jmjm treatment duration

[orleans]

Hey, Do you have the info on shortened treatment time in a form I could present to my Dr. (ie. abstracts of something) I mentioned the possibility of 24 weeks if I were to rvr and he didn't much care for that idea. thanks, jerry

[Mikkimoe]

Yippi - I think I found it!  This was in 2004...but good results.
Is this the one you were refering to?

Etanercept as an adjuvant to interferon and ribavirin in treatment-naive patients with chronic hepatitis C virus infection: a phase 2 randomized, double-blind, placebo-controlled study☆

Nizar N. Zein, for the Etanercept Study Group†


Received 15 April 2004; received in revised form 12 October 2004; accepted 12 November 2004. published online 29 November 2004.

Background/Aims
Current therapies for patients with chronic hepatitis C virus (HCV) do not achieve sustained viral clearance in most patients, and are associated with severe toxic effects. Our aim was to investigate the efficacy and safety of etanercept as adjuvant to interferon and ribavirin in treatment-naive patients with HCV.

Methods
Double-blind, randomized, placebo controlled trial. Fifty patients with chronic HCV were randomly assigned to receive interferon alfa-2b and ribavirin with either etanercept or placebo for 24 weeks. The main outcome measure was the absence of HCV RNA at 24 weeks, the on treatment response at the end of the etanercept randomization period.

Results
At 24 weeks, HCV RNA was absent in 63% (12/19) etanercept patients compared to 32% (8/25) placebo patients (P=0.04). In addition, patients receiving etanercept had lower frequency of most adverse events categories compared to placebo.

Conclusions
Etanercept given for 24 weeks as adjuvant therapy to interferon and ribavirin significantly improved virologic response at the end of the etanercept randomization period among patients with HCV, and was associated with decreased incidence of most adverse effects associated with interferon and ribavirin.

[Mikkimoe]

Your're only stage 1 and remember the idea is to kill the virus, not the patient. This concept sometimes gets lost when we get into "warrior" mode on treatment.
>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>
Love it....thanks for the wake up call. Odds are on my side either way, I'll turn my panic button off for a while. Actually I think the zoloft did that for me. It's amazing how calm I have become in the last 2 weeks.

One last thing on the Enbrel/Peg relastionship - It was my impression that the Peg increased or stimulated the immune system to fight the virus whereas the Enbrel (TNF blocker) suppresses the immune system so it stops attacking the joints. But you mentioned that it may enhance SVR? I have to do some searching - it would be very interesting. It seems most folks with SRA have it post tx not pre so not much out there study wise - another **** shoot.

[jmjm530]

I'm not saying pay for every article, but if you're going to base an important tx decision in part on a study, often best to see full-text and not just the abstract -- whether you pay, get it in the library, etc, etc.

I was suggested Enbrel early-on in tx because of interferon-induced psoriasis.  I declined because I wanted to try light treatments instead, plus I already had enough of drugs and injections even at that early point in treatment. My research at the time showed that Enbrel at one time was trialed with Peg to enhance SVR, but don't believe that trial went anywhere. Still you could "Google" it. My tx doc said it was OK to take. It does appear to be very liver friendly.

Later in tx I asked the same question to a consulting liver specialist. His take was that mixing two immunosuppresives -- Enbrel and Peg -- could have unknown results. His recommendation therefore was not to use Enbrel unless I was forced to by the psoriasis.

I think that suggestion is most pertinent to your case. If stopping the Enbrel means "extreme pain and immobilization" then don't stop it.. Your're only stage 1 and remember the idea is to kill the virus, not the patient. This concept sometimes gets lost when we get into "warrior" mode on treatment. So, personally, I'd take the Enbrel, and take your chances. Maybe it will help, maybe hurt, maybe neutral in terms of SVR. I doubt anyone can really give you a definitive answer.  I really know nothing about Prednisone and how it might combine with both Enbrel and treatment. I'm sure others here have at least more experience with Prednisone.

-- Jim

[Mikkimoe]

Thanks for the great information...I'm glad I like to research, although I'm not real fond of paying for information that is probably public info somewhere. I had been to several of the sites you mentioned above but not others...I'll go exploring.

I have another question for you if you are OK with that...I have it posted on a dead thread somewhere. This is a tough one...
Here's my dilemma.... I am taking Enbrel for my severe RA (a TNF blocker) and prednisone. From what I understand they are immune suppressives. Since the HCV tx is an immune stimulant will they work together without contraindications? There have been no studies on this that I am aware of. My UCI doc believes it may be OK to do them both at once. I don't want to risk it not working. If I stop the enbrel I will be in extreme pain and immobile but will do it if I have a better chance to SVR. I can't stop the prednisone - been on it too many years.  Maybe I could taper the Enbrel. Instead of the 2 injections each week I could take 1 per week...I see Dr. Poordad at Cedar Sinai next week and will get his take on it but thought I'd gather as much info as possible before hand. What is your take on this?

[jmjm530]

Just to clarify a little. The implication from the liver specialist was that an additional 12 weeks at a tapered dose would be more effective than stopping treatment without the dose.

However, my read was not that it was the taper per say, that was beneficial, but just that there was more time on the inteferon.

BTW his actual suggestion was to stop at week 48 given I was RVR. The taper was more in response to some of the hypotheticals I presented to him in terms of treating beyond 48 weeks.

[jmjm530]

I'm sort of neutral as to tapering. I didn't do it when presented to me as an option way back then. Reason being I was RVR, figured I had an excellent shot at SVR, so why rock the boat with something unproven that in some strange and unexpected way might backfire? That said, maybe if I was a slow responder, I might have reasoned why not try something different. Also, looking back, I did have a very rough time of it coming off the Peg, and maybe tapering would have made a difference. Or maybe not.

But as to your specific question, I would think the most protective (of SVR) way to taper would be to taper at the end of the planned tx as opposed to somehow figuring in the taper as part of the treatment like you seem to be suggesting.

Actually, one very well known liver specialist did suggest that instead of extending to 60 weeks from 48 (that was a plan at one point in time) that I do some sort of taper (half dose, then quarter dose) for the additional 12 weeks. However, when I questioned him much later whether he thought I would have a better chance of SVR with 60 weeks at full-dose or 48 at full and 12 at a taper dose -- he said a better chance of SVR with 60 weeks at full dose.

Is he correct? Are others here correct when they hypothesize that somehow a taper will help prevent an immune "dead spot" at EOT where relapse may occur? These are all just theories as I see it. No one knows. Anyway, I ended up doing 54 weeks at full dose and stopped all at once. No taper. YMMV.

-- Jim