Peginterferon and Ribavirin Combination Therapy Recommended

BRUSSELS, Belgium, Jan. 28 /PRNewswire/ -- Schering-Plough Europe, which markets PegIntron(R) (peginterferon alfa-2b) Injection and Rebetol(R) (ribavirin) Capsules for chronic hepatitis C, commends the United Kingdom's National Institute for Clinical Excellence (NICE) for its guidance on the clinical management of chronic hepatitis C, a potentially life-threatening disease. The official guidance recommends the use of pegylated interferon in combination therapy with ribavirin(1), and specifically acknowledges that this combination therapy is both clinically effective and cost effective compared with standard interferon alfa combination therapy.(2)

The NICE decision is welcomed news for the estimated 500,000 people in England and Wales infected with the hepatitis C virus (HCV) and serves as yet another source of encouragement to seek treatment for the estimated 5 million infected people throughout Europe. Chronic hepatitis C is a leading cause of chronic liver disease in Europe and one of the most common reasons for liver transplant.

In its Final Appraisal Determination, NICE recognized factors that affect the efficacy of treatment for hepatitis C, including patient body weight.(3) The guidance states, "People who weigh more than the average have a lower response rate to treatment than those who weigh less than the average when the doses of interferon alfa (and ribavirin for combination therapy) are fixed."(4)

According to data included in the PegIntron EU labeling, which was reviewed by NICE, the overall SVR for PegIntron and Rebetol combination therapy adjusted to patient body weight was 61%.(5) For genotype 1 patients, the SVR for weight-based PegIntron and Rebetol was 48%(6). For genotypes 2/3 patients, the SVR was 88%.(7)

"The NICE guidelines are important in the UK and have an impact throughout Europe, where the Institute is recognized for its role in providing treatment guidance to patients and their doctors, said John Dillon, M.D., F.R.C.P. consultant hepatologist. "Treatments such as PegIntron and Rebetol have demonstrated increased efficacy compared with standard interferon alfa combination therapy as well as improved convenience for patients with hepatitis C, and should be more widely used."

In its guidance, NICE also noted that peginterferon and ribavirin combination therapy is a cost-effective intervention compared with treatment with standard interferon alfa combination therapy.(8)

About NICE
The National Institute for Clinical Excellence was set up in 1999 as a Special Health Authority for England and Wales. It is part of the National Health Service (NHS), and its role is to provide patients, health professionals and the public with authoritative, robust and reliable guidance on current "best practice." NICE covers individual health technologies, including medicines, medical devices, diagnostic techniques and procedures, and the clinical management of specific conditions.

About PegIntron and Rebetol Combination Therapy
PegIntron and Rebetol combination therapy for chronic hepatitis C was approved in the European Union (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 the only peginterferon approved for dosing according to patient body weight. It 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., USA. PegIntron, recombinant interferon alfa-2b linked to a 12,000 dalton polyethylene glycol (PEG) molecule, is a once-weekly therapy 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 Valeant Pharmaceuticals International (NYSE: VRX), formerly ICN Pharmaceuticals Inc., of Costa Mesa, Calif., USA.

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.

REFERENCES:
All referenced sections originated from the following document:

NATIONAL INSTITUTE FOR CLINICAL EXCELLENCE FINAL APPRAISAL DETERMINATION:
INTERFERON ALFA (PEGYLATED AND NON-PEGYLATED) AND RIBAVIRIN FOR THE
TREATMENT OF CHRONIC HEPATITIS C

(1) Page 4, Section 1.1: "Combination therapy with peginterferon alfa
and ribavirin is recommended within its licensed indications for the
treatment of people aged 18 years and older with moderate to severe
chronic hepatitis C ... "

(2) Page 21, Section 4.3.2: "The Committee considered that
peginterferon alfa combination therapy was both clinically and cost
effective compared with interferon alfa combination therapy."

(3) Pages 9-10, Section 2.21: "The following factors affect the
efficacy of treatment: Genotype of the virus, high viral load, age,
the period between infection and treatment and weight."

(4) Page 10, Section 2.21: "People who weigh more than the average have
a lower response rate to treatment than those who weigh less than
the average when the doses of interferon alfa (and ribavirin for
combination therapy) are fixed."

(5) Page 13, Section 4.1.2.1: "In this arm of the study, all patients
received 800 mg of ribavirin with 1.5 mg per kg body weight of
peginterferon alfa-2b. The effect of ribavirin dose according to
body weight was analysed in a subset of 188 of these patients. In
this subpopulation, the SVR for peginterferon alfa 2-b in
combination was 61% versus 47% for interferon alfa-2b in combination
(95% CI on the difference of 14 percentage points is 5 to 22
percentage points)."

(6) Pages 14, Section 4.1.2.3: "For G1 ... when peginterferon alfa-2b
combination therapy and interferon alfa-2b combination therapy were
compared, the SVR values were 42% and 33%, respectively, on an
intention-to-treat basis. On a weight-based ribavirin dosage, they
were 48% and 34% respectively."

(7) Page 14, Section 4.1.2.3: "For G2/3 ... when the peginterferon
alfa-2b and interferon alfa 2b combination therapies were compared,
the SVR values were 82% and 79%, respectively, on an intention-to-
treat basis. On a weight-based ribavirin dosage, they were 88% and
80%, respectively."

(8) Page 18, Section 4.2.1.1: "The Assessment Report shows that
peginterferon alfa combination therapy is a very cost effective
intervention compared with interferon alfa combination therapy."

Web site: http://www.schering-plough.com

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