New News and use for other post's

[Tony-z]

Docs Promote Longer-Term PEG-Intron Therapy for Resistant Patients
  
by John C. Martin
Article Date: 11-10-04

Taking therapy for a longer period of time than you expected might not be appealing. But patients who are found to be resistant to hepatitis C (HCV) treatment might find relief in a longer-term schedule using the pegylated or longer-lasting, interferon known as peginterferon alfa-2b (PEG-Intron/Schering-Plough). Doctors who published promising findings in a clinical trial at a medical conference in late October say this longer treatment plan may help prevent complications of liver cirrhosis in these patients.1

A 'Greater Risk' for Liver Disease
Conducted at 40 locations around the United States, the study is the first to demonstrate that the progression of hepatitis C can be prevented or delayed through long-term maintenance therapy with peginterferon alfa-2b. "When the hepatitis C virus doesn't respond, as occurs in about half of all patients who are treated, those patients who already have cirrhosis are at a far greater risk for developing liver cancer or suffering liver failure," Afdhal explained. In fact, hepatitis C is the leading cause of liver transplants in the United States for that very reason. So far, no treatment has been available for therapy-resistant HCV patients.

Treatment resistance is not uncommon among hepatitis C patients. It is one of the reasons that approximately one-fifth of those with genotypes 2 and 3 HCV and about half of those with genotype 1 fail to eradicate the virus after taking pegylated interferon in combination with ribavirin,2 considered the therapy standard nowadays.

A 'New Paradigm'
Afdhal hopes his study findings will help change that. He and his team tested the effectiveness of low-dose peginterferon alfa-2b, with colchicine, an anti-inflammatory, anti-fibrotic medication historically used as a therapy for gout, but which has hinted in previous studies that it might help prevent further liver cirrhosis development.3 Afdhal says he and his colleagues found that peginterferon alfa-2b reduced the risk that patients will reach a clinical endpoint with their disease; that is, variceal bleeding, liver failure, a liver transplant, hepatocellular carcinoma or death by 50 percent.

The findings are early results of the ongoing trial. "This is a new treatment paradigm, showing for the first time that we can prevent the serious complications of liver disease," said Afdhal. "The results found that when used in this way, the therapy reduced by half the risk of the virus advancing to cause liver damage."

For the study, 550 people with chronic hepatitis C and advanced fibrosis were recruited. Each of them had previously been treated unsuccessfully with an interferon-based treatment. Of those, 59 reached a previously described endpoint. But while 39 of the patients taking colchicine reached this endpoint, 20 of those in the group taking peginterferon alfa-2b did so. Patients were selected at random to receive 0.5 micrograms (mcg) of peginterferon alfa-2b per kilogram of body weight once per week, which is considered a low dose. The minimum recommended dose, based on body weight, is approximately 1.5 mcg per kilogram of body weight. The rest received 0.6 milligrams (mg) of colchicine orally twice per day.

Well Tolerated Doses
Afdhal pointed out that the low dose of peginterferon alfa-2b used in the study, which is one-third the dose used in standard combination therapy with ribavirin, was well tolerated by patients, and prevented the need to include ribavirin, which often causes anemia as a side effect.

"Patient adherence to their prescribed regimen is critical to success in hepatitis treatment, and is an important consideration for long-term maintenance therapy," he said.

[Tony-z]

BobK


Thanks for clarifying . The study I cut and pasted was sponsored by Schering-Plough. Peg-Intron.


              TonyZ

[BobK]

Peg 2A = pegasys
Peg 2B = peg intron

The study we are discussing is the CO-PILOT study with peg 2b and with the dosing arms including either colchocine or placebo.  The authors are not comparing peginterferon to colchocine but rather the combination of peginterferon + colchocine to the otehr treatment arm peginterferon + placebo.

From  my understanding the results have been dramatic enough that the trial is being halted early in order to make all the results public so that this maintenence therapy can be initiated in the general population of HCV patients.

regards,
BobK

[cuteus]

you have to read the full study and learn who is sponsoring it. whichever drug co sposnsors it, will be the main reason for using one over the other,  noticed that it is compared to colchine, not peg 2a.

[stc1993]

What I have been reading it seems like it's always peginterferon alfa-2b. The one I'm on is peginterferon alfa-2a.  Does anyone know the difference?

Monte

[scruffy]

Good info-thanks Tony.

[Tony-z]

Hepatitis C is believed to be one of the most prevalent strains of hepatitis around the globe. Worldwide, more than one million new cases of HCV are reported each year. In the United States, nearly 4 million people are believed to be infected, and it's estimated that 30,000 new acute infections occur in this country annually. Without effective treatment, that number could triple in the next 1 or 2 decades, experts predict.4

             More Hope!

                         TonyZ