Telaprevir - 18 yes 0 no

[frijole]

Whew - that was dicey.  One of the FDA advisory committee panelists was agressive in his pursuit of issues with the rash, but in the long run, he and everyone else on the panel voted to approve.

Now it goes to the FDA.  Approval date (or not) is May 23. Some people are betting that the FDA will announce both BOC and TEL on May 7 - the date for Boceprevir approval (or not)

[coeric]

mremeet - definitely a hero's journey if i ever heard one.  i've seen folks bouncing off walls on big doses of prednisone, but not on top of three hcv tx drugs!  thank you for coming back and sharing.  i recall a story about someone tasting the tela pill in order to insure they were getting the real thing - wondering if that was you?

andiamo1 - part of my interest in a lead-in is sort of like sticking my toe in the pool to check the water temp before i jump in.  let's see how this naive responds to interferon/riba before jumping into the deep end with the PI.  i appreciate your advice to jump into the deep end and get on with it.  certainly enduring any more time with interferon and riba on board does not make much sense.   i know that in order to replicate the trials i would need to stick to the 24 weeks of 48 weeks after adding the PI.  

willing -  interesting that only 38% on the placebo went to SVR in the sprint2 trials.  makes me wonder if these trials can be compared strictly on the numbers.  your point to concentrate on confidence intervals is well taken.  thanks so much for the links.  i will definitely take a closer look at the briefing docs.

thanks everyone

eric

[Andiamo1]

Great to see you back.  I am here intermittently, but this time got involved in some heated discussions about Vertex.  I do agree with what you said.

[mremeet]

Thanks for the kind words nygirl and mike. I deeply depended on this place during my treatment and everyone here helped me learn and get through my treatment. That's what this place is all about, and thank god it was here to help me through. And it's not always easy for everyone to get along while being on these drugs and going through these side effects. Basically I entered into a period of temporary insanity and I got so wrapped up into my own world and my desperate attempt to kill this farking virus once and for all. Anyway, apologies for any harsh words said in the past. The whole experience seems like a long ago dark dream already. I hope more and more people get treated successfully and come out on the other side like we all did.

Andiamo when you say "The standard thinking is that the combo of interferon and ribaviron will exacerbate any skin problems." I believe this is generally true, except I would change the "will" in your statement to a "may." Of course it is a general statement and it will not apply to everyone, but generally I believe it is true. On the upside, I think if Tx does exacerbate an existing condition during treatment, it usually will not leave a lasting effect after treatment ends. One thing's for sure, IFN, Ribavirin and Telaprevir are all powerful drugs and they can make your body do bad things, especially in regards to your skin.

And Javi you ask about the solumedrol. I'm not a doctor, but to my knowledge solumedrol is a drug that is only used in rather extreme circumstances when no other choice exists. Like in the situation I was in or if memory serves Mike Simon also received it to deal with organ rejection issues pertaining to his liver transplant (correct me if I'm wrong mike). As previously stated, prednisone and solumedrol are immunosuppressants. Immunosuppressants, as its name implies, suppresses your immune system and if not used judiciously they can make you vulnerable to infections and other serious health problems. And you also do not want to take them during treatment because the whole point of treatment is to boost your immune system into overdrive for the purpose of driving the virus from your body once and for all. Taking solumedrol and prednisone will counteract the immune system boosting effects of IFN and possibly ribavirin, which are essential for achieving SVR.  Good luck with your treatment.

[Andiamo1]

I can only describe my own experience.  I never had psoriasis before I treated with interferon.  After I completed my next to last treatment, I developed a mild case of it.  When I started my last treatment, it disappeared!  After I stopped, it came back once again.

My conclusion from this is that no one has a clue what psoriasis and interferon have in common.  Some people thought it might be a predictor of a Telaprevir rash, but I didn't get the rash.  The standard thinking is that the combo of interferon and ribaviron will exacerbate any skin problems.  That was not my experience.

[Javi1962]

wow great story!!! I am scared for treatment because I have bad psoraisis and not sure how that is going to do on treatment, due to the immune boost I will recieve may cause psoraisis to flare and go crazy! anyone experience this? and I wonder if solu-medroli will help with this? I know prednisone is a drug they prescribe for psoraisis

[mikesimon]

That's a great story.
You fought and won one very hard battle.
Solu-Medroll is one serious drug - yes indeed.

Be well,
Mike