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Failed Rebetron, should I wait for Pegasys; what about RBV unbundling?

Question from L. in New Mexico:

First, let me thank you for this much needed site! Thank You!

A little background on myself: I am 39 yr old female, diagnosed one year ago, 1a, had this for 22 years now, and have a viral load of over 1million. I am Stage 3, grade 2 from the liver biopsy. I just finished 6 months on Rebetron. I did have about a third reduction in viral load at 12 weeks, then at 24 weeks it was the same, so we decided to stop.

What are your thoughts on starting the Scherring peg w/ribaviran? I feel this is basically the same as the old interferon, just longer lasting and don't feel it will work for me. I am thinking I should wait for Roche's? Also, once the FDA unbundles the ribaviran (September?), can the ribaviran be prescribed with other interferons or only Scherrings? I heard that it will be approved by the FDA to be used only with Scherrings new peg.

Thanks again,
L.

There are three answers to your question, from Dr Ching, Dr Rodriguez and Jules Levin:

Dr. Chung writes--

L.
The data for rebetron nonresponders being treated with peg interferon + ribavirin are not yet available. However, given the liver biopsy result, I think you should move forward with PEGinterferon + ribavirin. The multicenter data show that both combinations have equivalent sustained response rates. we do not know what the FDA will do, but i would treat with combination when it becomes available. If you do not tolerate it, you can try to switch to the other PEG interferon + ribavirin. RC

Dr. Rodriguez writes--

Nobody can know for sure when RBV is going to be available. I have used compounded RBV and I think it works the same. Pegylated interferons are different drugs, especially Pegasys which is a much larger molecule than PegIntron.There is not much data in non responders, (from Jules Levin: but the little data there is is encouraging and suggests that Rebetron non-responders can respond to both Pegylated interferons in combination with ribavirin).

There is a strong suggestion that Pegasys will be a better choice for genotype 1 and cirrhotics. (from Jules: the problem is that it appears that Pegasys won't be approved until January, perhaps at the earliest. Can you wait? Even if it's approved in January what if ribavirin is not unbundled by the FDA. As suggested you can consider getting compunded ribavirin. There is a mail order pharmacy in Florida as well as Fishers Pharmacy in Pittsburgh that makes it available). MR


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