Good article on PI drug treatment regimens

Found this article also that I thought might be of general interest. I appologize if this information has already been posted and/or discussed. It portrays a different picture than when the drugs were finishing trials. We new there would be many problems and hurdles to overcome once they were approved. From my standpoint, the difficulties in treating liver transplant patients was a concern. It turns out to be more of a problem of just the problem that it wasn't studied in TP patients. There is a serious problem of maintaining therapeutic levels om immune suppression in patients taking Prograf.

http://www.idse.net//ViewArticle.aspx?ses=ogst&d=Hepatitis&d_id=213&i=ISSUE%3a+August+2011&i_id=753&a_id=18862

[HectorSF]

Maybe my HE is worse than I thought. It is a good article but I don't see anything about post transplant patients. I'm I missing something?...

There will be lots of discussions about the new DAAs at the next AASLD meeting here in San Francisco in Novemeber.

AASLD Monday, November 7
Developed by the Hepatitis C Special Interest Group
Moderators: Gary L. Davis, MD, Raymond Chung, MD and John Ward, MD

"This program is designed to educate the provider on newly approved and anticipated therapies for HCV and how these should be integrated into clinical practice. As these agents represent new classes of drugs in this field, they present new challenges for treatment monitoring, side effect management, drug resistance emergence, and personalizing therapy. This program will lay a basic mechanistic foundation upon which to build clinical management guidelines, but the emphasis will be on the latter. Important emerging issues on public policy and methods of implementation will be discussed.

Goals and Objectives:
* Know how direct acting antiviral agents (DAA) work and strategies for therapeutic development;
* Understand which DAA are currently available or likely to be available in the near future;
* Have a clear understanding of how to use DAA in the clinic and tailor treatment to specific patients;
* Follow recent developments in public policy and health care delivery as related to hepatitis C."
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Tuesday, November 8
Hepatitis Debrief
Gregory T. Everson, MD
"The first two direct-acting antiviral medications for hepatitis C were approved earlier this year and several new ones are currently in clinical development. We anticipate the rate of new drug development to increase rapidly in the next 12 – 18 months, possibly involving multiple drugs with the goal of obtaining viral clearance and interferon free regimens. This session is designed to rapidly synthesize and summarize the new data presented at The Liver Meeting® in such a way that the information will be meaningful and useful on a real-time basis."
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Another good development will be AASLD will release a new practice guideline soon that will cover the new DAAs treatments for HCV.


Thanks.
Hector

[IAmTheWalrus]

Thanks, Hector. About hslfway down in the article is a short statement including the fact that the new drugs are not approved for post transplant patients (caps are mine):

"In the meantime, the AASLD has issued a summary statement (http://publish.aasld.org/aboutus/publicpolicy/Pages/newhepctreatments.aspx) reminding physicians that neither drug can be used as a single agent but only in combination with pegylated interferon and ribavirin. Used alone, these drugs are not effective and can cause antiviral-resistant mutants that may be more difficult to treat. The AASLD also reminds physicians that the new therapies are only approved for use in patients with HCV genotype 1 and are NOT APPROVED FOR USE IN POST-TRANSPLANT PATIENTS WITH RECURRENT HCV, patients coinfected with HIV/HCV or children."

Of course, off-label treatment is possible, but based on what my doctor is saying, TP patients should wait until some further study is done. I believe there is a trial going on in Colorado right now assesing this problem. According to my doctor, some TP patients are taking the minimum dose of Prograf and are still getting toxic (to the kidneys) levels of tacrolimus in the blood.

They do not want to treat me yet, and I am not sure I would push them. I think waiting a while in my case is the right thing to do. Waiting for nucleoside polymerase inhibitors to be approved might even be advisable for me, There are still a lot of issues up in the air for some patients. I think that is the gist of the article.

I know the AASLD is addressing this issue and I look forward to the information that will come out here in a few months.

[IAmTheWalrus]

What is "HE"?

[yodennis]

HE = hepatic encephalopathy. And if this is Hector's presentation with HE, i.e., a cognitive deficit, I can't imagine how Olympian an intellect he must be when lucid ;)

[IAmTheWalrus]

Thank you, Dennis?

HE ... that's like a musician going deaf, or a baseball pitcher with a rotator cuff tear. Really hits where it hurts the most, I guess.

Don't worry, Hector. I see your comment has fewer typos than mine. :-)

Brent

[fingrsxd]

Hello...I thought you might be interested in the all oral HCV study being conducted by Pharmacette. I'm in my 11week and was UND at about my 4th week. No side effects. The 2 study drugs are PSI and BMS. Lots of excitement for these drugs because everyone participating is UND. I have posted info in my journals on MedHelp. If your interested in reading these go to medhelp and do a search on fingrsxd. Good luck..

[Dee1956]

Thank is wonderful news!  Congratulations
Dee