study within the HALT-C trial.
Recent data has suggested that interferon therapy may selectively reduce portal hypertension
in patients with cirrhosis. In an abstract presented at the 2004 annual meeting of the
European Association for the Study of the Liver (EASL), portal pressure declined
significantly in patients with NR after 6 months of treatment with peginterferon and
ribavirin. At the time portal pressure was measured in this study, a transjugular liver
biopsy was also performed to assess the effects of treatment on hepatic histology. Despite a
reduction in portal pressure, no reduction in hepatic fibrosis score was observed. This
suggested that interferon may reduce portal pressure through a direct affect on the hepatic
vasculature; and suggests that interferon may prevent complications of cirrhosis regardless
of its effects on HCV RNA and hepatic inflammation. Since portal pressure is the primary
factor responsible for complications of cirrhosis including variceal hemorrhage, ascites and
hepatic encephalopathy, these preliminary results suggest that maintenance interferon
therapy could possibly prevent these complications.
Preliminary results form a randomized, controlled trial of maintenance interferon therapy
(Co-Pilot) presented at the 2004 annual meeting of the American Association of the study of
Liver Disease (AASLD) did in fact demonstrate that patients with advanced fibrosis or
cirrhosis who received maintenance peginterferon maintenance therapy over a two year period
had a significant reduction in the incidence of variceal hemorrhage compared to that
observed in the control group. The HALT-C trial provides an ideal patient population in
which to further assess the effects of maintenance interferon therapy on portal
hypertension.
The first patients who were enrolled into the HALT-C trial are scheduled to complete four
years of maintenance therapy near the end of 2004. This provides an optimal time point at
which to assess the impact of maintenance interferon therapy on portal pressure. Although an
ideal study design would have been to measure portal pressure at baseline and then again
after 4 years in both the control and treatment groups, measuring portal pressure at the
completion of the study will still provide significant information regarding the impact of
maintenance interferon therapy on portal hypertension. The number of patients enrolled into
HALT-C at these two sites is substantial (nearly 400 patients) and since the control and
maintenance therapy groups were well matched at the start of the study we can assume that
baseline portal pressure at the time of randomization was not significantly different in the
two groups. Thus, if 4 years of maintenance interferon therapy does indeed reduce portal
pressure a significant difference in mean portal pressure should be observed between the two
groups at the completion of the HALT-C trial.
Patients who were randomized to the control arm of HALT-C during the past four years have
received no treatment for chronic HCV during the past 4 years. Such patients will be offered
the opportunity to receive peginterferon maintenance therapy for 6 months as part of this
protocol and then undergo repeat measurement of portal pressure to determine if they could
potentially benefit from remaining on peginterferon maintenance therapy long term
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