| Peginterferon
Alfa-2b (PegIntron) as Maintenance Monotherapy for HIV-HCV Coinfected Patients:
The ENDURE Study Schering-Plough
(SP) has announced that the company is initiating a large multinational clinical
trial to evaluate the use of low-dose
PegIntron (peginterferon alfa-2b) maintenance monotherapy to prevent
or delay the progression of chronic hepatitis C. The objective is to reduce the
onset of clinical events such as liver
transplantation, liver
cancer and death
in cirrhotic
patients with hepatitis C who are coinfected with HIV. Called
the ENDURE study, the trial aims to enroll 448 patients at approximately
80 sites worldwide, including centers in the United States, Europe and Canada. Following
is the text of the SP announcement about the trial: “Approximately
one third of HIV patients, or about 10 million people worldwide, are coinfected
with the hepatitis C virus (HCV) and HIV. Liver
disease caused by chronic hepatitis C is now a leading cause of
morbidity and mortality
among HIV-infected patients in the developed world. Furthermore, studies have
shown that HCV can aggravate the course of HIV infection. “The
principal goal for treating patients infected with hepatitis C is viral
eradication, with pegylated
interferon and ribavirin combination therapy being the current
standard of care. However, many coinfected patients fail to respond to this combination
therapy and there currently is no approved treatment for such patients. Until
more effective HCV agents such as protease and polymerase inhibitors are available,
it is critically important to try to prevent or delay progression of liver disease
in these patients,” said Mark S. Sulkowski, M.D., associate professor of medicine
in the Division of Infectious Diseases, Johns Hopkins University School of Medicine,
Baltimore, USA,
and co-lead investigator of the study. “Another
patient group that may benefit from low-dose PegIntron maintenance monotherapy
is cirrhotic patients with coinfection who are ineligible for combination therapy
due to contraindications to ribavirin or who simply cannot tolerate full-dose
combination therapy,” added co-lead investigator Massimo Puoti,
M.D., associate professor in the Department of Infectious Diseases, University
of Brescia, Italy, directed by professor G. Carosi. “The purpose of the ENDURE study is to address this
question with a large, randomized, controlled clinical study.” Study Design “ENDURE
is a randomized, open-label, multicenter, Phase III, parallel-group clinical study
evaluating the efficacy and safety of maintenance therapy with low-dose PegIntron
(0.5 mcg/kg once weekly) versus standard supportive care in patients with cirrhotic
hepatitis C who are coinfected with HIV. “The
primary objective of the study is to compare efficacy for the two treatment groups
at the end of the study, using the time to any of the following clinical events
as primary endpoints: death, liver decompensation, liver transplant or liver cancer
(hepatocellular carcinoma). All patients will be enrolled within the first 12
months of this 36-month study and treated until the end of the study or until
a clinical event occurs. Written informed consent will be obtained and all other
regulatory requirements adhered to for all patients participating in the study. The
slides posted with this article include the entry and exclusion criteria of the
ENDURE study.
“The
ENDURE study is consistent with Schering-Plough’s research strategy to conduct
and support clinical studies with weight-based
PegIntron therapy, particularly in hepatitis patients with difficult-to-treat
forms of the disease. “Although
we have made great advances over the past decade in the effective treatment of
chronic hepatitis C, one of the most common blood-borne infections in the world,
improved treatment options are still needed” said Robert J. Spiegel, M.D., chief
medical officer and senior vice president of medical affairs, Schering-Plough
Research Institute. “ “Schering-Plough
is undertaking studies with our existing hepatitis C products to explore new approaches
to treatment, including maintenance therapy with our ongoing EPIC
3 study * in HCV patients and the new ENDURE study in coinfected
patients, while at the same time developing new antiviral agents such as our investigational
hepatitis C protease inhibitor.** These research efforts underscore our long-term commitment
to this therapeutic area and the hepatitis community.” About PegIntron PegIntron
is approved in the United States
as monotherapy and for use in combination therapy with Rebetol (ribavirin, USP)
for the treatment of chronic hepatitis C in patients with compensated liver disease
who are at least 18 years of age, and is not approved for treatment of patients
who are coinfected with HCV and HIV. PegIntron,
recombinant interferon alfa-2b linked to a 12,000 dalton
polyethylene glycol (PEG) molecule, is a once-weekly therapy dosed according to
patient body weight that is designed to achieve an effective balance between antiviral
activity and elimination half-life. “ *
EPIC 3 (Evaluation of PEG-INTRON in Control of
Hepatitis C Cirrhosis), a large multicenter, multi-part treatment
and maintenance therapy clinical study involving nearly 4,000 patients at approximately
140 sites worldwide. Schering-Plough Research Institute. **
SCH-503034, an investigational oral HCV NS3 protease inhibitor, Schering-Plough
Research Institute. 01/17/06 Source
Schering-Plough. SCHERING-PLOUGH INITIATES PEG-INTRON® MAINTENANCE STUDY
IN PATIENTS COINFECTED WITH HEPATITIS C AND HIV. Press Release.
January 13, 2006.
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