Early Response to Individualised Weight-Based PegIntron(R) and Rebetol(R) Hepatitis C Therapy Allows Accurate Prediction of Treatment Success
BRUSSELS, BELGIUM (ots) -
80 Percent of Early Responders Achieve Sustained Response After Full 48-Week
Early Response Can Motivate Patients to Complete Treatment
Early virologic response (EVR) in patients with chronic hepatitis C following
12 weeks of individualised, weight-based dosing of PegIntron(r) (peginterferon
alfa-2b) and Rebetol(r) (ribavirin) combination therapy can accurately predict
the likely outcome of a full, 48-week course of treatment, according to a paper
appearing in the current issue of Hepatology.(1) The findings show that EVR is
important to physicians in making treatment decisions and to patients as a
treatment milestone. This analysis is consistent with the current European Union
(EU) labeling for PegIntron.
As noted in the paper, 76 percent of patients demonstrated an EVR following
12 weeks of individualised, weight-based dosing of PegIntron and Rebetol
combination therapy, and, of those, 80 percent of patients went on to achieve a
sustained virologic response (SVR) after full treatment. EVR is defined as at
least a 99 percent (2 log10) reduction in hepatitis C virus (HCV) load at week
12 of therapy. SVR is defined as the sustained undetectability of HCV six months
following 48 weeks of treatment and is the accepted criterion for efficacy.
The paper also noted that, of the patients who failed to attain an EVR at 12
weeks, none achieved an SVR (100 percent negative predictive value). When cost
was considered, it was estimated that discontinuing treatment in early non-
responders could reduce total overall drug treatment costs nearly 20 percent.
"A 12-week EVR provides patients and physicians with an early goal, and, for
the majority of patients who attain EVR, can motivate treatment adherence and
completion to achieve a sustained virologic response," said Michael P. Manns,
M.D., professor, Department of Gastroenterology and Hepatology, Medical School
of Hannover, Germany. "On the other hand, as noted in the EU labeling for
PegIntron, for patients who do not demonstrate an EVR or take longer to respond
to therapy, physicians should consider discontinuing treatment or continuing it
based on other prognostic factors," he added.
Dr. Manns said that the positive predictive value of individualised, weight-
based dosing of PegIntron and Rebetol combination therapy in this study is very
encouraging in that, of those patients who achieved an EVR, 80 percent went on
to achieve an SVR. He also stated that the 100 percent negative predictive value
of this combination therapy indicates that physicians can predict, with a high
degree of confidence, which patients will not respond to further treatment, and
ensure that therapy is not prematurely discontinued for any potential
PegIntron and Rebetol combination therapy is the most prescribed treatment
for hepatitis C worldwide and is indicated for the treatment of chronic
hepatitis C in patients with compensated liver disease who have not been
previously treated with interferon alpha and are at least 18 years of age. More
than 300,000 hepatitis C patients worldwide, including 150,000 U.S. patients,
have received this combination therapy since its introduction in 2001.
About PegIntron and Rebetol Combination Therapy
PegIntron and Rebetol combination therapy for hepatitis C was approved in the
EU in March 2001. PegIntron had previously received centralized marketing
authorization in the EU and is marketed as a monotherapy in cases of intolerance
or contraindication to ribavirin for the treatment of adult patients with
chronic hepatitis C.
PegIntron is a longer-acting form of Intron(r) A (interferon alfa-2b,
recombinant) Injection that uses proprietary PEG technology developed by Enzon,
Inc. (NASDAQ: ENZN) of Bridgewater, N.J. 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. Schering-Plough holds an exclusive worldwide license to PegIntron.
Rebetol is an oral formulation of ribavirin, a synthetic nucleoside analog
with broad-spectrum antiviral activity. It is approved worldwide for use in
combination with PegIntron or Intron A for the treatment of adult patients with
chronic hepatitis C. Schering- Plough has rights to market oral ribavirin for
hepatitis C in all major world markets through a licensing agreement with ICN
Pharmaceuticals, Inc. (NYSE: ICN) of Costa Mesa, Calif.
Schering-Plough Europe, based in Brussels, Belgium, is part of Schering-
Plough Corporation (NYSE: SGP) of Kenilworth, N.J., USA, a research-based
company engaged in the discovery, development, manufacturing and marketing of
pharmaceutical products worldwide.
Note to Editors: PegIntron and Rebetol are licensed to Aesca in Austria,
Essex Pharma in Germany and Essex Chemie in Switzerland.
(1) Davis GL, Wong JB, McHutchison JG, Manns MP, Harvey J, Albrecht J. Early
virologic response to treatment with peginterferon alfa-2b plus ribavirin in
patients with chronic hepatitis C. Hepatology, Vol. 38, No. 3, 2003, pp. 645-