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Ribavirin Oral Solution Now Available for Treating Pediatric Patients With Hepatitis C

KENILWORTH, N.J., January 20, 2004 /PRNewswire-FirstCall/ -- Schering-Plough Corporation , the leading innovator of interferon-based therapies for chronic hepatitis C, today announced the launch of REBETOL (ribavirin, USP) Oral Solution for use in combination with INTRON A (interferon alfa- 2b, recombinant) Injection for treating pediatric chronic hepatitis C. Previously, there was no therapy approved for children with hepatitis C. An estimated four million people in the United States are infected with the hepatitis C virus, and approximately 160,000 of these are children.

"Now for the first time, children with hepatitis C have a treatment option that has been proven effective and, importantly, the doses may be tailored to a child's individual body weight and size," said Maureen Jonas, M.D., associate professor of pediatrics at Harvard Medical School and associate in gastroenterology at Children's Hospital Boston. "Combination therapy is now available for children as young as three years of age, with the REBETOL dosing made easier by the availability of the oral solution. This is an important step forward in treating pediatric hepatitis C, a disease that can cause a myriad of medical complications and eventually lead to serious liver damage."

In a clinical study of previously untreated pediatric patients, INTRON A and REBETOL combination therapy achieved a sustained virologic response (SVR) in 46 percent of patients overall, with an SVR rate of 36 percent in genotype 1 patients and 81 percent in genotype 2 or 3 patients.

In the pediatric population, the combination of INTRON A and REBETOL is indicated for the treatment of chronic hepatitis C in patients three years of age and older with compensated liver disease previously untreated with alpha interferon. For these patients, individualized combination therapy is recommended, with REBETOL dosed according to patient body weight (15 mg/kg daily in divided a.m. and p.m. doses) and INTRON A dosed according to patient size measured in body surface area (3 MIU/m2 three times weekly). The recommended duration of therapy is 24 weeks for pediatric patients with genotype 2 or 3 virus. The recommended duration of therapy for pediatric patients with genotype 1 virus is 48 weeks. Treatment discontinuation should be considered for any patient who has not achieved a virologic response after 24 weeks of treatment.

The New Drug Application (NDA) for REBETOL for pediatric use was reviewed by the U.S. Food and Drug Administration (FDA) on a priority basis. Priority review status is granted to drugs that, if approved, would address unmet medical needs and represent significant advances over existing treatments. Schering-Plough also noted that FDA has granted orphan-drug designation to REBETOL for the treatment of chronic hepatitis C in pediatric patients.

REBETOL Oral Solution represents a new formulation of ribavirin, USP, and was developed specifically to meet the needs of pediatric patients. It has a pleasant bubble gum flavor. REBETOL Capsules also are now approved for use in combination therapy with INTRON A for the treatment of chronic hepatitis C in pediatric patients. REBETOL Capsules were previously approved for use in combination therapy with INTRON A for the treatment of chronic hepatitis C in patients 18 years of age and older with compensated liver disease previously untreated with alpha interferon or who have relapsed following alpha interferon therapy. REBETOL Capsules also are indicated in combination with PEG-INTRON(R) (peginterferon alfa-2b) Powder for Injection for the treatment of chronic hepatitis C in patients with compensated liver disease who have not been previously treated with interferon and are at least 18 years of age.

Since the introduction of PEG-INTRON and REBETOL combination therapy in 2001, more than 300,000 hepatitis C patients worldwide have received this treatment, including more than 200,000 U.S. patients.

Approximately 70 percent of patients infected with the hepatitis C virus (HCV) go on to develop chronic liver disease, according to the Centers for Disease Control and Prevention (CDC). Hepatitis C infection contributes to the deaths of an estimated 8,000 to 10,000 Americans each year and this toll is expected to triple by the year 2010, according to the CDC. The CDC has reported that HCV-associated end-stage liver disease is the most frequent indication for liver transplantation among adults. It is predicted that direct U.S. medical costs to treat HCV-related disease will exceed $13 billion for the years 2010 through 2019, according to a study published in the American Journal of Public Health.

Source: Schering-Plough Corp.

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